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Is Quality manual a mandatory requirement for ISO 17025?

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Guest user Created:   Feb 25, 2021 Last commented:   Feb 25, 2021

Is Quality manual a mandatory requirement for ISO 17025?

Is Quality manual a mandatory requirement for ISO 17025?

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Feb 25, 2021

A Quality Manual is no longer a mandatory requirement for ISO 17025:2017. There are a number of reasons. One is that there is less requirement for stating policies on almost each activity, which was typically done in the manual. Another reason is that laboratories had different views on what the Quality Manual was and often it was found to not suite the purpose. Some laboratories considered it a collection of separate documents making up the QMS manual, whilst most a separate document, supported by separate procedures. In this last case, often it was too long and there was too much repeated between the manual and the specific procedures. Even worse, often contradictory policies and processes were documented. That said, if structured and written well, a Quality Manual is very useful and provides an efficient way to reference and interlink policies, systems, processes, documents and records of your management system. This interlinking is a requirement of ISO 17025 – see clause 8.2.4. The Advisera Quality Manual is structured to achieve that and guide personnel in awareness of how these processes interlink.

For more information, read the whitepaper Clause-by-clause explanation of ISO 17025:2017, available for download from https://advisera.com/17025academy/free-downloads/ and preview the Quality Manual as part of the toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

You may also benefit from reading these two articles in the ISO 9001 academy, which is also applicable to the concept of a Quality Manual in ISO 17025:

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