NISTIR 6440

2004 ED

NVCASE Program Handbook

Procedures for Obtaining NIST

Recognition as an Accreditor

Jogindar S. Dhillon

David F. Alderman
 

ii

NISTIR 6440

2004 ED

NVCASE Program Handbook

Procedures for Obtaining NIST 

Recognition as an Accreditor

Jogindar S. Dhillon

David F. Alderman

Standards Services Division

Technology Services

National Institute of Standards and Technology

Gaithersburg, MD 20899-2150

December 2004

U.S. Department of Commerce

Carlos M.Gutierrez, Secretary

Technology Administration

Michelle O’Neill, Acting Under Secretary for Technology

National Institute of Standards and Technology

Hratch G. Semerjian, Acting Director

Table of Contents
 

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1.0 INTRODUCTION..............................................................................................................1 

1.1 Definitions ...................................................................................................................1 

1.1.1 Authorized Representative.............................................................................1 

1.1.2 Evaluation ....................................................................................................2 

1.1.3 Assessment/Audit ........................................................................................2 

1.1.4 Witness Audit ...............................................................................................2 

 

2.0 REQUESTING EVALUATION.......................................................................................2 

2.1 Who May Apply ..........................................................................................................2 

2.2 Application Package ....................................................................................................2 

2.3 NIST Acknowledgment ...............................................................................................3 

3.0 FEES....................................................................................................................................3 

3.1 Application Fee............................................................................................................3 

3.2 Re-assessment Period and Fee.....................................................................................3 

3.3 Additional Costs ..........................................................................................................3 

3.4 Refund Policy...............................................................................................................3 

3.5 Payment of Fees...........................................................................................................4 

4.0 NVCASE EVALUATION PROCESS..............................................................................4 

4.1 Assessment Team.........................................................................................................4

4.2 Ethics - Confidentiality................................................................................................4

4.3 Quality System Review and Evaluation ......................................................................5 

4.4 On-site Assessment......................................................................................................5

4.4.1 Entrance Meeting...........................................................................................5 

4.4.2 Walk Through and Staff Introductions ..........................................................6 

4.4.3 Assessment.....................................................................................................6 

4.4.4 Development of Draft Assessment Report ...................................................6 

4.4.5 Exit Meeting ..................................................................................................6 

4.5 Witness Audits/Assessments .......................................................................................6 

4.6 Final Report .................................................................................................................7 

4.7 Applicant Response to Assessment Report/Deficiency Notification ..........................7 

4.8 Recognition Decision...................................................................................................7 

4.9 Surveillance .................................................................................................................8 

5.0 PROGRAM ACTIONS .....................................................................................................8 

5.1 Granting Recognition...................................................................................................8 

5.2 Denial...........................................................................................................................9 

5.3 Suspension ...................................................................................................................9 

5.4 Termination..................................................................................................................9 

5.4.1 Voluntary Termination ..................................................................................9 

5.4.2 Involuntary Termination ................................................................................9 

5.4.3 Involuntary Termination Procedures ...........................................................10 
 

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5.5 Options in Response to an Adverse Action ...............................................................10 

5.6 Appeal........................................................................................................................11 

5.7 Scope Amendment (Extension or Reduction) ...........................................................11 

5.7.1 Scope Extension .........................................................................................11 

5.7.2 Procedures for Scope Extension .................................................................12 

5.7.3 Recognition Decision ..................................................................................12 

5.7.4 Procedures for Scope Reduction .................................................................12 

5.7.5 Involuntary Scope Reduction ......................................................................12 

 

6.0 OBLIGATIONS OF A RECOGNIZED ACCREDITOR............................................13 

6.1 Continuous Conformance ..........................................................................................13 

6.2 Proper Use of Accredited Status and Claims.............................................................13 

6.3 Keeping NVCASE Informed .....................................................................................14 

6.3.1 Organizational Changes...............................................................................14 

6.3.2 Accredited Body Status ...............................................................................14 

6.3.3 Recognized Accreditors List........................................................................14 

7.0 ACCREDITOR REQUIREMENTS ..............................................................................14 

ANNEX A - Requirements for accreditors of testing laboratories .........................................16 

ANNEX B- Requirements for accreditors of certification bodies...........................................18 

ANNEX C - Requirements for accreditors of management system registrars......................20 
 

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1.0 INTRODUCTION

This handbook provides guidance to bodies desiring to obtain recognition as an Accreditation Body 

(accreditor) under the National Voluntary Conformity Assessment Systems Evaluation Program 

(NVCASE). It explains the generic procedures, conditions, and requirementsfor NIST recognition. 

 NIST established NVCASE in 1994. Its operating rules are found at 15 CFR Part 286. This 2004 

edition supersedes the 2002 edition. 

The NVCASE program supports NIST obligations as a Designating Authority for Conformity 

Assessment Bodies (CABs) as specified in inter-governmental Mutual Recognition 

Agreements/Arrangements (MRAs) with other nations (e.g., the U.S./European Union (EU) MRA, 

the Asia Pacific Economic Cooperation (APEC) MRA, Inter-American Telecommunications 

Commission (CITEL) MRA). It also supports requests from other Government regulatory agencies 

when CAB evaluation is required, (e.g., the Federal Communications Commission (FCC) 

Telecommunications Certification Body (TCB) Program, FCC Docket 98-68. In addition, industry 

can request to set up a program in order to fulfill a need in the market place facilitating trade. 

A CAB that has been accredited by a NIST-recognized accreditor through the NVCASE evaluation 

process can request CAB designation under one of the MRAs that have been implemented between 

the United States and foreign governments. Under the domestic program, NIST recommends a 

conformity assessment body, which has been accredited by a NIST-recognized accreditor, to an 

appropriate Regulatory Agency. Qualified CABs may then test and/or certify products either to 

satisfy mandatory foreign requirements or to support domestic or international regulatory programs. 

 

Prior to September 2004, the requirements described in this handbook were based upon ISO/IEC 

documents Guides 58 and 61. Since publication of ISO/IEC 17011 standard, this Handbook has 

been revised to conform to the requirements of the new standard. Annexes A, B, and C provide 

criteria for the type of accreditation offered by an applicant, namely laboratory accreditation, 

certification body accreditation, and management system registrar accreditation, respectively. 

Technical requirements for the scope of accreditation under a particular MRA agreement or 

regulatory program are contained under “Specific Requirements” in the annexes. 

NIST invites readers/users to offer comments, suggestions for clarification or improvement, or other 

constructive feedback regarding the NVCASE program or this document. 

1.1 Definitions

For purposes of this handbook the following definitions are used. 

1.1.1 Authorized Representative: An employee of an accreditor with the authority to 

make binding commitments on behalf of the organization. The authorized 

representative is the person who is responsible for all communications with NVCASE 

and who ensures that the accreditor complies with all NVCASE program requirements. 
 

2 

1.1.2 Evaluation: The overall process of NVCASE review and appraisal of an 

accreditor, to determine if an entity (an accreditor, a laboratory, a certifier, or a 

registrar) satisfies all applicable requirements (e.g., quality system review, results of onsite assessment, witness audits, applicant proposals to correct non-conformities, etc.) 

1.1.3 Assessment/Audit: The NVCASE on-site review of an accreditor, or the on-site 

review of a client of an accreditor (i.e., laboratory, certifier, or registrar) by the 

accreditor. (The term “assessment” is normally used in conjunction with review of 

laboratories and product certifiers; “audit” is normally used in conjunction with review 

of quality systems.) 

1.1.4 Witness Audit: The observation by NVCASE staff and/or its designated 

technical experts/assessors of an applicant accreditor's assessor(s)/auditor(s) performing 

an assessment/audit of a client's facilities. 

2.0 REQUESTING EVALUATION

2.1 Who May Apply

Any domestic accreditor, government or private, that wishes to be recognized may submit an 

application for evaluation to NVCASE. The application must be completed and signed by 

the Authorized Representative of the accreditor. 

2.2 Application Package

An application package may be requested from the NVCASE Program Manager, NIST, 

100 Bureau Drive, Stop 2150 Gaithersburg, Maryland, 20899-2150. The package may 

include the General Application, the Program Handbook, and other pertinent information 

needed for understanding of the program and requirements. Requests may be made by mail, 

or by fax to: (301) 975-5414. 

All application forms must be completed in English with sufficient information and detail to 

fully describe the accreditation organization. The applicant may submit any applicable 

enclosures or attachments appropriate to describe capabilities or resources. 

An application may be amended at any time prior to a final decision. However, depending 

upon the nature of changes, the applicant may incur delay and additional cost in order for 

NVCASE to evaluate such changes. An application may be withdrawn at any time prior to a 

final decision. If an application is withdrawn, the entity may later reapply. (See section 3.4 

for NVCASE's refund policy). 

2.3 NIST Acknowledgment 
 

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NVCASE will acknowledge receipt of each application, confirm payment of the application 

fee, and specify to the applicant the next step(s) in the evaluation process. If necessary, 

further information may be requested. If an applicant is deemed to be ineligible, all 

submitted information and fees will be returned with an explanation of the ineligibility. 

3.0 FEES

NVCASE Program operates on a cost-reimbursable basis; fees are charged to users for services 

rendered. 

3.1 Application Fee 

The application fee is based on the scope and type of evaluation. Upon request, NVCASE 

will provide an estimation of the fees that will be charged to process a specific application. 

The fees may include consultant cost, travel costs, contract administration, and any other 

incidental expenses in the course of evaluation. Evaluation will begin upon the submission 

of the application and the estimated fee. Once the evaluation has been completed, the 

applicant will either be billed for, or refunded, the difference between the amount submitted 

and the actual costs incurred by NVCASE. 

3.2 Re-assessment Period and Fee

Each recognized accreditor will undergo a re-assessment visit every two years. The reassessment fees are based on the scope and type of evaluation. Upon request, NVCASE will 

provide an estimation of the fees that will be charged to conduct the re-assessment. Reassessment begins upon submission of the application form and the fees. 

3.3 Additional Costs 

 From time to time, additional NVCASE evaluation activities may be necessary. Since these 

activities are not predictable (e.g., special assessments resulting from citation of major 

deficiencies, investigation of complaints received, changes in management or location of a 

participant, etc.), attendant costs will be billed to participants as appropriate. The costs 

incurred for on-going surveillance activities must be paid in advance by the recognized 

accreditor. 

3.4 Refund Policy 

If an applicant is deemed to be ineligible or withdraws the application prior to any action by 

NVCASE described in section 4, the application fees will be fully refundable. Once 

NVCASE has begun an evaluation and has incurred costs, it will refund the application fees 

minus these incurred costs. Refunds must be requested from the NVCASE Program 

Manager. 
 

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3.5 Payment of Fees 

All fees must be paid before recognition can be granted. An applicant must also pay all fees 

for costs incurred in processing the application or in conducting the reassessment even if 

recognition is not granted. 

4.0 NVCASE EVALUATION PROCESS

The process of evaluating an applicant consists of a number of activities that must take place prior to 

and after granting recognition. The process begins with an initial review of the application followed 

by review of the applicant’s quality system (document review), on-site assessment/reassessment of 

the premises, witness audits of assessments performed by the applicant's assessors, writing an 

assessment report, review of applicant response to the assessment report, and final evaluation and 

decision. Re-assessments of recognized accreditors are conducted every two years as specified in 

Section 3.2. Surveillance activities are conducted as specified in Section 4.9. 

4.1 Assessment Team

An assessment team consisting of one or more NVCASE staff members and one or more 

appropriate technical experts conducts the assessment. In some instances selected observers 

may also be involved, such as representatives of cognizant regulatory agencies, special 

technical consultants, persons participating in cooperative assessments, NIST staff for 

training. 

4.2 Ethics - Confidentiality 

All persons involved in the evaluation process, including NVCASE staff, the assessment 

team, review panel, observers, etc., will maintain the confidentiality of all information and 

conversations pertaining to the evaluation. Such information will be disclosed only as 

required by law. All persons involved in the evaluation process are required to sign an ethics 

statement. The ethics statement contains provisions that address confidentiality of 

assessment information, freedom from conflict-of-interest, impartiality, and other 

requirements needed to ensure the integrity of the assessment process. All persons 

participating in the evaluation process will also be required to adhere to a strict code of 

conduct. 

All persons participating with the evaluation process who review information considered 

proprietary shall take all reasonable measures necessary to maintain the confidentiality of 

that information. Refusal by an applicant to provide access to all materials needed for the 

conduct of the assessment may result in denial of recognition. 

4.3 Quality System Review and Evaluation
 

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Each applicant must submit copies of its quality documentation for review and evaluation. 

The applicant will complete a checklist, based on ISO/IEC 17011, providing cross-reference 

to each clause where compliance can be validated in the applicant’s documents. The 

applicant shall provide all supporting documents. The documentation must show that the 

quality system is capable of ensuring an adequate level of performance and quality. 

Before visiting the applicant’s facilities for on-site assessment, NVCASE staff in 

coordination with a technical expert/assessor, will review applicant’s documents for 

completeness. NVCASE may request that the applicant provide clarification of items 

contained in the documentation or may request additional information. 

4.4 On-site Assessment

An on-site assessment of an applicant’s facilities is conducted prior to initial recognition and 

every second year thereafter unless the recognition is terminated. The assessment includes 

an on-site review of selected procedures and operations for all sites involved in accreditation 

activities covered by the recognition. 

NVCASE will contact the applicant to arrange a mutually convenient date for the visit, and 

to develop an agenda, and will inform the applicant of the identity of the assessment team. 

The applicant may appeal the inclusion of any member of the team. Such appeals must be 

received in writing at least 20 working days prior to the scheduled date of the visit and must 

include the reason why the team member is unacceptable. 

If the applicant’s accreditation personnel normally speak a language other than English (or 

any documentation needing review is not available in English), either NVCASE or the 

applicant may arrange for an independent interpreter to accompany the assessment team. 

Any cost incurred by NVCASE for interpretation services will be charged to the applicant. 

The normal sequence of a NVCASE on-site assessment is: 

4.4.1 Entrance Meeting: Upon arrival at the applicant’s premises, the assessment team 

meets with management to discuss the scope and content of the assessment and to agree 

on a plan of action. The meeting allows all parties to become acquainted and gives the 

assessment team the opportunity to understand the applicant’s organizational structure. 

It is recommended that a staff member be designated as the liaison between the 

applicant and the assessment team. 

4.4.2 Walk Through and Staff Introductions: The assessment team briefly tours the 

premises to familiarize themselves with its layout and to become acquainted with staff 

members who are responsible for areas of interest. 

4.4.3 Assessment: The assessment focuses on ascertaining if the accreditor’s actual 

operation is the same as that described in the accreditor’s quality documentation. All 
 

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procedures involved in the accreditation process are reviewed. All phases of the 

operation that are relevant to the scope of the request for recognition are subject to 

review. The criteria contained in Section 7 of this Handbook are used to guide the 

review and to ensure uniformity of assessment from one applicant to another. 

The assessors review relevant documents and files, observe specific operations, and 

interview staff members on such topics as: information and reporting systems; database 

systems; files, records, documents relating to accreditation procedures, policies, and 

activities; assessment reports of selected clients; final evaluation reports on which 

accreditation was based; appeals and complaints regarding the accreditor; and auditor 

qualification, training, and competency records. 

All staff involved in the functions of accreditation must be available for interview. The 

auditors/assessors, and persons (accreditation committee) who make accreditation 

decisions, need not be on-site but must be able to be contacted for interview. 

4.4.4 Development of Draft Assessment Report: The assessment team develops a draft 

report that includes a comprehensive review of its findings. The report will include 

assessment results from both the on-site visit of the applicant and any witness audits. 

Any deficiencies requiring resolution are clearly identified in the report. [Note: The 

terms “findings” and “non-compliances” are used interchangeably.] 

4.4.5 Exit Meeting: Once the assessment team is satisfied that the on- site assessment is 

 complete and the team has developed a draft report, the team holds a meeting with the 

applicant’s management representatives to discuss the findings in the draft report. At 

the conclusion of this meeting, the Authorized Representative of the Accreditor must 

sign the draft report, acknowledging the discussion of the findings and the applicant’s 

responsibility to respond to all identified deficiencies within a specified time. 

4.5 Witness Audits/Assessments

As part of the evaluation process, an applicant must allow NVCASE assessment team 

members to witness the applicant’s auditors/assessors performing an assessment/audit of a 

client’s facilities. NVCASE staff will discuss with the applicant the number and identity of 

the witness audits to be performed. The applicant must pay all applicable costs incurred by 

NVCASE in conducting witness audits. 

4.6 Final Report

After the assessment, the NVCASE staff prepares a final report and forwards it to the 

applicant. The final report will be essentially the same as the draft report unless additional 

information relevant to the assessment has been uncovered after the completion of the on-site 

assessment, or other issues have arisen that require clarification. 

The final report normally includes all definitive findings of the assessment. However, if 
 

7 

additional information surfaces that is significant and relevant to the assessment after the 

issuance of the final report, a supplementary report may be necessary. Any supplementary 

report that requires action will be promptly forwarded to the applicant. 

4.7 Applicant Response to Assessment Report/Deficiency Notification

The applicant must provide a written response to NVCASE on all identified deficiencies. 

The written response must include detailed information on all completed corrective actions 

and any proposed plans to be taken to resolve cited deficiencies. Plans must include detailed 

information on the specific actions to be taken and the time frames or dates when the actions 

are to be conducted and/or completed. In some cases, an additional on-site visit may be 

necessary to observe stated resolutions of deficiencies. Costs associated with the conduct of 

such additional audits will be billed to the applicant. 

New applicants are generally expected to resolve deficiencies within 90 days. NVCASE 

must be informed if additional time is required. If deficiencies are not corrected within 90 

days, or within a mutually agreed upon time period, NIST may terminate further evaluation 

and refund any unused funds. The applicant may reapply after paying necessary fees. If the 

applicant’s actions cause the evaluation process to take longer than one year, additional 

administrative costs may be incurred. 

Accreditors holding a current NIST recognition must resolve all deficiencies cited within 30 

days of the receipt of a deficiency notification. If any cited deficiencies are not resolved 

within 30 days of the receipt of the notification, recognition may be suspended until full 

conformance is demonstrated. 

4.8 Recognition Decision

Upon completion of all evaluation activities, NVCASE will convene an evaluation panel to 

review all information collected regarding an applicant and make a final decision on the 

appropriate recognition action. (See 5.0 Program Actions) 

The decision is based on the review and evaluation of all materials submitted by the 

applicant, reports covering the quality system review, on-site assessment(s) report, witness 

audit reports, and deficiency resolution information. 

The panel consists of NIST staff, selected technical experts, and representatives of cognizant 

regulatory agencies and representatives of joint evaluation bodies, as appropriate. Observers 

from NIST staff who are not the voting members of the panel may also be invited. 

The panel will consist of a minimum of three voting members, including at least one 

technical person, preferably from a federal or state government regulatory agency. The 

NVCASE assessor will present the results of the on-site evaluation, witness audit(s) 

reports, deficiency reports and their resolutions by the candidate accreditor, and will 

make a recommendation for a decision. The presentation will be followed by a 

question/answer and discussion session. At the end of the discussion period, the 
 

8 

NVCASE assessor will ask for a vote on his/her recommendation. Consensus is always 

the desired goal. However, one-hundred percent agreement may not always be possible. 

If a formal vote is necessary, a minimum of two-thirds favorable vote by the voting panel 

members is required for recognition of the candidate accreditation body. In addition, at 

least one technical panel member’s vote must be favorable. 

4.9 Surveillance 

NVCASE may, at its discretion, whether or not for cause, conduct a full or partial on-site 

visit or other forms of surveillance of a recognized accreditor or any accredited body to 

observe or verify conformance with program requirements. Any deficiencies noted as a 

result of surveillance must be responded to in accordance with Para. 4.7. 

On-going surveillance may be conducted as agreed upon with the recognized accreditor 

which may include periodic meetings or teleconferences with accreditor’s staff to review ongoing activities. These activities may include changes in: personnel, contact information, 

changes in policies and procedures, internal audits, management reviews, complaints and 

appeals logs, updates on accredited bodies, etc. 

5.0 PROGRAM ACTIONS

NVCASE may grant, deny, suspend, or terminate recognition of an accreditor. 

5.1 Granting Recognition 

An applicant who demonstrates conformance with all Program requirements will be granted 

recognition as having demonstrated the ability to evaluate and accredit bodies and to 

publicly attest to such bodies’ conformance with NVCASE requirements. The applicant is 

provided with documentation stating the terms and conditions of the recognition and the 

specific Scope of Activities for which recognition is granted. 

5.2 Denial

Recognition will be denied if an applicant fails to demonstrate conformance with the 

NVCASE Program requirements. NVCASE will notify the applicant in writing of its 

intention to deny recognition and the reason(s) for denial. An applicant is given 90 days to 

resolve all deficiencies that form the basis of the proposed denial. Unless resolution is 

achieved in that time, the applicant will be denied recognition. 

An applicant may appeal a denial by submitting a statement of reasons why recognition 

should not be denied to the NIST Director (See 5.6 Appeal.) 

5.3 Suspension
 

9 

If it is determined that a recognized accreditor temporarily cannot demonstrate conformance 

(e.g., a serious deficiency is uncovered during surveillance, or the accreditor has changed 

ownership or location, or other substantive reason emerges), NIST may suspend recognition 

until full conformance has again been demonstrated. 

If recognition is suspended by NIST, the accreditor may neither grant any additional 

accreditations, nor conduct any other evaluation activities covered by the recognition after 

the date of the suspension. Within five days of receipt of notification of suspension, the 

accreditor must provide written notification to all bodies that it has accredited under the 

terms of the NIST recognition that the accreditor’s NIST recognition has been suspended. 

The accreditor’s written notice shall state the effective date of its suspension and shall also 

inform the accredited bodies that their current status with NIST will not change unless the 

bodies contributed to the conditions which led to the accreditor’s suspension or if, in NIST’s 

judgment, a change is otherwise justified. 

5.4 Termination

Termination of participation in the NVCASE Program of a recognized accreditor may be 

voluntary or involuntary. 

5.4.1 Voluntary Termination: A recognized accreditor may at any time voluntarily 

terminate its participation in the Program by giving written notice to NVCASE and to 

all bodies it has accredited. 

5.4.2 Involuntary Termination: NIST may terminate, fully or partially, the recognition 

of an accreditor whenever it deems such action to be in the public interest. Such an 

action may result if the recognized accreditor engages in fraud or other illegal activity, 

is unable to meet NVCASE requirements, or exhibits other factors detrimental to 

producing an acceptable accreditation program. 

5.4.3 Involuntary Termination Procedures: NIST will notify the recognized accreditor 

in writing of the intent to terminate the recognition and the reason(s) therefore. The 

notice will state, as a minimum, that recognition is suspended as of the date of the 

notice, and that the accreditor may not grant any additional accreditations or conduct 

any evaluation activities covered by the recognition. 

The recognized accreditor is given the opportunity to respond to or rebut stated reasons 

for termination or to correct any deficiencies which formed the basis of the proposed 

termination. If the basis for the termination is not reconciled within 30 days, or such 

longer time as NIST may allow, the termination becomes effective. 

The recognized accreditor may appeal to the NIST Director by submitting a statement 

of reasons why the recognition should not be terminated. NIST may, at its discretion, 

delay implementing the termination action pending a final decision by the Director. If 
 

10 

recognition is terminated, the accreditor may neither state nor imply that it has NIST 

recognition, nor may it grant any accreditation covered by the terminated recognition. 

NVCASE may send a written notice to all bodies accredited by the terminated 

accreditor informing them of the termination and the effective date. The notice shall 

inform all affected bodies that their accredited status will not change unless they 

contributed to the conditions which led to the suspension of the accreditor. They will be 

advised that, if they want to continue their accredited status, they should expeditiously 

seek accreditation from another NIST-recognized accreditor. 

An accreditor whose recognition has been terminated may submit a request for reevaluation when it believes that it can again demonstrate conformance with the 

NVCASE requirements. 

5.5 Options in Response to an Adverse Action

If NVCASE proposes to deny, suspend, or terminate recognition, and the applicant or 

recognized accreditor has been so notified in writing, citing the specific reasons or elements 

of nonconformance with the requirements, the accreditor may choose to: 

a) Appeal the decision and request that recognition be granted or continued by providing 

appropriate justification. 

b) Submit additional information for further evaluation. If additional on-site visits, etc., are 

required, additional costs may be incurred by the accreditor. 

c) Accept the decision.

5.6 Appeal

An applicant or a recognized accreditor under the Program may appeal to the Director of 

NIST for any action taken against it. All appeals must be in writing and must include 

complete documentation setting forth the appellant’s position. The appeal of an action must 

be filed with NIST within 30 days of that action. 

Appeals should be addressed to: The Director, National Institute of Standards and 

Technology, Stop 1000, Gaithersburg, Maryland 20899-1000. The applicant or recognized 

accreditor will be informed of the Director’s decision within 60 days following receipt of an 

appeal. 

5.7 Scope Amendment (Extension or Reduction)

A NIST-recognized accreditor under the NVCASE program may apply for scope 

amendment (extension or reduction). The types of scope extension/reduction available 

may relate to any of the following: 
 

11 

(a) The requirements of a product certification program administered by a Federal 

agency (e.g., FCC’s Telecommunication Certification Bodies Program) 

(b) Government-administered product certification requirements of an individual 

country signatory to a Mutual Recognition Agreement/Arrangement (MRA) that the 

United States Government has negotiated with that government (e.g., Industry 

Canada’s product certification requirements under the Asia Pacific Economic 

Cooperation MRA for Telecommunications Equipment) 

(c) Product certification requirements of an industrial sector 

(d) Product categories (e.g., telecommunications equipment that includes fixed terminal 

equipment, radio, and transmitter equipment) 

5.7.1 Scope Extension: A NIST-recognized accreditor may request an extension of 

its current scope of recognition by providing the following documentation to 

NVCASE: 

(i) A cover letter requesting the type(s) of scope extension 

(ii) Copies of any additional documents or documents that have been revised 

as a result of scope extension. These documents may include the revised 

Policy/Quality Manual, Procedures, and Forms etc. Provide a list of 

revised sections in these documents. There is no need to submit 

documents that have not changed and were included in the prior 

assessment. 

(iii) The name(s) and qualifications of the assessor(s)/technical expert(s) who 

have the capability to assess the expanded scope. 

 

NVCASE will provide an estimate for the scope extension fee in conformance with 

Section 3.0 of this Handbook. The accreditor must pay the estimated fees to 

NVCASE before the request for scope extension can be acted upon. 

5.7.2 Procedures for Scope Extension 

(i) Upon receipt of a request for scope extension, NVCASE will review the 

request and the documentation. 

(ii) If an on-site visit is necessary, NVCASE will inform the accreditor and 

schedule an on-site evaluation for scope extension at a mutually agreeable 

date. The on-site evaluation may be combined with a regularly scheduled 

audit. 

(iii) NVCASE will participate in at least one witness audit conducted by the 

accreditor’s assessors that involves an assessment to the expanded scope 

being sought by the accreditor. 

5.7.3 Recognition Decision: Upon successful completion of evaluation activities, 

NVCASE will obtain a panel decision in accordance with Section 4.8 of this 

Handbook. This decision will be communicated to the accreditor. If the scope 
 

12 

extension is denied, the accreditor may appeal in accordance with Section 5.6 of this 

Handbook. 

5.7.4 Procedures for Scope Reduction: A NIST-recognized accreditor may in 

writing voluntarily reduce its currently recognized scope. 

(i) The accreditor shall inform NVCASE for a voluntary scope reduction in a 

letter listing all the current scopes, specifying the scope that is to be 

reduced. 

(ii) The accreditor shall inform in writing all the Certification Bodies that are 

affected by its scope reduction. 

5.7.5 Involuntary Scope Reduction: NVCASE may involuntarily reduce the scope 

of an accreditor if NVCASE determines that the accreditor is unable to comply with 

the requirements of a particular type of scope. 

(i) The matter will be discussed with the accreditor before taking this action. 

(ii) If the accreditor is not agreeable to reduce the scope as discussed by 

NVCASE then a surveillance visit will be required. NVCASE shall 

conduct the surveillance in accordance with Section 4.9 of this Handbook. 

The accreditor must pay the fees for the surveillance visit as assessed by 

NVCASE. 

(iii) The procedures for an accreditor’s appeal of an adverse action shall be in 

accordance with Section 5.6 of this Handbook. 

(i) Upon a reduction in scope by NVCASE, the accreditor shall inform in 

writing all the Certification Bodies that are affected by its scope reduction. 

 

6.0 OBLIGATIONS OF A RECOGNIZED ACCREDITOR

6.1 Continuous Conformance

It shall be incumbent upon a recognized accreditor to conform to all requirements throughout 

the period of participation. Failure to maintain conformance is cause for 

suspension/termination of recognition. 

Upon request, a recognized accreditor shall make available to NVCASE any document, 

information, or material related to the recognized accreditation activities. 

6.2 Proper Use of Accredited Status and Claims

A recognized accreditor shall not make any claim which: 

a) constitutes or implies certification, approval, or endorsement by NIST or any other 

agency of the U.S. government of any product manufactured or entered into commerce in the 
 

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United States based on its recognition by NIST. 

b) constitutes or implies that the accreditor, or an accredited body is recognized by NIST or 

NVCASE for any activities other than those specifically stated in the NIST recognition 

documents. 

A recognized accreditor must follow NVCASE guidance when advertising its accredited 

status on letterheads, brochures, reports, or in professional, technical, trade, or other 

publications. 

a) Certified products must not be stamped with the acronym “NVCASE” signifying that the 

product is endorsed or approved by NIST. 

b) A NIST-recognized accreditor may not refer to the acronym NVCASE in any reports 

issued, advertisements, or other document issued by the accreditor except to state that they 

have been recognized by NIST to offer accreditation for a specific scope of recognition. 

c) An accredited body may not refer to the acronym NVCASE in any reports issued, 

advertisements, or other document issued by the body except to state that they have been 

accredited by a NIST-recognized accreditor and that accreditor is specifically named in the 

statement. 

6.3 Keeping NVCASE Informed

6.3.1 Organizational Changes: A recognized accreditor must inform NVCASE within 

10 days of any major change in any factors which might affect its ability to operate, 

such as replacement of personnel (e.g., the Executive, key supervisors, and accreditation 

decision makers); any major change in procedure, policy making or direction; or change 

in location, ownership, or business affiliations. Failure to provide timely and accurate 

information may result in suspension or termination of recognition. 

6.3.2 Accredited Body Status: NVCASE will maintain a list of all bodies that have 

been accredited by all accreditors recognized by NIST. The list will be made available 

through various media including the Internet. Alternatively, NVCASE may provide a 

link to the recognized accreditor’s web page that lists accredited bodies. 

Each recognized accreditor must keep NVCASE informed of all accreditation actions 

under the NIST recognition. This information is vital for maintaining up-to-date lists. 

All applicable new accreditations, renewals, terminations, revocations, suspensions, 

changes in scope (additions or deletions) must be reported to NVCASE within a 

reasonable time but not to exceed 90 days, in English, by the recognized accreditor. 

This information could be provided during periodic on-going surveillance meetings 

and/or teleconferences. 

6.3.3 Recognized Accreditors List: NVCASE will maintain a list of the names and 
 

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pertinent information for all recognized accreditors. A recognized accreditor must 

remain in conformance with all NVCASE conditions and requirements to retain its 

listing. The list will be made available through various media including the Internet. 

7.0 ACCREDITOR REQUIREMENTS

Accreditors must comply with the appropriate generic standard (e.g., ISO/IEC 17011 Standard) and 

specific requirements. The annexes noted below contain the requirements for each specific type of 

accreditation body. Each annex has specific requirements with additional criteria for the specific 

sector, MRA or regulatory program. 

Annex A - Requirements for accreditors of testing laboratories 

Annex B - Requirements for accreditors of certification bodies 

Annex C - Requirements for accreditors of management system registrars 
 

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ANNEX A - Requirements for accreditors of testing laboratories

1.0 INTRODUCTION 

This annex sets out generic organizational, operational and other requirements that must be met in 

order for an accreditor of testing laboratories to be recognized by NIST. It also sets out the 

requirements against which an accreditor shall assess the competence of a testing laboratory desiring 

accreditation. 

2.0 ACCREDITOR REQUIREMENTS

2.1 General

The basic generic criteria that an accreditor must satisfy are contained in ISO/IEC 17011:2004 - 

Conformity assessment-General requirements for accreditation bodies accrediting conformity 

assessment bodies (or its replacement). 

2.2 Specific NIST requirements

a) The Senior Executive shall have sufficient experience and demonstrated ability in the 

successful operation of an accreditation program operating on a national or international 

scale. The executive shall have appropriate experience/education in management 

principles/application, technical knowledge, and personnel management. 

b) The Accreditor shall have access to appropriate experts, professional services or 

resources that can be used for technical support, advice and assistance in the specific 

technical area(s) that it will perform accreditation under the NIST recognition. 

c) The Technical Experts/Assessors of the accreditor must be knowledgeable about the 

technical requirements specified in paragraph 3.2 of this annex for the specific 

MRA/Sector/Economy/Program for which a conformity assessment body is being 

evaluated. 

3.0 ACCREDITATION CRITERIA FOR LABORATORIES

3.1 General Requirements

An accreditor shall accredit applicant laboratories against ISO/IEC 17025:1999, General 

requirements for the competence of testing and calibration laboratories (or its replacement). 

3.2 Specific Requirements

 a) US-EU MRA: Follow links to specific Sectoral Annex technical requirements for which 

NIST is accepting CAB designations at http://ts.nist.gov/mra. NIST has implemented 
 

16 

following Sectoral Annexes in the Operational Phase of this MRA: 

 i) Electromagnetic Compatibility (EMC) 

 ii) Telecommunications 

b) APEC MRA Phase-I: Follow links to specific economy’s technical requirements for 

which NIST is accepting CAB designations at http://ts.nist.gov/mra. NIST has 

implemented phase-I of this MRA with the following economies: 

 i) Australia 

 ii) Canada 

 iii) Chinese-Taipei 

 iv) Hong Kong 

 v) Korea 

 vi) Singapore 

vii) In future, APEC MRA will be implemented with additional economies. For upto-date information regarding implementation of this MRA with additional 

economies, refer to the above web site. 

c) CITEL MRA Phase-I: Follow links to specific country’s technical requirements for 

which NIST is accepting CAB designations at http://ts.nist.gov/mra. As of December 

2004, NIST is in process of implementing this MRA with CITEL countries. For up-to-date 

information, refer to the above web site. 
 

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ANNEX B- Requirements for accreditors of certification bodies

1.0 INTRODUCTION

This annex sets out generic organizational, operational and other requirements that must be met in 

order for an accreditor of certification bodies to be recognized by NIST. It also sets out the 

requirements against which an accreditor shall assess the competence of a certification body desiring 

accreditation. 

2.0 ACCREDITOR OF CERTIFICATION BODIES REQUIREMENTS

2.1 General

The basic general criteria that an accreditor must satisfy are contained in ISO/IEC 17011:2004 - 

Conformity assessment-General requirements for accreditation bodies accrediting conformity 

assessment bodies (or its replacement). 

2.2 Specific NIST requirements

a) The Senior Executive shall have sufficient experience and demonstrated ability in the 

successful operation of an accreditation program operating on a national or international 

scale. The executive shall have appropriate experience/education in management 

principles/application, technical knowledge, and personnel management. 

b) The Accreditor shall have access to appropriate experts, professional services or 

resources that can be used for technical support, advice and assistance in the specific 

technical areas that it will perform accreditation under the NIST recognition. 

c) The Technical Experts/Assessors of the accreditor must be knowledgeable about the 

technical requirements specified in paragraph 3.2 of this annex for the specific 

MRA/Sector/Economy/Program for which a conformity assessment body is being 

evaluated. 

3.0 ACCREDITATION CRITERIA FOR CERTIFICATION BODIES 

3.1 General Requirements

An accreditor shall accredit applicant certification bodies to ISO/IEC Guide 65 - General 

Requirements for Bodies Operating Product Certification Systems (or its replacement). 

3.2 Specific Requirements

a) Telecommunications Certification Bodes under the Federal Communication 

Commission (FCC): Visit the NIST web site at http://ts.nist.gov/tcb. 
 

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i) Commission's Report and Order (R&O) in GEN Docket 98-68 (FCC 98-338). 

Follow link to 

http://www.fcc.gov/Bureaus/Engineering_Technology/Orders/1998/fcc98338.txt 

ii) FCC’s Public Notice DA 99 1640. 

Follow link to 

http://www.fcc.gov/Bureaus/Engineering_Technology/Public_Notices/1999/da99

1640.txt 

b) US-EU MRA: Follow links to specific Sectoral Annex’s technical requirements for 

which NIST is accepting CAB designations at http://ts.nist.gov/mra. NIST has 

implemented following Sectoral Annexes in the Operational Phase of this MRA: 

i) Electromagnetic Compatibility (EMC) 

ii) Telecommunications 

c) APEC MRA Phase-II: Follow links to specific economy’s technical requirements for 

which NIST is accepting CAB designations at http://ts.nist.gov/mra. NIST has 

implemented phase-II of this MRA with the following economies: 

i) Canada 

ii) Hong Kong 

iii) Singapore 

iv) In the future, APEC MRA for Phase-II will be implemented with additional 

economies. For up-to-date information regarding implementation of this MRA 

with additional economies, refer to the above web site. 

 d) CITEL MRA Phase-II: Follow links to specific country’s technical requirements for 

which NIST is accepting CAB designations at http://ts.nist.gov/mra. NIST is in the 

process of implementing this MRA with CITEL countries. For up-to-date information, 

refer to the above web site. 

 e) International Federation of Organic Agriculture Movements (IFOAM) norms: The 

information about IFOAM requirements can be obtained at www.ifoam.org which 

contains: 

i) IFOAM Basic Standards 

ii) IFOAM Accreditation Criteria which is based on ISO/IEC Guide 65 plus some 

additional requirements 
 

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ANNEX C - Requirements for accreditors of management system registrars

1.0 INTRODUCTION

This annex sets out generic organizational, operational and other requirements that must be met in 

order for an Accreditor of Quality System Registrars to be recognized by NIST. It also sets out the 

requirements against which an accreditor shall assess the competence of a quality system registrar 

desiring accreditation and the requirements for a registrar to register an organization as satisfying 

specified quality system requirements. 

2.0 ACCREDITOR REQUIREMENTS

2.1 General

The basic generic criteria that an accreditor must satisfy are contained in ISO/IEC 17011:2004 - 

Conformity assessment-General requirements for accreditation bodies accrediting conformity 

assessment bodies (or its replacement).

2.2 Specific NIST requirements

a) The Senior Executive shall have sufficient experience and demonstrated ability in the 

successful operation of an accreditation program operating on a national or international 

scale. The executive shall have appropriate experience/education in management 

principles/application, technical knowledge, and personnel management. 

b) The Accreditor shall have access to appropriate experts, professional services or 

resources that can be used for technical support, advice and assistance in the specific 

technical area that it will perform accreditation under the NIST recognition. 

c) The Technical Experts/Assessors of the accreditor must be knowledgeable about the 

technical requirements specified in paragraph 3.2 for the specific 

MRA/Sector/Economy/Program for which a conformity assessment body is being 

evaluated. 

3.0 ACCREDITATION CRITERIA FOR REGISTRARS

3.1 General Requirements

An accreditor shall accredit applicant registrars against ISO/IEC Guide 62 - General 

Requirements for Bodies operating assessment and certification/Registration of Quality 

Systems (or its replacement). 

3.2 Specific Requirements
 

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The specific requirements will be posted as NVCASE sub-programs develop under this section. 

 

4.0 REQUIREMENTS FOR REGISTERED ORGANIZATIONS

A registrar shall audit organizations desiring registration against the appropriate quality standard(s) 

required by the particular MRA partner, regulatory requirement or other document specified in the 

applicable supplement to this annex.