Standards

This International standard provides and guidance for developing normative documents that contain specified requirements for objects of conformity assessment to fulfill’ specified requirements for conformity assessment systems that can be employed when demonstrating whether an object of conformity assessment fulfills specifiedrequirements. It is intended for use by standards developers not applying the ISO/IEC Directives, industry associations and consortia, purchasers, regulators, consumers and non-government groups, accreditation bodies, conformity assessment bodies, conformity assessment scheme owners, and other interested parties, such as insurance organizations.

This Guide recommends good practices for all elements of conformity assessment, including normative documents, bodies, systems, schemes and results. It is intended for use by individuals and bodies who wish to provide, promote or use ethical and reliable conformity assessment services. These include, as appropriate, regulators, trade official calibration laboratories, testing laboratories, inspection bodies, product certification bodies, management system certification/registration bodies, personnel certification bodies, accreditation bodies, organizations providing declarations of conformity, and designers and administrators of conformity assessment systems and schemes, and users of conformity assessment. This Guide is designed to facilitate trade at the international regional, national and sub-national level.

This document recommends good practices for all elements of conformity assessment, including objects of conformity assessment, specified requirements, activities, bodies, systems, schemes and results. It is intended for use by individuals and bodies that wish to provide, promote or use impartial and reliable conformity assessment services. Providers of conformity assessment can include conformity assessment bodies, accreditation bodies, peer-assessment agreement groups, and organizations providing declarations of conformity. Individuals or organizations that promote or use conformity assessment can include, as appropriate, regulators, trade officials, and owners of conformity assessment systems and schemes.

This Guide provides an introduction to the development, issuance and operation of arrangements for the recognition and acceptance of results produced by bodies undertaking similar conformity assessment and related activities. The activities to which this guidance is intended to apply are those related to the conduct of unregulated marketplace transactions extending across borders from one country to another. While agreements among governments pertaining to transactions of regulated goods and services can take into account the agreements addresses by this Guide, the guidance provided here is introductory and general in nature and does not specifically address any special requirements that governmental agreements might generate.

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 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 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.

NOTE 1 In this International Standard the term “product” can also be read as “process” or “service”, except in those instances where separate provisions are stated for “processes” or “services”. Definitions of product, process and service are given in ISO/IEC 17065.

NOTE 2 The certification of products, processes and services is a third-party conformity assessment activity (see ISO/IEC 17000) carried out by product ertification bodies. The requirements for product certification bodies are specified in ISO/IEC 17065.

This guide gives guidance on product certification systems by identifying their various elements based on current practices. It is intended for use by product certification bodies and other interested parties wishing to understand systems, , develop, establish or compare third- party product certification, This Guide is not intended to describe all existing forms of product certification, It does not address first and second- party product conformity assessment.

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 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.