ISO 17025 Quality Manual and 58 page Checklist - And how many procedures do I need?

[Ken K]

I am in the process of trying to fill out a 58 page checklist to submit to our assessor for ISO17025 accreditation. In order to do that, I also need to write a QM to cover each clause and sub-clause specified in the checklist.

I could really use your imput concerning a couple of questions I have.

1. Did you address each clause and sub-clause with a separate procedure or did you just write one procedure for the clause which covered all sub-clauses?

Example: Main Clause - 4.10 Corrective Action
Sub Clause - 4.10.1 General
Sub Clause - 4.10.2 Cause Analysis
Sub Clause - 4.10.3 Slection and Implementation
Sub Clause - 4.10.4 Monitoring of Corrective Action
Sub Clause - 4.10.5 Additional Audits

2. Since we are only seeking accreditation for two GM test specifications, should the QM only address procedures pertaining to GM and those specifications and test methods?


Talk about a pain in the :ca:

 

[David Mullins]

my thoughts

Ken,
Could send examples if you were accessible.

1. the compliance matrix in the example treats 4.10 Corrective Action as 1 line item, and references the procedures which provide evidence of compliance.

2. Yes, only the scope of tests being accredited, but you need the management system to support it, as per the std.

The 17025 compliant lab manuals I wrote are 6 pages.

 

[Catherine Lim]

Hi David,
Need some help with the 17025 manual. Can u pls email to me the 6 pages of 17025 compliant lab manuals.

Thanks alot.

 

[Mickeyman]

May I also have a copy?

kensingtonlabs.com

Thanks!

 

[Ken K]

Well Dave, our manual is quite a bit over your 6 pages, but today I finally got a call from our assessor to discuss the manual. After a 2.5hr discussion, we ended up with 6 minor changes that need to be made. Our pre-assessment is scheduled for Oct. 29th.

To keep things somewhat simple, I went right through the standard and addressed each clause and sub-clause. The one thing the auditor did not like was the labeling of the clauses that do not apply as N/A, mostly the claibration clauses which we are not seeking accreditation for.

Dave, if your out there I would like your thoughts on one thing.
We had an outside lab come in last week to calibrate some of our equipment. Two of those were balances. When he printed out the calibration certificates, there were no stated uncertainties listed. When asked he told me they do not list uncertainties for balances because each is different. (?) Upon examination of previous certificates from the same company for our weights, a thermohygrometer and a dual channel thermometer, neither had uncertainties listed. This time when asked he could not give a reason why and said he would have someone call me to discuss.

Do you calculate uncertainties for balances you calibrate? I discussed this with our assessor and he stated uncertainties shall be listed on all calibration certificates. He got a little quiet when he asked if they were accredited and my reply was...Yes, by you.

Your thoughts?

 

[David Mullins]

Ken,

Everyone has their own approach to content and structure of the QMS.


I'd like to give you a definitive answer, but I can't.
If anyone else can, that's great.

Talk with other cal service providers and if they say they do calc uncertainty for scales, get them to facs you a sample report so you can see it for your self (you can't trust what they say they can do unfortunately).
Armed with evidence you can talk to your acreditation authority about what they are going to accept.