ISO 9002 - Testing Laboratory - Scope and Discussion on Several Issues

ONE OF MY CLIENT IS PROVIDING LABORATORY SERVICES IN THE AREAS OF AIR / WATER POLLUTION. THIS LAB RECEIVES SAMPLES FOR ANALYSIS AND IT PROVIDES BACK ANALYTICAL REPORTS.
WHERE REQUIRED, THIS LAB PROVIDES SUITABLE POLLUTION CONTROL MEASURES.
ADDITIONALLY, THIS LAB HAS ENGINEERING EXPERTISE ALSO.
THIS LAB IS INTERESTED IN GETTING A RECOGNITION THROUGH ISO CERTIFICATION. HOW DO THEY GO ABOUT : SHOULD THEY GO FOR ISO9002 OR ISO 9001 ?
WILL THIS CERTIFICATION HELP THEM GET A SPECIAL RECOGNITION FOR THIER LABORATORY.
THANKS
Dr P R MADHAVAN

[Don Winton]

If by engineering, you mean design and development, they could go for either ISO 9001 or ISO 9002. If they are willing to have the design and development a part of the audit scope, do 9001. If not, do 9002.

Will the certification help them get special recognition? ISO 900x is a Quality Management System that is registered against a standard. The registration certifies that a Quality Management System exists and is in compliance with the standard. Only their customers or potential customers can determine if this is worthy of “special recognition.”

Regards,
Don

[Don Winton]

Subject: iso 9001 - laboratory
Date: Sun, 14 Mar 1999 06:51:30 +0530
From: "Dr.MADHAVAN" <mjaya@md2.vsnl.net.in>
To: dwizard@ficom.net

thanks for the response

the client will go for iso9001 as he has full scope for design.

1. since there is no process involved , how do i give treatment to clause 4.9?

2. again, the laboratory which is serving the environment sector (air & water pollution), will it be expected that the procedures for the laboratory activity comply with provisions of IEC25 even though the lab may not get certified for IEC25 separately.

dr p r madhavan

since there is no process involved , how do i give treatment to clause 4.9

I would suggest that the procedures for 4.9 be prepared regardless. Remember, “the range and detail of the procedures that form part of the quality system depend on the complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.” When the question is asked, there is a procedure in place, whether it is in actual use or not.

...that the procedures for the laboratory activity comply with provisions of IEC25...

I would humbly suggest that this be considered separately from ISO 9001.

Regards,
Don

[SteelWoman]

This is an old thread, but I found it through the search feature because I have a strange issue I need some help with. I have a company I deal with, a supplier, who has recently acquired a cold mill facility which includes a lab. The lab performs tests like tensiles, chemistry analysis, etc. The newly acquired facility is not yet certified to any standard. I know that with customer approval to do so (which we have) we can accept their testing results on their own material while they pursue certification. However, if I read 7.6.3.2 correctly if we use them to process someone else's material (another vendor's substrate) for us, and we want them to test the material, we ALSO have to have either them certified to a lab standard (not practical at this time) or a copy of their lab scope.

The PROBLEM is I'm running into a novice quality person at their facility who is inexplicably refusing to give me a lab scope document. I've explained that it's really just a list of the testing their lab is ALREADY doing - a document that would take her about 5 minutes to prepare from scratch, which they don't even have to do because they inherited the scope document from the previous owners. But she keeps coming back to me telling me why she is not "required" to have a lab scope! For whatever reason, she's turning this into a big pissing contest and I'm not going to be able to get a scope from them. Is customer approval to use them for testing, despite the lack of certificaton and lack of a lab scope document sufficient?

I also got the same response from her when I asked her to complete a Vendor Self Assessment - she told me they aren't certified so they shouldn't have to fill one out??? I'm starting to lean toward scheduling a full day audit over there of their new facility and their lab - if I can't get the simple documents completed I don't see where I have much choice but to perform an audit myself? Before you ask, this is not a vendor we can ditch - they provide a critical product.

[Hershal]

A lot of your question is dependent on YOUR certification/accreditation.

If you are registered to ISO 9K2K or to a sector-specific, then someone else may give a better answer, but I suspect you will have to do a good evaluation of them.

If your organization, or the part of your organization that uses this other lab, is accredited under ISO/IEC 17025, then you are in a higher level playing field and the rules are different - and much more involved. The comments you mention suggest that you need an accreditation of that lab ultimately, as you need a scope.

Feel free to contact me directly if 17025 is the driving issue and I may be able to help answer the questions a bit better.

Hershal

[Cari Spears]

Originally Posted by SteelWoman

I also got the same response from her when I asked her to complete a Vendor Self Assessment - she told me they aren't certified so they shouldn't have to fill one out???

Sheesh! If she knew anything, she'd know that it's BECAUSE they aren't certified that people want these things.

[D.Scott]

Did you try explaining that it isn't a requirement of their certification (which they don't have), it is a requirement of doing business with you. If their quality group won't provide what you need, get on their salesmen and have them put some pressure on. There doesn't seem to be much choice about scheduling an audit though. In my opinion you will need to do one anyway.

Dave