Standards

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 document specifies requirements for a food safety management system [FSMS] to enable an organization that is directly or indirectly involved in the food chain.

a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use;

b) to demonstrate compliance with applicable statutory and regulatory food safety requirements) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them;

d) to effectively communicate food safety issues to interested parties within the food chain;

e) to ensure that the organization conforms to its stated food safety policy;

f) to demonstrate conformity to relevant interested parties;

g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document.

This international standard provides guidelines for an organization to plan, develop, operate, maintain and improve an effective and efficient dispute-resolution process for complains that have not been resolved by the organization, This International standard is applicable to complaints relating to the organization's products intended for, or required by, customers, the complaints-handling process or dispute-resolution process.

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 International standard provides guidance for planning, developing , implementing, maintaining and improving customer satisfaction codes of conduct. This international standard is applicable to product-related codes containing promises made to customers by an organization concerning its behavior. Such promises and related provisions are aimed at enhanced customer satisfaction. Annex A provides simplified example of components of codes for different organizations.

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.