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ISO/IEC 17025 specifies the general requirements for
the competence to carry out tests and/or calibrations, including
sampling. It covers testing and calibration performed using standard
methods, non-standard methods, and laboratory-developed methods.
- The standards full title is “General Requirements for the
Competence of Testing and Calibration Laboratories”;
- The current version is 17025 . The 2005 version does not
suggest technical changes from the previous version; changes
were to allow harmonization with ISO 9001;
- If a testing and calibration laboratory complies with ISO
17025, it will also operate in accordance with ISO 9001.
However, certification against ISO 9001
does not itself
demonstrate the competence of the laboratory to produce
technically valid data and results;
- There is a discussion document ISO/IEC DIS 17025 to offer
guidance on implementation;
- The standard can also covers in-house laboratories or
testing operations where assurance of results is at a premium;
- It applies to organizations that want to assure their
customers of precision, accuracy and repeatable results;
- It may be important to first-, second- and third-party
laboratories, and laboratories where testing and/or calibration
forms part of inspection and product certification;
- ISO/IEC 17025 is applicable to all laboratories
regardless of the number of personnel or the extent of the scope
of testing and/or calibration activities;
- When a laboratory does not undertake one or more of the
activities covered by ISO/IEC 17025 , such as sampling and
the design/development of new methods, the requirements of those
clauses do not apply;
- Laboratory customers, regulatory authorities and
accreditation bodies may also use it in confirming or
recognizing the competence of laboratories;
- ISO/IEC 17025 was formerly ISO Guide 25 & EN45001;
- Compliance with regulatory and safety requirements on the
operation of laboratories is not covered by ISO/IEC 17025 ;
- ISO/TS 16949, the Automotive Quality Management System has
stipulated that first tier suppliers of calibration and test
services be ISO 17025 certified, and that suppliers upstream of
them be compliant.
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