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ISO 17025:2017 mandatory documentation requirements

fahimk

Starting to get Involved
#1
Dear Fellows:

I got confused after giving the ISO 17025:2017 document a quick look. Can anybody give me an idea about the documentation requirements of ISO 17025:2017 )? Is it that one is required to prepare a separate document (policy/procedure/form etc) to address each of the 130 (or perhaps more) clauses? Is it mandatory to furnish all documentation stated in SAC's checklist (google 'LAFM03_ISO 17025-2017 Chklist')?

I understand that documentation has to be customized to a particular Calibration Laboratory. But, for an idea, is there sample list of document to be prepared? Any additional information will be much appreciated.

Thanks and looking forward. Cheers!
 

Benjamin Weber

Involved In Discussions
#2
Dear Fellows:

I got confused after giving the ISO 17025:2017 document a quick look. Can anybody give me an idea about the documentation requirements of ISO 17025:2017 )? Is it that one is required to prepare a separate document (policy/procedure/form etc) to address each of the 130 (or perhaps more) clauses? Is it mandatory to furnish all documentation stated in SAC's checklist (google 'LAFM03_ISO 17025-2017 Chklist')?

I understand that documentation has to be customized to a particular Calibration Laboratory. But, for an idea, is there sample list of document to be prepared? Any additional information will be much appreciated.

Thanks and looking forward. Cheers!
Of course you don't need one separate document for each single requirement. But using the checklist you should be able to find the implementation of each single requirement somewhere in your documentation. Here is aonther thread that might help:

My company is looking to start a materials testing lab that conforms to ISO17025:2017

Usually you find one major document, where you describe the way how you are fulfilling major requirement. This is called the quality management handbook (though it is not formally required any longer to have this QMH, it is a well proven tool). Such requirements might be for example commitments such as to impartiality. And handbook is really a good description. Ideally this is the first document a new staff member gets to read, in order to know, how your lab works.
These general descriptions of your work are usually supported by more detailled process descriptions that are referred to in the QMH, for example how to perform management system review or how to handle calibration of your own equipment. And there may be an additional more detailled level of standard operation procedures which are refered to in the QMH or in the process descriptions, for example instructions how to perform a certain calibration or test in detail. Additionally you may also need different forms, which you use to generate your records (e.g. management system review records, personell qualification records, equipment calibration records, checklists used during a calibration/test...). These records are essentially the only way an auditor can check, if you follow your own rules (commitments, processes and maybe standard operation procedures)! Keep that in mind: An auditor wants to see, that your QMS enables you to meet the 17025 requirements and that you actually work according to your own rules!

The SAC checklist hepls you a lot, by not just citing the requirements. But is also gives you advice, how to implement!

Important: The structure described above is only one possible way of implementation. There are as many different structures as there are test and calibration labs. You have to find a structure, that fits your situation regarding structure of staff and their qualification, your infrastructure, your customers...
 
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