[ Pharmaceutical Sciences Asia - ONLINE ]
Print ISSN 2586-8195 E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974

 
Abstracts

Pharm Sci Asia ; 41(2),
 

Policy, Requirements and Conditions for Reference Material Producer Accreditation Bureau of Laboratory Quality Standards, Department of Medical Sciences

A. Tanunkat, W. Piyasiranond, and C. Sinthusarn

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Reference materials are material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus. The assessment of a measurement method, or for assigning values to materials. If a reference material accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence are called certified reference materials. The producers of reference material and certified reference material shall demonstrate their competence by formal compliance with a set of internationally recognized criteria. They shall accredit by the accreditation body who’s signed MRA with APLAC.

The Bureau of Laboratory Quality Standards (BLQS) which is an accreditation body was approved to be a full member and signatory to APLAC MRA in the scope of testing laboratory accreditation for ISO/IEC 17025 and ISO 15189 on November 14, 2002 and on April 18, 2007, respectively. Set an accreditation program for Reference Material Producers since 2006 for training the staff and set criteria for accredited. In October 2013, BLQS expanded its Asia Pacific Laboratory Accreditation Cooperation Mutual Recognition Arrangement (APLAC MRA) Scope to include the Reference Material Producer Accreditation Program. This arrangement calls for the signatory Accreditation Bodies to operate to ISO/IEC 17011 and assess reference material producers to ISO Guide 34 in combination with ISO/IEC 17025. This program is designed for producers of certified reference materials and reference materials who wish to demonstrate their competence by formal compliance with a set of internationally recognized criteria. The program will also provide users of reference material, such as testing and calibration laboratories, with increased confidence that the reference materials being relied upon are being produced in accordance with specified technical and management system requirements and are of appropriate quality.



Keyword:

Reference material, Accreditation, ISO guide 34




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Vol.41
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October - December 2014

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Vol.41
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