ISO/IEC/EN 17025 - General Requirements for the Competence of Calibration and Testing Laboratories.
ISO/IEC 17025 is the international standard for testing and calibration laboratories. It sets out requirements for the competence, impartiality, and consistent operation of laboratories, ensuring the accuracy and reliability of their testing and calibration results.
1. Introduction
Effective implementation of a quality management system as per the requirements of ISO 17025:2005, either on its own or in conjunction with the requirements of ISO 9001:2016:19 03/05/202400, is a key requisite for laboratories who provide testing and calibration services commercially, or as an internal department providing the service within a larger organisation.
ISO 17025 covers every aspect of laboratory management. It involves everyone in the lab, including the laboratory manager, assistant laboratory manager, or quality manager. The standard also involves all laboratory staff whose functions relate to the quality of laboratory data generated. A laboratory showing fulfilment of the requirements of ISO/IEC 17025:2005 demonstrates that it meets both the technical competence requirements and management system requirements that are necessary for it to consistently deliver technically valid test results and calibrations.
The standard was revised in 2005, the purpose of which was to align it with ISO 9001:2000. Unlike before, the two standards are now considered to be compatible rather than fully aligned. The revision makes it clear that meeting the requirements of ISO/IEC 17025 does not automatically mean that the requirements of ISO 9001 are met. The standard does however recognise that, by being accredited to ISO/IEC 17025, a laboratory will meet the principles of ISO 9001.
The standard was revised in 2005, the purpose of which was to align it with ISO 9001:2000. Unlike before, the two standards are now considered to be compatible rather than fully aligned. The revision makes it clear that meeting the requirements of ISO/IEC 17025 does not automatically mean that the requirements of ISO 9001 are met. The standard does however recognise that, by being accredited to ISO/IEC 17025, a laboratory will meet the principles of ISO 9001.
2. ISO/IEC 17025 Accreditation
In the United Kindom all aspects of accreditation are the sole responsibility of UKAS, The United Kingdom Accreditation Service. In the U.S. there are two bodies that are mutually recognised to provide accreditation to ISO/IEC 17025. They are the National Voluntary Laboratory Accreditation Program (NVLAP) and the American Association for Laboratory Accreditation (A2LA). There are many other bodies in the US that provide accreditation to ISO/IEC 17025, but most do not have either bilateral or multilateral recognition arrangements with other recognised bodies.
A first step to obtaining accreditation is to contact one of the bodies mentioned above, or you own national accreditation organisation. They will be able to provide you with detailed information on how to prepare your management and other sytems, ready for the accreditation process to begin.
3. Scope of ISO/IEC 17025
ISO/IEC 17025 is a specification for calibration and testing laboratories, applicable to any type of organisation regardless of size, location or the range of services they provide. The majority of information is contained in 2 of its sections:
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Management requirements (Section 4) |
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Technical requirements (Section 5) |
Management requirements include paragraphs on:
* Organization and management
* Quality system
* Document control
* Review of request
* Subcontracting of tests and calibrations
* Purchasing services and supplies
* Service to the client
* Complaints
* Control of non-conformity testing
* Corrective action
* Preventive action
* Records
* Internal audits
* Management reviews
Technical requirements include paragraphs on:
* General
* Personnel
* Accommodation and environmental conditions
* Test and calibration methods including sampling
This includes requirements for method validation (laboratory developed, non-standardized, standardized but used outside of their intended range) and measurement uncertainty
* Equipment
* Measurement traceability
* Sampling
* Handling and transportation of of test and calibration items
* Assuring the quality of test and calibration results
4.Benefits of Accreditation
As with any well constructed standard, ISO 17025 is not to be considered as an unecessary imposition on your time and efforts. It is designed to be help you improve, and then maintain, your quality and standards. By following the procedures and methods specified, everyone can be assured of the accuracy and integrity of your laboratory. However, you will have to continually monitor your quality processes to ensure that they continue to meet the guidelines of this standard. This is a good thing for everyone, rembember: rigorous quality processes equate to fewer failures and errors.
It is also important to remember that as more calibration laboratories become accredited, correlation between these accredited laboratories’ measurements will improve, thereby improving the general quality of the measurement process everywhere.
