ISO/IEC 17025
ISO/IEC 17025:2005 is an international Standard, which specifies the general requirements to ensure that a laboratory is competent to carry out specific tests and/or calibrations.
ISO/IEC 17025:2005 contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they:
- operate a management system;
- are technically competent; and
- are able to generate technically valid results.
ISO 9001 is related to item 1 above. It does not, however, cover items 2 and 3, which relate to technical competence. Therefore, it is internationally accepted practice for laboratories to obtain accreditation to ISO/IEC 17025, not ISO 9001 certification. Obtaining ISO 9001 certification for laboratories does not demonstrate technical competence to undertake scientific tests or measurements and issue reports that can be relied on.
On the other hand, care has been taken to incorporate all the elements of ISO 9001:2000 that are relevant to the scope of testing and calibration services covered by the laboratory's management system.
ISO/IEC 17025:2005, clause 1.6, states: 'If testing and calibration laboratories comply with the requirements of this International Standard, they will operate a quality management system for their testing and calibration activities that also meets principles of ISO 9001'
But ISO/IEC 17025:2005 also says that demonstrated conformity to ISO/IEC 17025 does not imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001:2000.
ISO/IEC 17025:2005 focuses on the following two elements:
- Clause 4 - Management requirements
- This clause specifies the requirements for sound management.
- Clause 5 - Technical requirements
- This clause specifies the technical requirements for the specific type of tests and/or calibrations the laboratory undertakes.
Revision of ISO/IEC 17025:
ISO/IEC 17025: 1999 was published in Japanese as JIS Q 17025:2000. This replaced ISO/IEC Guide 25.
ISO/IEC 17025:1999 referenced ISO 9001:1996 and ISO 9004:1996 to cover quality management system aspects. In 2000, these QMS Standards were superseded by ISO 9001:2000, which meant that ISO/IEC 17025 also needed to be amended.
The revised version of ISO/IEC 17025:1999 was published as ISO/IEC 17025:2005. (The Japanese version is JIS Q 17025:2005)
Japanese version of ISO/IEC 17025:2005
The Japanese version of ISO/IEC 17025:2005 is published by the Japanese Standards Association (JSA). If you would like to purchase a copy, please contact JSA.
JAB is recognized as a national accreditation body for ISO/IEC 17025 in Japan, and is a signatory to the international Mutual Recognition Arrangements (MRAs) within ILAC and APLAC. Membership of these MRAs is only granted following rigorous peer evaluation to ensure that the accreditation process is equivalent and that test or calibration reports issued by laboratories accredited by any MRA partner can be relied on.
ILAC: International Laboratory Accreditation Cooperation
APLAC: Asia Pacific Laboratory Accreditation Cooperation
ISO 15189:2003
ISO 15189 is an international Standard, based on ISO/IEC 17025 and ISO 9001, covering requirements for competence and quality that are particular to medical laboratories. The first edition of ISO 15189 was established in 2003.
ISO 15189, like ISO/IEC 17025, focuses on the following two elements:
- Clause 4 - Management requirements
- This clause specifies the requirements for sound management.
- Clause 5 - Technical requirements
- This clause specifies the technical requirements for the specific types of tests that the medical laboratory undertakes.
JAB has been offering a medical laboratory accreditation service based on ISO 15189:2003 since 1 August, 2005.
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