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 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 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.