Standards

This standard specifies the requirements for the operation of POCT sites with special requirements for VCT and PMTCT sites. The requirements of this standard apply when testing is carried out at POCT, VCT, PMTCT and community testing sites. This standard does not cover home testing or self testing sites

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 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 international standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this International standard apply when POCT is carried out in hospital , clinic and by a healthcare organization providing ambulatory care. This International standard can be applied to transcutaneous measurements ,the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of this International standard can be applicable.

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 document specifies requirements for safe practices in the medical laboratory (herein after referred to as “the laboratory”).