Standards

This standard outlines a code of safety for chemical laboratories.

This standard specifies requirements for the operation of testing and/or calibration laboratories. It is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing activities.

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 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.

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 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.

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