OK Covers, a little help por favor!

We outsource our calibration process as many organizations do. We currently do not notate on our Purchase Order the ISO standards (9001/17025) requirements that we are holding them accountable too. My Purchasing department doesn't want to list that requirement on the PO, for no good reason. I'm under the impression that in order for me to conduct a supplier audit of the vendor AND to demonstrate control over the outsourced process that we have to document (somewhere) to the vendor what our expectations of them are. If I only do this verbally, is that acceptable?

What are your opinions?

Thanks,
Scott

OK Covers, a little help por favor!

We outsource our calibration process as many organizations do. We currently do not notate on our Purchase Order the ISO standards (9001/17025) requirements that we are holding them accountable too. My Purchasing department doesn't want to list that requirement on the PO, for no good reason. I'm under the impression that in order for me to conduct a supplier audit of the vendor AND to demonstrate control over the outsourced process that we have to document (somewhere) to the vendor what our expectations of them are. If I only do this verbally, is that acceptable?

What are your opinions?

Thanks,
Scott
If your system documentation says that you must use a duly registered/accredited source and you do, then there shouldn't be a problem with what the PO says in this regard. You just need to be able to show that the supplier was registered/accredited at the time that calibration services were performed, which is normally noted on calibration certificates.
On the other hand, if maintaining accreditation is a condition of doing business with a given supplier, that requirement should be a part of a contract, such as a purchase order.

For calibration of equipment your organization is required by 7.4.1 of ISO 9001 to evaluate and select suppliers based on their ability to supply products or services per your requirements or those imposed by your customer.

The standard charges your organization with performing evaluations (supplier survey, audit etc.) to assure they meet your or your customer imposed requirements and in this cases you can select only those calibration labs that meet ISO 9001 or ISO 17025.

Now if your customers are mandating that you only use ISO 9001 or some other QMS requirement then that should be clearly stated in the PO requirements. Also it is a good idea (mandated is AS9100) that there be a PO requirement for your suppliers to notify your organization when a change (loss of certification / obtaining certification) has occurred related to supplier QMS.

Quit hitting that brick wall - go around it. Specify an ASL vendor be used for the calibration PO. For calibrations, it's best to use an ISO 17025 Accredited Lab (unless it is the OEM) - those labs, and the personnel within them, have had to demonstrate proficiency in the actual calibration methods, plus standard quality requirements. Write your procedures to require that calibrations must be done by (a) in-house to approved procedures by trained personnel, (b) by the original equipment manufacturer, or (c) an ISO 17025 accredited laboratory. Then use the third-party accreditation auditors to do your audit for you, and accept the accreditation certificate (with the Accredited Scope) as the supplier qualification requirement. Look on the A2LA or NVLAP (NIST National Voluntary Laboratory Accreditation Program) websites to find appropriate vendors. Then place those labs on your approved supplier list..

RSantos:

Although your thoughts are great for an ideal world, not all of us live there. I am in an area where I have ONE calibration supplier who is 17025 registered, and ONE who is OEM approved (CMM calibration). I have a significant number and variety of IM&TE which (for one reason or another) I either cannot or will not calibrate in-house. Should I just buy all new equipment each calibration period? Should I set my calibration period at 99 years?

Far better (IMHO) is to advise all my customers that our supplier base for calibration/service/repair of IM&TE consists of the following (insert .xls file here) who are registered/accredited to the following standards (also shown in .xls file).

Failure to respond to this notification will be construed to indicate acceptance of the above-noted suppliers as 'ACCEPTABLE' , per the requiements of TS 16949

So far, I haven't recieved ANY negative responses.

The best approach is to specify ISO/IEC Standard 17025 for calibration providers. If you are seeking one, I suggest a competitive bid. Check the Quality Digest issues in February 2005 and May 2005 to get some guidance on running a competitive bid to find a calibration provider, and to discover WHY to use an accredited lab. The May 2005 article should help explain to upper management and purchasing why the requirement should be specified.

As for how to find one, let me point out that in North America there are FIVE, repeat FIVE accrediting bodies that are internationally acceptable. They are: IAS, NVLAP, A2LA, SCC/CLAS, and L-A-B.

http://www.aplac.org
http://www.ilac.org
http://www.nacla.net

Hope this helps.

Hershal

Thanks everyone for your input, I certainly have enough clarification to make an appropriate decision and establish a minimum direction moving forward.

Scott :applause: