ISO 10012 and ISO 17025 - Understanding the Differences
The difference between ISO 10012 and ISO 17025 lies majorly in their scope.
ISO 10012 specifies the quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met, while ISO 17025 is for use by laboratories in developing their management system for quality, administrative and technical operations.
The focus of ISO 10012 is on the requirements of the measurement management system. It can be seen as a system within the quality management system defining the requirements applicable to the measurement management system in a way that illustrates the interrelations with other parts of the quality management system.
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It is a guidance document that is not intended for certification. For example, a company may choose to have a quality management system certified to ISO 9001:2015. Even if such company chooses to follow the requirements of ISO 10012, getting certified to ISO 9001 isn’t the same as getting certified to the requirements of ISO 10012. ISO 17025 on the other hand describes the requirements for a quality management system that can be accredited through a process that is comparable with certification but actually different from it.
ISO 17025 requirements covers all aspects of the laboratory of any type and/or size. An aspect of ISO 17025 requirements refers competence, this relates to the competence of the entire system – not just training of laboratory personnel, addressing such factors as contracts with customers, purchasing, internal auditing, and management review of the entire quality management system. However, ISO 10012 does not.
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Rounding it all…
ISO 10012 is a guidance document that addresses one element (i.e. managing the measurement system) of a quality management system, while ISO 17025 defines requirements for the entire quality management system of laboratories that can be accredited, not certified to.
About the Author
Adebayo is a thought leader in continuous process improvement and manufacturing excellence. He is a Certified Six Sigma Master Black Belt (CSSMBB) Professional and Management Systems Lead Auditor (ISO 9001, 45001, ISO 22000/FSSC 22000 etc.) with strong experience leading various continuous improvement initiative in top manufacturing organizations.
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