ISO GUIDE 34 3rd Edition, January 1, 2009
General requirements for the competence of reference material producers
Includes all amendments and changes through Change/Amendment , 2009
Additional Comments: ENGLISH * W/D S/S BY ISO 17034
Published By:International Organization for Standardization (ISO)
This Guide specifies general requirements in accordance with which a reference material producer has to demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials.
This Guide is intended for the use by reference material producers in the development and implementation of their management system for quality, administrative and technical operations. Reference material customers, regulatory authorities and accreditation bodies may also use it in confirming and recognizing the competence of reference material producers.
NOTE This Guide is not intended to be used as the basis for conformity assessment by certification bodies.
This Guide sets out the management system requirements in accordance with which reference materials shall be produced. It is intended to be used as part of a reference material producer's general quality assurance (QA) procedures.
This Guide covers the production of certified and non-certified reference materials. For non-certified reference materials, the production requirements are less stringent than for certified reference materials. The minimum requirements for the production of non-certified reference materials are specified throughout the Guide.