Hello. I am working on updating my approved calibration vendor list and I have one or two companies that either have no accreditation or are compliant with ISO 9001 that I would like to add to my list. My main concern is figuring out how to add the manufacturers of equipment (only ones that we can find to calibrate some equipment) that have no intention of obtaining ISO 17025 on my approved list. Any way around this I should mention that my company maintains ISO 17025 certification. Thanks everyone for your help.:)

In my context (TS16949 formerly QS9000), our requirement is that the OEM may be used only when an accredited calibration supplier is not available. On our approved supplier list are the ISO17025 Accredited suppliers, and a separate listing for non-accredited OEM's. For each non-accredited OEM we use, we maintain a document stating that there are no accredited calibration suppliers available capable of calibrating a given instrument. We maintain this file by each manufacturer/model where it applies. A sticking point we have had in the past on this is that to use any non-accreditedOEM, we must document each instance that an accredited supplier is not available. We were given no guidance by the assessor as to what the document should contain. We made it very simple: Manufacturer, Model(s), Reason(s).

I should say that I don't want to recommend what detail you need, since the assessor didn't make it clear to us. It was clear that we may only use accredited labs(within their scope). If and only if that is not available, we may use the OEM. And when we use the OEM under those conditions only, we must document that we looked for an accredited source, but none was available.

To underscore, the only acceptable time a non-accredited calibration supplier may be used is at the OEM, and then only when no accredited source is available.

Get your customer to approve a "2nd party audit" or some other evidence acceptable to the customer.

Good catch. It's late Friday afternoon. Yes, but it is cumbersome (why we haven't really used it).

Under 17025 clause 4.5 the Standard does allow for non-accredited providers to be used.....now the AB for your lab may have tighter rules, however the Standard does allow it.

Now the tricky part.....you need to do a 17025 evaluation of the provider, using a checklist from your AB (they should be able to provide one for you), and for the technical evaluation you must take someone trained and experienced in that/those calibration discipline(s).

As Jerry pointed out, some ABs only allow non-accredited providers if the provider is the manufacrturer and there is no other reasonable option. You need to ask your AB what their rules are.

With respect to DI Foundry, your suggestion is a good one, and for almost any other Standard very workable.....for ISO/IEC 17025, the AB makes the rules for that.

Hope this helps.

Hershal

I just wanted to thank everyone for all of their suggestions. I will contact the AB and see what other information they are able to provide. Understanding ISO\IEC 17025: A2LA specific applications of the standard (download from A2LA website) was helpful; however, in regards to my original question it didn't give any help with respect to manufacturers of equipment when there is no one else available. What I am having difficulty with is the fact that they list so many examples of how to approve a subcontractor that for me opens a door to wonder what else will they accept. For example. the Understanding ISO\IEC 17025 states that "as an example, the laboratory should require the following records of their subcontractor to demonstrate their compliance with ISO\IEC 17025 (only as related to the subcontrated work in question:
A copy of the subcontractor's quality manual demonstrating compliance with ISO\IEC 17025;
A copy of the subcontractor's procedure(s) for the work in question and demonstration of adequate performance through profeciency testing;
A copy of the training records for the personnel responsible for performing the subcontracted work; and
An example of the report or certificate for the work intended to be subcontracted.

This information has helped me greatly except for how to handle calibrations when the only source available is the manufacturer who has no intention of obtaining certification and who has no quality manual. Simple enough but might be difficult to get someone to compose a quality manual which can be a pretty big undertaking. Especially if you are only doing it for one customer who only needs one piece of equipment calibrated annually.

It may seem like there is only the one customer asking.....but if you are, chances are so are others, even though the manufacturer may not admit it.....

Still, your point is well taken, and most of the non-accredited manufacturers won't give you the information. There are a few who will.

What kind of equipment are you having this dilema with?

Hopefully, more of the manufacturers will become accredited, as many already have.....

Also, if they ask you about accreditation, please do point out there are five ABs operating in North America that are recognized (IAS, A2LA, NVLAP, L-A-B, and SCC/CLAS), and they should talk to all five before deciding.

Hope this helps.

Hershal

I contact A2LA to find out what their rules are regarding this and I have attached their response for review.

If requesting an exception to the A2LA Traceability Policy in response to a deficiency, you are required to submit the following information for each, individual case for which an exception is requested:
1. Equipment name and model;
2. Parameter and range of calibration needed;
3. Key words used in any website search for an accredited calibration provider;
4. List of all sources investigated (e.g., specific accreditation body websites, hardcopy directories, state metrology labs, etc.)
5. Objective evidence that the measurement being provided by your present calibration vendor is traceable to the SI (a reverse traceability study verifying the sources of calibration to include a certificate of calibration showing direct calibration by an NMI or by an accredited laboratory). A traceability statement found on the calibration certificate is not adequate objective evidence.
If an exception is granted, you will be notified in writing, however circumstances surrounding the exception will be re-evaluated during your next full assessment and a deficiency will again be cited if you are still using a calibration provider that does not meet the A2LA Traceability Policy.

Please note also that if you are using a calibration provider that does not meet the A2LA Traceability Policy, to satisfy the deficiency you do not need to immediately re-calibrate the equipment in question using an acceptably accredited calibration source. You must demonstrate in your corrective action response that you will use an acceptable source of calibration for the next regularly scheduled calibration cycle. An acceptable source is a calibration laboratory accredited by A2LA or one of our mutual recognition partners. We invite your attention to our website www.a2la.org for a listing of our partners.

Just pointing out.....

All five ABs operating in North America that are recognized (IAS, A2LA, NVLAP, L-A-B, and SCC/CLAS) have nearly identical requirements, but there may be minor differences.....check with YOUR AB to get their specific information.

Hershal