CEN/CLC/TC 1 - Criteria for conformity assessment bodies

This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.

This document provides general requirements for third-party marks of conformity, including their
issue and use.
This document is applicable to third-party marks of conformity issued and used in different forms and
various media, including digital representation employing electronically stored and displayed marks,
machine readable code, blockchain (distributed ledger) or other electronic means.
NOTE 1 This document can also be used as guidance in using marks of conformity in activities other than
third-party conformity assessment.
NOTE 2 Third-party marks of conformity in accordance with this document also include symbols of
recognition, such as accreditation symbols. For consistency of terminology, they are referred to as accreditation
marks.
NOTE 3 Third-party marks of conformity in accordance with this document can include logos (e.g. the sign of
a conformity assessment body or trademarks), symbols (e.g. the representation of recognition in an accreditation
agreement or the depiction of the applicable programme) or a combination thereof.
NOTE 4 Third-party marks of conformity as a graphic representation of demonstrated conformity in
accordance with this document can be a combination of multiple marks (e.g. indications of compliance with
several sets of specifications, codes for individually fulfilled specifications).
NOTE 5 This document does not apply to markings that provide indication of a designation, a code, or a
classification only. Furthermore, it does not apply to graphic representations (e.g. of conformity assessment
systems or schemes/programmes) or logos (e.g. of an association of accreditation bodies or an association of
conformity assessment bodies).
NOTE 6 Third-party marks of conformity are based on a conformity assessment scheme that includes the
function of surveillance.

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1    International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2    For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.

This document specifies general terms and definitions relating to conformity assessment (including the
accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to
conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology,
standardization and statistics. The boundaries of conformity assessment are not defined in this
document.

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.

ISO/IEC 17011:2017 specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.

This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.
Bodies operating according to this document can provide validation/verification as a first-party, second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.
This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.
This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.
This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or other forms of recognition of validation/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.
NOTE    This document contains generic requirements and is neutral with regard to the validation/verification programme in operation. Requirements of the applicable programmes are additional to the requirements of this document.

This document specifies additional competence requirements for personnel involved in the audit
and certification process for quality management systems (QMS) and complements the existing
requirements of ISO/IEC 17021-1.
NOTE This document is applicable for auditing and certification of a QMS based on ISO 9001. It can also be
used for other QMS applications.

This document specifies additional competence requirements for personnel involved in the audit and
certification process for environmental management systems (EMS) and complements the existing
requirements of ISO/IEC 17021-1.

This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.

ISO 17034:2016 specifies general requirements for the competence and consistent operation of reference material producers.
ISO 17034:2016 sets out the requirements in accordance with which reference materials are produced. It is intended to be used as part of the general quality assurance procedures of the reference material producer.
ISO 17034:2016 covers the production of all reference materials, including certified reference materials.

ISO/IEC 17021-1:2015 contains principles and requirements for the competence, consistency and impartiality of bodies providing audit and certification of all types of management systems.
Certification bodies operating to ISO/IEC 17021-1:2015 do not need to offer all types of management system certification.
Certification of management systems is a third-party conformity assessment activity and bodies performing this activity are therefore third-party conformity assessment bodies.

ISO/IEC 17067:2013 describes the fundamentals of product certification and provides guidelines for understanding, developing, operating or maintaining certification schemes for products, processes and services.
ISO/IEC 17067:2013 is intended for use by all with an interest in product certification, and especially by certification scheme owners.

1.1 This International Standard contains principles and requirements for the competence, consistency and impartiality of the certification of products (including services; see clause 3.3 of ISO/IEC 17000) and processes and for the bodies providing those activities. Certification bodies operating to this International Standard need not offer all types of product, service or process certification.
1.2 Certification of products, services and processes is a third party conformity assessment activity (see clause 5.5 of ISO/IEC 17000:2004). Bodies performing this activity are therefore third party conformity assessment bodies, (named in this standard "certification body/bodies").
Note 1 A certification body can be non-governmental or governmental (with or without regulatory authority).
Note 2 This International Standard can be used as a criteria document for accreditation or peer assessment or other assessment processes.

ISO/IEC 17024:2012 contains principles and requirements for a body certifying persons against specific requirements, and includes the development and maintenance of a certification scheme for persons.

ISO/IEC 17020:2012 specifies requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities.
It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection.

ISO/IEC 17050-1:2004 specifies general requirements for a supplier's declaration of conformity in cases where it is desirable, or necessary, that conformity of an object to the specified requirements be attested, irrespective of the sector involved.
For the purposes of ISO/IEC 17050-1:2004, the object of a declaration of conformity can be a product, process, management system, person or body.

ISO/IEC Guide 2:2004 provides general terms and definitions concerning standardization and related activities. It is intended to contribute fundamentally towards mutual understanding amongst the members of ISO and IEC and the various governmental and non-governmental agencies involved in standardization at international, regional and national levels. It is intended also to provide a suitable source for teaching and for reference, briefly covering basic theoretical and practical principles of standardization, certification and laboratory accreditation.
It is not the aim of ISO/IEC Guide 2:2004 to duplicate definitions of terms adequately defined for general purposes in other authoritative international vocabularies.
NOTE 1 From this point of view, particular attention is drawn to the International vocabulary of basic and general terms in metrology (VIM) jointly prepared by ISO, IEC, BIPM, IFCC, IUPAC, IUPAP and OIML, and published in 1993 (second edition).
NOTE 2 In addition to the terms given in the official languages of ISO and IEC (English, French and Russian), equivalent terms provided by the relevant member bodies are given in the following languages:
German (de);
Spanish (es);
Italian (it);
Dutch (nl);
Swedish (sv).

ISO/IEC 17050-2:2004 specifies general requirements for supporting documentation to substantiate a supplier's declaration of conformity, as described in ISO/IEC 17050-1.
For the purposes of ISO/IEC 17050-2:2004, the object of a declaration of conformity can be a product, process, management system, person or body.

ISO/IEC 17040:2005 specifies the general requirements for the peer assessment process to be carried out by agreement groups of accreditation bodies or conformity assessment bodies. It addresses the structure and operation of the agreement group only insofar as they relate to the peer assessment process.
ISO/IEC 17040:2005 is not concerned with the wider issues of the arrangements for the formation, organization and management of the agreement group, and does not cover how the group will use peer assessment in deciding membership of the group. Such matters, which could for example include a procedure for applicants to appeal against decisions of the agreement group, are outside the scope of ISO/IEC 17040:2005.
ISO/IEC 17040:2005 is applicable to peer assessment of conformity assessment bodies performing activities such as testing, product certification, inspection, management system certification (sometimes also called registration), and personnel certification.
More than one type of activity can be included in a peer assessment process. This can be considered particularly appropriate when the body under assessment conducts combined assessments of multiple conformity assessment activities.
ISO/IEC 17040:2005 is also applicable to peer assessment amongst accreditation bodies, which is also known as peer evaluation.

This International Standard supplements the existing requirements of ISO/IEC 17021-1 for third-party certification of management systems and provides additional requirements with respect to the audit process and the management of competence.  This International Standard provides a framework for the development of specific criteria for third-party certification auditing and management of competence for different types of management systems or sector applications.  The generic requirements in this International Standard take into account the relevant guidance given in ISO 19011:2002 in order to promote harmony between these three documents (ISO/IEC 17021-1, ISO/IEC 17021-2 and ISO 19011).

ISO/IEC 17043:2010 specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. These requirements are intended to be general for all types of proficiency testing schemes, and they can be used as a basis for specific technical requirements for particular fields of application.

This International Standard provides general requirements for third-party marks of conformity, including their issue and use.

ISO/IEC 17000:2004 specifies general terms and definitions relating to conformity assessment, including the accreditation of conformity assessment bodies, and to the use of conformity assessment to facilitate trade. A description of the functional approach to conformity assessment is included as a further aid to understanding among users of conformity assessment, conformity assessment bodies and their accreditation bodies, in both voluntary and regulatory environments.
ISO/IEC 17000:2004 does not set out to provide a vocabulary for all of the concepts that may need to be used in describing particular conformity assessment activities. Terms and definitions are given only where the concept defined would not be understandable from the general language use of the term or where an existing standard definition is not applicable.

This Technical Specification complements the existing requirements of ISO/IEC 17021. It includes specific
competence requirements for personnel involved in the certification process for quality management
systems (QMS).
NOTE This Technical Specification is applicable for auditing and certification of a QMS based on ISO 9001. It
can also be used for other QMS applications.

This Technical Specification specifies additional competence requirements for personnel involved in the audit
and certification process for Environmental Management Systems (EMS) and complements the existing
requirements of ISO/IEC 17021.

ISO/IEC - Taking over of an ISO Technical Corrigendum

ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.
Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005.

ISO/IEC 17011:2004 specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs). It is also appropriate as a requirements document for the peer evaluation process for mutual recognition arrangements between accreditation bodies.
Accreditation bodies operating in accordance with ISO/IEC 17011:2004 do not have to offer accreditation to all types of CABs.
For the purposes of ISO/IEC 17011:2004, CABs are organizations providing the following conformity assessment services: testing, inspection, management system certification, personnel certification, product certification and, in the context of this document, calibration.

ISO/IEC 17021:2011 contains principles and requirements for the competence, consistency and impartiality of the audit and certification of management systems of all types (e.g. quality management systems or environmental management systems) and for bodies providing these activities. Certification bodies operating to ISO/IEC 17021:2011 need not offer all types of management system certification.
Certification of management systems is a third-party conformity assessment activity. Bodies performing this activity are therefore third-party conformity assessment bodies.

This document specifies general requirements that a third party operating a product certification system shall meet if it is to be recognized as competent and reliable. In this document the term certification body is used to cover any body operating a product certification system. The word product is used in its widest sense and includes processes and services; the word standard is used to include other normative documents, specifications or technical regulations.

ISO/IEC 17024:2003 specifies requirements for a body certifying persons against specific requirements, including the development and maintenance of a certification scheme for personnel.

ISO/IEC 17021:2006 contains principles and requirements for the competence, consistency and impartiality of the audit and certification of management systems of all types (e.g. quality management systems or environmental management systems) and for bodies providing these activities. Certification bodies operating to this International Standard need not offer all types of management system certification.
Certification of management systems is a third-party conformity assessment activity. Bodies performing this activity are therefore third-party conformity assessment bodies.

This Guide specifies general criteria for a supplier's declaration of conformity in cases where it is desirable, or necessary, that conformity of a product, process or service to normative documents be indicated, irrespective of the sector involved. The supplier may then declare under his/her responsibility the conformity to normative documents.

This European Standard defines the requirements for: a) the Accreditation of Attestors and/or Attestation Bodies; b) the Attestation system; c) the assessment, with a view to obtaining a Certificate of attestation, of the contract award procedures and practices of those entities falling within the scope of national rules implementing Council Directive 93/38/EEC, respecting the requirements in Articles 3 to 7 of Council Directive 92/13/EEC.

The Guide provides general terms and definitions concerning standardization and related activities. It is intended to contribute fundamentally towards mutual understanding amongst the members of ISO and IEC and the various governmental and non-governmental agencies involved in standardization at international, regional and national levels.

This document specifies general requirements that a third party body operating quality system certification/registration shall meet, if it is to be recognized as competent and reliable in the operation of quality system certification/ registration. Note: In some countries, the bodies which verify conformity of quality systems to specified standards are called "certification bodies", in others "registration bodies", in others "assessment and registration bodies" or "certification/registration bodies", and in others still, "registrars".

Migrated from Progress Sheet (TC Comment) (2000-07-10): CEN/CLC/TC1 Res 3/1996: Draft revision of ISO/IEC Guide 25 to be sent ++ out for common CEN/CLC ENQ, in parallel with the ISO/CASCO ++ consultation process ++ Attachment 4 to N 176 (Minutes of the 18th CEN/CLC/TC1 meeting): Revision of ++ EN 45001 will be published as EN ISO 17025 (TA/980526) ++ **ATTENTION** Parallel ENQ  missed ---> Agreement with ISO and D.Lennan to catch ++ up at FV. Therefore a short ENQ. of 3 months was initated with a TD of 99-07-15. ++ At the close of the Enq., D.Lennan will aim to aligh the document with the ISO d

This Guide specifies general criteria for a supplier's declaration of conformity in cases where it is desirable, or necessary, that conformity of a product, process or service to normative documents be indicated, irrespective of the sector involved. The supplier may then declare under his/her responsibility the conformity to normative documents.

This document sets out guidelines 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. Conformance to the requirements of this document will promote equivalence of national systems and facilitate agreements on mutual recognition of accreditations between such bodies.

This European standard specifies general criteria for the competence of impartial bodies performing inspection irrespective of the sector involved. It also specifies independence criteria. This standard is intended for the use of inspection bodies and their accreditation bodies as well as other bodies concerned with recognising the competence of inspection bodies. This set of criteria may have to be interpreted when applied to particular sectors, or to in-service inspection.

This document sets out the general requirements for the operation of a system for accreditation of calibration and/or testing laboratories so that the accreditations granted and the services covered by the accreditations may be recognized at a national or an international level and the body operating the accreditation may be recognized at national or international level as competent and reliable.

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.

Migrated from Progress Sheet (TC Comment) (2000-07-10): First formal vote negative. Second formal vote to be launched asap.