E36.60 - Accreditation Bodies

SIGNIFICANCE AND USE
3.1 In a situation where an organization is performing an evaluation of another, either formally or informally, the single most important element in the evaluation may well be the selection and assignment of a properly qualified assessor/assessment team to perform an on-site assessment. Therefore it is imperative that the person(s) performing the assessment be selected and assigned with care by the assessing organization. Two basic types of individuals normally participate in an on-site assessment: assessors/auditors and technical experts; each perform separate functions (see definitions).  
3.2 This guide focuses on providing guidance regarding the responsibilities and obligations of an assessing body in the selection, training, assignment and monitoring of assessors/auditors and technical experts to carry out their evaluation functions.
Note 1: In some cases, others may also participate in an assessment who are beyond the control of the assessing body: for example, government regulatory personnel, or other observers specified by a client. Such participants are not covered by this guide.
SCOPE
1.1 This guide provides guidance to organizations that need to utilize persons to perform assessments/audits (assessing bodies) of other organizations (assessed bodies) for purposes of recognition, accreditation or other type of approval to perform a function.  
1.2 An assessing body should consider the contents of this guide and apply it according to its unique situation. The elements of this guide should be applicable to the selection, assignment, and monitoring of assessors, auditors, and technical experts whether they are contract or permanent staff members.  
1.3 The text of this standard refers to notes and footnotes that provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of this standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
3.1 In a situation where an organization is performing an evaluation of another, either formally or informally, the single most important element in the evaluation may well be the selection and assignment of a properly qualified assessor/assessment team to perform an on-site assessment. Therefore it is imperative that the person(s) performing the assessment be selected and assigned with care by the assessing organization. Two basic types of individuals normally participate in an on-site assessment: assessors/auditors and technical experts; each perform separate functions (see definitions).  
3.2 This guide focuses on providing guidance regarding the responsibilities and obligations of an assessing body in the selection, training, assignment and monitoring of assessors/auditors and technical experts to carry out their evaluation functions.
Note 1: In some cases, others may also participate in an assessment who are beyond the control of the assessing body: for example, government regulatory personnel, or other observers specified by a client. Such participants are not covered by this guide.
SCOPE
1.1 This guide provides guidance to organizations that need to utilize persons to perform assessments/audits (assessing bodies) of other organizations (assessed bodies) for purposes of recognition, accreditation or other type of approval to perform a function.  
1.2 An assessing body should consider the contents of this guide and apply it according to its unique situation. The elements of this guide should be applicable to the selection, assignment, and monitoring of assessors, auditors, and technical experts whether they are contract or permanent staff members.

SIGNIFICANCE AND USE
In a situation where an organization is performing an evaluation of another, either formally or informally, the single most important element in the evaluation may well be the selection and assignment of a properly qualified assessor/assessment team to perform an on-site assessment. Therefore it is imperative that the person(s) performing the assessment be selected and assigned with care by the assessing organization. Two basic types of individuals normally participate in an on-site assessment: assessors/auditors and technical experts; each perform separate functions (see definitions).
This guide focuses on providing guidance regarding the responsibilities and obligations of an assessing body in the selection, training, assignment and monitoring of assessors/auditors and technical experts to carry out their evaluation functions.
Note 1—In some cases, others may also participate in an assessment who are beyond the control of the assessing body: e.g., government regulatory personnel, or other observers specified by a client. Such participants are not covered by this guide.
SCOPE
1.1 This guide provides guidance to organizations that need to utilize persons to perform assessments/audits (assessing bodies) of other organizations (assessed bodies) for purposes of recognition, accreditation or other type of approval to perform a function.
1.2 An assessing body should consider the contents of this guide and apply it according to its unique situation. The elements of this guide should be applicable to the selection, assignment, and monitoring of assessors whether they are contract or permanent staff members.

SIGNIFICANCE AND USE
In a situation where an organization is performing an evaluation of another, either formally or informally, the single most important element in the evaluation may well be the selection and assignment of a properly qualified assessor/assessment team to perform an on-site assessment. Therefore it is imperative that the person(s) performing the assessment be selected and assigned with care by the assessing organization. Two basic types of individuals normally participate in an on-site assessment: assessors/auditors and technical experts; each perform separate functions (see definitions).
This document focuses on providing guidance regarding the responsibilities and obligations of an assessing body in the selection, training, assignment and monitoring of assessors/auditors and technical experts to carry out their evaluation functions.
Note 1—In some cases, others may also participate in an assessment who are beyond the control of the assessing body: e.g., government regulatory personnel, or other observers specified by a client. Such participants are not covered by this document.
SCOPE
1.1 This document provides guidance to organizations that need to utilize persons to perform assessments/audits (assessing bodies) of other organizations (assessed bodies) for purposes of recognition, accreditation or other type of approval to perform a function.
1.2 An assessing body should consider the contents of this document and apply it according to its unique situation. The elements of this document should be applicable to the selection, assignment, and monitoring of assessors whether they are contract or permanent staff members.

SCOPE
1.1 While there are a number of uses for interlaboratory tests, and variations in their design and implementation, it is still possible to specify the essential principles that need to be considered when organizing such tests. Part A of this guide defines those principles and describes the factors that should be taken into account in the organization and conduct of proficiency testing programs.  
1.2 This guide also covers how laboratory accrediting bodies, which assess technical competence of testing laboratories, should select and use proficiency testing programs (refer to Part B).  
1.3 Part A of the guide is intended for use by various parties, such as accrediting bodies, regulatory authorities and clients of laboratory services which have a need to assess the technical competence of laboratories. It is also useful for laboratories in self-evaluation, but recognizes that proficiency testing is only one mechanism that can contribute to establishing equivalent confidence among users of different testing laboratories.  
1.4 It is currently a condition of some accreditation bodies that laboratories participate regularly in "approved" proficiency testing programs. Therefore, it is essential that program operators comply with principles for conduct of professionally managed proficiency programs, both in terms of technical requirements and quality management (see Annexes A1 and A2).  
1.5 The methods of operation within different proficiency testing organizations are not expected to be identical and this guide does not give specific operational details for interlaboratory test comparisons. It does, however, cover both measurement comparison and testing programs in which large numbers of laboratories (over 20) or small groups of laboratories (1 to 20) are tested. Therefore, the contents of this guide are intended only as a framework to be modified appropriately for particular situations.  
1.6 A list of some relevant references is given in Appendix X1.

SCOPE
1.1 This guide covers key elements of an evaluation of a laboratory's measurement practices and the statistical analysis of the resulting data. This guide addresses an evaluation that covers a broad range of in-house quality measurements, some of which may be directly related to accreditation requirements.
1.2 This guide describes what to look for as documentation in order to verify the operation of the practices, and what parts of the data to test and interpret in order to verify the quality of data being generated by the laboratory.
1.3 This guide does not specify or provide guidance for the establishment or assessment of a quality program. Note-Generic guidelines dealing with elements of a quality program may be found in ANSI, A1, A3, Q1, Q2, Z34.1; ISO9000-9004; and ILAC/ISO Collected Reports 1979-1983.

SCOPE
1.1 This guide specifies general requirements for a body to follow if it is to be recognized at a national or international level as competent and reliable in assessing and subsequently accrediting certification bodies or registration bodies. Conformity to the requirements of this guide will promote equivalence of national systems and facilitate agreements on mutual recognition of accreditations between such bodies.  
1.2 The primary objective of this guide is to describe accreditation as providing, by means of assessment and subsequent surveillance, an assurance that the market can rely on certificates issued by the acredited bodies. However, organizations other than accreditation bodies, concerned with recognition of competence, also may use it by replacing accreditation by recognition  
1.3 In some countries, bodies which verify conformity of products, processes, services, or systems to specified standards are called certification bodies, in other countries registration bodies, and in still others assessment bodies. For ease of understanding, this guide always refers to such bodies as bodies. This should not be understood to be limiting, as this guide also may be applicable to the assessment and acccreditation of conformity assessment bodies other than certification or registration bodies, such as inspection bodies.
Note 1--It is recognized that agreements on mutual recognition of accreditations aiming at the removal of barriers to cross-border trade may have to cover other aspects not explicitly specified in these general requirements, such as the exhcange of staff or training programs. In particular, with a view to create confidence and harmonize the interpretation and implementation of standards, each accreditation body should encourage technical cooperation and exchange of experience among bodies accredited by it, and it should be prepared to exchange information or accreditation procedures and practices with other accreditation bodies. Certification and certification/registration body standards often cntain nonspecific requirements, such as "staff shall be competent". Mutual recognition of accreditation requires harmonization of interpretation of such clauses.
WITHDRAWN RATIONALE
This guide specifies general requirements for a body to follow if it is to be recognized at a national or international level as competent and reliable in assessing and subsequently accrediting certification bodies or registration bodies. Conformity to the requirements of this guide will promote equivalence of national systems and facilitate agreements on mutual recognition of accreditations between such bodies.
Formerly under the jurisdiction of Committee E36 on Conformity Assessment, this guide was withdrawn in May 2004 due to lack of interest and support for continued use.

SCOPE
1.1 This guide covers the general requirements for the operation of a system for accreditation of calibration and testing laboratories so that the accreditation granted and the services covered by the accreditations may be recognized at a national or an international level and the body operating the accreditation system may be recognized at a national or international level as competent and reliable.  
1.2 Users of the services of an accreditation body, other than the laboratories accredited by that accreditation body, may require compliance with additional requirements to those specified in this guide.  
1.3 The object of this guide is to provide guidance for the set-up and operation of an accreditation body and to facilitate agreement on mutual recognition of accreditation of laboratories between such bodies.  Note 1-It is recognized that agreements on mutual recognition of accreditation aiming at the removal of barriers to across-border trade may have to cover other aspects not explicitly specified in these general requirements, such as proficiency testing or other interlaboratory comparisons, exchange of staff or training programs. In particular, with a view to create confidence and harmonize the interpretation and implementation of standards, each accreditation body should encourage technical cooperation and exchange of experience among laboratories accredited by it, and it should be prepared to exchange information on accreditation procedures and practices with other accreditation bodies.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsiblity of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide covers the general requirements for the operation of a system for accreditation of calibration and testing laboratories so that the accreditation granted and the services covered by the accreditations may be recognized at a national or an international level and the body operating the accreditation system may be recognized at a national or international levels as competent and reliable.
Formerly under this jurisdiction of Committee E36 on Conformity Assessment, this guide was withdrawn in December 2003.

SCOPE
1.1 While there are a number of uses for interlaboratory tests, and variations in their design and implementation, it is still possible to specify the essential principles that need to be considered when organizing such tests. Part A of this guide defines those principles and describes the factors that should be taken into account in the organization and conduct of proficiency testing programs.
1.2 This guide also covers how laboratory accrediting bodies, which assess technical competence of testing laboratories, should select and use proficiency testing programs (refer to Part B).
1.3 Part A of the guide is intended for use by various parties, such as accrediting bodies, regulatory authorities and clients of laboratory services which have a need to assess the technical competence of laboratories. It is also useful for laboratories in self-evaluation, but recognizes that proficiency testing is only one mechanism that can contribute to establishing equivalent confidence among users of different testing laboratories.
1.4 It is currently a condition of some accreditation bodies that laboratories participate regularly in "approved" proficiency testing programs. Therefore, it is essential that program operators comply with principles for conduct of professionally managed proficiency programs, both in terms of technical requirements and quality management (see Annex A1 and Annex A2).
1.5 The methods of operation within different proficiency testing organizations are not expected to be identical and this guide does not give specific operational details for interlaboratory test comparisons. It does, however, cover both measurement comparison and testing programs in which large numbers of laboratories (over 20) or small groups of laboratories (1 to 20) are tested. Therefore, the contents of this guide are intended only as a framework to be modified appropriately for particular situations.
1.6 A list of some relevant references is given in Appendix X1.
WITHDRAWN RATIONALE
While there are a number of uses for interlaboratory tests, and variations in their design and implementation, it is still possible to specify the essential principles that need to be considered when organizing such tests.
Formerly under the jurisdiction of Committee E36 on Accreditation Certification, this guide was withdrawn in July 2012 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.