Standards

This international standard specifies requirements for quality and competence in medical laboratories. It can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

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 Technical Report provides examples of EPE that represent a range of applications from simple to elaborate.  They also represent a range of organizations (e.g., manufacturing and service companies; non-governmental organizations; government agencies; small medium and range enterprises; organizations with and without certified environmental management systems) and geographic locations.

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 International Standard provides guidance on the establishment, implementation, maintenance and improvement of an environmental management system and its coordination with other management systems. The guidelines in ISO 14004:2004 are applicable to any organization, regardless of its size, type, location or level of maturity. While the guidelines in ISO 14004:2004 are consistent with the ISO 14001:2004 environmental management system model, they are not intended to provide interpretations of the requirements of ISO 14001:2004.

This International Standard provides guidance on how to conduct an EASO through a systematic process of identifying environmental aspects and environmental issues and determining, if appropriate, their business consequences. It covers the roles and responsibilities of the parties to the assessment (the client, the assessor and the representative of the assess), and the stages of the assessment process (planning, information gathering and validation, evaluation and

reporting). 

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.