Three ISO 17025 Questions

[isolisa]

Hi All:

I need a little assistance with the ISO 17025 Standard. My company is ISO 9001:2008 Certified, so here are the questions:

1.) It appears that I need to create a "sub-Quality Manual" for our Calibration Lab, complete with it's own Quality Policy Statement.

2.) It seems as if we need to hold at least one additional Management Review just for the Calibration Lab?

3.) Can I modify my current Company Standard Procedures to accommodate 17025 (i.e.: Contract Review, Purchasing, etc.), or do I need to recreate the wheel?

Annex B in the Standard has me a bit perplexed; it appears that one can go either way on documentation. Any help would be greatly appreciated.

Lisa

 

[qusys]

Re: ISO 17025 Questions

Hi Lisa,
I would like to know if you are trying to apply for ISO17025 and if it is necessary for your business too.
Are you a Lab that provides external services?

If not , ISO 9001 is enough.
To have ISO 17025 is a cost and should be part of strategical decision too.

To respond to your question 1 and 2 , it needs a manual for your Lab if you will pursue ISO 17025, including management reviews of hte related activities and process.

Hi All:

I need a little assistance with the ISO 17025 Standard. My company is ISO 9001:2008 Certified, so here are the questions:

1.) It appears that I need to create a "sub-Quality Manual" for our Calibration Lab, complete with it's own Quality Policy Statement.

2.) It seems as if we need to hold at least one additional Management Review just for the Calibration Lab?

3.) Can I modify my current Company Standard Procedures to accommodate 17025 (i.e.: Contract Review, Purchasing, etc.), or do I need to recreate the wheel?

Annex B in the Standard has me a bit perplexed; it appears that one can go either way on documentation. Any help would be greatly appreciated.

Lisa

 

[isolisa]

Yes, we do calibration work, for our product line. At this point, we're looking at going after accreditation. Of course, to a small company (25 people), cost is a big factor I'm trying to get all my ducks in a row before I discuss this further with the Company President.

It looks as if there will be extra paperwork, as anticipated. But if I can wedge a good chunk of the requirements into existing paperwork, that's less maintenance along the way....

 

[qusys]

Which kind of calibration work do you perform? What type of production do you do?

Does you Lab calibrate gages ( such as powermeters, voltmeter, hoscillope and so on ) that the technicians use when they perform maintenance activities on equipment?
If so it is not required ISO 17025 , because Lab is only internal.
You shall only respond to 7.6 clause of ISO 9001.

On the other hand, ISO TS 16949 for automobile sector has more stringent clauses of Laboratories requirements.

Hope this helps

 

[Jim Wynne]

Hi All:

I need a little assistance with the ISO 17025 Standard. My company is ISO 9001:2008 Certified, so here are the questions:

1.) It appears that I need to create a "sub-Quality Manual" for our Calibration Lab, complete with it's own Quality Policy Statement.

2.) It seems as if we need to hold at least one additional Management Review just for the Calibration Lab?

3.) Can I modify my current Company Standard Procedures to accommodate 17025 (i.e.: Contract Review, Purchasing, etc.), or do I need to recreate the wheel?

Annex B in the Standard has me a bit perplexed; it appears that one can go either way on documentation. Any help would be greatly appreciated.

Lisa

Unless you are planning to have your internal cal lab accredited under 17025, there is no need to create a new system for it. You can put it all under the general aegis of your 9001 QMS.

 

[isolisa]

Our Cal lab would be certified (btw, it does fall under the realm of our 9001:2008 Cert). We manufacture (and calibrate) Calibrators; our customers send product in for us to Recals.

I'm guessing that this accreditation would be to appease the foreign customer base. It doesn't seem like getting the paperwork in order would be *too* time consuming, but I'm not sure. If I need to write specific procedures just for our Cal Lab for 17025; that's two sets of doco that needs to be controlled, etc. yuk.

 

[Sarge]

Hello Lisa,

It sounds like I am in a situation similar to yours. We are investigating 17025 as an internal testing lab for only our company and then expanding to the calibration of our products delivered to or serviced for our external customers.

Some other things that need to be considered are:
• traceability of your standards
• proficiency testing to prove the competency of your technicians
• validation of your procedures

These are by no means insurmountable obstacles but they things that need to be considered when weighing the ROI of accreditation.

Hope this helps,

Sarge

 

[CalRich]

isolisa,

I worked in a situation just like yours - the main company ISO 9001 registerd and the calibration lab ISO 17025 accredited. We (unfortunately) in the lab maintained a separate quality system. It was in one sense not so hard because there were only 10 people involved, thus document control and record keeping wasn't so hard. Later on, there was need for the company's testing lab to become 17025 accredited as well. That accreditation, however, was tied to the main QMS.

Ideally, it's better to have the "Company X quality system" and include all of the standards applicable for the company. Since many common standards (9001, 16949, 17025...) all require certain fundamental elements (document control, management review, etc.), it seems better to marry them all into your one corporate QMS. You just have to take into account there ARE differences in them. (ISO 17025 is a competency standard, for example. It's not just another flavor of 9001.) Ensure you are meeting the intent of each standard in your company management system.

If you can pull it off, merge it with your existing QMS.

 

[Hershal]

Isolisa, some hopefully simple answers.

First things first. Get to a training session on ISO/IEC 17025, so that you have a good grasp on the application of the Standard. Also, make sure you have and read the Standard.

Also, get training on measurement uncertainty. It is a requirement for accreditation for calibration.

You almost certainly will need a manual for the lab itself. Where the ISO 9001 manual ADEQUATELY addresses the topics in ANS/ISO/IEC 17025:2005, then piggy-back on that. However, you will find that much of the time, that will not be the case, as 17025 has specificity in requirements that 9K does not. Address those differences in the lab manual.

You will need an internal audit and Management Review prior to any accreditation assessment, and should do them anyway to make sure everything is implemented. Now having stated that, both can dovetail onto the parent audit and review; however note that there are requirements for the lab. The audit must include not just the QMS, but also the technical component of the lab. The Management Review can be included in the parent's review, but note that 17025 has a prescriptive agenda in Clause 4.15.1, and the topics must be easily identifiable within the review if combined with the parent.

Lower level procedures can be modified, and should make it a bit easier for you. Remember, 17025 may well have additional specific requirements that must be taken into account.

One last point. Regarding accreditation, there are six internationally recognized accreditation bodies (ABs) based in the US. Do NOT sign with ANY of them until you have had some in depth discussion with ALL of them. And make sure that you are talking with technical folks, not just sales people. Remember, the assessment requirements include technical review so you should have confidence and comfort that the AB understands your needs.

Hope this helps.