Pursuit of ISO 17025 accreditation for materials testing laboratory - Some Questions

[rmccallum]

I am in pusuit of ISO 17025 accreditation for our materials testing lab. I am attempting to write the manual myself. I am pretty green at this point and have a few question. What defines the lab as an entity legally? Do all subsections of the standard require a policy statement or can the procedures cover these requirements?

 

[Hershal]

The question is fairly deep, but the answers may be a bit simpler than the question.

The legal entity is typically something like an incorporation. I don't know how Canada handles that exactly. That is best addressed by your lab.

As to the level and volume of the documentation, having a bit better idea of whether your lab is sizable or one-person or something in between, and what kind of material testing you do, would be helpful.

Generally, you must address every point in the Standard. Having stated that, some things may not apply. State that and why, and move on. Now, any clause that requires policy/procedure, and that does apply to your lab, must have the requirement actually addressed. In some cases, you may easily be able to include the policy/procedure in the quality manual. An example is document control, including computer systems, electronic document control, security and integrity of data, and confidentiality of information, all of which is SPECIFICALLY to be addressed.

Some parts are best handled with external procedures, referenced in the quality manual. An example is the procedure for measurement uncertainty, which is also a specific requirement. Procedures that are validated (e.g. ASTM) can be referenced.

Procedures developed by the lab must be validated, which requires a plan. the plan can be simple, and basically includes a description of the method, what it should do and not do, and what the acceptance results are. Have Management sign off on it. Then the report should include the results, related right back to the requirements outlined in the plan, and a specific statement as to whether the procedures is valid for intended use. The report is also to be signed off by Management.

You will also have to participate in at least one proficiency test or inter-laboratory comparison (PT/ILC). Check with SCC to see what they have available or can recommend.

All this sounds like a lot - and it is - but hopefully you'll pick up enough help to write the manual and succeed on your assessment.

Hope this helps.

Hershal

 

[rmccallum]

Lab

Thanks a bunch.....it is just myself operating the lab. The lab is part of a small tube making company and I provide metallurgical and material testing services. I am interested in accreditation to improve the credibility of the lab and to address TS 16949 requirements. Currently ISO 9001:2000 The amount of time to completion is not necessarily a factor at this point.

 

[Hershal]

Thanks for the information.

You will likely have to address the issue of confidentiality with respect to your parent. If the parent is the only customer, the issue is not intense, you will just likely just have to define how you ensure only authorized folks have access to the test information and what measures are in place to keep unauthorized folks out. Don't try to rival the CIA there, be pragmatic.

You should be able to get a bit more direct guidance on some of those types of issues from your accrediting body. I presume that is SCC.

Hope that helps.

Hershal

 

[rmccallum]

Registrar

Thanks for the info. We are most likely going through L-A-B as their canadian affiliate is QMI. I might be wrong but I think this is our only option Our ISO 9001:2000 registration is through QMI.

 

[J_McDaniel]

Just a small point here but from the looks of it QMI does list ISO 17025 as one of their registration services (but I could be wrong). Just to reaffirm what Hershal has already said, I was in a similar situation as you a few months ago and found the SCC was very helpful once you get past the initial "did you go to our website?" conversation.

Jesse