1.1 This Standard 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.
1.2 This Standard 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.
1.3 This Standard 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.
1.4 This Standard 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 Standard.
JIS Q 0034:2012 Referenced Document
ISO 15189 Medical laboratories - Requirements for quality and competence [Standard in Spanish]
ISO/IEC Guide 98-3 Uncertainty of measurement - Guide to the expression of uncertainty in measurement (GUM:1995). Extension to any number of output quantities