What is ISO/IEC 17025?
ISO 17025 is the main international standard used by testing and calibration laboratories.
ISO/IEC 17025 is the standard most labs must be accredited to so that they may be considered to be technically competent. There are many commonalities with the ISO 9001 standard, but ISO/IEC 17025 is more specific in requirements for competence, and applies directly to those organizations that produce testing and calibration results and is based upon more technical principles.
The current version is ISO 17025:2017 which was released on 1st December 2017. Prior to that there was a release in in 1999 and in 2005. The most significant changes occurred with the 2005 release which introduced a greater emphasis on the responsibilities of senior management, specific requirements for continual improvement of the management system, and communication with the customer.
ISO 17025:2017 and ISO 9001:2015
The difference between ISO 17025:2017 and ISO 9001:2015 is in the applicability of the standards.
ISO 9001:2015 can be applied to all types of businesses and industries as its requirements are very generic. ISO 17025:2017 is however only applicable to testing and calibration laboratories as its requirements are very specific to them.
ISO 17025:2017 explains that a Quality Management System is necessary for the proper functioning of a laboratory, and then provides two options. Option A, is for a situation where the laboratory has not implemented ISO 9001 and therefore needs to comply to a minimum set of QMS requirements that are applicable to ISO 17025:2017. Option B, which is when the organization meets the requirements of ISO 9001:2015 and hence does not need to comply with any additional requirements.
Note that while being certified to ISO 9001 is a nice to have, it is not a requirement to comply with ISO 17025:2017.
If the minimum requirements of ISO 17025:2017 are complied with then some requirements of ISO 9001:2015 will be missing:
- Context of The Organization: There is no requirement in ISO 17025 about identifying interested parties, recognizing internal and external issues nor about establishing the scope of the QMS.
- Quality Objectives: The improvement goals of ISO 9001:2015 are not present in ISO 17025:2017.
- Leadership: The leadership requirements of ISO 17025:2017 are not as comprehensive as those in ISO 9001:2015.
- Monitoring and Measurement: The monitoring and measurement requirements of ISO 17025:2017 are not as comprehensive as the requirements of ISO 9001:2015.
- Some Support Processes: While they are many support and resource requirements in ISO 17025:2017 as it applies to testing and calibration laboratories it does not include all the requirements from ISO 9001:2015. For instance it does not include the organizational knowledge requirements.
Key changes from ISO 17025:2005 to ISO 17025:2017:
The most substantive changes from the 2005 version to the 2017 version are as follows:-
- The scope has been revised to cover all laboratory activities, including testing, calibration and the sampling associated with subsequent calibration and testing.
- A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as ISO/IEC 17000 for conformity assessment.
- The process approach now matches that of standards such as ISO 9001 putting the emphasis on the results of a process rather than a detailed description of its tasks and steps.
- As most organizations are moving or have moved away from holding hard-copies towards electronic versions of manuals, records and report, the new version of the standard has a stronger focus on information technologies. It incorporates the use of computer systems, electronic records and the production of electronic results and reports.
- A new section has been added introducing the concept of risk-based thinking and describes the commonalities with ISO 9001:2015.
- The terminology has been updated. Examples include changes to align with the vocabulary used in international metrology, being the study of measurements, and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.
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