ISO 17025 - Seeking Example Quality Manual

[Lily lawrence]

ISO 17025

Hi ! Our laboratory is trying for accreditation according to ISO 17025
Can anyone provide me with a sample Quality Manual?
How do address the question of conflict of interest?

 

[David Mullins]

I've drafted one manual to ISO 17025, and have to do another soon.

NATA, the accrediting body in this instance, has looked at the manual and doesn't have any concerns over the structure, etc. It's the structure that's the point - the manual follows my statements over the last year on this forum that manuals need very little in them, it's the procedures that count. Or conversely, put everything in the manual and don't have any procedures.

The Manual is the same structure as the 9001:2000 manual I've nearly finished drafting. This is our "Business Systems Manual" and is the mother document. It contains the systems level procedures and references other (separate) manuals that come under it and form part of the overall system (e.g. Lab Manuals, Forms Manual, Induction Manual, External Document Manual, Job Description Manual.....).

Your lab manual should contain:
- the lab quality policy;
- reference to procedures (I put the documentation master list in the manual); and
- outline the documentation that makes up the system (a compliance matrix covers that).

The roles and responsibilities must also be included, but I include the procedures themselves within the manual, as individually identified and controlled documents.

Any help?

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[lily]

Thank you very much for the web site
and the sugestions for the structure of the quality manual. Most likely my lab. in Malaysia will be seeking NATA accreditation

Lily

 

[lily]

David ,
Do you know where I would be able to get
a sample of the Quality Manual which would
be O.K. with NATA requirements?

thank you,

Lily

 

[David Mullins]

Lily,
On the same row as my name appears on this reply is a mail button.
Send me an e-mail, so I can contact you, and we'll see what we can organise.



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[David Mullins]

I was attempting to help Dr Lawrence, but my e-mail crashed about 6 weeks ago and she didn't receive anything I sent her. Worse, my email history was wiped, including Lily's contact details.
If Dr Lawrence is reading this could she please email me again.
OR, if you know Dr Lawrence, let her know that my email is back.
Cheers,
[email protected]

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[zamclachia]

Before starting with 17025 I read 3 different manuals. One from Nestle York, Nestle Singapore and lastly Nestle research center. All three were different regarding structure and information contained within. I have done my own thing. Follow the advice of David Mullins.
Google "ISO 17025". There are many examples out there, but don't simply do a cut and paste exercise. Document what you are doing and make sure you do what you document. The whole system must be a living one and reflect what is happening.

As an absolute minimum I have concentrated on all the requirements that are preceded with 'SHALL'. SHALL is not negotiable in the standard.

Would any parties want to participate in an exercise where we share the contents of of our quality manuals and procedures etc. I believe we could benefit from each others ideas and writings.