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QM where its mentions the requirement of cl. 4.1.1, 4.1.2, 4.1.3, 4.1.4 separately

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Guest user Created:   Feb 24, 2021 Last commented:   Feb 24, 2021

QM where its mentions the requirement of cl. 4.1.1, 4.1.2, 4.1.3, 4.1.4 separately

I have reviewed the sample copy of Quality Manual and it seems that QM is not covering each sub-clauses.
I am looking for QM where its mentions the requirement of cl. 4.1.1, 4.1.2, 4.1.3, 4.1.4 separately.

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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.

Expert
Tracey Evans Feb 24, 2021

The Quality Manual serves as the core of the QMS, documenting a description of the organization’s structure, and stating how the requirements of impartiality and confidentiality along with requirements for structure, resource, process and management are met.  Remember if you were implementing without a toolkit, you would document what you do, then look at the standard and fix the gaps. It is not advisable to implement by a copy approach from the standard and where it states, for example  “The lab shall..”, a laboratory simply states, “We do..” The approach taken with the Toolkit is not to document each subclause in the Quality Manual; otherwise, a laboratory might as well just extract the information straight from the Standard. It is a more effective approach to look at each activity / requirements of ISO 17025; for example, Impartiality, review each subclause (e.g., clauses 4.1.1 to 4.1.5) and state how these are met. Of course, if you prefer to structure the manual directly linked to each subclause, that is your choice.

The manual does in fact cover all the subclauses 4.1.1 to 4.1.5. In some sentences the stated process covers more than one subclause- a reason for not just listing each subclause. For example, for a sentence you can see in the preview – “[Job title] ensures that laboratory personnel are free from pressures both internal and external that may compromise the results of their work” , the toolkit indicates this is typically the Quality Manager; so this statement covers both subclause 4.1.1 - activities to be structured and managed to ensure impartial and 4.1.2 - management must be committed to impartiality.

My suggestion is when you go over the toolkit Quality manual and your procedures you review where you cover the requirements. This is an important part of awareness. If you prefer, you can indicate the subclauses in brackets after each section.

For more information on what is required for ISO 17025 impartiality, read the whitepaper Clause-by-clause explanation of ISO 17025:2017, section 4.1, available for download from https://advisera.com/17025academy/free-downloads/ and preview the toolkit further at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

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Feb 24, 2021

Feb 24, 2021