Standards

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 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 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 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 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.

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”).

This International Standard specifies requirements for safe practices in the medical laboratory.

This guide gives guidance on product certification systems by identifying their various elements based on current practices. It is intended for use by product certification bodies and other interested parties wishing to understand systems, , develop, establish or compare third- party product certification, This Guide is not intended to describe all existing forms of product certification, It does not address first and second- party product conformity assessment.