UGA - Conformity assessment

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.

This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies
providing validation and verification as conformity assessment.
Bodies operating to this document can be internal (first party), collaborative (second party) as well as independent (third party) bodies
and need not offer both, validation and verification activities.
This document is applicable to validation and verification bodies in any sector, providing assurance through confirmation that claims or
declarations are either plausible with regard to the intended purpose (validation) or correctly stated (verification).
This document shall be applied in conjunction with sector specific programmes that contain requirements for validation and verification
processes and rules.
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 and verification bodies by international or regional organizations, governments, regulatory
authorities, program or scheme owners, industry bodies, companies, customers or consumers.
NOTE This document contains generic requirements and is neutral with regard to the operated validation or verification programme. 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 environmental management systems (EMS) and complements the existing
requirements of ISO/IEC 17021-1.

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 an occupational health and safety (OH&S) management system and
complements the existing requirements of ISO/IEC 17021-1.
Three types of personnel and certification functions are defined:
— auditors;
— personnel reviewing audit reports and making certification decisions;
— other personnel.
NOTE This document is applicable for auditing and certification of an OH&S management system based on
ISO 45001. It can also be used for other OH&S applications.

This document specifies requirements for the competence, consistent operation and impartiality of
accreditation bodies assessing and accrediting conformity assessment bodies.
NOTE In the context of this document, activities covered by accreditation include, but are not limited to,
testing, calibration, inspection, certification of management systems, persons, products, processes and services,
provision of proficiency testing, production of reference materials, validation and verification.

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.

This International Standard specifies general requirements in accordance with which a reference material producer has to demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials.
This International Standard is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical operations. Reference material customers, regulatory authorities and accreditation bodies may also use it in confirming and recognizing the competence of reference material producers.
This International Standard sets out the requirements in accordance with which reference materials shall be produced. It is intended to be used as part of a reference material producer's general quality assurance (QA) procedures.
This International Standard covers the production of all reference materials. For certified reference materials, the production requirements are more stringent than for other reference materials.

This part of ISO/IEC 17021 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 this part of ISO/IEC 17021 do not need to offer all types of management
system certification.
Certification of management systems is a third-party conformity assessment activity (see
ISO/IEC 17000:2004, 5.5) and bodies performing this activity are therefore third-party conformity
assessment bodies.
NOTE 1 Examples of management systems include environmental management systems, quality management
systems and information security management systems.
NOTE 2 In this part of ISO/IEC 17021, certification of management systems is referred to as “certification” and
third-party conformity assessment bodies are referred to as “certification bodies”.
NOTE 3 A certification body can be non-governmental or governmental, with or without regulatory authority.
NOTE 4 This part of ISO/IEC 17021 can be used as a criteria document for accreditation, peer assessment or
other audit processes.

This International Standard describes the fundamentals of product certification and provides guidelines for understanding, developing, operating or maintaining certification schemes for products, processes and services. It is intended for use by all with an interest in product certification, and especially by certification scheme owners.

This International Standard contains requirements for the competence, consistent operation and impartiality of product, process and service certification bodies. Certification bodies operating to this International Standard need not offer all types of products, processes and services certification. Certification of products, processes and services is a third party conformity assessment activity (5.5 of ISO/IEC 17000:2004). In the text the term "product" can be read as "process" or "service", except in those instances where separate provisions are stated for "processes" or "services".

This International Standard specifies requirements for a body certifying persons against specific requirements, including the development and maintenance of a certification scheme for persons.

This International Standard contains 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 this International Standard, and it applies to any stage of inspection.

This part of ISO/IEC 17050 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 this part of ISO/IEC 17050, the object of a declaration of conformity can be a product, process, management system, person or body. This part of ISO/IEC 17050 does not define any particular object for the declaration of conformity. Instead of "supplier's declaration of conformity", the term "declaration of conformity" can be used when appropriate.

This International Standard 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.

The document defines the process of peer assessment used to evaluate and monitor the competence of conformity assessment bodies to operate within international schemes. The document describes how peer assessment interfaces with accreditation as covered in ISO/IEC Guide 61:1996.

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.

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).

Partial superseding note: Clauses 12-17 of EN 45020:1998.

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.

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.

ISO/IEC - Taking over of an ISO Technical Corrigendum

This International Standard 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. This International Standard 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. This International Standard is applicable to all laboratories regardless of t he number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not under take one or more of the activities covered by this International Standard, such as sampling and the design/development of new methods, the requirements of those clauses do not apply. The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this International Standard. This International Standard 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. This International Standard is no t intended to be used as the basis for certification of laboratories.

Setting out the "General requirements for bodies proving assessment and accreditation" as an European Standard.

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 International Standard 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 (named in this International Standard “certification”) is a third-party conformity assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party conformity assessment bodies (named in this International Standard “certification body/bodies”).

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.

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.

Might be processed under VA/ISO with ISO/IEC 17024 (to be decided by TC1 during meeting 2001-11-19) - (NT/2001-10-29) ++ VA/ISO (CC/011206)

This International Standard 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 (named in this International Standard "certification") is a third-party conformity assessment activity (see ISO/IEC 17000:2004, 5.5). Bodies performing this activity are therefore third-party conformity assessment bodies (named in this International Standard "certification body/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.

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 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.

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 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 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.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Transferred from WI CSF06003 (P. Pieters 97-03)

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.

Mutual understanding and communication. Quality.