I need to draft the Quality Manual for ISO17025. We are already ISO9001:2000 certified.

My idea was to have one quality manual and incorporate ISO17025 requirements within the existing manual of ISO9001.

I don't know where to start. I have read the standard and lots of things are common with 9001. Can anyone help, maybe with some manual examples etc.?

Thanks
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Welcome to The Cove! :bigwave:

I agree with incorporating the requirements for 17025 into your present quality manual. This does not need to be difficult.

I do not know how your manual is set up, but what I'd expect is a set of descriptions of how your company does this and that. There is no need to say, ever, "in accordance with ISO ___" or anything of the sort. The descriptions of how your system operates answers the question "How do you conform?" for any savvy reader. If the manual is formatted in the same numbering system as 9001, that just makes the dot-connecting easier - but it's absolutely not required.

And so you can just add your process and method descriptions for 17025, if they are new or different, to existing manual clauses. For example, in the training and infrastructure readiness, you can add brief certification, OJT and environmental information that's specific for 17025; don't forget to include directions to the actual process document for the detailed information.

Does this clarify things for you?

I agree with Jennifer. Iso 9001 compliance will cover the first half of the ISO 17025 requirements. I completed this same process two years ago. :bigwave:

Since you seem to be in the very beginning stages I would suggest the basics. Familiarize yourself with the 17025 standard, as Jennifer mentioned, compliance to 17025 is intended to also cover compliance to the core components of 9001, so you will have overlapping requirements.

If your goal is to accurately identify what additions must be made to your manual I might suggest using a gap analysis checksheet against your current qms. Conveniently enough there was one already available on the cove

http://elsmar.com/Forums/fileslist.php?mode=allfiles&sortby=filename&pageamt=2&criteria=17025

However, I'm not sure what revision level it's written to.

Don't forget that you need to address the specific additional requirements under such clauses as 4.6 (Purchasing), 4.15 (Management Review), 5.2 (Personnel and Qualification), 5.9 (Assurance of quality), 5.10 (reports or certificates), and clauses for environmental, validation of procedures, control of non-conforming work, uncertainty of measurement, sub-contracting, and pay special attention to the locations for the IT infrastructure and integrity of data.

When you select your accrediting body, go to:

http://www.ilac.org

Select the one(s) closest to you if you don't have a signatory for Malta, and discuss fees, schedules, and any AB-specific requirements.

Hope this helps.

Is your lab seeking accreditation? How big is it compared to the rest of the organization? Is your lab seeking revenues from outside customers?

Depending on the answers to these, I might not advise integrating the quality manuals. For example, if you are going for accreditation, the differences in key areas of the ISO/IEC 17025 requirements are different enough that you might want a stand alone manual.

I'd be interested (as would others) in the background to the lab and the motivation to commonize the manual.......

I agree with Andy.

If the lab is a small part of the organization and the work is internal, it's a lot simpler to set up a different manual for the lab. It may be simpler to set up a different set of procedures, too.

17025 requires many more policies, procedures and records than 9001. To expose the larger organization to these requirements would be confusing, or even disruptive. This is particularly true if you are working toward, or have achieved, a low-overhead QMS.

If you were a test or calibration lab changing from 9001 to 17025, that would be different.

I would agree with CliffK and AndyN. Our position is that of a small 17025 accredited unit of about 35 staff within a much larger 9001 registered one of several hundred. Our 17025 QM is separate, except where there is value in common procedure.

For us the main common documentation elements with our 9001 management system are contract review, recording of complaints and non-conforming work, corrective/preventive action and internal auditing, but even here at the insistence of our AB we have been unable to avoid interpreting our 9001 manual with some subsidiary 17025 procedures. Our 17025/9001 documentation is electronically hyperlinked in many other ways as well.

Many thanks, I found the links very useful.

Many thanks to all of you for your helpful explenations. I will study it further and in case of questions I would let you know. My compliments to those responsible for this forum. Very helpful!

We are a small company of 30employees and our laboratory plays a great role within the organisation.

So I guess that going for one quality manual is the best solution.

Hi josephkj,

Pl note that I have deleted your response as you have already started a new thread on the subject. Pls avoid posting duplicate questions as you may not get good responses that way