Standards

This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It 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 this document in confirming or recognizing the competence of laboratories.

This standard specifies the general requirements for a laboratory safety management system, which will enable a laboratory to formulate a policy and objectives, taking into account legislative requirements and information about significant risks, which the laboratory can control and over which it can be expected to have an influence, to protect its employees and others, whose health and safety may be affected by the activities of the laboratory. In addition this standard specifies specific requirements for medical laboratories. This standard is applicable to any laboratory that wishes to: (a) implement, maintain and improve an Occupational Safety and Health Management System; (b) assure itself of its conformance with its stated safety policy; and (c) make s self-determination and self –declaration of conformance with this standard.

 This standard specifies the general requirements for a laboratory safety management system, which will enable a laboratory to formulate a policy and objectives. It takes into account legislative requirements and information about significant risks, that the laboratory can control and over which  it can be expected to have an influence, to protect its employees and others, whose health and safety may be affected by the activities of the laboratory. 

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.

NOTE The stages of inspection include design stage, type examination, initial inspection, in-service inspection or surveillance.

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 (see ISO/IEC 17000:2004, definition 5.5).

In this International Standard, the term “product” can be read as “process” or “service”, except in those instances where separate provisions are stated for “processes” or “services” (see Annex B).

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.

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.

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 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.