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Brittany Vogel
Published: Tuesday, July 21, 2009 - 12:01
ISO/IEC 17025 is an international standard that consists of general requirements for testing and calibration laboratories. The standard provides accreditation for the procedures carried out by these laboratories, ensuring consumers that the products are safe. It assures customers that a lab is technically competent, and is able to generate technically valid results. ISO/IEC 17025 is an update from its 1999 version in that it is compatible with ISO 9001.
ISO/IEC 17025 details all of the necessary requirements for testing and calibration laboratories must follow to gain customer confidence. A competent management system is key, which is where ISO 9001 comes into effect. The two standards are compatible but not interchangeable. ISO 9001 applies generic management standards, while ISO 17025 involves more laboratory specific management details.
ISO/IEC 17025 contains five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. Within these five categories of the standard, only two contain actual accreditation requirements—management requirements and technical requirements. There are 15 management requirements; among those are organization, client service, and the control of nonconforming testing and calibration results. A few of the 10 technical requirements include personnel’s accommodations and environment, equipment, and the reporting of test results.
ISO/IEC 17025 applies to any organization that performs tests and calibrations, but is applicable to all laboratories, regardless of the number of personnel or the amount of tests and calibrations performed. Organizations must effectively implement key values for quality such as management review, corrective and preventative practices, and a focus on customer opinion. Businesses must demonstrate to both customers and regulators that they run a competent management system that produces accurate test results to be accredited.
The ISO/IEC 17025:2005 update from 1999 didn't implement any new requirements. It only became more ISO 9001 compatible and shifted its focus to implementing proper management for a more effectively run laboratory.
Referrences
www.iso.org/iso/pressrelease.htm?refid=Ref956
www.quality.co.uk/custpage.htm
www.quality.co.uk/inetcons.htm
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Requirements for testing and calibration laboratories.
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Brittany Vogel
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