NATIONAL INSTITUTE OF STANDARDS &

TECHNOLOGY

Research Information Center

Gaithersburg, MD 20699

National Institute

of Standards and Technology GW National Voluntary

Laboratory Accreditation Program

NEW NIST PUBLICATION

June 12, 198?

ASSESSMENT AND EVALUATION

MANUAL

NISTIR 88-3853

JULY 1989

f \

^TES Of

U. S. Department of Commerce

National Institute of Standards and Technology

Gaithersburg, Maryland 20899

NVLAP

ASSESSMENT AND EVALUATION

MANUAL

Robert L. G I ad hill

National Voluntary Laboratory

Accreditation Program

NISTIR 88-3853 July 1989

U.S. DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

Gaithersburg, Maryland 20899

NVLAP ASSESSMENT AND EVALUATION MANUAL

FOREWORD

The National Voluntary Laboratory Accreditation Program (NVLAP) , established

in 1976, is administered by the National Institute of Standards and Technology

(NIST) formerly the National Bureau of Standards (NBS) . NVLAP is a voluntary

system for assessing and evaluating testing laboratories and accrediting those

found competent to perform specific test methods or types of test methods.

Laboratory Accreditation programs are established for specified product or

service areas in response to requests and demonstrated need.

This publication, intended for the NVLAP technical experts (TEs) who serve as

assessors and evaluators, describes general policies and practices of NVLAP

assessment and evaluation. The specific technical criteria for assessing and

evaluating laboratories are provided elsewhere, in NVLAP Handbooks and

checklists for each technical area.

iii

Table of Contents

Page

Foreword iii

I . INTRODUCTION 1

II. NVLAP APPROACH TO ACCREDITATION 1

III. ROLE OF NVLAP TECHNICAL EXPERTS 1

On-Site Assessor 2

Technical Evaluation 2

Technical Resource 2

Conflict of Interest 2

IV. PREPARATION FOR AN ON-SITE ASSESSMENT 2

NVLAP Assignment of a TE 2

Preparation 3

V. ON-SITE ASSESSMENT 4

Checklists 4

Typical Steps of an Assessment 5

Monitoring Visits 9

General Assessment Conduct and Techniques 9

Information Collection 11

Questioning Techniques 12

VI. TECHNICAL EVALUATION 13

VII . SUMMARY .... 14

890720 v

NVLAP ASSESSMENT AND EVALUATION MANUAL

I

.

INTRODUCTION

This manual describes the role of a NVLAP Technical Expert (TE) in performing

the laboratory assessment and evaluation functions of the National Voluntary

Laboratory Accreditation Program (NVLAP) . The information covers the

responsibilities of a NVLAP TE as a representative of NVLAP who must

understand all aspects of the accreditation process, including NVLAP policies

and procedures, the prescribed sequence of events, and the conduct of an onsite assessment.

The NVLAP accreditation process is described in handbooks specifically

prepared for each field of testing in which accreditation is offered.

Handbooks are included in the application packages provided to prospective

participants in a given laboratory accreditation program. Each handbook also

identifies the specific criteria and other technical requirements for that

particular program.

II. NVLAP APPROACH TO ACCREDITATION

NVLAP provides an unbiased third-party evaluation of an applicant

organization. Potential clients of that organization can consider NVLAP

accreditation as an indicator of confidence in selecting required services.

NVLAP helps both laboratories and their clients. It provides assistance and

support to applicant organizations and encourages self-improvement. Users are

supplied with information about accredited organizations so that they can make

appropriate choices with respect to the services they need.

The NVLAP approach is non-adversarial ; it is non-antagonistic , and helpful,

but not patronizing. There are no unreasonable demands nor unnecessary

requirements. Although conformance with the accreditation criteria is firmly

required, flexibility is exercised by assisting applicants in achieving that

conformance

.

III. ROLE OF NVLAP TECHNICAL EXPERTS

NVLAP TEs carry out several functions in the accreditation process. They

conduct on-site assessments of applicant laboratories, evaluate pertinent

information (including assessment reports, responses to reports of

deficiencies, and proficiency test results) for the purpose of recommending

appropriate accreditation actions, and they are a technical resource to NVLAP.

The TE's main contribution is technical expertise. TEs provide technical

advice and analyses required to evaluate a laboratory's compliance with the

accreditation requirements. NBS technical staff and others may also

contribute technical expertise at various stages of the development and

implementation of NVLAP activities.

1
Each laboratory must be evaluated, as uniformly as possible in relation to

others. Assessments and evaluations must be fair and even-handed.

Interpretations of requirements must be consistent among all TEs within the

same technical area. If doubts arise about a requirement, they should be

discussed with other TEs as well as the cognizant NVLAP staff.

On-site Assessor

As an on-site assessor, a TE travels to the laboratory site and performs an

in-person assessment of personnel, equipment, procedures and records. In this

role, a TE represents NVLAP directly and is expected to act in a friendly,

courteous, professional manner. Two types of assessments are performed, a

regular on-site, where all aspects of the laboratory are reviewed, and

monitoring visits, where the review is limited.

Technical Evaluation

In conducting a Technical Evaluation, the TE reviews the complete file of

information gathered on a laboratory to determine if the technical

requirements for accreditation have been met. This may be done individually,

in a group meeting with other TEs, via conference telephone call, by mail or

other appropriate means. The result will be a recommendation to accredit, a

request for further information, or a recommendation not to accredit.

Technical Resource

Issues requiring technical assistance occasionally arise. The NVLAP staff may

not include the requisite technical experts and hence must have access to

appropriate technical resources. These resources may be immediately available

from an NIST technical division; otherwise, the NVLAP TEs for that technical

area will be called upon for assistance.

Conflicts of Interest

Since the TEs review extensive information about applicants, perhaps including

sensitive data about the operation competition, or other business practices of

the applicant organization, it is vital to avoid any real or apparent conflict

of interest. If a TE knows or anticipates that there is or may be a conflict

of interest with a given assignment it is incumbent on that TE to advise the

appropriate NVLAP staff immediately.

IV. PREPARATION FOR AN ON-SITE VISIT

NVLAP assignment of a TE

The assignment of TEs to perform assessments is based on matching individual

expertise with an applicant's requested scope of accreditation, at the same

time avoiding any conflict of interest. A TE should notify NVLAP immediately

if technically unprepared to assess or evaluate a laboratory or if aware of

possible conflict of interest. Normally, different assessors are scheduled on

successive visits to a laboratory.

2
For the first one or two assessments, an assessor is usually accompanied by a

NVLAP staff person. The assessor subsequently works alone although a NVLAP

staff person, or possibly a new TE in training, may occasionally accompany an

assessor

Laboratories have the right, with appropriate cause, to refuse acceptance of

an assessor. Since applicants are usually informed in advance about the

proposed assessor, any objections will normally be considered prior to the

assessor's contacting the applicant or going to the premises. In the event

that an applicant refuses an assessor when called, or at the door, the

assessor should notify NVLAP staff immediately.

When a TE is assigned to perform an assessment, NVLAP will send copies of the

applicant's application form, any proficiency test data, the last assessment

report, any deficiency response letters from the applicant, and any other

pertinent information. These documents should be kept in confidence. After

the assessment has been completed, the TE must return all documents to NVLAP.

An assessor typically has at least 60 days to schedule and complete the

assigned assessment(s) . A faster response may occasionally be requested.

Preparation

An assessor must prepare for an assessment by thoroughly reviewing all

information and organizing the time available during the assessment to the

best possible advantage. Inadequate preparation will slow down the

assessment, create an unfavorable impression of NVLAP and the assessor, waste

the applicant's time, and render the results less valuable.

Preparation for an initial assessment (first-time applicant) may be

substantially different from that of a renewal applicant. The initial

assessment will require more concentration in all areas of activity, whereas

the renewal assessment should concentrate on problems previously noted.

When preparing for an assessment, the TE should:

1. Notify the applicant at least one month in advance.

2. Discuss with the applicant by telephone: the laboratory location,

directions, dates, time of arrival, security arrangements, names of

laboratory staff who will be involved in the assessment, suitable lodging

arrangements, proposed agenda, requested demonstrations of specific

tests

3. Request that the applicant send appropriate information for the TE to

review before the visit (e.g., QA manual and procedures). Explain to the

applicant that any documents sent in advance will be held in confidence

and will be returned upon completion of the assessment.

4. Review all relevant information (e.g., criteria, test methods, QA

manual, application information, previous assessment reports,

deficiency correction letters, proficiency test results). Prepare

3
questions based on previous assessment reports and correspondence to

address weaknesses previously observed. Review any proficiency test

results and look for trends that might indicate weakness of any apparatus

or of procedures. This information may be used to decide what tests need

to be demonstrated.

5. Develop an agenda. If time allows, send the proposed agenda to the

applicant

.

V. ON-SITE ASSESSMENT

The on-site assessment is an extremely important element of the evaluation

process. An assessment is conducted before initial accreditation and

periodically thereafter. Assessments may last from one to several days and

may involve more than one assessor depending on the scope of accreditation

desired by the applicant.

Checklists

The assessment is conducted with checklists, which are used to:

ensure uniformity of assessments among assessors;

guide each assessment;

provide a place for recording notes during an assessment;

help assessors prepare exit briefings and assessment reports;

provide physical evidence that an assessment was performed and that all

applicable aspects of the laboratory were examined; and

provide information for future assessments, thus facilitating continuity.

The structure and content of assessment checklists differ with technical area.

Specific instructions are provided with each set of checklists.

Some general tips in completing the checklists:

Be sure that each item on the checklists has been completed or that

there is a definite indication that no answer was feasible or

applicable

.

Keep as many notes as possible on the checklists; if there is

insufficient space, use additional sheets of paper;

Although many of the items on the checklists are arranged in a

suggested sequence, the sequence may be altered as necessary.

4
Typical Steps of an Assessment

After the entry briefing, an assessment may be performed in any order. It is

generally advisable to follow the checklist sequence, but not always required.

Some assessors plan a sequence of activities with which they are more

comfortable. The purpose of the assessment is to verify that the laboratory

complies with all applicable NVLAP accreditation requirements.

During the assessment, the laboratory contact person should be kept informed

of any deficiencies that are uncovered so that corrective actions can be

effected as soon as possible, perhaps even prior to the exit interview. This

policy avoids surprises at the exit interview, establishes good rapport, and

makes for a smoother assessment.

A typical sequence of an assessment follows:

1. Conduct an entry briefing. Upon arrival at the laboratory to be assessed:

meet with the laboratory's authorized representative and all others who

will assist with the assessment;

explain the purpose of the assessment and announce the agenda;

request an escort who is knowledgeable about the laboratory's

management , quality assurance, and procedural systems to ensure

cooperation of laboratory personnel;

confirm that any laboratory documents previously reviewed are still

current

request a place to review laboratory documentation and records, to

complete the checklists, and to compose findings;

discuss the schedule for the day, conforming as far as possible to the

laboratory's working hours, lunch hour, and coffee breaks;

agree on a tentative time for holding the exit briefing;

write down all names and positions of relevant persons for future

reference

2. Walk through all areas of the laboratory where testing activities are

carried out pertinent to the requested accreditation to become acquainted

with the layout and to meet the cognizant laboratory personnel.

3. Examine QA manuals, personnel competency records, equipment maintenance

and calibration records, sample handling, and recordkeeping procedures.

4. Examine test plans, reports, data logs, and related records.

5
5. Trace one or more samples through the laboratory process, from receipt to

final test report. Three possible approaches are to:

trace a test through the testing process forward from receipt of

sample to final test report;

trace a test back from final test report to receipt of sample; or

randomly select certain files, data sheets, reports, etc.

The first two approaches are generally more efficient and effective than the

third. Indeed, some questions on the checklists are sequenced for these two

approaches. The third approach should be used when a large number of test

methods must be covered.

6. Witness demonstrations of selected procedures by laboratory staff.

These should usually be performed by the individuals who normally do

them, not by the supervisor or manager.

7. Interview technicians. If possible, conduct these interviews in

private with the supervisor not present.

8. Physically examine equipment and facilities. Observe the equipment

for appropriateness, general appearance and working condition. Do

not operate, disassemble or otherwise manipulate the equipment. Ask

the regular operator to perform any operation, adjustment or

disassembly required to establish evaluation conditions.

9. Complete the assessment report. Review all checklist items, notes

and other information collected. Summarize all findings on the

report form and add anything thought to be significant, whether

complimentary or negative. Specify any items that are deficient and

require a response from the laboratory.

Be sure to discuss any observed deficiencies. Sometimes further information

can be provided and change first impressions. If a deficiency is found, ask

questions to discover the cause. After determining the underlying cause,

suggest corrective action that might help to satisfy requirements. A

constructive suggestion for corrective action is likely to be acted upon

promptly by the laboratory, particularly if it is easy to implement and holds

promise of being effective.

Note whether the laboratory is already aware of a deficiency. If so,

determine what action has been taken to determine the cause and to implement

corrective action.

Some deficiencies are more critical than others. It is virtually impossible,

however, to provide decision rules for objectively ranking deficiencies. Here

the assessor's expert technical judgment comes into play.

6
Some typical causes of deficiencies can be categorized as follows:

Measures have not been taken to ensure that an activity is performed,

or that it is performed properly.

Lack of indoctrination/training of the personnel

Lack of time --too much pressure of work, overwork, or inadequate

manpower

Lack of resources- - incorrect equipment.

Lack of top management support.

Typical deficiencies include:

Required items in the criteria are not addressed.

Contents of instructions are not adequate.

Procedures/test plans do not have sufficient detail.

Outdated copies of documents are still in use.

Procedures described in the QA manual or instructions have been

ignored.

Samples/specimens bear no identification to permit traceability.

Responsibility for keeping documents updated has not been assigned.

No planned maintenance records of equipment are available.

Equipment is out-of- tolerance and/or has not been calibrated or

verified at requisite intervals.

Cleanliness is inadequate.

No provision is made for protected storage in the laboratory.

Substitute equipment is used without acceptable evidence that it

performs as specified by the pertinent standard involved.

Supervision is inadequate.

On-the-job practice is careless.

Personnel are not adequately trained to perform their tasks.

Objective evidence that attests to the training/certification of

competence of the personnel is not available in laboratory files.

7
10. Conduct an exit briefing.

The laboratory will decide who attends the exit briefing. However, the

assessor should request that, as a minimum, the laboratory's QA manager or

equivalent and the laboratory supervisor should attend. For future reference,

the assessor should identify the attendees at the exit briefing on the first

page of the assessment report.

For each deficiency, describe the finding, the justification or reason for

stating the finding and, if appropriate, the proposed corrective action. Make

sure that the laboratory understands each deficiency and what is required to

achieve compliance.

Some identified deficiencies may be challenged. The laboratory Is technical

staff are also experts hence differences of opinion may arise. Try to resolve

disagreements and be satisfied that the NVLAP criteria have been met. If the

laboratory is adamant about a contrary position, don't argue: ask them to

document their position in a written response to NVLAP. The NVLAP

accreditation process provides a second level evaluation, including a review

by other technical experts and NVLAP staff of each assessment report.

Advise the laboratory to write NVLAP within 30 days describing action taken or

planned to be taken for each specific deficiency identified in the assessment

report. The letter must be signed by the authorized representative of the

laboratory, who can verify the statements made in the letter.

Laboratories assessed for initial accreditation must correct or provide a

substantive plan for correction of all deficiencies prior to accreditation.

If considerable time will be required to meet the criteria, they may request

that NVLAP hold their application inactive until they are ready to proceed.

If any deficiencies are noted at laboratories which are currently accredited,

such deficiencies must be corrected within 30 days or they may face suspension

or revocation of accreditation. When out-of-calibration apparatus is cited,

emphasize that the apparatus should not be used until corrective action has

been completed.

During the exit briefing, watch for warning signs of difficulties in obtaining

compliance. Normally, the management should be advised of all problems

encountered at the laboratory. However, in unusual circumstances, a separate

follow-up note to NVLAP should be considered if major problems at the

laboratory could not be openly or comfortably discussed with the laboratory's

management

.

Make any necessary revisions or additions to the assessment report in light of

the exit briefing. At least one laboratory representative, preferably the

authorized representative, must sign the assessment report indicating that it

has been discussed during the exit briefing. Leave a copy of the report with

the person who signs it or allow the laboratory to photocopy the report. Do

not leave a copy of the checklists.

8
After leaving the laboratory, mail the original copy of the checklists and the

signed original of the report to NVLAP. Retain a copy of all sheets in case

the originals are lost in the mail, and to refer to during the technical

evaluation. After an accreditation decision is made by NIST, return all

documents pertaining to the assessment to NVLAP. Mail all documents to:

NVLAP

National Institute of Standards and Technology

Bldg. 411, Room A124

Gaithersburg, MD 20899

Monitoring Visits

In addition to regularly scheduled on-site visits, an assessor may be asked to

conduct monitoring visits. These may be scheduled for cause or on a random

selection basis during the accreditation period. These visits serve to verify

reported changes in the laboratory facilities and operations or to explore

possible reasons for poor performance in proficiency testing. The scope of

the monitoring visit may range from checking a few designated items from the

checklists to a complete review. An assessment report is written and left

with the laboratory as is done during a regular assessment, but only pertinent

checklist items need be covered or completed.

When an assignment is made for a monitoring visit, NVLAP will specify what

should be examined, but the assessor has considerable latitude to make

judgments about other items that should be reviewed. Monitoring visits

generally last no longer than one day.

General Assessment Conduct and Technique

A successful assessment will require more than technical expertise.

Courtesies to be observed, attitudes to be taken, ethical issues, assessment

concepts, and questioning techniques all come into play.

While conducting an assessment, an assessor should:

Conform to the normal operating schedule of the laboratory insofar as

possible

Be determined, decisive and direct.

Keep the assessment moving and be aware of the overall progress to

avoid wasting time. Having obtained enough evidence to form the basis

for a sound judgement, there is no point in going over the same ground.

Be honest and fair. Personal dislike/prejudices must not interfere

with the assessment.

9
Be independent. The assessor decides what will be examined.

Recognize the difference between a "clean-up" job and a "cover-up" job.

Discuss and clarify problems right away to deter later arguments after

memories have grown hazy, then collect new information. If the

discussion reaches an impasse, do not argue but proceed to the next item.

Be prepared to return to an area, if necessary, to obtain new information

and to reassess the operation in the light of new information.

Keep a sense of proportion. Keep the magnitude and significance of a

deficiency in perspective. Don't pursue trivial matters which waste

time and effort and risk alienating the laboratory.

Be constructive at all times. If a deficiency is found, an assessor

may suggest possible corrective action.

Admit mistakes when wrong; this elicits cooperation and respect from

the laboratory.

Be helpful. Suggest procedures that may be beneficial to the

laboratory. Such helpful suggestions need not be NVLAP- oriented. Be

careful, however, not to give away another laboratory's "trade secret"

in an attempt to be helpful. Open literature sources are preferred.

At the end of each day, give the laboratory representatives a brief

summary of activities, as a courtesy measure. It limits the need to

make embarrassing revelations at the exit briefing and in the

assessment report and forewarns the laboratory about any deficiencies

encountered. A deficiency observed early in the assessment can often

be corrected before the exit briefing.

Try to answer all questions posed; if you lack information, offer to

provide an answer at a later date, but be sure to follow up or to refer

questions to the NVLAP staff.

Thank the laboratory for its assistance and hospitality. Even if there

were some contentious issues and differences indicate that you

appreciated the laboratory's cooperation.

Treat privileged information as such.

Avoid all situations which might be construed as undue or improper

influences on your assessment findings.

Do not request favors from laboratories which can be construed as

improper or an imposition.

10
Plan to pay for all meals. In some cases, the only eating facility is

a laboratory-operated cafeteria. Lunch supplied by a laboratory in

these cases is acceptable. However, always offer to pay.

Avoid making derogatory remarks about specific manufacturers or

suppliers of equipment or about their products.

Do not promote any specific vendors products.

Avoid making derogatory remarks about individuals either within or

outside the laboratory.

Avoid becoming involved in intra- laboratory personnel problems.

Information Collection

Assessment is an information collection process that includes verification of

application information; questioning staff; examining facilities, equipment,

and records; and reviewing applicable proficiency testing results. An

assessor should collect information by observing and listening (allowing

laboratory staff to do most of the talking). While conducting the assessment,

please note the following:

key persons interviewed;

applicable document designations, revision dates, where found, and

descriptions

equipment numbers and identification to cross reference with calibration

and maintenance records

sample/specimen identification system;

identification of document/information/equipment recipients in

laboratory

flow charts showing how the laboratory functions in terms of

input(sample receipt), prerequisites (people, equipment, etc),

processing (testing procedures) , and output (test report)

latest revision dates in the QA manual, procedures, and instructions.

Do the laboratory staff members know their jobs?

Do the lab managers/supervisors want to answer all questions? Some may

want to address them all, either fearing that subordinates will commit

an error that reflects adversely on the laboratory, or because they

feel it is their right and responsibility to be the knowledgeable

spokesman. Make it clear that the "worker" should answer the

questions, explaining that the purpose of the assessment is to

determine what is actually being done and to verify that the procedures

are implemented as indicated in the quality manual.

11
Does the staff try to bluff its way out of a tight corner?

Does the staff know the QA manual and associated procedures and where

these documents are?

What is the condition of facilities and equipment? Are the requisite

calibration tags or stickers on the equipment?

Does it appear that the QA and procedural documents are used?

Questioning Techniques

Effective questioning is vital to an assessment's success. It is of great

value to keep the systems concept in mind, to separate the laboratory's work

into input, prerequisites, process, and output, and to ask questions on each

of these individually and in turn. Verbalizing an understanding of how the

system works will allow the laboratory to correct any misconceptions.

Ask questions that require a substantive response (e.g., "Who, What, How,

When, Where, and Why" questions force a substantive response), rather than a

"Yes/No" answer. Questions that require a "Yes/No" answer are useful to

clarify particular points. Statements or questions such as: Show me what you

do. /Where do you put that?/How do you do that?/ are recommended. If there is

a variation from written procedures, then ask "Why do you do it that way?"

Hypothetical questions are good when little objective evidence is available.

"What if..." or "Let us suppose..." or "I don't understand..." is usually

effective in such situations. Avoid questions that suggest the expected

answers

.

Silence can be extremely powerful. When faced with a silent person, some

people may feel a response is expected, or because they are not quite sure

what the response should be, they may say more than they otherwise would.

This often produces useful information.

Be aware of what the laboratory staff does not say. If answers are

superficial or evasive, be prepared to continue the line of questioning.

Be alert to differences in information presented from different sources (i.e.,

conflicting answers from staff members or differences between documented

procedures and what is actually observed or said)

.

Attempt to put the staff at ease at the beginning of a questioning session

since they will probably be nervous and, if so, may become withdrawn or

defensive, or worse- -by responding aggressively. Do not be aggressive in

return, but be thorough (and occasionally persistent) enough to establish the

factual situation. Keep the following points in mind:

12
Direct questions to the person who performs the task being assessed, not

to that person's superior.

Never talk down to anyone

Talk the " lab's language".

Give credit where credit is due. A compliment, sincerely given, goes

a long way towards eliciting cooperation.

Be interested in the laboratory's work and responses.

Don't appear to be distrustful of people or to regard their responses

with criticism.

Be calm and courteous and thank people for their time.

VI. TECHNICAL EVALUATION

A technical evaluation (second level review) of all applicants is performed

prior to granting accreditation. Normally, one or more TEs who were not

involved in the assessment, along with NVLAP staff, review the evaluation

folder for each laboratory. The evaluators provide technical judgments on

whether an applicant complies with the conditions and criteria for

accreditation and make recommendations on appropriate accreditation actions.

In some cases, a special form is used to record TE evaluation recommendations.

A TE recommendation is based on:

information provided on the application;

assessment reports;

actions taken by the laboratory to correct deficiencies observed during

the on-site visit;

results of proficiency testing from current and previous assessment

periods; and

information from any monitoring visits.

If a laboratory is not considered to be in compliance with all requirements,

it is notified with a request for additional information to demonstrate

compliance. An additional assessment may occasionally be scheduled.

The NVLAP staff prepares the paperwork, including the transmittal of

correspondence to any laboratory for which the evaluators need additional

information concerning deficiencies that must be resolved before accreditation

can be recommended.

13
When a laboratory is notified about specific deficiencies, it must respond

within 30 days to provide documentation or certification by an authorized

member of management that the specified deficiencies have been corrected.

Clarification of some issues may be requested by telephone. All deficiencies

must be corrected before accreditation is granted.

Whenever an applicant laboratory satisfies all requirements, a certificate and

scope of accreditation is sent to the laboratory.

SUMMARY

NVLAP is a system which provides fair, unbiased evaluation of the competence

of testing laboratories to provide various but specific testing services.

Rigorous criteria, are rigorously applied. The resulting accreditation

benefits both the accredited laboratory and the potential user of laboratory

services who may use accreditation as a selection factor that will inspire

confidence

.

The NVLAP Technical Experts play an extremely important role in the

accreditation process, both as on-site assessors and as technical evaluators.

To carry out their functions these individuals must possess extensive

technical knowledge and excellent communication skills.

The principles and techniques described in this manual, if understood and

followed, will provide a solid basis for performing the functions of a NVLAP

technical expert. An individual who represents NVLAP, is expected to

demonstrate the highest standards of competence, character and ethical

conduct

.

14
14A U.S. DEPARTMENT OF COMMERCE

)-89) NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

BIBLIOGRAPHIC DATA SHEET

1. PUBUCATION OR REPORT NUMBER

NISTIR 88-3853

2. PERFORMING ORGANIZATION REPORT NUMBER

3. PUBUCATION DATE

JULY 1989

JE AND SUBTITLE

NVLAP Assessment and Evaluation Manual

HOR(S)

Robert L. Gladhill

[FORMING ORGANIZATION (IF JOINT OR OTHER THAN NIST, SEE INSTRUCTIONS)

DEPARTMENT OF COMMERCE

IONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

THERSBURG, MD 20899

7. CONTRACT/GRANT NUMBER

8. TYPE OF REPORT AND PERIOD COVERED

MSORING ORGANIZATION NAME AND COMPLETE ADDRESS (STREET, CITY, STATE, ZIP)

>PLEMENTARY NOTES

DOCUMENT DESCRIBES A COMPUTER PROGRAM; SF-185, FIPS SOFTWARE SUMMARY, IS ATTACHED.

iTRACT (A 200-WORD OR LESS FACTUAL SUMMARY OF MOST SIGNIFICANT INFORMATION. IF DOCUMENT INCLUDES A SIGNIFICANT BIBLIOGRAPHY OR

ERATURE SURVEY, MENTION IT HERE.)

The National Voluntary Laboratory Accreditation Program ( NVLAP )

,

established in 1976, is administered by the National Institute of

Standards and Technology (NIST) formerly the National Bureau of

Standards (NBS). NVLAP is a voluntary system for assessing and

evaluating testing laboratories and accrediting those found competent

to perform specific test methods or types of test methods.

Laboratory Accreditation programs are established for specified

product or service areas in response to requests and demonstrated

need

.

This publication, intended for the NVLAP technical experts (TEs) who

serve as assessors and evaluators, describes general policies and

practices of NVLAP assessment and evaluation. The specific technical

criteria for assessing and evaluating laboratories are provided

elsewhere, in NVLAP Handbooks and checklists for each technical area.

Y WORDS (6 TO 12 ENTRIES; ALPHABETICAL ORDER; CAPITAUZE ONLY PROPER NAMES; AND SEPARATE KEY WORDS BY SEMICOLONS)

accreditation; assessment; assessor; evaluation; evaluator;

laboratory; technical expert

fAILABIUTY

UNUMITED

FOR OFFICIAL DISTRIBUTION. DO NOT RELEASE TO NATIONAL TECHNICAL INFORMATION SERVICE (NTIS).

ORDER FROM SUPERINTENDENT OF DOCUMENTS, U.S. GOVERNMENT PRINTING OFFICE,

WASHINGTON, DC 20402. ORDER FROM NATIONAL TECHNICAL INFORMATION SERVICE (NTIS), SPRINGFIELD, VA 22161.

14. NUMBER OF PRINTED PAGES

19

15. PRICE

$9.95

TRONIC FORM
. ,