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ISO 9001:2015 vs ISO 17025

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Guest user Created:   Apr 14, 2020 Last commented:   Apr 16, 2020

ISO 9001:2015 vs ISO 17025

When a testing laboratory is ISO 9001:2015 certified, what requirements are not met for 17025? We are 9001:2015 certified, but comparing the two standards, it seems that we meet all the requirements of 17025. Is this correct?

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ISO 17025 DOCUMENTATION TOOLKIT

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ISO 17025 DOCUMENTATION TOOLKIT

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Tracey Evans Apr 15, 2020

In the case such as yours, where a testing laboratory has ISO 9001:2015 certification; not all ISO 17025:2017 requirements are met. ISO 17025:2017 does accommodates what is called Option B (as per ISO 17025:2017 Annex B  Management system options). This means that your ISO 9001:2015 certification is considered to cover the management system requirements of ISO 17025:2017, namely clauses 8.2 to 8.9. What is missing is the requirements to demonstrate your laboratory’s competence to produce technically valid results and data. You will need to develop your management system to include the requirements of ISO 17025:2017 clauses 4 to 7, being the General, Structural, Resource and Process requirements. You may however, already covered some of these ISO 17025 requirements in your ISO 9001 management system; in which cases I suggest you do a gap assessment to determine what needs to be added.

Have a look at the article ISO 17025 vs. ISO 9001 – Main differences and similarities for some more information, available at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities//

 

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Beverly Brooking Apr 15, 2020

Regarding meeting all requirements, if the requirements set out in clauses 4-7 are added to an existing ISO 9001:2015 QMs, this would meet the requirements, along with the required procedures and records?

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Tracey Evans Apr 16, 2020

The answer to your question is most likely no, but depending on the extent of your ISO 9001:2015 management system and the planned ISO 17025 scope. As mentioned above, a laboraory will need to develop the management system to include the requirements of ISO 17025:2017 clauses 4 to 7. The clauses do not stand alone – they are intertwined, which means you need to make sure the requirements of clauses 4 to 7 are covered by, or added to, the existing management system processes and activities.

Once you have established the scope of accreditation, i.e. which tests are going to be included for accreditation; a gap assessment should be done. Here you will perform an audit to see to what extent the existing activities, processes, procedures and records (created for ISO 9001:2015) meet the requirements for ISO 17025. For example, you may have an audit program (ISO 17025:2017 clause 8.8) that meets ISO 9001:2015 requirements; however if technical audits had not been included, or your scope has changed, you may not have audited the method validations (clause 7.2) or monitored the environmental conditions (clause 6.3) of a test which is part of your ISO 17025 accreditation scope. Another example is risks and opportunities (clause 8.5), where assessments would be required and the register updated, to cover ISO 17025 activities.

I suggest the following article may provide some more insight  What is ISO 17025? especially the section Practically speaking, what are the steps to becoming ISO/IEC 17025 accredited?  Available at https://advisera.com/17025academy/what-is-iso-17025/

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