Standards

This document is intended to help reference material producers (RMPs) in preparing clear and concise documentation to accompany a reference material (RM). It lists and explains mandatory, recommended and other categories of information to be considered in the preparation of product information sheets and RM certificates. This information can be used by RM users and other stakeholders in confirming the suitability of an RM or certified reference material (CRM). This document also contains the minimum requirements for a label attached to the container of an individual RM unit.

This Guide is intended to help producers to prepare clear and concise certificates to accompany certified reference materials. Such certificates, while maintaining their essential character, should help to provide, in summary form, all the information needed by the user of the reference. material.

This document specifies the requirements for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000 (or other specified FSMS requirements). It also provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.

Certification of FSMS is a third-party conformity assessment activity (as described in ISO/IEC 17000:2020, 4.3), and bodies performing this activity are third-party conformity assessment bodies.

NOTE 1 In this document, the terms “product” and “service” are used separately (in contrast with the definition of “product” given in ISO/IEC 17000).

NOTE 2 This document can be used as a criteria document for the accreditation or peer assessment of certification bodies which seek to be recognized as being competent to certify that an

FSMS complies with ISO 22000 or other sets of specified FSMS requirements. It is also intended to be used as a criteria document by regulatory authorities and industry consortia which engage in direct recognition of certification bodies to certify that an FSMS complies with ISO 22000. Some of its requirements can also be useful to other parties involved in the conformity assessment of such certification bodies, and in the conformity assessment of bodies that undertake to certify the compliance of FSMS with criteria additional to, or other than, those in ISO 22000. FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, an FSMS requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.

NOTE 3 Certification of an FSMS according to ISO 22000 is a management system certification, not a product certification. Other FSMS users can use the concepts and requirements of this document provided that the requirements are adapted as necessary.

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.

This International Standard specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs). It is also appropriate as requirements document for the peer evaluation process for mutual recognition arrangements between accreditation bodies.

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 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 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 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.