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Section 2 Normative references

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Sally R Created:   Jan 31, 2022 Last commented:   Feb 02, 2022

Section 2 Normative references

I have been asked to review the quality manual for accuracy before the owner reprints it. I never noticed this before, but under section 2 normative references, the owner of the laboratory listed reference such as textbooks and guides like: Bam, ISO/IEC guide to general terms in the definitions, and many other ISO guides like 7218, ISO guide 8402:1986. Do all of these references have to be put on a list of controlled external documents? Our lab has a list of internal and external controlled documents. These textbooks and guides listed in Section 2 of the QM are not of the list of external controlled documents. Isn't this a non-conformance?

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Tracey Evans Feb 02, 2022

You asked 

Do all of these references have to be put on a list of controlled external documents?

You also asked

Isn't this a non-conformance?"

A non conformance against control of external documents would be valid if either a mandatory requirement of the standard or the accreditation body is not met or if the laboratory fails to follow its own established process. 

There is no mandatory requirement for a list of controlled documents (internal nor external) as this is not a requirement of the standard. It is typical however for laboratories to use such lists as it makes for an easy process to follow.

If in their document control procedure they refer to the use of a list of controlled external documents and don’t have normative documents listed, then yes in that case it would be a non conformance.

What ISO 17025 requires is the linking and reference of all related documentation, processes, systems and records in the QMS (clause 8.2.4). This the laboratory has met, by adding them in their section 2 of the Quality Manual.

There are of course, a number of control requirements as per clause 8.3, including the periodic review of the suitability of documents (including external). You should obtain evidence of  how the laboratory achieves that. They must be able to describe the process  - who is responsible, how and when the control and review takes place and evidence thereof. i.e how do they know they are using the latest published version of the external document ? 

In summary, it is up to the laboratory to decide, based on risk, if they need to use a list. As a reviewer you can assess their response yo meeting 8.2 and 8.3 requirements. If there is no nonconformance, you could at least comment on the risk to meet the mandatory requirements and provide evidence.

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Jan 31, 2022

Feb 02, 2022