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NBS SPECIAL PUBLICATION 632

U.S. DEPARTMENT OF COM M ERCE/National Bureau of Standards

Laboratory Accreditation:

Future Directions in the United States
NATIONAL BUREAU OF STANDARDS

The National Bureau of Standards' was established by an act of Congress on March 3, 1901. The Bureau's overall goal is to strengthen and advance the Nation's science and technology

and facilitate their effective application for public benefit. To this end, the Bureau conducts

research and provides: (1) a basis for the Nation's physical measurement system, (2) scientific and technological services for industry and government, (3) a technical basis for equity in trade, and (4) technical services to promote public safety. The Bureau's technical work is per- formed by the National Measurement Laboratory, the National Engineering Laboratory, and

the Institute for Computer Sciences and Technology.

THE NATIONAL MEASUREMENT LABORATORY provides the national system of

physical and chemical and materials measurement; coordinates the system with measurement

systems of other nations and furnishes essential services leading to accurate and uniform

physical and chemical measurement throughout the Nation's scientific community, industry,

and commerce; conducts materials research leading to improved methods of measurement,

standards, and data on the properties of materials needed by industry, commerce, educational

institutions, and Government; provides advisory and research services to other Government

agencies; develops, produces, and distributes Standard Reference Materials; and provides

calibration services. The Laboratory consists of the following centers:

Absolute Physical Quantities2 — Radiation Research — Thermodynamics and

Molecular Science — Analytical Chemistry — Materials Science. THE NATIONAL ENGINEERING LABORATORY provides technology and technical ser- vices to the public and private sectors to address national needs and to solve national problems; conducts research in engineering and applied science in support of these efforts; builds and maintains competence in the necessary disciplines required to carry out this research and technical service; develops engineering data and measurement capabilities;

provides engineering measurement traceability services; develops test methods and proposes

engineering standards and code changes; develops and proposes new engineering practices;

and develops and improves mechanisms to transfer results of its research to the ultimate user. The Laboratory consists of the following centers:

Applied Mathematics — Electronics and Electrical Engineering2 — Mechanical

Engineering and Process Technology 2 — Building Technology — Fire Research —

Consumer Product Technology — Field Methods.

THE INSTITUTE FOR COMPUTER SCIENCES AND TECHNOLOGY conducts

research and provides scientific and technical services to aid Federal agencies in the selection, acquisition, application, and use of computer technology to improve effectiveness and

economy in Government operations in accordance with Public Law 89-306 (40 U.S.C. 759), relevant Executive Orders, and other directives; carries out this mission by managing the Federal Information Processing Standards Program, developing Federal ADP standards

guidelines, and managing Federal participation in ADP voluntary standardization activities; provides scientific and technological advisory services and assistance to Federal agencies; and

provides the technical foundation for computer-related policies of the Federal Government.

The Institute consists of the following centers:

Programming Science and Technology — Computer Systems Engineering.

'Headquarters and Laboratories at Gaithersburg, MD, unless otherwise noted; mailing address Washington, DC 20234.

2 Some divisions within the center are located at Boulder, CO 80303.
Laboratory Accreditation:

Future Directions in the United States

Report on the Proceedings of the NBS Workshop

on Laboratory Accreditation held at the

National Bureau of Standards, Gaithersburg, MD

November 16-17, 1981

John W. Locke, Editor

Office of Product Standards Policy

National Bureau of Standards

Washington, DC 20234

U.S. DEPARTMENT OF COMMERCE, Malcolm Baldrige, Secretary

NATIONAL BUREAU OF STANDARDS, Ernest Ambler, Director

Issued March 1982
Library of Congress Catalog Card Number: 82-600525

National Bureau of Standards Special Publication 632

Nat. Bur. Stand. (U.S.), Spec. Publ. 632, 172 pages (Mar. 1982) CODEN: XNBSAV

U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 1982

For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402

Price $6.50

(Add 25 percent for other than U.S. mailing)
FOREWORD

The National Voluntary Laboratory Accreditation Program (NVLAP) of

the U.S. Department of Commerce (DOC) was initiated as a result of re- quests from the private sector over 10 years ago. As a voluntary program,

the fundamental operating policy of NVLAP is to publish requests for

programs or procedural changes in the Federal Register for comment, to hold public hearings or workshops, and to assess and respond to all comments from the public and private sectors. The Department's programmatic decisions are developed by consensus among interested parties within

the framework of Federal Government goals and objectives.

When representatives of the American Council of Independent Laboratories (ACIL) suggested that NVLAP significantly change its procedures from the accreditation of laboratories to the accreditation of sys- tems for accrediting laboratories, they were urged to present their

suggestions in writing. ACIL was joined in this request by the American

Association for Laboratory Accreditation (AALA). Letters from both of

these organizations were published in the Federal Register (46 FR 40785,

dated August 12, 1981). Representatives from these organizations and

other interested parties were invited to assist in preparing the agenda for a workshop at which the key issues could be explored.

Written comments were requested both before and after the workshop.

The workshop program, as stated in the brochure inviting all interested

persons to attend, was developed around the following key issues:

•Whether the DOC should abandon its present role and substitute in

its place a program to accredit organizations which, in turn, would

accredit private sector testing laboratories.

•What, if any, additional measures should be taken to assure that an

effective U.S. presence remains in international laboratory accreditation activities, including bilateral arrangements.

• What action, if any, can be taken by the private sector and/or the Government to reduce the proliferation of inspections and paperwork arising

from duplicative accreditation activities within the United States.

These proceedings document all relevant communications, in the spirit

of openness which has been fundamental to NVLAP operations. Summaries of the proceedings and comments after the proceedings are presented

in Parts 1 and 2. The formal papers are presented in Part 3, formal comments at the workshop in Part 4, and all letters received in Part 5. Opinions expressed by authors who are not employees of NBS do not

necessarily reflect the opinion of NBS and the content and quality of their

papers are the responsibility of those authors. Trade names and trademarks

shown in this volume are in no sense an endorsement or recommendation.

John W. Locke

Proceedings Editor

March 1, 1982

iii

EXECUTIVE SUMMARY

In his keynote address at the start of the workshop, Dr. Ernest Ambler,

Director of the National Bureau of Standards (NBS), said, "I hope we

can formulate a rational, responsive set of proposals that serve the nation

in this field of laboratory accreditation." Further, he indicated that these

proposals must come within the framework of NBS policy and funding

guidelines. The findings in this Executive Summary evolved from a con- sensus* of participants at the workshop and all other interested parties

who responded in writing.

Findings:

1 . There is a needfor laboratory accreditation. The growth in the number

of accreditation systems and the statements presented by a majority

support this view.

2. NVLAP should not abandon its present role in accrediting laboratories. There was little support for the AALA proposal as presented,

although about one-fourth of opinions suggest that the accreditation of

laboratories should be a private sector function.

3. Coordination of accreditation activities at the national level is desirable. The AALA proposal itself suggests that NVLAP perform a

portion of this role, and although there is no consensus on the AALA

proposal, there is a consensus on the need for some form of national

coordination.

4. NVLAP involvement in international laboratory accreditation

activities should continue. This involvement should include more

emphasis on coordination with public sector and private sector laboratory accreditation systems in the United States.

5. There is no single, best way to accredit laboratories. Laboratory users and certifiers prefer accreditation based on the competence of laboratories in testing specific products. Laboratories organized to do only one type of testing (such as concrete) appreciate the rigor of an ac- creditation system designed for testing that product. Multipurpose

laboratories cannot efficiently use accreditation systems which

focus only on specific, narrow areas of testing. A national accreditation system should be able to accommodate the needs for both a nar- row and broad approach to accreditation.

6. Both national and international organizations demonstrate that

accrediting laboratory accreditation systems is feasible. The papers in

Session 4 describe major international accreditation and certification systems which recognize laboratories in other countries, based

on use of identical test methods and uniform laboratory assessment

procedures. Other agreements between national systems demonstrate that mutual acceptance of accrediting systems with some- what different operating procedures can be achieved.

"Consensus is defined as more than a simple majority but not necessarily unanimity of opinion of all interested

parties responding.

v

PROPOSAL FOR ACTION

Presentations and comments during the workshop and written comments

since the workshop do not warrant an immediate drastic change in the

current NVLAP operations. The consensus, as identified in the Executive Summary, does point to the need for more coordination among all interested parties. To accomplish this, the National Bureau of Standards

will support the following actions:

1 . Formation of a Quasipublic National Laboratory Accreditation Council

(NLAC). This council, initiated and managed by the private sector, should

have participation from government agencies, professional societies,

and certification systems which accredit laboratories. It might be

organized under the auspices of a national coordinating body, such as the American National Standards Institute or the National Research

Council of the National Academy of Sciences, or as an independent

body which could take the form of an association or conference. This

council would have the following objectives:

• Provide forums for written and oral exchange of information on all levels of accreditation in the United States;

• Develop criteria for comparing or evaluating laboratory accreditation systems;

• Encourage the recognition of laboratories among laboratory accreditation systems;

• Encourage use of existing laboratory accreditation systems where

new needs arise;

• Foster consolidations of existing laboratory accreditation systems; and,

• Develop a basis for reciprocal recognition of laboratories among national and international systems.

2. Revision of NVLAP Procedures and Improving NVLAP Operations.

NVLAP, over the next several years, should:

• Revise and simplify procedures, based upon the considerable operating

experience gained to date;

• Form an advisory committee to regularly review and comment on NVLAP operations;

• Encourage more active participation of the private sector in simplifying

the NVLAP procedures for assessing laboratories;

• Implement bilateral and multilateral agreements with other national

and international laboratory accreditation systems to recognize the

competence of each system's accredited laboratories;

• Promote the national and international recognition of U.S. accredited laboratories;

• Support the organization of the National Laboratory Accreditation

Council; and,

• Reassess periodically the relationship between NVLAP and the

private sector.

vii

Table of Contents

Page

Foreword iii Executive Summary v

Proposal for Action vii Table of Contents ix Part 1. Summary of Workshop Proceedings 1 Part 2. Summary of Post-Workshop Comments 19 Part 3. Formal Papers Prepared by Participants for the Workshop 21 Welcome Address: Ernest Ambler 22

Session 1 Meaning of Accreditation and Certification Baron Whitaker 24

History of Laboratory Accreditation in the United States Theodore R. Young 28

Status of Laboratory Accreditation in the United States Charles W. Hyer 36

Session 2

International Trade Implications of Laboratory Accreditation Donald S. Abelson 40

Session 3 Purpose of Laboratory Accreditation John W. Locke 43 The Need for a Practical Laboratory Accreditation Program from the Perspective of a Small Multi-Discipline Independent Laboratory

Earl H. Hess 46

Independent Laboratory with Many Separate Laboratory Locations

W. H. Levelius 52 Why Concrete Laboratory Accreditation—Why NVLAP

Richard D. Gaynor 54 Laboratory Accreditation as Viewed by a Manufacturing Concern

John A. Grant 57 Problems Confronting a U.S. Firm Exporting a Complex Product

Frank Walters 59 Laboratory Accreditation of Interest to the National Conference of States on Building Codes and Standards

Donald F. Pinkerton 61 Advantages to the Nuclear Regulatory Commission of Third-Party

Laboratory Accreditation Programs

Robert E. Alexander 63 The Consumer Interest in Laboratory Accreditation David A. Swankin 65

Session 4 Work of ASTM Committee E-36 on Criteria for Testing Laboratory

Evaluation and Accreditation Gerald A. Berman 68

Characteristics of Laboratory Accreditation Systems—The Product

Certification Program Point of View

Theodore P. Pritsker 70 General Guidelines for a Laboratory Accreditation System

John F. Magnotti, Jr 73 The IEC's Way of Evaluating Certifiers in Participating Countries

Howard C. Kontje 74 ILAC: A Means for Removing Technical Barriers to Trade by Recognizing Laboratory Accreditation Systems in Different Countries

Howard I. Forman 76 Implementation of Good Laboratory Practice: International Considerations Carl R. Morris 79

Recognition of Accrediting Agencies, State-of-the-Art Theodore R. Young 81 Session 5

Proposal to Transfer the Current NVLAP System into a System for Accrediting Private Accreditation Systems

Louis R. Rossi 92

ix
Part 4. Formal Statements Presented by Attendees at the Workshop 99

A Statement on Laboratory Accreditation by the National Institute of Building Sciences (NIBS)

Joseph O'Grady 100

Contribution to the Discussion P.G.Forrest 102

Position Statement W. D. Edsall 103 Comments on the AALA Proposal Pertaining to Laboratory

Accreditation

B. D. Barton 104

Position Statement

R. A. Woodall 105 An Opinion on Laboratory Accreditation Policy

Geoscience Ltd 106

Part 5. Letters Received Commenting on Papers and Other Aspects of the Workshop Proceedings (in the order received) 107

1. Chester, Robert L., Genstar Stone Products Company 108

2. Forman, Howard I., Consultant 109

3. Wright, Harold, The Tanner Companies 1 12

4. Hurley, William D., American Association of State Highway and

Transportation Officials 113

5. Sparrell, James K., Sparrell Engineering Research Corporation 114

6. Green, M.R., The American Society of Mechanical Engineers 115

7. Fargo, Harland E., Owens-Corning Fiberglas Corporation 116

8. Robbins, Joseph S., DSET Laboratories, Inc 117

9. Isaak, Merl, Testing Engineers, Inc 117

10. Carlson, Ronald O., Pacific Inspection and Research Laboratory, Inc 118

11. Hauser, Ray L., Hauser Laboratories 118

12. Cavanaugh, William J., Cavanaugh Tocci Associates, Inc 119

13. Oehme, Fredrick W., Comparative Toxicology Laboratories 120

14. Tyson, S.E., Carpenter Technology Corp., Carpenter Steel Division 121

15. Jackson, Jonathan, Commercial Testing Co., Inc 122

16. Cady, Sheldon H., Mineral Insulation Manufacturers Association 123

17. McCune, Lawrence, R.W. Sidley, Inc 124

18. Edsall, W. D., Allegheny Ludlum Steel Corp 125

19. Masland, Charles H., Ill, The Carpet and Rug Institute 126

20. Clark, R.T. Jr., Newport News Shipbuilding 128

21. Venzhe, Donald E., Danart, Inc 129

22. Slate, Chris G., Kelso Industries, Inc 130

23. Gilley, Harold W., American Concrete Institute 131

24. Cox, Geraldine V., Chemical Manufacturers Association 132

25. Brungraber, Robert J., Bucknell University 133

26. Schock, Harvey, Product Assurances Consulting 135

27. Frank, John H., Certified Testing Laboratories, Inc 137

28. Gmoser, Earl J., ETL Testing Laboratories, Inc 138

29. Herr, J.C., General Dynamics 140

30. Heilstedt, Paul K., Building Officials and Code Administrators

International, Inc 141

31. Cattafesta, P. J., Occupational Safety and Health Administration 143

32. Barnhart, S. M., Thermal Insulation Manufacturers Association 144

33. Gaynor, Richard D., National Ready Mixed Concrete Association,

and Vencill, Ralph, Material Service Corporation 144

34. Kidd, Ronald E., Microwave Associates, Inc 146

35. Mittelacker, Martin, Florida Rock Industries Inc 147

36. Garcia, Aureo W., Ready Mix Concrete, Inc 148

37. Floyd, Robert W., Conrock Co 149

38. Dickson, D.C., Standard Sand and Gravel Co 149

39. Callison, Earl F., Jr., The Walt Keeler Company, Inc 150

40. Magnotti, John F., Jr., American Association for Laboratory Accreditation 151

41. Geohringer, Warren, Transit-Mix Concrete and Foundation Company 151

42. Adams, Thomas, Ernst Fuel and Supply Co 152

43. Belfit, Robert W., Jr., Dow Chemical U.S.A 153

44. Goller, Karl R., Nuclear Regulatory Commission 153

45. Nunley, Robert B., Blue Rock Industries 154

46. Smith, R. L., Insta-Foam Products, Inc 155

Appendix 1. Designing the Workshop 157 Appendix 2. Program Participants 162

x
Part I

SUMMARY OF WORKSHOP PROCEEDINGS*

Theodore R. Young, Consultant

5016 Euclid Drive, Kensington, MD

INTRODUCTION

On November 16-17, 1981, the National Bureau of Stan- dards (NBS), an agency of DOC, conducted a Workshop on

the Future Direction of Laboratory Accreditation in the United

States. As stated in the program announcement, the workshop's

general purpose was ". . . to provide a public forum for the expression of views upon which recommendations could be developed to bring about a desirable and effective distribution of responsibilities between the government and private

sectors in the area of laboratory accreditation." The impetus

for the workshop came from related requests received by DOC

from the American Council of Independent Laboratories (ACIL) and from the American Association for Laboratory

Accredditation (AALA), ". . . to change the NVLAP proce- dures in order that NVLAP's laboratory accreditation activities would be transferred to the private sector and DOC's role would

be limited to that of an accreditor of accreditation systems."

A second specific purpose was to provide a public forum for consideration of the growing importance of laboratory accredit- ation to international trade. The workshop was organized according to the program description shown in appendix 1 of these proceedings, with five sessions interspersed with discussion sessions. In each session, oral presentations or summaries of formal invited papers

contained in part 3 of these proceedings were presented to generate questions and discussion from attendees. The questions

and discussion periods were taped and transcribed. Opportunity was also provided for attendees to present formal written state- ments. These formal statements are included in part 4. This summary of the workshop proceedings draws from the formal papers, oral presentations, and the oral and written comments at the workshop.

THE WELCOMING ADDRESS

(the relevant paper(s) can be found on page 22)

In his welcoming address, Ernest Ambler, director of NBS,

defining laboratory accreditation as "a formal recognition that

a testing laboratory is competent to carry out specific tests or types of tests," indicated its economic significance in promoting

domestic and international trade. Noting that NBS has stat- utory responsibility for the Nation's measurement system, Ambler mentioned NBS resources and attributes in support of laboratory accreditation. He observed that government should work closely with the private sector in the public interest, noting

that the way for government to increase effectiveness is through

close cooperation with the private sector. He presented a number of examples of how NBS has done this in the past. Ambler welcomed the workshop attendees to help define areas

in laboratory accreditation for more effective cooperation

between NBS and the private sector and expressed the hope

that a rational, responsive set of proposals could be formulated to serve the Nation well in the field of laboratory

accreditation.

'Prepared under contract.

BACKGROUND OF

U.S. LABORATORY ACCREDITATION

Accreditation and Certification (page 24)

Baron Whitaker, in his paper, "Meaning of Accreditation and Certification," referenced proposed definitions for "laboratory accreditation" and "conformity certification" expected to be adopted by the International Organization for Standardization (ISO) and the International Laboratory

Accreditation Conference (ILAC). "Laboratory accreditation"

is defined as "a formal recognition that a testing laboratory

is competent to carry out a specific test or specific types of

tests." Thus it is clearly evident that laboratory accreditation is oriented and limited to assessing testing competence.

Whitaker observed, however, that laboratory accreditation systems are not uniform. "Conformity certification" is defined as "the action of certi- fying by means of a certificate of conformity or mark of con- formity that a product ... is in conformity with specific stan- dards or technical specifications." Whitaker noted that product

certification, being oriented to product conformance vis-a-vis testing competence, is (should be) also concerned with the

materials, assembly, design, and features of production that

relate to the manufacture of a uniformly complying product.

Confusion in the meaning of product certification and

laboratory accreditation exists at both the national and international levels; Whitaker pointed out that during our discussions we must remember that certification refers to the conformance

of a product delivered to a consumer in the market place. Accreditation refers to the competence of a laboratory to perform tests. Charles Hyer, in his paper, "Status of Laboratory

Accreditation in the United States," seems to agree. Hyer noted

that laboratory accreditation as it relates to product certifi- cation is not a "mutually inclusive or exclusive term." He stated

that an accredited testing laboratory affiliated with a product certification system may or may not validate products for

certification. In fact, the certifying authority may be neither

a laboratory nor accredited. Assuming that assurance that a product conforms to a stan- dard is an important ingredient in many domestic and inter- national trade transactions, Whitaker identified discrete differ- ences between laboratory accreditation and stringent product

certification in regard to fulfilling the need for such product

assurance. He concluded that laboratory accreditation does

not provide needed assurance in situations such as: where con- formance to a product standard relates to aspects other than

testing; where proficiency testing required by accreditation does not specifically demonstrate ability to test the product

(a likely situation where complex technical products are in- volved); and where there is need for each conforming product

to be publicly identified. Whitaker concluded that laboratory accreditation can serve many needs for product assurance where products are bought

and sold by lots or batches on the basis that they pass prescribed

laboratory tests. When purchasers or regulators need assur1
ance that ongoing production complies with all requirements

of specific standards, together with a mechanism for identi- fying such complying production, then product certification that includes concern for factory quality control is needed.

History of Laboratory Accreditation (page 28)

Theodore Young, in his paper "History of Laboratory

Accreditation in the United States" utilized the publication,

"Principal Aspects of U.S. Laboratory Accreditation Pro- grams"* to characterize historical trends of some 70 programs

dating from 1932. Young classified the programs into two types based upon

their motivation, and describes characteristics, trends, and

impact of each type. One type of program is motivated by product certification needs. The principal parties served by such programs are the motivators and the laboratory users who seek from test data produced by accredited testing laboratories evi- dence of conformity of their products to standards. The motivators include Federal, State, and local product regulators,

product certification programs, procurement officials, inter- national trade negotiators, and trade association product

enhancement programs. Young estimated that this type of

accreditation program is experiencing an exponential growth

rate in recent decades. The other type of accreditation program develops from the need to assure that qualified testing services exist to serve

the public and the government. Motivations for this type of program are directed toward the laboratories rather than the laboratory users. Entities such as public health laboratories,

environmental laboratories, clinical laboratories, and those providing product testing services for the public or government

are motivated to obtain accreditation (or license) by government

regulations or procurement protocols for testing services and

by peer group qualification programs. Participation of laboratories in such programs is often mandatory. Young noted

that this type of accreditation program shows an approximately

linear rate of growth since 1960. Young observed that most of the programs accredit less than 100 laboratories; a few accredit as many as 500 laboratories. However, accreditation services can be provided on a large

scale. This is demonstrated by the program of the Health Care

Finance Administration (HCFA), which accredits 13,000 clini- cal laboratories serving Medicare and interstate commerce.

Observing that NVLAP and AALA, initiated in 1976 and

1978 respectively, were both established to serve general needs

for laboratory accreditation, Young noted that each pro- gram could have difficulties in meeting all the needs exemplified by those accreditation programs reviewed. AALA's

intent to accredit laboratories on the basis of broad technical

disciplines or narrower subdisciplines may not meet the requirements of users who need laboratories accredited for competence related to specific test methods and product specifications. On the other hand, NVLAP's requirement that ac- creditation be referenced to particular test methods may not meet the needs for competent laboratory services that cannot

be characterized by a set of test methods or that involve a set of test methods so large as to make it impractical or unrea- sonably costly for laboratories to achieve accreditation.

Present Status of Laboratory Accreditation (page 36)

In his paper, "Status of Laboratory Accreditation in the United States," Charles Hyer commented on his preparation

of the report, "Principal Aspects of U.S. Laboratory Accreditation Programs," and described recent activities of three of the accreditation programs reported: the NVLAP, AALA, and

the IECQ systems.

NVLAP, in developing its new accreditation programs,

provides an opportunity to help resolve technical issues rele- vant to the test methods involved. Hyer observed that only a small percentage of the 100 laboratories accredited by NVLAP

offer testing services for fees. He believes that this meager

participation by commercial laboratories is a temporary sit- uation that will change as NVLAP programs increase and as commercial laboratories find the need for and value of such

accreditation. Observing that AALA's purpose is to serve overall needs

for laboratory accreditation rather than limited specific areas such as those related to product certification, Hyer stated that AALA programs now relate to three discipline areas (electrical, chemical, and construction material testing). He noted that AALA has offered accreditation for subdisciplines within these, making such accreditation more meaningful. Hyer mentioned

that some 40 organizations have shown interest in AALA's

accreditation, and that commercial laboratories have shown

particular interest. All of the seven laboratories now accredited are commercial laboratories, and six are members of the American Council of Independent Laboratories. Speaking of the IECQ Quality Assessment System for Electronic Components, Hyer observes that this product certifi- cation effort of national scope and international effect has appointed Underwriters Laboratories, Inc., to serve as its national supervising inspectorate. A task of the inspectorate

is to accredit participating manufacturers' laboratories and

those commercial laboratories employed by such manufacturers. Mentioning the potential significance of this sys- tem, Hyer noted that the system's accreditations could possibly

gain government recognition if it uses appropriate standards. Further, he indicated that the system will serve the electronics industry, which has had a de facto laboratory accreditation program for years; that the syseem, being the first inter- national quality certification system, will, if successful, become

the standard for worldwide certification programs; and that, for the system to succeed, reliable performance of testing laboratories will be essential. As an example of newly established accreditation activities, Hyer mentioned the recent program of the Institute of Electrical and Electronic Engineers. Its purpose is to accredit envi- ronmental testing of safety equipment used in nuclear power

stations. Accredited testing will be required by NRC, which

will use the program as a means of reducing multiple audits. Hyer said he believed that near future trends in laboratory

accreditation will be governed by economics. Reduced gov- ernment budgets will force more reliance on the private sector. He estimates that some 50,000 laboratories currently

require one or more forms of accreditation. Over 2,500 laboratories requiring multiple accreditations have been identified; some, such as large commercial nondestructive testing laboratories, require as many as 100 accreditations. Noting that opportunities for consolidation of laboratory

accreditation activities will be viewed differently by various

interests, Hyer asserted that the market for accreditation will demand cost-effective programs. He observed that existing accreditation programs will extend their scope to serve developing needs. Duplicative accreditations now justified on the basis of national, State and local jurisdictional concerns need to be

eliminated. Hyer concluded that the worldwide need for as- surance of product quality, by itself, provides economic justification for increased use of laboratory accreditation.

•Referring to this publication in his workshop presentation, Charles Hyer, its principal author, stated his belief that it is the most informative source presently available on government and

private association programs dealing with assessment of testing, examination, and inspection services. However, Mr. Hyer advised that the selection of programs for the publication was somewhat arbitrary, favoring those related to product verification and certification, and that the summary may be incomplete due to economic constraints of the study.

2
An attendee inquired about the future of NVLAP and its current and future financial prospects. Stanley Warshaw of NBS advised that government programs, including NVLAP,

were currently operating under a continuing resolution until December 1981. Thereafter, NVLAP funding would depend upon congressional action on the fiscal year 1982 budget re- quest. However, Warshaw noted that direct costs of accreditation under operational programs are supported by fees charged to participating laboratories. Future alternatives

for NVLAP, now under consideration, include working with, or in support of, the private sector in the area of laboratory

accreditation. In response to a question regarding who might use AALA's

accreditation, Hyer indicated that he did not know of any

organization that currently requires AALA accreditation. He estimated that the future would depend upon diminishing

ability of existing programs to fund their own programs and

the ability of AALA to tailor its programs to meet the exist- ing requirements.

Another attendee inquired whether AALA plans accreditation of environmental testing laboratories, such as those re- quired by EPA's NPDES program. Louis Rossi of AALA in- dicated that AALA has no program for environmental testing

except wherein its program for chemical testing would apply.

INTERNATIONAL TRADE IMPLICATIONS

OF LABORATORY ACCREDITATION (page 40)

Charles Hyer (above) noted in his paper that opportunities

will exist in the future for laboratory accreditation to meet

the needs of international trade. Laboratory accreditation that would allow U.S. laboratories to be on-site approval agencies

for foreign procurement activity could be an important adjunct

to international trade. The General Agreement on Tariffs and Trade (GATT), and in particular, its Agreement on Technical Barriers to Trade,

popularly called the Standards Code, provide challenges to our national federated standards system. In his paper, "International Trade Implications of Laboratory Accreditation,"

Donald Abelson, director of Technical Trade Barriers for the Office of the U.S. Trade Representative, noted that the Standards Code contains obligations on GATT treaty partners

pertaining to development of standards, conformity testing,

and final certification of products. The code is applicable to industrial and agricultural products; however, government pur- chasing specifications and inhouse standards are exempted.

Abelson listed several provisions of the Standards Code,

which require that: product standards must utilize performance

criteria whenever possible; access must be provided to national and regional certification systems; and imported products are to be tested in the same manner as domestic products. The code

recognizes that the mutual acceptance of test methods and

data can significantly liberalize trade. From his experience

in handling trade problems, Abelson claimed that the recip- rocal acceptance of tests and test data will be the most signifi- cant technical issue in future Standards Code discussions,

requiring priority attention of U.S. Government experts. Abelson noted that bilateral discussions concerning specific

products with key Standards Code signatories, inevitably address reciprocal acceptance of test data and the accreditation

of laboratories. Observing that there is a problem for the United

States in responding to foreign requests for "official" approval

of test results, he commented that the United States is not eager to provide such official guarantees. Abelson pointed out

that current U.S. policy is to encourage foreign governments

to accept the U.S. standards system, which operates "smoothly"

without Government interference. He noted various ways of

serving product assurance needs that the United States successfully supports as alternatives to providing Government

approvals of products in international trade. The United States:

• Favors the development of international standards of Good

Laboratory practice, such as those being developed by

OECD;

• Sees promise in national voluntary laboratory accreditation programs, such as NVLAP, if they can develop the required scope of product coverage;

• Encourages foreign governments to recognize the American system of private laboratories independent of manufacturing;

•Claims that its legal system, particularly its product lia- bility laws, guarantees product reliability better than could

be done by a Government agency; and,

• Supports establishing a framework for international accreditation of laboratories that does not rely heavily upon

official Government sanction of laboratories.

In regard to U.S. reliance upon its national federated standards system, Abelson noted that we differ from most of our foreign competitors, where Government intervention is common. However, the United Kingdom has an active private

sector standards community that enjoys a degree of recognition by the Government. Also, the United Kingdom is experienced in dealing in reciprocal trade arrangements within

the Common Market. Thus, recent U.K. actions in establish- ing its national laboratory accreditation system are of interest. Dr. P. G. Forrest, in a statement presented to the work- shop (see part 4 of these proceedings) noted that the National

Testing Laboratory Accreditation Scheme (NATLAS), the U.K. counterpart to NVLAP, was recently established as a Government operation. The development of NATLAS was

guided by a steering committee of representatives of laboratories, their customers, and organizations that accredit laboratories. Considering whether NATLAS should accredit laboratories or organizations that accredit laboratories, the United

Kingdom concluded that laboratories' results would be more

readily accepted overseas if laboratories were directly accredit- ed by NATLAS. In addition, a centralized system using a single

set of regulations and criteria would make it easier to negoti- ate mutual recognition with other national laboratory accreditation schemes.

Relating experiences in marketing tractors internationally, Frank Walters of the John Deere Company, in his presentation to Session III of the workshop, said that our Govern- ment agencies and industry need to work together. We must

operate in the most efficient manner, if the United States is to remain competitive. Because of attitudes of many importing countries, some international trade functions can be ac- complished more efficiently by Government; these functions

relate to authoritative testing/inspection of products for compliance to regulations.

In response to a question, Abelson indicated that Australia

intends to sign the Standards Code. It has not done so due to problems arising from their Federal-State relationship. In response to an inquiry about problems in trade agreements

deriving from reference to international, rather than U.S., stan- dards. Abelson said that the United States is obliged to use appropriate international standards and to participate in ap- propriate international standards activities. Abelson stressed the importance of our participation in developing international standards that we can use and in resisting block voting efforts of groups of countries to put our technology at a disadvantage.

Asked for recommendations regarding "rational or due

process" procedures that might be implemented to improve

our acceptance by foreign interests, Abelson pointed out that the United States has systems, such as the ASME system, that are in fact international. He recommended that the United

States strive to develop similar systems as efficiently as it can so

3
other countries will be obliged to use them. Responding to a

question as to whether the international trade needs for laboratory accreditation have become sufficiently general to warrant NVLAP providing accreditation programs of a broader

base, Abelson indicated that needs are still very product

specific.

NEED FOR LABORATORY ACCREDITATION

Purposes ofAccreditation (page 43)

In his overview paper, "Purpose of Laboratory Accreditation," John Locke described the findings of ILAC's Task Force C Report as adapted to the situation in the United States. Published in ILAC/80 Proceedings, this report describes the need

for and the objectives, effects, and consequences of laboratory

accreditation. Locke noted that the report reflects some 30

years' operating experience of the Australian program, modified

by experiences of participants from other countries operating more recently developed or developing systems.

Noting that the need for laboratory accreditation is demonstrated by the large group of programs existing in the United

States, Locke said such programs serve those needs:

• Private sector purchase of components and subsystems

• Private sector certification programs

• Government purchasing

• Government funding involving programs that provide fi- nancial support to the public

• Government regulations requiring premarket testing by

accredited laboratories

• Government certification of products

To summarize these activities, Locke related these needs

to saving money; reducing contractor risk; assuring product

adequacy, performance, and safety; enhancing industrial and professional image; and providing quality assurance for laboratory management.

Locke noted an additional need served by laboratory accreditation, namely, that manufacturers need qualified laboratories

for product development, quality control, and failure investigations, or need to have their own laboratories recognized

as being so qualified. Noting that a large number of accreditation systems are evolving, Locke cited the developing need to consolidate the examination of laboratories to reduce costs and minimize disruption of productive laboratory work. Claiming that the objectives of almost all laboratory accreditation systems emphasize correction of deficiencies rather than denial of recognition, Locke listed the following specific objectives that accreditation systems may have:

• Promotion of good testing practices and validity of test data;

• Improved efficiency in use of tejt facilities and reduction

of need for redundant testing;

• Public credibility and status rewards for competence;

• Effective support for international trade; and,

•Objective information on laboratory practice, including

feedback to standards developers.

Laboratory accreditation is affecting and benefiting laboratories, their users, and the community at large. Locke stat- ed that the management and staff of participating laboratories are now more aware of requirements for calibrating equipment,

documenting methodology, recording and reporting test data, and participating in interlaboratory proficiency tests. Users are placing greater reliance on test reports, reducing

their demands for duplicate testing. The community is more

aware that weaknesses can exist in testing services and is be- coming more selective in its use of laboratories. Laboratories

benefit by upgrading their capabilities and having available

a reference basis for assuring their own quality and improving the marketability of their services. Laboratory users benefit

from improved quality control and markets for their products.

The community benefits by having a better and more reliable testing resource. Additional benefits for the United States are to be obtained if international markets can be opened for accredit- ation systems. Locke claimed there is a need for an accredit- ation system or systems to focus on international reciprocity

in acceptance of test data produced in exporting countries. In conclusion, Locke pointed out that there are costs asso- ciated with the benefits of accreditation. There may be direct

costs to the laboratory for the accreditation service itself and

indirect costs resulting from meeting calibration, proficien- cy test, and procedural documentation requirements. Locke

suggested that such indirect costs would apply to any well-run laboratory and little should be attributed to accreditation

activities. He noted that the costs of accreditation, when passed on to the laboratory user, can be substantial or trivial depending

upon the laboratory's test volume. There was an inquiry from the audience as to whether any

accreditation systems now address or plan to address the important subject of sampling and sample preparation. Locke

said that the accreditation criteria do not address sampling

requirements directly, and that these requirements are con- sidered when addressed in the referenced standards and test methods. It was noted from the floor that EPA's program for drinking water laboratories and NVLAP's concrete program

pay due attention to sampling requirements.

An attendee, commenting that many laboratories enjoy "Federal credibility" even though the NVLAP accredit- ation may cover different test methods of varying sophistication,

inquired as to how NVLAP differentiates between sophisti- cated and basement operations. A NVLAP assessor replied that it is quality and reproducibility of test data reaching the user that is important, rather than size of the laboratory. Another question related to how NVLAP assures such reproducibility on the basis of criteria used. Locke said that the usual operational scope of accreditation systems, including

the Australian program, is recognition to do specific tests and

specific tests only. These programs are trying to recognize the competence of laboratories to do routine testing for ordinary

products. One should not extrapolate the capability of the labo- ratory beyond those specific findings. An attendee reminded

the workshop that NVLAP originally proposed accrediting

laboratories for disciplines, but changed to a product basis because of public comment. Currently, NVLAP has established

alternative procedures whereby the private sector or Federal

agencies can, by consensus or legal authority, find a need for an accreditation program and develop its accreditation criteria. If the private sector or a Federal agency can find a need and

develop the necessary criteria, NVLAP can establish accreditation programs of broader scope, such as disciplines.

Noting the discussion pertaining to international aspects

of laboratory accreditation, another attendee inquired about

what accreditation systems such as NVLAP are doing to en- courage State and local government recognition, and suggested

that more effort may be needed in this area. A question from

the floor asked how laboratory accreditation could fill State and local needs for product assurance (certification). Ted

Pritsker, a panelist, did not see a real difference, except that accreditation and certification are consecutive features of an overall assessment that also includes engineering eval- uation of test data. John Locke observed that State authorities have various needs; one is for product test data provided

by programs of the Code Officials' organizations. He noted

that NVLAP will continue to emphasize that its scope con- cerns only the competence of laboratories. However, persons

using laboratories are free to use the accreditation program

as needed to serve their requirements. Charles Hyer suggested

that a consensus was not needed on the need for accreditation of services for testing, sampling, design engineering, certifi4
cation, etc. Accreditation programs will be established if they

are economically viable and supported by significant laboratory

users that want the assurance provided.

Needs of the Independent Laboratory

(two papers, pages 46 and 52)

Earl Hess, in his paper, "The Need for a Practical Laboratory Accreditation Program from the Perspective of a Small

Multi-Discipline Independent Laboratory," observed that a laboratory accreditation system that ensures technical credibility of analytical laboratories is indeed the "primary stan- dard" on which product quality measaurements are based. Hess said he believed that his laboratory's diligent implementation of an internal quality assurance program is incomplete

until exposed to scrutiny by a qualified outside source. For

instance, regardless of any national recognition to be derived, he

said he believed his laboratory's accreditation by AALA for the chemical discipline was worth the entire cost and effort involved. However, narrow-gauge accreditation programs, such

as those that are product-by-standard oriented, are impractical for small multidiscipline laboratories. Despite experience

over the years with a "plethora" of such narrow-gauge pro- grams, he estimated that 75 percent of his laboratory's work

was still not covered by these specialized accreditation pro- grams. Even if coverage was available, the number of specialized accreditations needed would be excessive, cumulative

accreditation fees would be prohibitive, and attendant paper- work and lost productivity would be intolerable. Except for their impracticality for multidiscipline laboratories, Hess

did not fault product-oriented accreditation programs. He

noted that NVLAP had developed valuable criteria and pro- cedural materials that have advanced the state-of-the-art, and had enhanced appreciation of the need for and worth of

accreditation. He said, however, that NVLAP's awakening

the public to the need for accreditation without supplying a program to serve the overall need had been a disservice to labo- ratory activities outside the scope of NVLAP's accreditation. Hess's first conclusion was that the only national laboratory accreditation system both practical and efficient

is accreditation by discipline.

Hess's second conclusion was that an effective national system for laboratory accreditation must be based in the pri- vate sector. He claimed that laboratory accreditation is not

inherently governmental any more than is standards devel- opment, and that a consensus supports the government leav- ing the provision of standards to qualified private sector bodies. Hess noted that significant private sector interests and accreditation programs exist that should be assisted and relied upon by

government to perform accreditation functions. He stated that AALA is one such private sector body. Hess observed, however, that the U.S. Government must maintain responsibility

for laboratory accreditation in the international arena. As a

result of GATT and the activities of the International Laboratory Accreditation Conference, to be credible to our trad- ing partners, the Government must represent U.S. interests

in laboratory accreditation.

In addition, Hess pointed out that Government's reliance on private sector services would be consistent with long- established Government policy. Stating support for the the ACIL and AALA proposals, Hess concluded that NVLAP

should gradually withdraw from accreditation of laboratories and become the accreditor of private-sector accredit- ing systems and serve as the U.S. international liaison in lab- oratory accreditation. Hess concluded by identifying specific advantages laboratory

accreditation on a discipline basis to the general public of the

users of laboratory services, and the laboratories themselves.

Hess was asked why he hadn't requested a NVLAP program

to serve the needs of his laboratory, particularly a laboratory

accreditation program under NVLAP alternative procedures

"Part 7c" established in October 1978. The alternative NVLAP

procedures might allow establishment of an accreditation program of a broader than product scope. Hess replied that he could not accept a program on a product-by-product basis, as required by the original NVLAP procedures, and by the time the alternative procedures had been introduced he had

decided to seek the services of AALA.

Another attendee asked Hess how AALA assures credibility for various subdisciplines when it accredits laboratories

for a whole discipline, such as chemistry. Wouldn't competitors, equally accredited but having lesser qualifications in some

subdisciplines, have a competitive advantage? Hess replied that AALA's accreditations for disciplines are supplemented by accreditations for subdisciplines including the specific

products in such subdisciplines. A laboratory entering a new

field (within the discipline) must advise AALA and demonstrate its capability in order to be listed by AALA. Asked

whether AALA accreditation, in effect, does list test methods and products covered, Hess said that AALA accreditation

for disciplines provides an umbrella under which the credibility of a laboratory can be established (staff ability, equipment

inventory, quality control program). To supplement the general accreditation, his laboratory would be glad to perform,

at a client's request, a proficiency test on a blind sample to demonstrate ability to serve a specific need. Another attendee asked if AALA provided an appeal pro- cedure for laboratories subject to losing their accreditation. The attendee also wanted to know if AALA requires laboratories to notify clients if they lose qualifications necessary

for renewal of their accreditation. Hess stated that accredit- ed laboratories have an ongoing responsibility to notify AALA

of significant changes. For reaccreditation, AALA requires

a yearly update of information and biennial site visitations. For significant changes, site visits may be required at any time. Hess believed that AALA had an appeal procedure, but could

not comment on its details. Another attendee asked if there would be a benefit in es- tablishing a peer group of testing laboratory interests having concern for accreditation. Noting that there is a sizeable population that supports accreditation only for serving

particular needs, the attendee observed that the major issue may not be a product versus discipline approach; the problem

may be an inadequate definition and description of needs. A peer group of accreditation interests could respond to this problem. Hess indicated that he would support a broadening of AALA to include not only commercial and inhouse laboratories but also government agencies and other users of laboratory services. William Levelius, in his paper, "Independent Laboratory

with Many Separate Laboratory Locations," identified and

described the major components and subelements that should be

included and detailed in the corporation's quality assurance manual. Noting that the major components of the quality as- surance program are the essential elements contained in reg- ulations for the nuclear energy industry (10 CFR 21, Appendix B), he listed the major components of a quality assurance program.

Levelius observed that the corporation's quality assurance program should be controlled by a department in the executive offices reporting directly to management. Its duties should

include program writing and revision, maintenance of corporation calibration standards, calibration of certain equipment,

system operation review, and internal audits. In addition to continuous desk audits, the system should require yearly

indepth audits and spot audits by executive management during

regular visits to the branches. A most important control should be a stringent followup on customers' complaints.

5
Noting that a corporate quality assurance program and an

accreditation activity are similar in their work effort, Levelius

pointed out that a corporate quality assurance program has

the advantages of being continuous and being conducted by

personnel familiar with the corporation's testing business. An accreditation program that requires on-site examinations of

the corporation's branches is duplicative, creates an excessive amount of redundant paperwork, and takes an inordinate amount of time of both the laboratory and the accreditor. From the viewpoint of one of several hundred multilaboratory

corporations, Levelius concluded that an accreditation system

should consider blanket accreditation of such corporations

in lieu of individual accreditations of each branch. He based

this conclusion upon the assumption that the multilaboratory

corporation must have an operational corporate quality assurance program. William Levelius's second conclusion was that accreditation can benefit the laboratory industry only if properly de- signed and administered. A system that would replace the multitude of existing accreditation programs needs to be flawless, satisfy all needs and desires, and be mandated by law. He listed several aspects that should be of concern:

• Prohibitive costs of accreditation to small laboratories;

• Intolerable overall cost of accreditation on a product by

product basis;

• The capability and impartiality of assessors;

• Flexibility beyond basic requirements to allow laboratories

to tailor methods to meet their needs; and

• Recognition that national standards sometimes contain

impossible or impractical test requirements—the exposure

to litigation that accreditation for meeting such require- ments might entail. An attendee questioned Mr. Levelius concerning Pittsburgh

Testing Laboratories' inhouse quality assurance program. What

followup process is conducted if a current audit of one of the

laboratories provides evidence that faulty test results were produced since the time of last audit? Levelius indicated that followup depends upon the significance of the error. The audit group reviews the testing log books to see whether or not the

error has a significant bearing upon test results issued. Needs of Manufacturers (two papers, pages 54 and 57)

Speaking for manufacturers, Richard D. Gaynor provided

a viewpoint of concrete producers in his paper, "Why Concrete

Laboratory Accreditation—Why NVLAP." Noting that concrete producers are responsible for quality of material deliv- ered to the job site, he observed that in the United States the producers do not perform the acceptance testing of their own

product. Building code officials, architects, engineers, and

contractors, who generally hire concrete testing laboratories, are involved. According to Gaynor, current practices and competitive conditions frequently create conditions for an unacceptably low standard of testing quality. Concrete testing laboratories, requiring modest capital and little scientific knowledge, are often garage operations selected by contractors on

the basis of lowest bid. Stating that incorrect testing generally

produces concrete strength results that are too low, requiring unnecessary followup investigations of the structure involved,

Gaynor estimated that a third of all low-strength test results were due to improper testing.

Noting that accreditation now provides a method for eval- uating the capability of producers' quality control programs and concrete testing laboratories, Gaynor said that significant

developments in serving the need came with the establishment

of ASTM Committee E36, the promulgation of their standard E548 (general evaluation criteria for testing agencies), and

the initiation of the Concrete Laboratory Accreditation Program under NVLAP. For the first time in concrete test- ing, a user of laboratory services can identify and specify the

quality of service he/she wants and expects.

In commenting on the issue of whether NVLAP should leave accreditation of laboratories to private sector organizations

such as AALA, Gaynor expressed confidence that NVLAP is accessible and can change, improve, and evolve. For example, he

noted that NVLAP has been criticized for being too detailed and requiring too much paperwork. However, he observed that NVLAP programs differ. The thermal insulation programs

cover many test methods; an applicant laboratory may choose

those for which it seeks accreditation. On the other hand, the concrete program covers only a few of a whole book of test methods available, selected because of commercial importance.

Gaynor expressed the hope that as the concrete program fur- ther evolves, it will not add other test methods based on similar technology and procedures. Gaynor claimed that it is now

clear that the benefits to be derived from the current concrete

laboratory accreditation program will greatly exceed Govern- ment expenditures on the program. Gaynor expressed several concerns regarding the AALA

program. His general concern was that the AALA program is supported by laboratories that would like a simple inspection

by peers without specific criteria that can be documented.

Although AALA intends to use ASTM E548 for every disci- pline, Gaynor claimed the real issue was the extent and detail that AALA would employ. Will AALA require proficiency

testing programs wherever critical test methods are being

assessed? He was also concerned that AALA does not appear

to have procedures which allow for comment by the general

public, such as those relating to accreditation criteria and

accreditation decisions. In addition, Gaynor wondered whether AALA could assemble the resources necessary to develop an adequate

program. He noted that the NVLAP system, designed to be

self-supporting, would take some time to achieve this goal.

He pointed out that the Australian accreditation program, NATA, relies on its Government for 60 to 70 percent of its funding. He believes that AALA's membership fees are now

sufficiently large to inhibit participation of many laboratories.

Finally, he questioned AALA's ability to defend a fair but tough accreditation system against legal challenge from a labo- ratory deprived accreditation. Admitting that NVLAP might be

similarly threatened by political pressures, Gaynor suggest- ed that there may be need for both NVLAP and AALA in their presently conceived roles. Speaking from years of experience with the oil industry,

John Grant, in his paper, "Laboratory Accreditation as Viewed

by a Manufacturing Concern," concluded that accreditation

is necessary and desirable for the independent and commercial testing laboratory community. Although inhouse laboratories should not be denied accreditation services, Grant stated

that accreditation for inhouse quality control laboratories of

technically advanced manufacturing industries, such as the petroleum industry, had doubtful value and could become an

unneccesary burden and expense. Using the petroleum industry as an example, he pointed out

that the work of ASTM and other standardization activities had provided specifications for essentially all petroleum

products. Standardized tests and analyses, with precision established by cooperative laboratory testing programs, are avail- able for determining compliance with the specifications. Most

petroleum companies have inhouse quality assurance programs

including interlaboratory testing programs for their several quality control laboratories. These laboratories usually can

receive assistance when needed from the industry's central research organizations. The independence and authority of the

quality control laboratories is generally assured by company

policy. Grant observed that excellent inhouse laboratories frequently

need to utilize commercial laboratories for specialized analytical work; and that there was a real need for a way of as- sessing such laboratories. Otherwise one selects laboratories

6
on the basis of personal acquaintance, recommendations of

others, society affiliations, or by submission of trial test samples

of known composition. These methods are time consuming,

expensive, and are subject to mistakes that can be costly. Accreditation of laboratories can simplify the selection pro- cess and make it more reliable. However, Grant expressed concern with the way accredit- ation systems were developing. There is too much significance attached to academic qualifications, organization, office routine, independence, and integrity. Laboratory performance

is what matters. This can be assured with proficiency samples,

interlaboratory comparisons, and use of competent and knowledgeable evaluators. In addition, the time and expense of accrediting laboratories must be reduced—an obvious conclusion considering that a laboratory might be called upon

by the petroleum industry to perform 500 to 700 different analyses on over 500 different products. Competent and knowl- edgeable assessors are keys to a successful laboratory accreditation program. Grant concluded that cooperative efforts of all interested parties is necessary to achieve the required systems.

An attendee questioned Grant as to whether the petroleum

industry needed accreditation of non-product oriented lab- oratories, such as pollution control (NPDES) laboratories. Mr.

Grant observed that some petroleum companies are doing their own testing whereas many are contracting for this testing.

Where Federal or State regulations require accredited test- ing, the petroleum industry would cooperate to get laboratories accredited as required.

Needs as Seen by an Exporter (page 59)

To illustrate ihe problems of exporting, Frank Walters used

the example of the agricultural tractor. According to Walters,

the first problem was to determine the impact of governmental regulations on tractor design. As of 1978, he noted 52 tractor components subject to various requirements imposed by 30

countries. For comparison, Walters observed that the United

States imposes only one rule on importers of tractors; that manufacturers self-certify their tractors as meeting OSHA require- ments regarding roll-over protective structures. Walters assert- ed that some alleviation of this export problem was underway

in the Common Market but that a major problem still exists. The second problem facing exporters is the process that Walters called "homologation," which is defined as the premarket

testing and/or inspection for compliance with regulations con- ducted by the importing country's officials. This requirement

involves presenting one or a batch of tractors to various for- eign testing or inspection authorities for certification prior

to obtaining a permit to sell. Depending upon the country in- volved, the homologation process may take 2 weeks or as long

as 18 months. Walters explained that because of this process the manufacturer must either stockpile the product ready for sale or build expensive prototypes in advance of production.

Subjective interpretation of the requirements can result in emergency changes in the product design. Walters estimated

that a manufacturer may need to build 100 prototypes to gain

the necessary certificates to market a new tractor line. Walter noted that EEC's present effort to harmonize requirements

includes the homologation process. Walters observed that because of attitudes of foreign

countries, there were international trade functions that could be accomplished more efficiently by Government. U.S. exporters need a homologation process performed in the United States

that is acceptable to foreign countries' importing authorities. NVLAP or a form of it is needed to verify laboratory

competence to perform the required tests. In addition, exporters

need a system where an organization, acceptable to importing countries' authorities, issues documents attesting to review and findings of compliance when test results are found to meet

the importing countries' regulatory requirements.

Needs of State and Local Governments (page 6 1

)

Constitutional police powers granted to the States include

those assuring healthful and safe buildings and building

products, including appliances. Donald Pinkerton pointed

out that State and local governments must be assured that a system is in place that provides for a minimum acceptable

level of performance, safety and useful life of materials and

products. He noted that State and local governments are generally opposed to the concept of self certification, and in some

instances must deny the acceptance of new products and tech- nology when recognized standards and test methods are not

available. Pinkerton observed that State and local governments

make widespread use of product standards, certification, and laboratory accreditation in regulation and procurement

activities. Use is prescribed in a number of State laws and

local ordinances that vary among jurisdictions, thus burdening both laboratories and product manufactuers.

Citing several existing laboratory accreditation programs

dealing with building products, Pinkerton conjectured about problems for building officials should these programs offer different findings in regard to the accreditation of a laboratory. He noted that the intent of the National Conference of

States on Building Codes and Standards (NCSBCS) Laboratory Accreditation Program is to use existing accreditation systems when available. NCSBCS is discussing with NVLAP

and AALA participation by the States in their programs.

Pinkerton stated the need for:

• A general agreement by all involved parties that a special- ized or programmatic voluntary accreditation system is desirable;

• Acceptance throughout the United States of laboratories accredited by the system; and

• Establishment of an advisory council of State and local

officials to make Federal Government and others aware

of concerns and needs regarding imported building products and appliances.

Pinkerton concluded that a voluntary system acceptable to both the private and public sector must be established if Federal

legislation on the subject is to be avoided. He noted that NCSBCS wants to become an equal partner in such a system.

Needs of Federal Regulators (page 63)

Licensees of the Nuclear Regulatory Commission (NRC)

are required to measure the radiation dose received by workers (personnel dosimetry), measure the amount of airborne

radioactive material ingested by the body (bioassay), and sample the environment for radioactive material content (en- vironmental monitoring). In his paper, "Advantages to the Nuclear Regulatory Commission of Third-Party Laboratory

Accreditation Programs," Robert Alexander noted that personnel dosimetry, bioassay, and environmental monitoring all require competent laboratory performance in which

NRC must be confident. Because of limitations on NRC's staff and resources, NRC plans to use other laboratory accreditation programs based on performance testing and quality- assurance inspection. The plan involves adopting an appropriate consensus performance standard, including quality assurance

criteria, and mandating a requirement for use of accredited

laboratories after establishment of an operational program

by a laboratory accreditation system selected by NRC.

Observing that the plan has been initiated for personnel

dosimetry and bioassay utilizing NVLAP, Alexander identi- fied advantages and disadvantages for NRC, for industry, for nuclear workers, and for the public. Advantages for NRC are

that NVLAP has the necessary legislative authority, liaison

staff, accrediting experience, proficiency testing, inspection

processes, and criteria components to serve NRC requirements.

7
NRC supplies minimal staff, no long-term financial commitments, and is not involved in possible disputes. Other govern- ment agencies can use these programs without funding commitments. Disadvantages and potential problems of using NVLAP

are that NRC must fund development of the accreditation pro- grams and costs of radiation sources and the approach may be viewed as an expansion of Federal regulation over industry.

Problems will arise if an inadequate number of laboratories

qualify, and for an interim period NVLAP will need to rely upon

the NBS Center for Radiation Research for technical support. For industry, laboratory accreditation programs provided

by NVLAP will promote better quality control, accuracy, and

credibility of test results leading to better laboratory ' per- formance and reliability and fewer customer demands for their own assessments of laboratory capability. Accreditation will provide laboratories with advertising advantages and will allow them more time than a regulatory action to correct problems

and deficiencies. Disadvantages to industry relate to the initial and continuing costs of maintaining accreditation, the

possible consequences of losing or failing to achieve accreditation, and the possible reluctance of accredited laboratories to introduce new innovative techniques.

Advantages for affected nuclear workers will be more as- surance that employers are using competent laboratories,

and producing accurate and verifiable measurement results, appropriately documented and maintained as required by

NVLAP criteria for accreditation. This may assist litigation

and is particularly important in assessing the long-term biological effects of low-level radiation. A disadvantage to the worker is that the employee might lose credibility should a laboratory lose its accreditation. In addition, employers that voluntarily provide radiation protection services for their employees might terminate such laboratory services if costs increase. Alexander observed that greater public confidence in lab- oratories resulting from NVLAP programs could be damaged if large numbers of laboratories were to fail to achieve accreditation. In addition, he noted that the public will indirectly pay the costs of these accreditation programs. Alexander

concluded that such accreditation programs will contribute

to U.S. radiological health protection at a cost that is small when compared to the benefit to be derived.

Needs of the Consumer (page 65)

Consumers' interest in laboratory accreditation is presently

secondary to their interest in product standards and certifi- cation. David Swankin defined "consumer" as the end-use

buyer, not others such as industrial buyers and users. Consumer

interest is based on the widely accepted consumer rights first introduced by President Kennedy: the right to be informed,

the right to choose, the right to safety, and the right to be heard. Regarding the consumers' right to be informed, Swankin

raised the issue of whether a laboratory accreditation system

should allow laboratories and laboratory clients to advertise

a laboratory's accredited status to the consuming public.

Whereas some claim that such advertisements would be in- terpreted as product certification, others claim that it can pro- vide useful information to end-use consumers. Swankin said he believed that laboratory clients should not be allowed to advertise that consumer products have been tested by an ac- credited laboratory. On the other hand, a laboratory should

be allowed to advertise to potential clients that it is accredited. As to the consumers' right to choose, Swankin based his position on the general proposition that monopolies ill-serve consumers. Therefore, consumers are better served if product

suppliers, particularly small businesses, have available quality

testing services of competing accredited laboratories. This is because monopolies can lead to unjustified high prices which

are passed to the consumer.

Swankin observed that accreditation programs should be

establised only when needed. They must be fair and unbiased,

and they must be perceived as such. They must be administered so that everyone is not always accredited. If everyone is accredited, it is time to reconsider the need for accreditation. Laboratory accreditation can enhance the consumers' right to safety. Swankin noted that laboratory accreditation systems

have the opportunity to exert an influential role in upgrading

safety standards relied upon by consumers. An accreditation body has the prestige, influence, and knowledge to identify

shortcomings in safety standards for the standard developers. This public service would enhance the prestige of lab- oratory accreditation systems.

Important to the consumers' right to be heard is the con- sumers' interest in the currently popular issue—the respective roles of the public and private sectors. However, Swankin

did not see the public versus private sector aspect of the NVLAP/AALA question as being the main issue. Either system

could administer a laboratory accreditation program well or

poorly. Swankin described the NVLAP/AALA question as an unnecessary "turf battle that should be avoided, as it di- verts attention away from the real effort that is needed. Swankin claimed that the consumer is best served by labo- ratory accreditation systems with the most integrity, the best

quality, the most efficient and cost effective processes, the

best accountability, and which display the greatest sense of public responsibility. Acceptable systems must maintain

standards of excellence without encouraging monopolistic practices. Private sector programs like AALA must earn acceptability by assuring accountability, which should be built into government programs. Government accreditation programs must overcome bureaucratic problems to achieve the efficiency

and cost-effectiveness more readily attained by private sector programs. However, efficiency will be judged on the basis of equality of programs. Swankin stated that NVLAP should not have an exclusive charter in the laboratory accreditation field, but also indicated

that AALA and other private accreditation programs should

not have status that they do not earn. The proposal that NVLAP

serve to accredit laboratory accreditation programs could be

a good idea for the future, when private sector programs demonstrate their quality, integrity, and accountability. Then one

could compare accreditation programs in regard to service to small laboratories, investigatory processes, advertising policies,

accountability, efficiency, adaptability to new technologies,

and service to the public interest. Swankin suggested that a

small, broadly representative group might be assembled to prepare a 5-year plan with measurable milestones. Its goal

would be the evolution of NVLAP into an accreditor of

accreditors.

DISCUSSION

One attendee wondered how very broad generic criteria, such

as ASTM standard E548, can be used to properly support

accreditation programs based either on product areas or dis- ciplines. When are specific technical criteria needed for a valid accreditation program developed, and how are specific criteria developed for a program based upon broad disciplines? It was

noted that work is underway by various ASTM committees

for different product areas. AALA had asked ASTM Committee E36 to coordinate these splintered activities within indi- vidual discipline accreditation standards. Standards of criteria are needed that cover all the capabilities of the laboratory,

whether it is a manufacturer's specialized product testing labo- ratory or a diversified independent laboratory. It was observed

that accreditation criteria standards are generally very broad, such as ASTM E699 covering test methods developed by ASTM

Committee E6 on buildings and structures.

8
CRITERIA FOR RECOGNIZING

LABORATORY ACCREDITATION SYSTEMS

ASTM Committee E36 (page 68)

Gerald Berman's paper, "Work of ASTM Committee E36

on Criteria for Testing Laboratory Evaluation and Accreditation," noted the accomplishments and activities of this committee since it was established in 1973. To date, Committee

E36 has developed and promulgated ASTM Standard E548,

"Recommended Practice for Generic Criteria for Use in the Evaluation of Testing and Inspection Agencies." Widely refer- enced by many accreditation systems, E548 provides guidelines on information that laboratory evaluators and accreditors should seek regarding laboratory organization, human and

physical resources, operational procedures, and quality assurance practices. At present, it does not specify mini- mum requirements for an organization to be assessed as competent.

Viewing a model of an accreditation system as consisting of an accrediting authority, accreditation criteria, and an evaluation and monitoring process, Berman noted that Committee

E36 has embarked on the development of standard documents to serve these component elements. A draft document has been prepared identifying the elements and attributes that should be present in a laboratory accreditation system. A similar document was presented at the In- ternational Laboratory Accreditation Conference (ILAC). The

draft includes those attributes of a laboratory accreditation system:

• It should accredit testing laboratories on the basis of national or international standards for well-defined fields of testing, scientific disciplines or technologies, or in re- lation to specific products or tests.

• Its technical criteria for accreditation should be formulated by persons technically competent in the relevant field of testing.

• Its criteria should be published and readily available.

• Its assessors should be impartial experts in the testing area

involved.

• Its assessments should include written reports.

• It should reassess accredited laboratories periodically.

• It should publish a list of accredited laboratories and the scope of accreditation, and should maintain a record of

tests for which each laboratory is accredited. Committee E36 is also reviewing a controversial draft of a standard covering generic criteria for use in evaluating and

accrediting laboratories. The draft subsumes the information

disclosure sections of E548 by adding sections of generic

requirements to be met by the laboratory. The requirements

are similar to those contained in proposed revisions of ISO

Guide 25. Berman noted that adding generic requirements to the information disclosure sections of E548 may encourage

harmonization of criteria and language used by existing accreditation systems. This will give impetus to mutual rec- ognition among systems and reduce duplicative evaluations. Stressing that the requirements of this draft document are completely generic, Berman pointed out that specific bench- marks for determining compliance with generic require- ments would be the province of the accreditor. Alternatively, specific criteria for test methods could be

established by technical committees with responsibility for the test methods, enhancing the potential for reciprocity among

accrediting systems.

Berman mentioned that a new subcommittee has been formed

to define areas of testing or disciplines in terms of test method groupings, procedures, or techniques.

A Certifier's View of Accreditation (page 70)

In his paper, "Characteristics of Laboratory Accreditation Systems—The Product Certification Program Point of View," Theodore Pritsker defined "accreditation as a systematic approach to universal acceptance by numerous parties."

He excluded individual relationships between purchasers

and suppliers. In regard to "laboratory accreditation," he sug- gested that it would be unwise to limit the extent of accredit- ation under consideration. He noted that there are several certi- fication programs which might prefer to accredit the laboratories they wish to use, and that it might be appropriate to subject some design evaluators or evaluative agencies to accreditation. He considered four aspects of accreditation from the certifier's view—adequate testing, relationship with testing laboratories, product liability, and minimum

requirements of an accreditation system.

Pritsker noted that the certifier needs laboratories that provide reliable results to serve as a basis for certification. He observed that some certification programs use multiple

cooperating laboratories, others use inhouse laboratories at several locations. These certification programs require

laboratories of proven ability that can produce results comparable from laboratory to laboratory. The certifier needs laboratories that are accredited by a system with resources to function properly.

Pritsker suggested that the relationship between certifier and testing laboratory should be minimized. Certifiers should

accept results from properly accredited laboratories, advis- ing the accreditor if discrepancies become apparent. Without

accredited laboratories, certifiers must "accredit" them by

contractional arrangements that specify conditions for acceptability, cancellation, limitations, and costs of maintenance. The relationship is "sticky" when the certifier is also the testing laboratory.

Regarding the issue of product liability, Pritsker indicat- ed that several certifiers of safety-related items have been

held liable, but is aware of no cases where laboratories or certifi- ers have been involved when only product performance is the

issue. He asserted that contractural arrangements between

parties and the claims of certifiers and manufacturers, rather than accreditation, are factors establishing responsibility in product liability actions. However, accreditation might enhance

the credibility of certification agencies in the courtroom.

Pritsker discussed the minimum requirements of an accredit- ation system. Observing that the accreditee poses no problem in definition and that requirements for criteria and methodolo- gy can be found in standard references (e.g., ASTM and

NVLAP), he asserted that the real question is, "Who is to be

the accreditor and what are his minimum requirements?". As a

certifier he wanted the accreditor of laboratories to have: technical expertise, competent personnel, ability to evaluate and

transmit the current and the latest methodology, organizational/administrative ability, and unassailable and unquestionable integrity beyond reproach.

According to Pritsker, the costs of accreditation will play

a minor part in a laboratory's budget if the accreditor meets

the above requirements and is not trying to make a profit. Pritsker characterized an accreditor as an evaluator and

communicator rather than a police officer. Accreditors should inform their clients of the latest developments in technology

and feed back problems and experiences to the standards

writing agencies. Accreditors must be open-minded, self- evaluating, and sensitive to the impact of accreditation. There must be appeal mechanisms and the capability of ascertain- ing the propriety of denying or revoking accreditation. The

accreditor's staff should be professional and motivated to provide excellence rather than the status quo. The relation- ship between accreditor and accreditee must be one of mutual respect and trust.

9
Pritsker asserted that integrity beyond reproach is the most

important and absolutely essential requirement for any

accreditor. The accreditor's only motive must be to upgrade

the testing field for the benefit of clients and industry. There must be no other motives, such as financial concerns or putting all laboratories on an equal basis. The accreditor should

not promote the benefits of specific laboratories or of any as- sociation. Pritsker asserted that no organization of laboratory members can become an accreditor because its base is in- herently suspect.

Pritsker observed that if a basic requirement for an accreditor

is integrity beyond reproach, then there is no need for an

accreditor of accreditors. Integrity and reputation beyond

reproach cannot be gained by an additional layer of accreditation. Integrity and reputation must be earned. Accreditation only evaluates performance, it cannot evaluate self interest, motivation or intent. Pritsker concluded that a Government

agency, such as NBS, must perform the primary role in labo- ratory accreditation, unless ASTM or ANSI or a similar organization offers to fill the role.

The AALA Proposal for Recognizing Accreditation

Systems (page 73)

In his paper, "General Guidelines for a Laboratory Accreditation System," John Magnotti recommended that the guidelines for the operation of laboratory accreditation systems,

as developed by Task Force C of ILAC, be used by NVLAP

to implement the proposed role of serving as an accreditor of

accreditation systems. Claiming that the purpose of his paper is to summarize these ILAC guidelines, which have been endorsed by AALA's Board of Directors, Magnotti noted that these

guidelines are consistent with the guidelines being considered by ASTM Committee E36. According to Magnotti, the guidelines recommend that a laboratory accreditation system

have the following operational requirements:

•The system must be actively engaged in accreditation of

testing laboratories.

• The system should accredit in terms of nationally or in- ternationally recognized standards or other well-defined standards and test methods within well-defined fields, scientific disiplines, or technologies.

• Technical criteria should be published and generally avail- able, and should be formulated by appropriate technical

experts. Criteria should be consistent with the current pro- posed revision of ISO/ILAC Guide 25.

• Laboratories should be assessed by impartial experts rigorously selected in accordance with clearly defined criteria. Assessments should be supported by written reports.

• The system should include a broadly based, impartial body

that reviews assessment reports and acts as the technical accrediting authority.

•The system must provide continuous accreditation by

inspection, proficiency testing, and requirements for laboratory information updates. Physical assessment

should be sufficiently frequent to ensure competence and

credibility.

• Lists of laboratories should be published, including their general capabilities and the scope of their accreditation. The publication should include the general features of the accreditation system.

• The system's precise policy dealing with advertising by

accredited laboratories should be published. The policy should specify the citation to be used with the system's

logo or acceptable forms of laboratory advertising.

•The system should have fully documented procedures,

including a contractual arrangement between the accrediting authority and accredited laboratories.

Magnotti concluded that a laboratory accreditation system must have complete and technically accurate documentation, impartial and competent assessors, and clear, understandable, and enforceable policies. An attendee suggested that AALA was proposing a twotiered bureaucracy with the inefficiency that this implied. Theodore Pritsker agreed, and noted that he knew of no other ac- creditation program looking to be accredited, in turn, by the Government. Magnotti responded that the AALA proposal

did not have both NVLAP and the accreditors doing the same

thing, but that the Government would serve as the arbiter of

private sector accrediting systems and the necessary link to the

international community. He observed that there is need for Government to provide some consistency among U.S. accreditation systems, as required by the international community.

Gerald Berman noted that ASTM E36 Committee's intent is to develop standards that can serve as a basis for such uniformity.

An attendee asked as to what was being done to encourage

harmonization, reciprocity, etc. with Canada, noting that Canada now has an accreditation system. Louis Rossi of AALA

indicated that AALA had contacted the Canadian Standards Council, received information from them, and intended

to pursue it further. Another attendee stated that it is not necessary for Govern- ment to approve accreditation systems. Noting that there is an existing and tested operating structure in the United States with criteria applicable to several areas, she inquired whether

AALA has a framework for accepting accreditations by other

accreditors. AALA representatives responded that they pro- posed that NVLAP serve as the accreditor of accreditors. Another attendee stated that laboratories vitally need a comprehensive national accreditation system to improve their own

capabilities and to drive inadequate laboratories out of business. She noted that feuding between AALA and NVLAP

should cease; neither system is adequate; some laboratories need accreditation by product, others need accreditation by

discipline. It's time to cooperate in developing a comprehensive system that can do the job, she said.

The Certification Program of the International

Electrotechnical Committee on Quality (IECQ)

(page 74)

In the paper, "The IEC's Way of Evaluating Certifiers in Participating Countries," Howard Kontje describes the IECQ

program as an international certification system for electronic components. The program is a system in which an international body, IEC, in effect accredits a national body. Manufacturers

in each country may submit their products to an appointed

National Supervisory Inspectorate (NSI). Each NSI evaluates the products in accordance with the appropriate component standard approved by the system, surveys the manufacturer's facilities, reviews the quality assurance program, and

supervises qualification tests. It is anticipated that products

granted a certificate of conformity will be accepted in other

countries. In conclusion, Kontje emphasized important elements of

the IECQ product certification system:

• Laboratory capabilities are judged for specific product

categories and in accordance with requirements for tests as specified by standards for those product categories.

• Laboratories are evaluated as part of the overall evaluation of manufacturers' quality assurance systems. For product certification, assessment of laboratories cannot be

isolated from evaluation of the total quality assurance program.

• The surveillance program is ongoing, providing at least yearly site visits to factories and laboratories to verify continuing compliance with requirements of the system.

10
An attendee inquired about the IECQ fee structure for ac- crediting independent laboratories. Howard Kontje responded

that the estimated cost for approving a laboratory for testing of a specific component (such as a capacitor) as covered by a

sectional IEC specification was $3,000. He noted that this amount would not be multiplied by the numbers of different components tested. Economies would depend upon the rela- tionship of components to the test equipment.

An attendee asked if UL , as the approved NSI for the United

States, has to pass on to the IEC the criteria that are used to evaluate laboratories. What kind of consistency and detail in criteria from country to country is required by the IECQ acting

as an accreditor of acceditors? Kontje replied that each country

is responsible for determining the acceptance criteria for laboratories within that country, and that ISO Guide 25 is being used as the general guideline for such criteria. Another attendee asked if Government funding of any sort was involved in the IECQ program. Kontje indicated that the program was a completely privately supported operation.

An attendee asked if the NSI is disqualified from doing the component testing required by the IECQ system. Kontje in- dicated that UL, as the NSI for the United States, will not perform the testing laboratory function. UL will conduct check

tests to determine that laboratory output is correct. However, in many other countries in the IECQ system, the NSI is doing the testing of the component itself. The French NSI

does all the testing of the components.

The International Laboratory Accreditation

Conference (ILAC) (page 76)

Howard Forman commented on the objectives of ILAC and

reported on the activity of one of its working groups in his paper, "ILAC: A Means for Removing Technical Barriers to Trade by Recognizing Laboratory Accreditation Systems in Different Countries." He stated that the objectives of ILAC

are to promote development of national programs for accrediting testing laboratories, employing harmonized accreditation criteria, and then to promote the development of agree- ments by which importers accept testing by accredited laboratories in exporting countries. He asserted that an ultimate

objective may be to promote worldwide agreement similar to the GATT code. Observing that 42 countries and 12 international organizations have attended 1 or more of the 5 annual ILAC Conferences held to date, Forman noted that, in intervening months,

various task and working groups have carried on relevant in- vestigations as mandated by ILAC at its annual meetings. One

working group presented its report to the ILAC 81 Confer- ence in Mexico City, entitled, "Information on Bilateral or Other Agreements for the Recognition of Laboratory Accreditation Systems."

The report identified two bilateral agreements in actual operation. One agreement between Czechoslovakia and

the German Democratic Republic provides for mutual acceptance of test data without reliance upon laboratory accreditation systems. The other identified agreement in operation,

between the Testing Laboratory Registration Council of New Zealand (TELARC) and the National Testing Authority

of Australia (NATA), provides reciprocal recognition of laboratory accreditation systems with the possible consequence

of mutual acceptance of test data. The ILAC Working Group also identified forms of recognition arrangements other than bilateral agreements. For in- stance, various foreign bodies accept test reports from laboratories accredited by the Danish National Testing Board. The

countries of the European Free Trade Association (EFTA)

have established a Convention for the Mutual Recognition of

Inspections Regarding the Manufacture of Pharmaceutical

Products. EFTA also has a scheme for recognition of pressure

vessel testing done in the exporting country. The Working

Group on Calibration Services, established by the Western European Metrology Club, announced in 1980 an agree- ment, "International Acceptance of Calibration and Measure- ment Certificates," and in 1981 published minimum require- ments for mutual recognition of certificates. From its initial study, the ILAC working group concluded that reciprocal rec- ognition of accreditation systems and mutual acceptance of

test data across international boundaries are possible when

national bodies or authorities are involved. The working group

requested and received approval at the ILAC/81 annual meeting to continue its work and to develop guidelines that would

serve as a basis for bilateral or other mutual agreements. The

guidelines would include:

1. Prerequisites for an agreement

• Description of accreditation system to be publicly

available.

• Scope of accreditation to be clearly stated.

• National authority to be competent to enter into mutual agreements.

• National authority to represent the scope of testing in agreements.

• Systems' accreditation criteria to be those endorsed by

ILAC.

2. Items to be covered by the agreement

• A communication channel with an identified inter- national contact point.

• A channel for transmitting information on accredited

laboratories and their fields of expertise.

• Provision for requests between parties for additional information regarding tests and services of particular

laboratories.

• Provisions whereby experts could be interchanged for laboratory inspections.

• Provisions for intercomparative testing.

3. Content and consequences of an agreement

The agreement should specify binding consequences, such as a provision that one party will recognize the test results or the laboratory accreditation system of the other

party as equivalent to its own test results or system.

An attendee, noting that the United States has many laboratory accreditation programs and that NVLAP has only three programs, asked whether the U.S. international position would

be better served if NVLAP were to serve as the overall coordi- nator of U.S. laboratory accreditation programs. He questioned

whether NVLAP and NBS could be the arbitrator of all U.S. programs and also accredit laboratories and compete with other

national systems. Forman indicated that this workshop was to provide advice on this subject. Since the international aspect

regarding laboratory accreditation was itself so new, Forman's

opinion was that NVLAP should not change its direction.

The Organization for Economic Cooperation

and Development (OECD) (page 79)

Carl Morris outlined several aspects of OECD's develop- ment of an international approach to mutual acceptance of

test data, particularly in regard to chemical testing related

to health and the environment.

The OECD expert group, under leadership of the United

States, was established as a result of a 1978 OECD council

decision giving high priority to development of principles of an international Good Laboratory Practice (GLP). The expert group was to provide for international discussion and agree- ment on such principles and also issues related to implementation of national GLP compliance within the international framework. Recommendations of the expert group would

provide a basis for high-level OECD discussions.

11
Seventeen countries and the Commission of the European

Communities participating in the OECD expert group devel- oped the "OECD Principles of Good Laboratory Practice." The OECD council approved this document in May 1981 and

recommended that it be provisionally implemented in member countries. Issues addressed in this document include: scope, purpose, and definitions; laboratory organization, facilities, equipment, and personnel; sample characterization, handling, storage, and disposal; reagents and solutions; standard

operating procedures and study methodology; and proce- dures for health and safety, quality assurance, record retention, and waste disposal. In May 1981, the OECD council also adopted a Decision Concerning the Mutual Acceptance of Data in the Assessment

of Chemicals. This decision determined ". . . that data generated

in the testing of chemicals in an OECD country in accordance

with OECD Test Guidelines and OECD Principles of Good

Laboratory Practice shall be accepted in other Member

countries for purposes of assessment and other uses relating

to the protection of man and the environment."

Noting that attainment of this goal could lead to elimination of duplicate testing and avoidance of non-tariff barriers

to trade, Morris observed the need for countries to harmonize

and implement the OECD test guidelines and principles of GLP, and to have in place an internationally harmonized national GLP program. In its second phase of activity, the ex- pert group has addressed the issues involved in implementing

the OECD principles of GLP at both the national and inter- national levels. At the national level, the expert group recommended that:

• National governments follow OECD principles of GLP,

• National governments have responsibility to implement

a GLP compliance program,

• National programs provide laboratory inspections and

audits,

• Inspections and audits be at sufficient frequency to assure continuing compliance,

• Qualified and properly trained inspectors and audit per- sonnel be used. At the international level, the expert group recommended:

• Establishment of national GLP compliance programs to assure application of OECD test guidelines and principles of GLP;

• Establishment of an international mechanism to recognize

national GLP compliance programs;

• Development of a notification system whereby the OECD

council can be advised that a member nation has in place

the elements for mutual acceptance of data;

• Regular and complete communication among National

authorities regarding compliance matters, including provisions for dealing with "questioned" data; and

• An International GLP Forum to share technical and ad- ministrative matters regarding GLP implementation.

Morris stated that the expert group has also developed

"OECD Guidelines for National GLP Inspections and Study

Audits" for use by national authorities and inspectors. The

expert group has recommended that this document be accepted

for use by member countries. In effect, OECD has developed

an international system for mutually recognition of national laboratory accreditation systems.

An attendee asked whether EPA intends to use the OECD

plan for the benefit of U.S. companies, and if so, when will EPA announce it. Noting that the U.S. has been an active participant in the OECD developments, Morris indicated that the U.S. position will be formulated only after the public com- ment period in early 1982. High level OECD meetings will occur in late 1982 and in early 1983 after which provisional

implementation could begin. EPA is developing a proposal

for health effects testing which is in fair harmony with FDA

and OECD activity. The FDA and EPA compliance programs

for health and environmental testing are being harmonized.

An interagency agreement provides EPA with FDA inspections of laboratories for health effects tests. EPA assessors are inspecting environmental laboratories for compliance with good laboratory practice.

On the State-of-the-Art (page 81)

In his paper, "Recognition of Accrediting Agencies,

State-of-the-Art," Theodore Young describes the program

of the U.S. Department of Education (DOE) as representative of the state-of-the-art of an agency which accredits other

accreditating agencies. He reviewed the history, scope, administrative structure, and procedures of the program, and identified a number of issues which could relate to labo- ratory accreditation. Currently, the U.S. Secretary of Education is required by

various statutes dating from 1952 to recognize and list accredit- ing agencies for postsecondary education. The program has pro- cedures and criteria for recognition of private sector accredit- ing agencies, for recognition of State approval agencies for vocational education, and for recognition of State approval

agencies for nursing education. Under these rules, some 80 pri- vate sector accrediting agencies and 20 State approval agencies

are recognized. As a group, these recognized agencies accredit about 3000 universities, colleges, and postsecondary schools and

about 8000 specialized programs of postsecondary education. The process through which the program recognizes accredit- ing agencies has five stages. The applicant accrediting agen- cy develops a petition consisting of a narrative statement with supporting documentation, showing compliance with the criteria. Next, the applicant submits the petition at least 3 months

before a scheduled review by the Advisory Committee. The

staff then prepares an analysis of the petition, visits the applicant agency, observes their administrative evaluation and

accrediting activity, and interviews agency staff and other

interested parties. An Advisory Committee conducts a tran- scribed public hearing, including the petitioning agency, the

staff, and requesting third parties. Recommendations are forwarded to an Assistant Secretary for final decision. Recognition may be denied, deferred, or granted for a period up

to 4 years. A statement of the scope of the agency's recognized

accreditation activities is included. Listings of recognized agencies are published periodically in the Federal Register and

appropriate brochures.

Criteria for recognition of accrediting agencies, first published in 1948, were revised in 1952, 1969, and in 1974. Six requirements in the 1948 criteria gradually increased to 47

requirements in the 1974 version. Whereas the 1948 criteria required an agency to provide on-site visits and published

criteria and listings, the 1974 criteria require an agency to also have on-going evaluation programs, and self-analysis

requirements for accredited schools involving faculty, students,

staff, and other constituents. For recognition, agencies are now required to have published statements of key personnel,

ownership, control, purpose, and objective; published standards and procedures for evaluation, accreditation, and appeal;

and written guidelines and procedures for on-site examinations and handling of complaints.

Young noted one particular aspect of the program's criteria for recognition of accrediting agencies. The criteria, except

for the 1948 version, are generally devoid of specific re- quirements that an accrediting agency needs to impose upon

schools or educational programs; i.e., criteria for recognition

of accrediting agencies do not embody criteria for the accreditation of schools. This is consistent with traditional Government policy that educational standards for postsecondary

education are the province of the private sector and the States.

12
The record indicates that private sector accrediting agencies increased from 5 in 1928 to 78 in 1981, despite the intro- duction of increasingly complex criteria, and despite efforts by the program and national associations to control such prolif- eration. Young observed that rules and criteria of Education's National Recognition Program act to discourage duplication

of accreditation activity but do not appear to discourage

fragmentation of such activity. For instance, instead of a single

recognized accrediting agency for the health technology field, there are 17. Young identifies a number of issues and poses questions rela- tive to a similar program in the testing laboratory:

• Whereas the DOE is the single Federal authority for education and depends wholly upon private and State accredit- ing agencies, and whereas accrediting agencies must be

federally recognized if their members are to be deemed

eligible for Federal funding, similar compelling associations are not apparent in the testing laboratory field for a centralized Federal recognition program or for accrediting agencies to seek such Federal recognition.

•Accrediting agencies for education are considered to provide a public service and, for recognition, are required to have a governmental or quasigovernmental character. Should a proposed recognition program in the testing labo- ratory field be restricted to accrediting agencies with a

similar charter?

• Should criteria for recognition of laboratory accrediting

agencies be limited to elements which assess technical and

professional competence of laboratories, or should criteria also contain elements which assess public concerns such

as accountability, integrity, due process, etc.? DOE's

program criteria evolved from one to the other as its public profile grew. •To what extent should fragmentation of the scope of lab- oratory accreditation be controlled? Can a recognition program for laboratory accrediting agencies place limits on the degree of specialization? Are there alternatives to an applicant accrediting agency defining the scope of

accreditation?

• Education's National Recognition Program minimizes

duplication of accrediting activities because it attracts

all such accrediting activity to seek recognition under

the program. What enticements could a program for lab- oratory accrediting agencies offer that would encourage

such agencies to seek recognition and to submit to the pro- gram's requirements for coordination? One attendee asked for references to the court case cited in the paper. The reference for the District Court decision is 302 F. Supp. 459 (1969); for the Court of Appeals decision, 432

F.2d650 (1970). The latter citation references the Supreme

Court position.

Another attendee asked whether the effort and costs involved

in DOE's National Recognition Program had improved the

quality of life over its long history. Young observed that the program was first initiated to assist students in selecting schools, and educators in accepting transfers and graduate students. The program was later mandated by legislation, starting in 1952, to better assure that billion-dollar education subsidy programs were properly utilized. Quality of life was improved to the extent that students obtained more reliable guidance and

protection from fraudulent educational programs. Another attendee asked whether DOE's National Recognition Program pays for audits and inspections conducted

by recognized accrediting agencies. Young indicated that DOE does not fund accreditation agency activities. Whether

agencies pay their assessors probably differs from one group

to another. The program's criteria require accrediting agencies to charge only reasonable fees for their accreditation

services.

DISCUSSION

An attendee indicated that initially NVLAP could establish an accreditation program only if requested by an outside

party, and only if the need was established. Only then could NVLAP establish standards and accreditation criteria and

implement an accreditation program. Howard Forman con- firmed that this is the general NVLAP procedure, 7a, except

that the requestor, not NVLAP, has to identify exisiting standards to be used, as NVLAP does not develop standards,

only the criteria by consensus procedures. The attendee asked if, under additional NVLAP procedures, any Government agency

issuing standards could require NVLAP to establish an accreditation program to monitor such standards. Could that Govern- ment agency also establish the accreditation criteria without

private sector participation? Under NVLAP, could a Govern- ment agency force affected parties in the private sector to participate in an accreditation program established by that agency?

An attendee noted that the answer is "yes," as this was done in establishing the NVLAP program for carpets. John Locke of NVLAP observed that the NVLAP Part 7b procedures, are

for Federal agencies already having authority to determine

need, to establish standards, and to determine compliance of products to the standards. Locke noted that the NVLAP proce- dures contain mechanisms for participation of the private

sector. NVLAP publishes a request from the Federal agency

in the Federal Register, providing for a 60-day comment period.

Responses, with copies to NVLAP, are reviewed by the requesting Federal agency which must decide whether it has the right

and authority to proceed with the requested accreditation pro- gram. With concurrence of the Federal agency that all public

comments received have been addressed, NVLAP proceeds

with the program. Howard Forman noted that in these NVLAP

programs, NBS retains responsibility for laboratory on-site investigations and proficiency testing programs, and that DOC

makes the final decision regarding a laboratory's accreditation. James Bryson of NBS added that any accreditation cri- teria proposed by the requesting Federal agency must be within

the framework of the general criteria already established by

NVLAP. A representative from the requesting agency for NVLAP's carpet program noted that criteria used in that pro- gram were already in Federal regulations 200.935 and are uti- lized in 14 existing HUD programs. An attendee, noting the close relationship between standards development, laboratory accreditation, and product certifi- cation, asked if the public sector-private sector roles in standards and certification area could be models for similar

roles in the laboratory accreditation field. Howard Forman

stated his belief that standards development should essentially

be a private sector activity and said he believed that laboratory accreditation has a different scenario. Voluntary standards have thousands of persons active in about 400 organizations with long histories of standards development. The 70 or so

identified laboratory accreditation programs are generally specialized, and do not cover the overall needs for laboratory

accreditation—the objective of the NVLAP and AALA pro- grams. Thus, there would not be a case of Government get- ting out of something well established in the private sector. Forman indicated his support for the establishment of AALA,

but noted that AALA had just started. Perhaps, in the future, when the private sector had established a track record, the question of Government involvement in laboratory accredit- ation should be reevaluated. The attendee agreed, with respect

to present day circumstances, but still favored the principle of a joint Government/private sector effort, stating that NVLAP and AALA, operating independently, have less chance

of survival. Earl Hess noted that Government officials fre- quently justify programs on the basis that the private sector

is not capable of filling the need. He asserted that the private

sector is ready to fill the need if the government will step aside.

13
Another attendee referring to the cost of funding the pro- grams, indicated that it was important to compare costs, particularly the costs of examining the laboratories. He noted

that the DOE program and the IECQ program for electronic components are self-supporting. Assessors for the Australian program are contributed by industry. We need to look at the implementation of the OECD activities by FDA, EPA, and

other regulatory programs, he said.

A MECHANISM TO ACCREDIT ORGANIZATIONS

WHICH ACCREDIT TESTING LABORATORIES

The AALA Proposal (page 92)

Louis Rossi, Chairman of AALA, noted in his paper, "Proposal, To Transfer the Current NVLAP System into a System for Accrediting Private Accreditation Systems,"

that the concern of this workshop was the future direction of laboratory accreditation and the recommendation that NVLAP

assume the role of accreditor of accreditation systems and pro- vide the link with the international laboratory community.

Rossi pointed out legal and policy guidelines supported by the Reagan Administration as impetus for shifting laboratory

accreditation to the private sector, noted the existence of criteria for standardizing and operating laboratory accreditation sys- tems, and cited recommendations to be included in a proposed

regulation to be published by DOC as a result of this workshop.

Regarding legal and policy guidelines of the current administration, Rossi referenced the recently published Office of Management and Budget (OMB) Circular A-119, stating that its general policy specifies that Federal Government will rely on

voluntary standards for procurement; will participate in vol- untary standards bodies when in the public interest and when

compatible with agencies' missions; and will coordinate such

participation to increase effectiveness and to ensure that Federal views are in the public interest. Rossi also noted the Reagan

Administration's support of OMB Cirular A-76, which intends

to enhance cost-efficient performance within the Federal Government by using the private market whenever possible. Rossi claimed that laboratory accreditation programs can and should operate in the private sector. Transfer of the re- sponsibility for accrediting laboratories to the private sector should begin now, with the Federal Government assuming a

role as an accreditor of laboratory accreditation systems. This

will relieve the current burden on the Federal budget. Beginning the transition process now will phaseout existing NVLAP

programs as private sector accreditation systems respond

and refine their accreditation capabilities. Rossi noted that a Federal precedent for programs to accredit accreditation programs has been long established in the DOE with its pro- cedures and criteria for recognition of systems that accredit educational institutions. A program for accrediting systems that accredit laboratories is needed because manufacturers, con- sumers, and government need a basis for determining the competence and quality of the large number of existing laboratory

accreditation programs. Since laboratories provide test data to support claims of conformity of products to standards, labor- atory accrediting systems provide an essential service. Using AALA as an example, Rossi claimed that the private

sector is prepared to provide voluntary laboratory accreditation

as NVLAP transforms its role to that of an accreditor of ac- creditation systems and primary U.S. link with the international laboratory accreditation community. AALA, patterned

after Australia's national accreditation system, organizes its accreditation system by discipline. Laboratories are accredited for specific tests or groups of tests within disciplines or

subdisciplines. This approach can provide laboratories with an evaluation for their total range of capabilities, and enables AALA to process a substantial number of accreditations in reasonable time.

Rossi observed that there are, in the private sector, inde- pendent, nonprofit organizations dedicated to voluntary laboratory accreditation which can maintain objectivity and balance

in accreditation systems. In addition, many other systems exist for the basic purpose of certifying products and, in the process, accredit laboratories which test these products. Serious

tasks facing private sector laboratory accreditation systems

are providing for balanced representation of government and

private sector interests, effectively disseminating fair and complete information, controlling advertising, and maintaining

technically valid and well-accepted reaccreditation systems. Rossi noted that the private sector cannot at this time pro- vide a model for an overall laboratory accreditation system.

It is not certain how the voluntary laboratory accreditation system will evolve as a cooperative venture with Government. He claimed that there will be a maturing and possibly a consolidation where one or a few systems will emerge as coordi- nating bodies for private sector laboratory accreditation effort. Rossi claimed that there is certain need for a body in the United States to accredit accreditation systems and to serve

as the link between accreditation systems in the United States and other countries, presumably within the ILAC structure. Regarding criteria for standardizing and operating laboratory accreditation systems, Rossi pointed out that if the Government accepts the proposition of accrediting laboratory accreditation systems, the evaluation criteria for accrediting such systems will be of paramount importance. Noting

that ILAC criteria seem to require additional work and co- ordination, he suggested that these criteria, endorsed by ILAC

81, be used as tentative criteria subject to modification by

ILAC or by the Government acting as an accreditor of accredit- ation systems. Rossi observed that use of these criteria would

provide a solid base for an eventual interlocking network of

global accreditation systems. He also noted that ASTM

Committee E-36 is developing similar criteria through the consensus process. Rossi reiterated highlights of these ILAC criteria:

• Accreditation systems must specify their accreditation

in terms of nationally or internationally recognized stan- dards and test methods in relation to well-defined fields of testing, scientific disciplines or technologies, or specific

products or tests;

• Accreditation criteria must be published and generally

available;

• Evaluation of technical competence of laboratories must

be in terms of ISO/ILAC criteria consistent with ISO

Guide 25;

• Accreditation systems must provide for periodic reas- sessments of accredited laboratories and written assessor

reports; and

• An impartial and independent appeals procedure must be

available to resolve disputes associated with accreditation. Rossi concluded by recommending that the role of NVLAP be transformed to one of accrediting accreditation systems and

providing that critical link with the international laboratory

community, to be accomplished as follows:

1 . NVLAP would establish no new laboratory accreditation programs.

2. During the transition, private sector accreditation systems

would accept the NVLAP accredited laboratories until accreditation expires.

3. Documents concerning specific areas of the accreditation procedures, including applications, checklists, advertising

policy, and assessor qualifications would be reviewed and

rewritten as necessary.

4. The adoption, at least in draft form, of the work done by

Task Force C, Working Group One of ILAC, in creating

criteria would be used in evaluating laboratory accreditation systems.

14
DISCUSSION

Opening the workshop to questions and opinions from the

floor, the session moderator, Stanley Warshaw, noted that AALA's proposal included more than transferring an exist- ing Government activity to the private sector. The proposal

includes the establishment of a new Government effort: the

accreditation of private sector accrediting bodies. The dis- cussion that followed not only responded to the AALA proposal, but also concerned the need for laboratory accreditation, and the significance of discipline versus product accreditation, and included questions about AALA and NVLAP.

Response to the AALA Proposal

Noting that the AALA proposal admitted uncertainty with regard to the model to follow in switching Government

responsibility for laboratory accreditation to the private sector, one attendee suggested that the collaborative effort between

the National Institute for Occupational Safety and Health

(NIOSH) and the American Industrial Hygiene Association (AIHA) could be an example. He stated that the AIHA ac- creditation program for industrial hygiene laboratories was

initially assisted by Government funding, particularly for a

proficiency testing program, and is now totally self-sustaining.

NIOSH is no longer technically involved. Howard Forman noted that NVLAP intended to become

self-sustaining, so that one of the benefits claimed for the AALA proposal—to save money for the Government—is not

a strong point. Forman asked if there might be other reasons

in the public interest why the change should be made, such as more efficient, meaningful, or effective accreditation. Rossi responded that AALA's proposal was based upon the current

situation and not upon possible future conditions. At the time of the workshop, NVLAP was not self-sustaining. Warshaw

observed that the AALA proposal's intent was to follow current Administration policy; namely, to transfer Government

activity to the private sector when the private sector is able

to conduct such activity.

Another attendee asked why an organization such as his, currently accredited by and satisfied with the NVLAP sys- tem, should have interest in the AALA proposal. What is the

benefit of AALA over NVLAP accreditation? Rossi indicat- ed that AALA did not propose to be the only accreditation system, or to provide better benefits to the accreditee. The

AALA proposal was that any accreditation system should be under an umbrella such as that to be provided by NVLAP.

The attendee asked how AALA's proposed accreditation process would differ in operation from the current NVLAP

process. To clarify the question Warshaw asked, if AALA

picked up the NVLAP activity, would laboratories be accredit- ed for product testing or on a discipline basis? Rossi stated

that, following a transition period, laboratories would be ac- credited on the basis of discipline standards. Noting that although AALA apparently believes that concurrent and independent operation with NVLAP is unsatis- factory and that the AALA proposal allows for concurrent

operation of more than one accreditation system, Howard

Forrnan asked how the AALA proposal would help AALA or

the public interest. Rossi indicated that he couldn't answer

this question, as he didn't know how private sector accreditation systems would evolve under AALA's proposal. Warshaw

stressed that the AALA proposal would allow practically any accreditation system that wished to be accredited by the Government to be recognized.

Another attendee observed that if the Federal Govern- ment accredits accreditors and the accreditors do the work

the Federal Government is now doing, it would seem that in- creased, rather than reduced, costs would result. Rossi

expressed the opinion that NVLAP accreditation on a product basis is too costly and time consuming. He said that AALA

believes that many of the same objectives can be accomplished

by accrediting on the basis of discipline standards. Gerald Berman of NBS noted that, under the AALA proposal, AALA could potentially have one patron and NVLAP

one client—not a very efficient or effective use of Federal funds. He asked whether AALA had identified other accrediting sys- tems that would like accreditation by NVLAP. Rossi indicated

that a purpose of this workshop was to answer this question.

No other accrediting systems were identified. An attendee stated that it is important in evaluating an ac- creditation system to assess the management function. He noted

that NBS is a recognized authority for measurement in tech- nological areas. The AALA proposal provided that NVLAP,

under NBS, would become an assessor of accreditation management rather than an assessor of technological activity. He suggested that whether Congress would fund such NBS

activity would require review by appropriate parties. Earl Hess reiterated the point made in his paper—that multidiscipline testing laboratories and their customers need comprehensive laboratory accreditation programs, a need

that has not been served by Government, specifically NVLAP's

product-oriented laboratory accreditation programs. Because

this need had been unmet for 10 years, multidiscipline laboratories had supported and developed AALA's discipline- oriented approach, putting their reliance in the private sector. If this was not the right answer, he asked, what were the

multidiscipline laboratories and the users to do—wait for devel- opment of accreditation programs that serve this need, under

NVLAP's new procedures under Part 7c, or the initiation and

development of some new program? It would take Government

too long to accomplish this, he said. Warshaw responded that the significant difference between the Government and pri- vate sector approach is the due process checks and balances

built into Government actions. He noted that the proceedings of

this workshop would be published in February 1982. Suggested

alternatives contained in the proceedings wouuld need to be

published for comment in the Federal Register—another 30- to 60-day period. If serious objectives did not arise, it would likely be next fall before alteration of the current NVLAP could

occur. On the other hand, the referenced NVLAP procedures,

Part 7c, were in effect and could be implemented immediately to establish needed programs. Hess observed that this response was the best reason given for switching to the private sector, where things can happen expeditiously. Warshaw noted that some others believe that private sector expediency is sometimes

achieved at the expense of needed visibility, public scrutiny,

and auditing.

Another attendee stated that accreditation by the Government rather than the private sector could reduce some of

the duplication of accreditation programs, and would be more

readily accepted by foreign governments.

The Need for Laboratory Accreditation

One attendee noted that the AALA proposal mentioned a strong demand for third-party accreditation. He asked for an identification of this demand from other than commercial

laboratories. Another attendee wanted to know what body of

facts substantiated the need for a centralized accreditation system. Louis Rossi responded that the AALA proposal ref- erenced needs in the international area, mentioning ILAC's

attempt to identify national laboratory accreditation programs. He also mentioned the interest in a national accreditation system as expressed at this workshop by the National Conference of States on Building Codes and Standards and by

the National Institute of Building Sciences. Warshaw observed

that market data was not available to demonstrate the need

15
for third-party accreditation, but if there was no need there would be no customer demand in this free enterprise system.

Another attendee stated that this workshop, concerning

third-party accreditation, should disclaim any intent to sell a need for accreditation. Warshaw noted that the workshop was in response to requests from the private sector, and was

not selling anything. Another attendee claimed that thousands

of people in the coal industry demand and need third-party

accreditation. A different attendee indicated that his company

had been anticipating a national accreditation system for laboratories, particularly in environmental monitoring. He noted

that they had initiated a voluntary good laboratory practices program, and now were establishing an internal accreditation program. An attendee indicated that part of the record regarding need

for laboratory accreditation had not been given at this workshop. He referred to the hearings held in the 1970s, including

the OSHA hearings on laboratory accreditation. A major reason

for these hearings derived from the practices of States, municipalities, and OSHA to require listing or labeling of products (certification) by nationally recognized laboratories. There

is still need for a system to recognize such laboratories. This

subject was also discussed in the FTC hearings relating to stan- dards and certification. He noted that AALA, under a small

contract with OSHA, developed a system and criteria for ac- crediting laboratories that certify occupational use products. He observed that this system plan has yet to be implemented by OSHA, but is being encouraged by a number of

States. (See OSHA letter in Part 5 of these proceedings.) John

Locke of DOC mentioned a related need. He noted that there

is an ANSI program for accrediting certification organizations, but this was not the only need. Many laboratories wanted to be recognized for the testing of products rather than for pro- viding quality control and other assurance requirements of a

certification system. The need of these laboratories was served by laboratory accreditation systems. Ted Pritsker did not agree, claiming that laboratories serving certification programs

are normally approved by the certification program. An at- tendee did see a difference between accrediting laboratories and accrediting certification programs. For instance, OSHA

would use AALA to accredit laboratories serving certification programs, where OSHA would retain responsibility for assuring

that the functions of the certifying body are adequate. In regard to ANSI's accreditation of certification programs,

he noted that there had been little demand for the service

to date. Howard Forman suggested that a market survey be conduct- ed to determine who really wants laboratory accreditation, other than those who have mandated such requirements in regulations or in contracts. Then the type of accreditation system

that would best serve the need could be determined. An at- tendee suggested that such needs be determined before any more accreditation programs are started. He noted that his laboratory is accredited by NVLAP because the Govern- ment requires accreditation for thermal insulation tests. His

laboratory had the choice of using NVLAP or hiring outside

services of accredited laboratories. But another attendee

disagreed, believing that manufacturers and the testing industry created the need. He noted that as an engineer he couldn't obtain reliable engineering information. Someone pointed

out that the aircraft industry required laboratory accreditation in the early 1960s. Because of conflict-of-interest concerns, ACIL rejected the idea of becoming a laboratory ac- creditation organization, and thereafter sought Government

assistance. Someone else pointed out that voluntary laboratory accreditation was for those industries that need it. If you

didn't need it, you didn't have to use it. A person noted the propensity for voluntary systems to become de facto mandatory systems, particularly in international trade.

Significance of Product Versus Discipline Accreditation

Two attendees pointed out that the AALA proposal included one issue that needs attention: the product versus discipline

approach to accreditation. Rossi responded that although

accreditation by discipline encompasses much more than

accreditation by product area, both approaches were alike in some respects. Both approaches examined performance of specific test methods or groups of test methods. He suggested

that the latest NVLAP proposal for a program in acoustical

testing was really a discipline oriented laboratory accreditation program. Gerald Berman of NBS stated that the difference between

the product and discipline approach to accreditation was

primarily a matter of semantics. He noted that the referenced NVLAP program in accoustical testing included some 50 test methods which, taken together, might constitute an acoustic

testing discipline. Peter Forrest of the National Testing Laboratory Accreditation Service (NATLAS) of England agreed with Berman. He observed that NATLAS, NATA of Australia, and

NVLAP of the United States all accredit laboratories to carry out particular tests or types of tests. Another observer indi- cated that if one were to evaluate a concrete testing laboratory on the basis of ASTM standard E329, using the discipline- oriented procedures of the Australian NATA program, one would have to evaluate the laboratory for 30 to 40 disciplines or subdisciplines.

Questions Concerning NVLAP or AALA

Louis Rossi indicated in response to a question that AALA

was a nonprofit organization, as recognized by the Internal Revenue Service, sustained by membership dues, contributions,

and accreditation fees. Ted Pritsker expressed the opinion that the AALA proposal,

in essence, requested the replacement of NVLAP accreditation activity by AALA. He said the workshop should have been

provided background information on AALA: its financial capability, its inspection procedures, its appeal mechanisms, and

its organizational structure. Warshaw, moderator of the ses- sion, asked if AALA would provide a background briefing to the workshop. Pritsker indicated that such a briefing at the end of the workshop would only contribute to the public re- cord of the workshop, but would not provide attendees an

opportunity to think about it or to question it. Rossi of AALA

observed that the planning meeting, which was attended by

Pritsker, had not scheduled a presentation of an AALA back- ground paper, and therefore AALA was not prepared to pro- vide such a briefing. Rossi noted that the workshop was as- sembled to consider a proposal made by AALA—not to learn about the AALA program. Warshaw observed that planning

may have been inadequate regarding the need for briefings on AALA and NVLAP, but this should not hamper discussions of the main issue—whether the Government should alter its role in accreditation, and if so, how?

An attendee requested that two-page explanations of AALA

and NVLAP be included in the workshop proceedings, with a matrix matching up the key elements of both programs. He

suggested that a task group of AALA and NVLAP representatives be assembled to prepare these documents. Rossi request- ed that a recent ASTM article on AALA be included as an addendum to the proceedings. Warshaw indicated that these requests would be considered, subject to concerns regarding

the cost and size of the proceedings. He noted that the NVLAP

program was described in the Federal Register and in condensed

summaries available at the workshop's registration desk. He

also referenced the ASTM article describing AALA in a paper

authored by Roger Amorosi appearing in ASTM Standardization News, Volume 8, Number 11, November 1980.

16
Another attendee expressed concern, but was unfamiliar with the mechanisms of the NVLAP and AALA programs. He noted that NVLAP's listing of accredited laboratories includes the laboratories of many suppliers. He interpreted

this to mean that such suppliers were now accredited by the Federal Government to certify their own products. Warshaw

said that such interpretation was wrong. He noted that accreditation was concerned with a laboratory's having capability to conduct certain tests and procedures. Accreditation did not concern itself with requirements for product certification, such

as continued quality control. The attendee observed, however, that in laboratory accreditation the laboratory's equipment

and personnel are certified. A laboratory was accredited to perform specific tests. If the laboratory performed such

tests, the laboratory user must assume that they were certi- fied tests. James Bryson of NBS commented that NVLAP did

not certify people or equipment. He said that NVLAP de- termined that laboratory personnel were capable of performing

a test in accordance with the standard, and that equipment was of the correct type and properly calibrated. Warshaw noted

that ISO definitions distinguish between laboratory accreditation and product certification, as pointed out by Baron

Whitaker's presentation. Laboratory accreditation could be

considered as an incremental step in product certification.

FORMAL STATEMENTS PRESENTED

BY ATTENDEES

Six formal statements were presented during discussion

periods of the workshop. These statements are presented in their entirety in Part 4 of these proceedings. A summary of

these statements follows:

A Statement on Laboratory Accreditation by the National Institute of Building Science (NIBS)

by Joseph O'Grady

The subject of certification and related topics pertaining

to building products, materials, subsystems, and systems is one of the highest priority issues in the NIBS 1982 Program

Plan. The subject of laboratory accreditation and this workshop is of interest and concern because the purpose of laboratory

accreditation is to maintain an acceptable level of quality in laboratories, providing reliable test results upon which to base such efforts as product certification. NIBS is in favor of lab- oratory accreditation to be provided by a recognized nation- wide system that would tend to eliminate the need for dupli- cate accreditations. Although not yet in agreement on the form

and management of such a nationwide system, NIBS will continue to serve as a forum where all sectors of the building community can address the issue.

Contribution to the Discussion by Peter Forrest

The United Kingdom's recently established National Testing

Laboratory Accreditation Scheme (NATLAS) is Governmentbased under the auspices of the Department of Industry. It is Britain's counterpart to NVLAP. In developing NATLAS,

an appointed steering committee, representative of testing laboratories, their customers, and accrediting organizations, considered whether NATLAS should accredit existing systems

or seek to incorporate existing systems into one central sys- tem that would accredit laboratories in accordance with a single

set of regulations, accreditation standards, and criteria. The

latter option was chosen because: •Direct accreditation by the Government NATLAS would

be more readily recognized and accepted by laboratories' customers;

• Participation of existing systems in NATLAS, rather than

their operating independently, would reduce the duplication

and multiple assessments of laboratories; and

•Negotiations for mutual recognition between a centrally controlled and operated NATLAS and other nations' labo- ratory accreditation systems would be eased; also, better overseas acceptance of tests results furnished by laboratories accredited directly by NATLAS.

Forrest noted that of eight existing laboratory accreditation programs identified in the United Kingdom, five had already

agreed to participate in NATLAS. The five agreed to recognize NATLAS accredited laboratories, to encourage their accredited laboratories to join NATLAS, to discontinue, where

practical, independent assessments of laboratories, and to provide for assessors to operate on behalf of NATLAS.

Position Statement by W. D. Edsall

Representing the Committee on General Metallurgy of

the American Iron and Steel Institute (AISI), "... the senior technical committee for the steel industry . . .", Edsall identified at least three interest groups at this workshop: NVLAP,

representing NBS interests; AALA, representing the interests of the American Council of Independent Laboratories (ACIL);

and the interests of major manufacturers operating captive

laboratories. He observed that the steel industry operated about 700 laboratories, and speculated that the petroleum industry

operated about the same number. He noted that these industries sold all of their products to specifications, and their laboratories were under continuous audit and survey by their cus- tomers. Edsall claimed that neither he nor the technical people

of AISI were convinced that there was a need for third-party

laboratory accreditation. He asked, where was the absolute proof that captive laboratories of manufacturers needed

third-party accreditation?

If independent commercial laboratories such as those

in ACIL need a laboratory accreditation program, they should

decide as to what best suits them and their business environ- ment. If or when a need for accreditation is proven for captive laboratories, it is unlikely that AALA would be accepted

as a meaningful third party. Such accreditation must carry

the stamp of the U.S. Government to be meaningful in the

world's markets, Edsall said. In this event the U.S. Government should not actually do

the accreditation, since it lacked, he said, sufficient qualified people to survey and audit all the laboratories. The

Government should instead define evaluation and accreditation

criteria similar to those in 10 CFR 50. The Government should

then recognize organizations to do the evaluations and accreditations, providing audits of the recognized programs. Accreditation certificates issued to laboratories should carry a U.S. Government imprint, Edsall advised.

Comments on the AALA Proposal Pertaining to Laboratory Accreditation by Derek Barton

Laboratories need to establish acceptance in the marketplace based upon their performance rather than their accreditation. However, Underwriters Laboratories (UL) does not oppose

laboratory accreditation in principle, provided it is based upon

valid specific criteria and provides reasonable assurance of compliance. In general, UL considers NVLAP an effective response to identified needs in specific product areas. NVLAP's effectiveness can be endangered if laboratory accreditaton is considered synonymous with, rather than an element of, product certification. Its effectiveness can also be damaged if requirements for participation are diluted in an

attempt to attract broader interests and participation. Valid

laboratory accreditation requires identification of specific

17
products and test methods, tailoring accreditation criteria accordingly. UL believes that NVLAP should continue accreditation programs in specific areas where need is determined

to exist. UL opposes the proposal that NVLAP accredit laboratory

accreditation systems. Many special-purpose laboratory

accreditation programs in the public and private sector have

operated successfully without higher levels of supervision. Addition of this unnecessary function would impose further costs upon consumers and provide credibility to accreditation programs (and their accredited laboratories) that would be

unjustified because, of necessity, only broad criteria and low

levels of supervision could be provided. The Department of Education's programs for recognition of educational accrediting

agencies, suggested by the proposal as a model, were mandated

by law as a condition for granting Federal funds. UL believes

that for privately operated businesses, such as those in the

field of laboratory accreditation, such regulation is unnecessary.

Position Statement by Robert Woodall

NVLAP should retain its present role, but the program should be modified to provide expanded benefits at reduced cost. Dealing with unmanageable numbers of specific test standards,

whether product or discipline oriented, should be abandoned

in favor of assessing generic concepts of good laboratory practice and qualifying laboratories' basic quality assurance

systems. Paperwork must be relieved. Efforts in this direction,

supported by NBS's adequate provision of specific proficiency

test samples, would discharge DOC's responsibilities, both

domestically and internationally. DOC should neither substitute for nor expand into the area of accrediting accreditors. Specific accreditation programs should be left to the judge- ment of our free enterprise system.

An Opinion on Laboratory Accreditation Policy

by Geoscience, Ltd. There are disadvantages in accrediting laboratories by complete field rather than by specific tests. One, the quality of

the performance of specific tests could be lowered. Two, the

services of small but high-quality laboratories that serve only one or two test methods could be lost. It is better to accredit by test method than by entire field. There are important advantages for Government, such

as NVLAP, acting as the accrediting agency for testing

laboratories:

• NBS has a high level of technical and scientific achieve- ment that can be brought to bear on the accreditation procedure.

• The Government can be impartial, effectively balancing

competitive forces that exist in regard to test methods,

procedures, and accuracy requirements.

• The prestige of Government plays an important role in international acceptance of U.S. laboratory accreditation. WRAPUP

Dr. Stanley Warshaw, NBS program manager for NVLAP,

closed the meeting by giving his tentative views of the workshop's discussions. He noted a lack of consensus on the issues and observed that the comments, criticisms, and suggestions were not too different from the record of the past. Warshaw claimed that, based upon the input at the workshop, he would have a difficult time in today's economic cli- mate to justify NVLAP's current program or any Government

role in the laboratory accreditation area. The proposal that NVLAP become an accreditor of laboratory accreditation pro- grams he viewed as academic at this time as the need for ac- creditation expressed at this workshop seemed to be conjecture.

Observing that market demand evidences the need, Warshaw

noted that NVLAP had three current programs and two more

ready to go. He observed, however, that there was some Government self-feeding in these programs. On the other hand, he observed that AALA had only accredited seven laboratories,

six of which are members of an organization (ACIL) that repre- sented about 5 percent of independent laboratories. Warshaw questioned whether a Government role in lab- oratory accreditation was necessary to assure international recognition, citing the IECQ program as an example of a private

sector approach. The degree of success of this program after

its January 1982 initiation may provide evidence of the need

for Government involvement in international activities. He

referred to the Workshop paper by Don Abelson of the U.S. Trade Representative's Office, which said that the Unit- ed States takes the view in negotiations with other countries

that we do things within industry in America; that we utilize

self certification and do not have government test laboratories involved in everything.

Warshaw stressed that these opinions were his personal assessment of the information so far received. He urged those having different perceptions to communicate their opinions within 30 days of the workshop so that they could be included

in the analysis of comments.

18
Part 2

SUMMARY OF POST WORKSHOP COMMENTS

Theodore R. Young, Consultant*

5016 Euclid Drive, Kensington, MD 20895

INTRODUCTION

Part 2 of the workshop proceedings summarizes the first 43 letters received in response to DOC-NBS requests for com- ment concerning the major issues considered by the workshop.

The request for comments was published in the Federal Register (FR), August 12, 1981. Thereafter, a copy of this FR

notice was distributed by letter to NVLAP's general mailing

list of persons interested in or concerned about laboratory

accreditation. In addition, the attendees at the Workshop were

orally invited to submit their written comments. Finally, a

letter reminding interested persons to submit comments was

distributed by NVLAP on November 30, 1981.

In this summary, numbers in parentheses refer to the number

designation given to the letters of comment as listed in Part 5 of the proceedings' Table of Contents. The reader who seeks more information concerning the position, comments, or opinion

summarized in this Part may refer to the letter referenced by

this number designation.

Issue Number One

"Whether the DOC should abandon its present role and substitute in its place a program to accredit organizations which, in turn, would accredit private sector testing laboratories." Forty- two letters addressed this issue in some manner. Seven letters, or about 17 percent of the responses, favored DOC-NBS abandoning its role as a direct accreditor of test- ing laboratories while retaining some role as an accreditor,

coordinator, or monitor of laboratory accrediting organizations.

Only three of these letters (8,9,12) specifically supported the AALA-ACIL joint proposal. All of these responses were from

independent commercial testing labortories, one of which is currently accredited under NVLAP's thermal insulation program; another laboratory is evaluated for concrete test- ing (not accredited) by the ASTM-NBS CCRL program. According to these laboratories, Government interference in private business has been devastating (8); the NVLAP pro- gram is too limited and costly (12); and NVLAP is unworkable and unrealistic (9). The other four letters of this group

(4,11,13,43) suggest arrangements that are essentially alternatives to the AALA-ACIL proposal. One of these responses

(4), representing State highway and transportation officials, opposes the AALA-ACIL proposal on the basis that it would

encourage unnecessary proliferation of accrediting agencies.

They prefer a system that would utilize existing laboratory

evaluation programs to their maximum effectiveness. Responses from a practicing consultant (11), a university laboratory

(13), and a manufacturer (43) favor accreditation of laboratories by others, with DOC performing a coordination, guidance, and surveillance function. Twenty-six letters, about 62 percent of the responses, supported the continuation of the NVLAP program. These

letters were submitted by a technical society (23); a university

professor (25); consultants (2,26); trade associations (16,19,32);

manufacturers (18,28,35,36,38,39,40,42); testing laboratories,

including inhouse laboratories (1,3,7,17,22,34,37); and

independent laboratories (5,15,27,30). The testing laboratories are all accredited under NVLAP programs. Advantages of

the NVLAP system frequently addressed by these letters in- clude the following:

• NVLAP is achieving the credibility needed for acceptance at the sub-national, national, and international level (2,7,16,22,25,27,28,30,32,34,35,37,42). At this time, the participation of the Federal Government is necessary

for such credibility and acceptance (2,7,16,22,23,25,

27,28,34,35). The association, participation and technical support of NBS is particularly important (5,7,16, 19,25,30,34,35).

• NVLAP provides opportunity for consolidation of needs

for laboratory accreditation, thereby lessening trends toward proliferation of laboratory accreditation pro- grams and duplication of effort (1,2,7,15,16,19,27,

28,30,34). NVLAP needs greater promotion and/or broader

scope (1,15,19,27,28,34,39).

• NVLAP should provide laboratory accreditation programs

to serve only proven needs (2, 1 8,26,27), in response to public

input (2,7,16,35), and in a voluntary and consensus mode

(2,7,16,18,27).

• NVLAP programs provide a worthwhile professional standard (1,3,5,22,23,26,27,30,35,36,37,38,39,40) and

improved quality assurance (1,3,5,22,23,36,37,40).

•NVLAP is achieving cost effectiveness (5,7,16,26) and is potentially self-supporting (2,7,16,19,23,42). Nine letters, or 21 percent of the responses are either uncertain about or opposed to NVLAP's serving as an accreditor of laboratories or as an accreditor of laboratory accrediting

agencies. These letters were received from manufacturers

(14,20,21); an independent laboratory (10); a technical soci- ety (6); a trade association (24); an association of building

code officials (29); a Federal agency (31); and an individual

(33). The positions of these respondents are:

• In general, laboratory accreditation should be a private

sector function and there is no need for a Federal accreditor of laboratory accrediting agencies (6,10,20,21,29).

• Self-evaluation or self-accreditation by laboratories to appropriate voluntary standards should be promoted

(14,24).

• Need for additional laboratory accreditation or the manner of its implementation requires further study (31,33).

Issue Number Two

"What, if any, additional measures should be taken to assure that an effective U.S. presence remains in international laboratory accreditation activities, including bilateral arrangements?" Ten letters responded to this issue.

•Prepared under contract.

19
Three responses specifically supported continued DOC

participation in the International Laboratory Accreditation Conference (ILAC) (2,18,28).

• An NBS workshop on international laboratory accreditation

is proposed to consider topics such as: determining U.S.

input to ILAC, and the future role of ILAC in international trade (2). •An advisory group representing major industrial associ- ations should be appointed to advise U.S. delegates to ILAC

regarding industrial interests (18). Seven responses suggest other approaches to international laboratory accreditation (12,14,15,19,20,26,29).

• The private sector should seek involvement in international laboratory accreditation when it is economically attractive (20) or of interest to the voluntary standards system

(26). Government involvement should be limited to in- tergovernmental actions (20).

• The American National Standards Institute and DOC

should collaborate to promote mutual acceptance of the various mandatory and voluntary approaches of participating countries (14).

• DOC should retain an international involvement regarding laboratory accreditation (12) while seeking a mechanism for mutual approval of test results (29).

• Reciprocal agreements should be arranged with foreign countries providing for acceptance of test results render- ed by NVLAP accredited laboratories (15).

• NVLAP should be publicized as an NBS program, to better enhance NVLAP's worldwide acceptance (19).

Issue Number Three

"What action, if any, can be taken by the private sector and/or the Government to reduce the proliferation of in- spections and paperwork arising from duplicative accreditation

activities within the United States?" Twenty-one letters re- sponded to this issue. Fifteen responses indicated a belief that there is need for a central accreditation system (1,2,4,7,10,15,16,19,21,25,

27,28,29,30,34). All but three (10,21,29) of these letters specifically identify NVLAP as being the appropriate agency. Some

suggestions for NVLAP's improvement are:

• NVLAP should seek reciprocity with credible existing pro- grams (4,19).

• NVLAP should accept responsibility for recognizing credible existing programs upon request (19).

• NVLAP should encourage Federal, State, and local interests to utilize NVLAP (15,19,27).

• NVLAP's accreditation of a test method under one accreditation program should be recognized under other NVLAP

programs (15,19).

• NVLAP should reduce the amount of paperwork required

(1,34).

• National building code groups and organizations listing laboratories should be urged to utilize NVLAP (15). One letter suggested a voluntary coordination between existing private sector efforts (29). One response (21) calls for an organization to develop unified product certification ap- proaches for States and building code groups. One letter proposed some methodology to identify, evaluate, and improve existing systems before creating additional ones (33). One letter suggested limiting accreditation efforts to pro- grams conducted by professional societies (13).

One letter saw no need for reducing duplicative efforts (20). Three letters expressed a belief that duplication of efforts could be reduced by relying upon the voluntary consensus sys- tem (14,18,26).

• Inspections and accreditation efforts could be reduced

by laboratories' compliance with voluntary standards devel- oped for the purpose of self-accreditation (14).

• Peer groups should implement evaluation and accreditation criteria standards developed by voluntary consensus

groups. An optional central agency should approve and

audit such implementation upon request (18).

• Federal, State, and local agencies should be encouraged

to use and rely upon the U.S. voluntary standards system

(26).

Opinions and Comment on Other Subjects

Two letters commented on the costs of NVLAP accreditations (19,27). One response (27) proposed that reduction of

cost should be a priority effort. One response (19) suggested

the appointment of an advisory committee consisting of one

representative from each NVLAP accreditation program. Such

a committee would recommend ways of improving effective- ness and reducing costs. Seven letters commented on the issue of accrediting on a product-by-product basis versus accrediting on a discipline basis (2,5,7,9,12,16,19). Two responses noted that accredit- ation by product derives from NVLAP's receipt of public comments during establishment of the program (7,16). Two

responses (5,19) said that accreditation by product best served

the needs of their laboratories. One letter (9) claimed that accreditation by discipline is required for any laboratory ac- creditation system. One response (12) advised that accredit- ation by discipline would be more suitable for the writer's own

laboratory. One letter (19) suggested that accreditation by

product and accreditation by discipline are probably both necessary. One comment (2) advised that NVLAP procedures allow

for both types of accreditation program. Two letters commented on justification of needs for labo- ratory accreditation programs (26,27). One letter (27) advised

that NVLAP should not seek to accredit accreditors or to re- place other adequate laboratory accreditation programs—this places too much authority with NVLAP. Furthermore, NVLAP

should guard against establishing accreditation programs with

the sole purpose of changing market acceptance of particular

types of laboratories. Another letter (26) suggested that NVLAP should establish a periodic review of continuing needs

for its ongoing accreditation programs. One letter (26) questioned whether DOC and NBS have the

capability or the authority to become an accreditor of accrediting agencies. It was pointed out that this function would in- volve the review of the management of accrediting agencies

rather than the review of technical competence of testing laboratories. One letter (31) advised that there is no existing plan to uti- lize criteria developed by AALA in implementation of an OSHA program for laboratory accreditation. The applicable

OSHA regulations (29 CFR 1907), are to be reviewed in accordance with the Regulatory Flexibility Act of January

1981. One letter (41) dated December 29, 1981, advises that 20

laboratories have "committed" to membership and 32 laboratories have "committed" to accreditation under AALA

procedures.

20
Part 3

FORMAL PAPERS

PREPARED BY PARTICIPANTS

FOR THE WORKSHOP
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TABLE I

TYPES OF CERTIFICATION SYSTEMS (ISO)

Forms of Follow-Up Action

Forms of Testing Testing Testing Assessment Approval

Assessment of Open of of Factory of Factory Audit of of Routine Market Factory Quality Quality Quality

Type No. Type Test Testing Samples Samples Control Control Control

1 X--- - - -

2 X-X- - - -

3 X--X - __ 4 X-XX - - -

5 ' X - XX X X X

6 - X- -X - -

7 Batch (2) - -

8 100% - -

(1) Type of certification usually used by third party certification bodies.

(2) Sample selection and testing procedure employed such as to determine

compliance of batch with specified requirements.

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25
TABLE II

How Related To Aspect or Element of Sy3tem

Third Party Certification System

Product standard or technical Certification is to the specification specific product standard

Technical competency

Impartiality

Type testing of product

On-going production testing

Batch or lot testing

Proficiency testing

Independence of party con- ducting product testing

Mechanism for relating evaluation to specific

product or product manufacturer

Use of mark of conformity

Published evidence of product conformance

Procedure for notifying public when its mark is applied to an unauthorized product, or

on a product found to be subsequently hazardous."

Covered in respect to a specific standard or technical specification

A requirement for the certification body

operating the system

Required by the system

Covered by the system

Covered by the system

Not required by the system

Required by the system

Required by the system

Required by the system

Required by the system

Required by the system

Laboratory Accreditation System

Laboratory is accredited to perform specific

tests or groups of tests - Not necessarily

to a specific standard nor to all the requirements of the standard

Covered in respect to specific tests, areas

of testing, or disciplines, but not necessarily to a specific standard or technical specification

Not required by the system - Evaluation

optional

Not a part of accreditation criteria

Not a part of accreditation criteria

Not a part of accreditation criteria

Generally required by the system

Not required by the system

Not a part of accreditation criteria

Not applicable

Not required by the system

Not a part of accreditation criteria

Ability to verify product conformance through marking

Procedures to evaluate quality assurance program for product

Reassessment of a laboratory's

ability to conduct specific

tests

Procedures for monitoring

factory quality control

of product

Procedures for corrective

action

Extent of legal exposure

Legal commitment of manufacturer of product

Verification of product

bearing mark of conformity

Required by the system

Continuous reassessment

by system operation

Required by the system

Required by the system

Not applicable

Not applicable

Required by the system

Not covered - Reassessment of a laboratory's ability to conduct specific

tests is made periodically

Required by the system

Proportional to volume and

use of product bearing

mark of conformity of certification body

By use of mark of conformity Not applicable

on product required

Related to extent of public reliance

and use on accreditation system,

but lack of use of marking greatly

reduces potential liability

On-site Inspection Required by the system Required by the system

26
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twenty-eight

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•

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the

fiftyfour

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,

in

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few

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by

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laboratory

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editation.

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in

ti

s

required

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of

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twelve

he

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sector.

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tories

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accreditation

program

ion

programs

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fir

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for

labor

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I

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ap

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ting

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Generic Guidelines for Laboratory Accreditation

Systems

Generic Criteria for Use

in the Evaluation of Testing Laboratories

Generic Guidelines for the Evaluation Process

Definition of Fields of

Test or Discipline

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Test Methods - Benchmarks

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Figure 1, Laboratory Accreditation Model

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Development

Branch

i

Agency

:en

by

the

Organization

for

)ECD)

in

the

area

of

toxic

on

good

laboratory

practices

;ed

that

in

order

to

enhance

lg

countries

and

avoid

non-

;

must

harmonize

and

implement

:D

Principles

of

GLP,

and

have

,

national

GLP

compliance

for

3

years

and

will

the

OECD

Management

Committee

Carl

R.

Morris

Chairman,

OECD

Expert

Group

c

Good

Laboratory

Practice

and

Senior

Scientist,

Test

Rules

Office

of

Toxic

Substances

U.S.

Environmental

Protectioi

Washington,

D.C.

20460

-

One

of

the

first

actions

taf

Cooperation

and

Development

CC

:s

was

to

develop

an

agreement

t

group

of

experts

met

and

agr€

tl

acceptance

of

test

data

amor

trriers

to

trade

,

the

countries

.zation

of

test

guidelines,

OEC

an

internationally

harmonized,

The

group

of

experts

has

met

:heir

final

recommendations

to

>er

1981.

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"The

releasi

ted

considerable

discussii

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criteria

would n

ion

(determining

eligibil:

at

the

same

time,

eliminai

d

upon

accrediting

agencii

een

the

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Committe<

r.

Convinced

that a

diff<

the

Commissioner

regardii

tee

considered

that

resoli

eafter,

the

Administratis

ave,

if

enacted,

removed ;

ty

for

public

funding.

Ii

ted.

The

Advisory

Commiti

functions

became

the

Nati(

itutional

Eligibility,

esi

ndments

Act

of

1980."

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the

Advisory

Comm

different

criteria

genera

would

seem

that

these

alt

toa

public

service

funct

for

public

funds)

while,

assumably

had

been

impose

a

public

service

function

An

exchange

of

views

betw

Office

occurred

thereafte

between

the

Committee

and

and

functions,

the

Commit

action

was

merited.

Ther

in

July

1979

that

would h

for

determining

eligibili

the

Commissioner

was

vaca

the

same

composition

and

on

Accreditation

and

Inst

under

the

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140
Building Officials & Code Administrators

International, inc.

17926 SOUTH HALSTED STREET

HOMEWOOD, ILLINOIS 60430 Area Code 312

799-2300

OFFICERS

President GERALD H. JONES, P.E. Code Administrator Overland Park, Kansas

First Vice President DOUGLAS E. GELDBACH

Planning Director Clayton, Missouri Second Vice President CHESTER PENZA

Dir., Inspection Services & Building Commissioner

Amherst, Massachusetts

Secretary MAGNUS MITCHELL

Building Commissioner

Windsor, Ontario, Canada

Treasurer CHARLES H. BANKS, P.E.

Dir. of Protective Inspections

Tulsa, Oklahoma

Immediate Past President WILBUR H. LIND

Dir., Dept. of Community Affairs Hackensack, New Jersey EXECUTIVE COMMITTEE

WILLIAM W. OUNLOP

Construction Official

Tertafly, New Jersey CHARLES EVERLY, P.E.

Dir., Building and

Mechanical inspections

Alexandria, Virginia BILLY H. HOLCOMB

Chief Building Inspector

Lexington, Kentucky PAUL IMHOFF

Supt., Bur. of Bldg. Inspections

Pittsburgh, Pennsylvania O.PAUL JACK

Building Official Hampton, Virginia EDWARD KARSKY

Director of Code Enforcement

Dickinson, North Dakota THOMAS F. RETTENBACHER

Building Commissioner

Elk Grove Village, Illinois PATRICK SHANAHAN

Director of Code Enforcement Hoffman Estates, Illinois LLOYD TOWERS. HABuilding Commissioner

Hamilton, Ohio ROBERT UHLS

Code Enforcement Superintendent Oklahoma City, Oklahoma EARL WAKELY

Chief Inspector

Inspection Service Division Grosse Pointe Woods. Michigan STAFF

Executive Director CLARENCE R. BECHTEL

Deputy Executive Director PAUL K. HEILSTEDT, P.E.

December 17, 1981

Mr. John W. Locke

NVLAP Coordinator

Department of Commerce

Room 4709

Washington, D.C. 20230

Dear Mr. Locke:

We recently had the opportunity to review your memorandum of November 30, 1981 regarding the Workshop on

Laboratory Accreditation c BOCA was not able to attend

the November 16 and 17 workshop but would like to comment on the three main issues identified in the workshop and repeated in your memorandum. Our comments are

as follows:

1. The Department of Commerce should cease its present

role in laboratory accreditation and rely on the

private sector to perform the accreditation function.

While the advantages of laboratory accreditation on

a national scale are obviously attractive, there is no reason why the process must be a governmental

function. The private sector has the organizations

and capabilities in place to accomplish this task

more economically and expeditiously.

2 0 The Department of Commerce should retain its status

as the international liaison for laboratory accreditation. While the submittal to American code officials

of test results generated by foreign laboratories

is becoming more prevalent, a mechanism should be

generated to facilitate the approval of the results

of tests conducted by foreign laboratories as well

as representation to the international community.

regional Offices

3021 East Dublin-Cranville Road

Columbus, Ohio 43229

Telephone 614/890-1064

274 Lafayette Avenue

Hawthorne, New jersey 07506 Telephone 201/423-4003

141
December 17, 1981

Mr. John W. Locke

Page 2

3. Coordination of laboratory accreditation efforts can be generated

through voluntary efforts in the private sector. A process much like

that used for the coordination of standards by the American National

Standards Institute can be developed. It is essential that a nationally

recognized system of laboratory accreditation be developed as opposed

to a multiplicity or duplication of systems.

Please contact us if you have any questions or comments.

Paul K. Heilstedt, P.E.

Deputy Executive Director

PKH/dlj

Building Officials & Code Administrators International, Inc. • 17926 South Halsted Street • Homewood, Illinois 60430

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FUEL U P P L Y C O .

«H5GSE«33BSSK "READY MIXED CONCRETE"

EAST SIDE PLANT (MAIN OFFICE) 23055 GROESBECK HWY.

CORNER 9 MILE ROAD WARREN, MICHIGAN 48089

LAkeview 7- 1 200

PRESCOTT 5-7200 December 31, 1981

Mr. John W. Locke

NVLAP Coordinator

Department of Commerce, Room 4709

Washington, D.C. 20230

Dear Mr. Locke:

It has come to our attention that due to budgetary considerations and

pressure from competing organizations, NVLAP may be severely restricted

in growth or dropped entirely.

As a member of the National Ready Mixed Concrete Association and a responsible supplier of concrete to the Detroit Metropolitan area, we

are deeply concerned that such a potentially valuable service to the

purchasers and users of concrete could be terminated before its true

worth can be established.

It is our observation that in Michigan, for example, the concrete LAP

has been largely ignored. We continue, as do the purchasers and users of our product, to suffer unnecessary costs directly attributable to poor performance by independent testing laboratories. Suggestions to these labs that they participate in NVLAP bring defensive responses

doubting the need for them to certify their capabilities. Yet these same firms vigorously market a "professional" image to the owners and

constructors. This enigma has persisted far too long.

What NVLAP needs now is better promotion, not cut-backs. If the

federal government would insist on NVLAP approval for testing firms

bidding on federal work, it could be a step toward encouraging independent laboratories to conduct their business in a more responsible manner.

We intend to recommend to our Michigan Ready Mixed Concrete Association

that a 1982 priority should be vigorous promotion of NVLAP, the concrete

LAP in particular.

Yours truly,

ERNST CONCRETE! ft SUPPLY CO.

Thomas Adams

WEST SIDE PLANT IINKSTER 29001 MICHIGAN AVE.

EAST OF MIDDLEBELT INKSTER. MICHIGAN 48141 PARKWAY 1-0422 LOGAN 3-6560

TA/ab

cc: Richard D. Gaynor, National Ready Mixed Concrete

900 Spring Street

Silver Spring, Maryland 20910

James R. Murner, Michigan Ready Mixed Concrete

1173 Trowbridge Road, East Lansing, MI 48823

DOWNRIVER PLANT (BROWNSTOWN 20O6O SIBLEY RD

WEST OF ALLEN WYANDOTTE, MICHIGAN 48192

AVENUE 5- 1O00

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Federal Register / Vol. 46, No. 155 / Wednesday, August 12, 1981 / Notices 40785

Federal Register

Vol. 46, No. 155

Wednesday, August 12, 1981

DEPARTMENT OF COMMERCE

Office of the Secretary

Public Workshop on Laboratory

Accreditation; Future Directions in the United States A two-day public workshop

concerning present status and future direction of laboratory accreditation

activities in the United States will be

held on November 1&-17, 1981, at the National Bureau of Standards in Gaithersburg, Maryland. The purpose of

the workshop is to provide a public

forum for the expression of views upon

which recommendations could be

developed to bring about a desirable and effective distribution of

responsibilities between the government

and private sectors in the area of laboratory accreditation. The Department of Commerce (DoC)

has operated the National Voluntary

Laboratory Accreditation Program

(NVLAP) since publication of the

original NVLAP procedures on February

25, 1978. The stated goal ofNVLAP is "to provide in cooperation with the private sector a national voluntary

system to examine upon request the professional and technical competence

of private and public testing laboratories

that serve regulatory and

nonregulatory * * * needs" (15 CFR

Part 7a). The original NVLAP procedures were amended so that other Federal agencies

could fulfill their laboratory

accreditation needs through NVLAP.

Another amendment streamlined private

sector use of NVLAP by encouraging

private sector organizations, through

due process procedures, to make a determination of need for a specific

laboratory accreditation program (LAP)

and to submit criteria for laboratory

accreditation in that LAP. The DoC has received two requests to amend further the NVLAP procedures.

The first request (Appendix 1), from

Roger J. Amorosi, President of the American Council of Independent

Laboratories (ACIL), advocates the

testing, chemical testing, construction

materials testing, electrical testing, thermal

testing, mechanical testing, metrology, nondestructive testing, and optics and

photometry. AALA currently has accreditied

five laboratories and has a number of additional applications in process. Its financial structure is designed to be self- jupporting. A large number of laboratory accreditation arograms are in operation both nationally advocates transferring NVLAP's

laboratory accreditation activities to the private sector and limiting the Federal Government's role to that of an

accreditor of accreditation systems.

The workshop has been scheduled in response to these requests and in consideration of the growing importance

of laboratory accreditation to international trade. The workshop

program has been developed around the following key issues: —Whether the DoC should cease its present role and substitute in its place a program to accredit organizations

which, in turn, would accredit private sector testing laboratories. —What, if any, additional measures

should be taken to assure that an

effective U.S. presence remains in international laboratory accreditation

activities, including bilateral arrangements. —What action, if any, can be taken by

the private sector and/or the government to reduce the proliferation of inspections and paperwork arising from duplicative accreditation activities within the United States. A second Federal Register notice is expected to be published in about two

months and will contain a detailed agenda for the November meeting. Persons wishing to attend this workshop

are invited to contact Mr. James O.

Bryson, Chief, Office of Testing

Laboratory Evaluation Technolgy,

National Bureau of Standards,

Washington, D.C. 20234 (301-921-2368). Papers on the subject from interested

parties will be considered for -. publication in the proceedings of the workshop. Such papers should be

submitted by December 18, 1981. Authors are invited to provide notice, of

their intention to submit a paper, to Dr. Jack Williams, Office of Product Standards Policy, Room 3876, Department of Commerce, Washington,

D.C. (202-377-1148) indicating the title and general content of the material to be

submitted, by September 1, 1981, if possible.

Dated: August 6, 1981. Robert B. Ellert, Acting Assistant Secretaryfor Productivity, Technology and Innovation.

Appendix 1 May 13, 1981.

Dr. Howard L Forman. Deputy Assistant Secretary for Product Standard Policy, U.S. Department of Commerce, Washington, D.C. 20230 Dear Howard: This letter is written on

behalf of American Council of Independent

Laboratories (ACIL) to respond to your letter dated March 6, 1981 commenting on the ACIL

white paper entitled, "Independent

Laboratories in 1981. Their Important Role, Their Critical Concerns " Youi written comments were of great interest to ACIL and

its members who share with you a common

interest in an effective national program of laboratory accreditation. Because of the

significant views expressed in your communication, the Executive Committee of ACIL has undertaken to review these points

carefully in an effort to respond in a

constructive manner. Inevitably, this process has delayed our response. In no way should

this delay be interpreted as a lack of ACIL

interest and concern about the problems which you have addressed. There should be no misunderstanding about the respect which members of the independent laboratory community have for the efforts undertaken by the Department of Commerce to initiate a national voluntary

laboratory accreditation program (NVLAP).

While the program as initiated departed

significantly from the original Department of Commerce plan, it nevertheless has made an

effective contribution to a better understanding for the need for a workable

national program. Additionally, H has served

to resolve and address many of the technical aspects of how such a program must function

to be credible. You will remember that the

original plan envisioned by the Department

of Commerce was to establish a quasi-public corporation which would administer a

national program. A number of interested

parties encouraged the Department to establish a program, whether quasi-public or wholly public, which was capable of recognizing in a coordinated procedural manner all aspects of a laboratory's

capabilities. ACIL was disappointed when

the Department failed to establish the NVLAP program on this basis. Nevertheless, ACIL has been consistently dedicated to trying to formulate a common approach which could meet the national and

international needs for laboratory

accreditation.

In 1977, Gene Rowland met with the Executive Committee of ACIL to confirm the

specific procedure which the Department of Commerce intended to implement As

presented by Gene, this procedure required

approximately 420 days to complete and

covered only product categories. We

expressed then and have expressed since oar disagreement with a system which required so much time and p/sced such substantial burdens on the laboratory seeking > accreditation. Almost five (5) years hare

passed and, as you report, only 5 programs have been initiated. To the best of our knowledge, only three have been

implemented. We think that had the Department implemented its original plans more rapid progress would have been

157
Federal Register / Vol. 46, No. 155 / Wednesday, August 12, 1981 / Notices 40787

accomplished. It should be noted that very

constructive measures have been taken by

the Department to modify and improve the

operation of the NVLAP program.

Nevertheless, the Department has not, on its own initiative, determined that it is in a

position to propose to recast substantially the NVLAP program to rely, io a me&imuia

extent, on private teeter organisations to administer such a program. We beHevetha!

the goal of NVLAP and private sector « organizations interested in accreditation should be to transform NVLAP from an

agency accrediting individual laboratories to an accreditor of private sector accrediting

organizations. Strong precedents for this kind

*of Federal role exist in other fields such as

education.

In this spirit, ACE, has been clear in expressing its view that NVLAP should be phased out as it now exists. The NVLAP staff can and should play an important role in participating in a transition to this new

approach and ultimately serving as the

accreditor of private accrediting

organizations. In turn, the private sector should continue to work hard to assure that there are broad capabilities in the private

secior to discharge the need to accredit

laboratories of all kinds. ACIL looks forward to further Department

initiatives to establish proper Federal

reliance on the private sector in meeting

international and national needs for laboratory accreditation and pledges its continued cooperation with all interested

parties to this end. Sincerely yours, Roger J. Amorosi,

President

Appendix 2

July 6, 1981.

Dr. Stanley I. Warshaw,

Director, Office of Engineering Standards, National Bureau of Standards, Department of Commerce, Washington, DC. 20234 Dear Dr. Warshaw: The American

Association for Laboratory Accreditation (AALA) suggests that there is a need for the Department of Commerce, National Voluntary Laboratory Accreditation Program

(NVLAP), to undertake to serve as the

principal federal agency that would accredit

private sector organizations as being

competent to accredit testing laboratories and function as the US. government

representative in the international laboratory

accreditation community.

AALA is a non-profit organization formed

in 1978 and chartered in the District of Columbia. Its purpose is to accredit the

technical competence of laboratories performing testing service in various

technical disciplines. It was patterned after the National Association of Testing

Authorities—Australia (NATAJ and was

supported in its formation by contributions from diverse private sector sources. Its membership and participation is freely open

to anyone. AALA is offering accreditation in the fields of acoustical and vibration measurement biological (microbiological)

testing, chemical testing, construction materials testing, electrical testing, thermal

testing, mechanical testing, metrology, nondestructive testing, and optics and

photometry. AALA currently has accredited

five laboratories and has a number of additional applications in process. Its financial structure is designed to be self- supporting. A large number of laboratory accreditation ^urogram* are in operation both nationally and internationally. Information on these programs is contained in: • "Principal Aspects of U.S. Laboratory

Accreditation Program" by C. W. Hyer, prepared under contract to DOC which

indicates that some 70 laboratory

accreditation systems are now operational within the United States.

• "International Directory ofNational Laboratory Accreditation Systems " prepared

by the International Laboratory Accreditation Conference (ILAC) which lists some 86

.laboratory accreditation systems presently in operation throughout the world, and

references nearly 20,000 laboratories having been accredited. Because of the large number of laboratory

accreditation programs, not all of the same

competence and quality, and since many

certification programs utlilize laboratories to obtain test data as the basis for claims of conformity with standards, neither the manufacturer, consumer nor government

have any basis to know if these laboratories are technically competent to provide the test data required to support these claims.

Industries and consumers require that laboratory results are reliable and are produced efficiently and with consistency. Accreditation of private accreditation systems will assure that a laboratory can

perform competently and reliably to meet

these needs.

International developments create a need

for a unified public/private U.S. approach to the aubject of laboratory accreditation. Under

the General Agreement of Tariff and Trade

(GATT), U is the obligation of the United

States to "accept test results . . . issued by

reliable bodies in the territories of other

parts." This key position of GATT can be

expected to have a significant impact on the United States. It is highly likely that the United States soon will be requested to accept test results produced by foreign

laboratories. To provide a uniform criteria for acceptance of the technical competence of

laboratories, to facilitate the handling of these requests for approveal of the results of

tests conducted by foreign laboratories and

to provide a basis whereby all laboratories, domestic or foreign, may compete equally, we

suggest that the most effective means to accomplish these goals is to transform the current National Voluntary Laboratory

Accreditation Program (NVLAP) into a

program to accredit accreditation systems in the private sector. The precedence for the establishment of a program to accredit accreditation systems is supported by procedures already in operation

in the United States' Department of Education for the accreditation of systems

that accredit educational intitutions. This program has been operated successfully for a number of years and specifies criteria such as scope of operations; responsibility, to include

clearly identified needs, responsiveness to

the public interest, due process in accrediting procedures, and a willingness to foster

ethical practices among the institutions and

programs which it accredits-, mawrtencance of

progs-ara evaluation: reliability and autonomy. The concept of accreditation by private

sector organizations is consistent with the goals of the present administration to transfer certain federal programs to the private sector.

It is apparent that laboratory accreditation programs can and should operate in the private sector since most private sector programs are designed to be financially self- sufficient. In so doing, this will tend to relieve the current burden on the federal budget

Transfer of the actual accreditation of laboratories to the private sector with the federal government performing in a different

role as an accreditor of accreditation systems

will act during a transition period to phase

out existing NVLAP programs as private

sector accreditation systems expand and

refine their accreditation capabilities. Once the concept of the government as an

accreditor of accreditation systems is accepted, the criteria by which the government evaluates accreditation systems becomes of paramount importance. AALA

has begun work to develop specific criteria that could be used in administering a government program to accredit private accrediting systems. It is our intent to make

this criteria document available for comment

by interested parties prior to the workshop

which has been scheduled by the Department

of Commerce on November 16-17, 1981. Because to the general approach and

organization of AALA, it is in a position to assume major responsibility for laboratory

accreditation in the United States. It is understood, of course, that NVLAP in its function of accrediting accreditation systems

will also be accrediting other systems whose

purposes might be more highly directed to

specific technical disciplines and products

than is AALA's. We look forward to the opportunity to work with the Department in developing this new approach further. Thank you for your

consideration.

Sincerely, Louis R. Rossi, Chairman.

[FR Doc. 81-23422 Filed 8-11-81: 8:45 am) BILLING CODE 3510-13-W

158
49630 Federal Register / Vol. 46, No. 194 / Wednesday. October 7. 1981 / Notices

DEPARTMENT OF COMMERCE

Office of the Secretary

Public Workshop on Laboratory

Accreditation; Future Directions in the

United States

In the Federal Register of August 12, 1981 (46 FR 40785-7), the Department of Commerce announced plans for a two- day public workshop concerning the present status and future direction of laboratory accreditation activities in the United States. That open workshop will take place on November 16-17, 1981 at the National Bureau of Standards in Gaithersburg, Maryland. Its purpose is to provide a public forum for the expression of views upon which

recommendations could be developed to bring about a desirable and effective distribution of responsibilities between

the government and private sectors in the area of laboratory accreditation. For

further information, contact James

Bryson at the Bureau's Office of Engineering Standards, telephone 301-

921-2368. This notice contains a detailed agenda

(Appendix 1) for the November

workshop. It also contains brief abstracts (Appendix 2) of the presentations to be made at the workshop. There will be opportunities

for audience participation in the discussion periods following each

session, except for session 2. As stated in the notice of August 12, papers on any of the subjects of the workshop by interested parties will be

considered for publication in the proceedings of the workshop. Such

papers must relate to one or more of the issues to be discussed at the workshop.

They should be submitted no later than

December 18, 1981, to Dr. Jack Williams,

Office of Product Standards Policy,

Room 3876, Department of Commerce,

Washington, D.C. (202-377-3221). In an

effort to provide uniformity and

facilitate reproduction, it will be helpful

if the papers could be submitted in "camera-ready" format, and according

to the following typing guidelines: Paper

size 6V2 x 11; margins; 1 inch all around;

single space with elite type (12 characters per inch).

Issued: October 1, 1981. Robert B. Ellert, Acting Assistant Secretary for Productivity,

Technology, and Innovation. Appendix 1.—Agenda—Workshop on

Laboratory Accreditation: Future

Directions in the United States; November 16-17, 1981 November 16

9:00 A.M.—Introduction

Stanley I. Warshaw, Director, Office of Engineering Standards, NBS

9:10 A.M.—Welcome Address

Ernest Ambler, Director, National Bureau of Standards (NBS)

Session No. 1—Background of U.S. Laboratory Accreditation. Stanley

Warshaw, Director OES/NBS,

moderator. Panel (Questions after last speaker.)

9:30 A.M.—(a) Meaning of Accreditation

and Certification

Baron Whitaker,

Consultant to UL

9:45 A.M.—(b) History of Laboratory

Accreditation in U.S.

Theodore

• Young, Consultant

10:05 A.M.—(c) Status of Laboratory

Accreditation in U.S.

Charles Hyer,

V.P. The Marley Organization

10:20 A.M.—Discussion

10:45 A.M.—Coffee break

Session No. 2: 11:15 A.M.-International Trade

Implications of Laboratory

Accreditation

Douglas Newkirk,

Assistant U.S. Trade Representative

for GATT Affairs Session No. 3—Need for Laboratory

Accreditation.

11:45 P.M.—Purposes of Accreditation

John Locke, Coordinator, National

Voluntary Laboratory Accreditation

Program (NVLAP) (Questions to follow).

1:00 P.M.—Lunch

2:00 P.M.—Panel on Advantages and

Disadvantages of Laboratory

Accreditation (Questions after last speaker). John Locke, moderator.

Presentations from perspective of

(al) Independent laboratory—Earl Hess,

President Lancaster Laboratories

(a2) William Levelius, Vice President,

Northern Region Pittsburgh Testing

Laboratories

(bl) Manufacturers—(2) Richard

Gaynor, Vice President for Engineering and Research, Ready

Mixed Concrete

(b2) John Grant, Consultant to American

Petroleum Institute

(c) Exporter—Frank Walters, Staff Engineer, Waterloo Project

Engineering Center, John Deere

(d) State and local government—Donald

Pinkerton, Executive Director,

NCSBCS

(e) Federal regulator—Robert

Alexander, Office of Standards

Development, Nuclear Regulatory

Commission

(f) Consumer Representative—David

Swankin, Swankin & Turner

4:00 P.M.—Discussion

5:15 P.M.—End of 34rd Session

November 17 Session No. 4—Criteria for Recognizing Laboratory Accreditation

Systems. James Bryson, Chief, Office of Testing Laboratory Evaluation

Technology, NBS, moderator

9:00 A.M.—(a) On ASTM E-36 Work—

Gerald Berman, Group Leader,

Laboratory Performance Group, NBS

9:15 A.M.—(b) A certifier's view

Theodore Pritsker, President,

Associated Laboratories

9:30 A.M.—(c) The AALA proposal—

Louis Rossi, Chairman, of Board,

American Association for Laboratory

Accreditation (AALA)

9:45 A.M.—Discussion

10:15 A.M.—Coffee break

10:45 AM.—(d) On IECQ—Howard

Kontje, Chief Engineer, Underwriters

Laboratories, Inc. 11:00 A.M.—(e) On ILAC—Howard

Forman, Consultant

11:15 A.M.—(f) On OECD GLP

Carl

Morris, Senior Scientist, Test Rules

Development Branch, EPA

11:30 A.M—(g) On the State-of-the Art—

Theodore Young, Consultant

12:00 P.M.—Discussion

1:00 P.M.—Lunch

Session No. 5—A Mechanism to Accredit Organizations Which Accredit

Testing Laboratories. Jack Williams,

Acting Director, Office of Product

Standards Policy, Department of Commerce, Moderator

2:00 P.M.—AALA Proposal and

ViewpointsLouis Rossi, Chairman,

AALA

3:00 P.M.—Discussion.

4:30 P.M.—Wrap-Up

Stanley Warshaw

5:15 P.M.—End of Workshop

159
Federal Register / Vol. 46, No. 194 / Wednesday, October 7, 1981 / Notices 49631

Appendix 2.—Abstracts of Presentations

Presentation of Baaron Whitaker, 9:30

a.m., Monday, November 16, 1981, la—

15 minutes.

Subject: Meaning ofAccreditation

and Certification,

This presentation clearly defines laboratory accreditation. Particular attention is given to the differences between laboratory accreditation and

product certification. Related areas

include:

• The meaning of accreditation to the laboratory user;

• The meaning of certification to the product user;

• The attributes which define a competent laboratory;

• Functions of a certifier over and

above functions of a laboratory

accreditor;

• Similarities in accreditors' and

certifiers' assessment techniques.

Presentation of: Theodore Young, 9:45

a.m., Monday, November 16, 1981, lb—

20 minutes.

Subject: History of laboratory

Accreditation in the United States. This presentation summarizes the evolution of accreditation in the United

States starting with the earliest accreditation systems (DOA Federal Grain Inspection Service which was

established in 1940) and identifies product areas for which accreditation programs were established roughly in chronological order. Special reference

will be made to the Clinical laboratory

Improvement Act (CLIA) system (the only system specifically identified in Federal Legislation) and the College of American pathologists system which is perhaps the largest non-governmental

system in terms of number of accredited

laboratories. The presentation will conclude with a summary of events which led up to NVLAP.

Presentation of: Charles Hyer, 10:05

a.m., Monday, November 16, 1981, lc—

15 minutes.

Subject: Status of Laboratory

Accreditation in the United States. This presentation provides the current and near future environment relative to laboratory accreditation, and describes

how that environment seems to be

affecting the operation of laboratory

accreditation systems. Issues addressed

will include the growth rate of laboratory accreditation systems,

special product areas supporting growth

in systems, any consolidation of systems, and percent of laboratories which have accreditation by more than one system. The relationship of public

and private accreditation systems to businesses, trade associations, and

professional associations will be

summarized. A prognosis in what's

ahead will conclude the presentation.

Presentation of: Douglas Newkirk;

11:15 a.m., Monday, November 16; 2—30

minutes.

Subject: International Trade

Implications of Laboratory

Accreditation.

This presentation will cover the significance of domestic and

international laboratory accreditation

activities for U.S. trade interests. Presentation of: John Locke, 12.00

p.m., Monday, November 16, 3—30

minutes.

Subject: Purposes ofLaboratory

Accreditation.

Task Force C of the International Laboratory Accreditation Conference

(ILAC) has prepared a report which

describes some 10 or more reasons why

laboratory accreditation is important.

Detailed examples (foreign and

domestic) illustrating each reason will be presented. Effects on all segments of

the laboratory accreditation community

will be summarized, as well as effects on international trade. Panel Session on Advantages and

Disadvantages of Laboratory

Accreditation 2:00 p.m., Monday,

November 16. Presentation of: Earl Hess, 3al—10

minutes.

Perspective: Independent Laboratory

advocating accreditation of laboratories. The nature of independent laboratory

support of laboratory accreditation will be summarized. Advantages to the laboratory, to clients, and to the public

will be described.

Presentation of: William Levelius,

3a2—10 minutes.

Perspective: Independent laboratory

with many separate laboratory

locations. Concerns about accreditation of each

independent site will be addressed in conjunction with how control of testing

in separate locations is managed by the corporation. Similarities and differences between corporate control of the laboratories at separate locations and

laboratory accreditation of those sites will be summarized. The advantages

and disadvantages of each approach

will be stated along with concerns about

accreditation procedures themselves.

Presentation of: Richard Gaynor,

3bl—10 minutes.

Perspective: Manufacturer supportive

of accreditation. The effect of laboratory accreditation on the manufacturer will be described,

along with advantages and

disadvantages of using an outside

accredited laboratory. Important

qualities of an accreditor will be stated.

An expression of general concerns with

respect to laboratory accreditation will conclude the presentation.

Presentation of: John Grant, 3b2—10

minutes.

Perspective: Manufacturer with

reservations about accreditation. The effect of laboratory accreditation on manufacturers will be summarized,

both for a manufacturer's laboratory

and for an "outside" laboratory. Values

used to judge competence of an outside

laboratory will be described. Credentials which others seek when

evaluating the work of a laboratory will be described. Concerns about and

advantages of accreditation will conclude the presentation.

Presentation of: Frank Walters, 3c—

10 minutes.

Perspective: Exporter.

The problems which a U.S. firm confronts when exporting a complex

product will be summarized. Different perspectives from different countries in accepting test data will be noted. The

implications of liability considerations

in different countries and insurance

considerations will be described.

Desirable characteristics of a U.S. laboratory accreditation system

important to the acceptance of test data

internationally will conclude the presentation.

Presentation of: Donald Pinkerton,

3d—10 minutes.

Perspective: State and local governments.

State and local government code

administrators have a special need for information about a product before they

permit its use in their geographic area. Recognition of the competence of a

testing laboratory is not sufficient for these purposes. The relationship

between the needs of code

administrators and laboratory

accreditation will be described. Also the

deficiencies of accreditation from the code administrator's standpoint and

related concerns will be mentioned.

Presentation of: Robert Alexander,

3e—10 minutes.

Perspective: Federal regulatory

responsibilities.

Regulatory responsibilities which can

be fulfilled by reliance on accredited

laboratories will be described. The need

for assuring ihe competence of testing laboratories will also be discribed. The

advantages and possible disadvantages

of accreditation to the government, to the regulated industry sector, and to the public will be summarized.

Presentation of: David Swankin, 3f—

10minutes.

Perspective: Consumers.

160
49632 Federal Register / Vol. 46, No. 194 / Wednesday, October 7, 1981 / Notices

The importance of laboratory

accreditation to consumer will be

described. Other issues include: When is laboratory accreditation "good enough"?

How can information about an

accredited laboratory be used? What

kind of information do consumers want

about product tests? . . about accredited

laboratories? The presentation will conclude by describing advantages of

accreditation and consumer concerns.

Presentation of: Gerald Berman. 9:00

a.m., Tuesday, November 17, 4a—15

minutes.

Subject: Generic Criteria for Laboratory Accreditation Being

Developed by ASTM Committee E-36. This presentation describes the development of generic criteria of a

laboratory accreditation system for the laboratory evaluation process and for assessment procedures. The discussion

will focus on the necessary attributes of an accreditation system and will summarize the work of ASTM

Committee E-36. Presentation of: Howard Forman,

11:00 a.m., Tuesday, November 17, 4e—

15 minutes.

Subject: Considerations in Recognizing Laboratory Accreditation

Systems in Different Countries. This presentation covers the status of deliberations in the International Laboratory Accreditation Conferences

(ILAC). The status of international agreements recognizing laboratory

accreditation systems in two or more

countries will be summarized. Efforts to develop international guidelines to judge

laboratory accreditation systems will be

summarized.

Presentation of: Carl Mdrris, 11:15

p.m., Tuesday, November 17, 4f—15

minutes.

Subject: OCED Agreement on

Inspection Agencies in Member

Countries. The OECD is proposing a complete

system for the recognition and

acceptance of animal test data among

testing laboratories in different countries. This presentation will summarized the guidelines which the laboratory inspection agencies in each

country should meet in order that data

from testing laboratories in that country

will be acceptable in other countries. Technical and administrative criteria will be described along with difficulties encountered in implementatign of the scheme.

Presentation of: Theodore Young,

11:30 p.m., Tuesday, November 17, 4g—

30 minutes.

Subject: Mechanisms for Acceptance

of Accrediting Organization—the Stateof-the-Art.

This presentation summarizes the key

factors used to accept or reject

accrediting organizations in the U.S. Some of these examples come from

fields other than laboratory evaluation,

and the presentation will relate the relevant features of these programs to accreditation of laboratories. The

administrative characteristics of accepting or denying accreditation will also be described.

Presentation of: Louis Rossi, 2:00 p.m., Tuesday, November 17, 5

One hour.

Subject: Transforming NVLAP Into a Program to Accredit Accreditation

Systems.

The American Association for Laboratory Accreditation (AALA) has

proposed that NVLAP be converted

from a laboratory accreditation system

to an accreditor of such systems. In this presentating, AALA will describe just

how it proposes that such a scheme

would work. This discussion will include mechanisms' used by existing

laboratory accreditation systems, such

as those Federal and State governments.

Presentation of: Theodore Pritsker, 9:15 a.m., Tuesday, November 17, 4b—15

minutes.

Subject: Characteristics of Laboratory

Accreditation Systems Which Certifiers Look For. This presentation identifies criteria which a product certification system

manager would want in an organization

which uses laboratories accredited by a laboratory accreditation system.

Included are: (a) A certifier's concern for adequate testing; (b) relationships

between a certifier and testing laboratories; (c) the question of product

liability and (d) minimum requirements

for an accrediation system.

Presentation of: Louis Rossi, 19:30

a.m., Tuesday, November 17, 4c—15

minutes.

Subject: An Accreditation System's

View of What Makes a Good

Laboratory Accreditation System.

This presentation includes a detailed description of criteria recommended by

AALA to be used by an organization

(such as a Federal agency) which would

recognize the competence of laboratory

accreditation systems. Administrative

procedures as well as technical

characteristics will be covered. Presentation of: Howard Kontje, 10:45

a.m., Tuesday, November 17, 4d—15

minutes.

Subject: The IEC's Way of Evaluating

Certifiers in Participating Countries. This presentation describes the IEC's

criteria for accepting member-country

inspectorates. Although this is a

certification scheme, the approved

member-country inspectorate must

accredit laboratories which test the

products covered by the system. Also

covered will be a description of the problems encountered in formulating the scheme and of potential future changes

to the system.

|FR Doc. 81-29143 Filed 10-6-81; 8:45 am| BILLING CODE 3510-BP-M

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164
NBS-114A 'rev. 2-8C) U.S. DEPT. OF COMM. BIBLIOGRAPHIC DATA

SHEET (See instructions]

1. PUBLICATION OR

REPORT NO. NBS SP 632

2. Performing Organ. Report No 3. Publication Date

March 1982

4. TITLE AND SUBTITLE

Laboratory Accreditation: Future Directions in the United States

Proceedings of a Workshop held at the National Bureau of Standards,

Gaithersburg , MD, on November 16-17, 1981

5. AUTHOR(S)

John W. Locke, Editor

6. PERFORMING ORGANIZATION (If joint or other than NBS, see instructions)

NATIONAL BUREAU OF STANDARDS

DEPARTMENT OF COMMERCE

WASHINGTON, D.C. 20234

7. Contract/Grant No.

8. Type of Report & Period Covered Final

9. SPONSORING ORGANIZATION NAME AND COMPLETE ADDRESS (Street. City, State, ZIP)

Same as No. 6

10. SUPPLEMENTARY NOTES

Library of Congress Catalog Card Number: 82-600525

21 Document describes a computer program; SF-185, FlPS Software Summary, is attached.

11. ABSTRACT (A 200-word or less factual summary of most significant information. If document includes a significant

bi blio graphy or literature survey, mention it here) The purpose of the Workshop sponsored by the National Bureau of Standards was to

provide a public forum for the expression of views upon which recommendations could be

developed to bring about a desirable and effective distribution of responsibilities

between government and private sectors in the area of laboratory accreditation. The

Workshop was initiated in response to two related requests to change the Department of

Commerce's (DoC) National Voluntary Laboratory Accreditation Program (NVLAP) in order

that NVLAP' s laboratory accreditation activities would be transferred to the private

sector and DoC's role would be limited to that of an accreditor of accreditation systerfs

As a basis for initiating public comment, 20 invited participants presented papers in

five sessions: 1) background of U.S. laboratory accreditation; 2) international trade

implications of laboratory accreditation; 3) need for laboratory accreditation;

4) criteria for recognizing laboratory accreditation systems; and, 5) a mechanism to

accredit organizations which accredit testing laboratories. Approximately 200 people

attended the Workshop and the written and oral reviews of all who participated are summarized in these Proceedings. Also included are written comments (letters) which

were sent in by participants and other interested persons after the Workshop was

concluded.

12. KEY WORDS (Six to twelve entries; alphabetical order; capitalize only proper names; and separate key words by semicolons)

Criteria; definitions; history; international trade; laboratory accreditation; need.

13. AVAILABILITY

| xj Unl imited

| | For Official Distribution. Do Not Release to NTIS

fx] Order From Superintendent of Documents, U.S. Government Printing Office, Washington. D.C. 20402.

[~~| Order From National Technical Information Service (NTIS), Springfield, VA. 22161

14. NO. OF

PRINTED PAGES

172

15. Price

$6.50

USCOMM-DC 6043-P80

]>U.S. GOVERNMENT PRINTING OFFICE: 1982-360-997/2054
\

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