Buetze
8th July 2008, 05:56 AM
Hello folks. We got the following nonconformity from our wellknown ISO TS 16949 "3 letter registrar": "Finding (7.4.1): The evaluation of service supplier (calibration services) is not included. Evidence: In the supplier evaluation list from central purchasing from 28.02.08 no calibration service is considered. This deviation is dedicated to central purchasing!"
Does someone know if calibration services should be included in *whatever*:confused: and if ISO TS 16949 request for listing calibration service suppliers? My version of ISO TS 16949, clause 7.4.1, just request criterias for selection, evaluation and re-evaluation. Isn't it? I must submit a corrective action to our registrar. Thank you for any comments on that subject.
yodon
8th July 2008, 07:53 PM
I'm coming from a medical device (13485) perspective, but my guess is that they are saying you have not qualified the calibration vendor to the specific calibration service you are procuring. For example, we needed to get our mass flow meter re-calibrated but our normal calibration lab said they were not qualified for that service. So we had to find one that was - and that became part of the qualification of that vendor. Since the calibration service provider is a vendor, they are required to be qualified. Hope that helps.
howste
8th July 2008, 08:09 PM
Hello folks. We got the following nonconformity from our wellknown ISO TS 16949 "3 letter registrar": "Finding (7.4.1): The evaluation of service supplier (calibration services) is not included. Evidence: In the supplier evaluation list from central purchasing from 28.02.08 no calibration service is considered. This deviation is dedicated to central purchasing!"
Does someone know if calibration services should be included in *whatever*:confused: and if ISO TS 16949 request for listing calibration service suppliers? My version of ISO TS 16949, clause 7.4.1, just request criterias for selection, evaluation and re-evaluation. Isn't it? I must submit a corrective action to our registrar. Thank you for any comments on that subject.
There is no requirement that you have a list of suppliers at all. If you choose to have a list, it should probably include all of your suppliers, including calibration sources.
If you look at the note under 7.4.1 it says "NOTE 1 Purchased products above include all products and services that affect customer requirements such as subassembly, sequencing, sorting, rework and calibration services."
As a 3rd party TS auditor I would expect, at a minimum, to see evidence that all external calibration sources are ISO 17025 accredited. If you look in 7.6.3.2 you will see that calibration service suppliers must be ISO 17025 accredited unless your customer(s) accept them in some other way.
Stijloor
8th July 2008, 08:10 PM
Hello folks. We got the following nonconformity from our wellknown ISO TS 16949 "3 letter registrar": "Finding (7.4.1): The evaluation of service supplier (calibration services) is not included. Evidence: In the supplier evaluation list from central purchasing from 28.02.08 no calibration service is considered. This deviation is dedicated to central purchasing!"
Does someone know if calibration services should be included in *whatever*:confused: and if ISO TS 16949 request for listing calibration service suppliers? My version of ISO TS 16949, clause 7.4.1, just request criterias for selection, evaluation and re-evaluation. Isn't it? I must submit a corrective action to our registrar. Thank you for any comments on that subject.
An "approved supplier" list is not required, but handy to have....and many organizations maintain one.
However, were you able to provide the Certification Body (CB) Auditor with the criteria for selection, evaluation and re-evaluation?
In addition, the calibration services supplier is considered an "External Lab."
Were you able to show the CB Auditor that they are ISO/IEC 17025 accredited?
Stijloor.
Randy
8th July 2008, 08:12 PM
There is no requirement that you have a list of suppliers at all. If you choose to have a list, it should probably include all of your suppliers, including calibration sources.
I'll bet they said they would have a list and didn't make one, and that could be the reason for the NC.
Stijloor
8th July 2008, 08:12 PM
Howste,
Telepathic responses :D one minute apart...
Stijloor.
howste
8th July 2008, 08:15 PM
Howste,
Telepathic responses :D one minute apart...
Stijloor.
I thought the same thing when I saw your post. Spooky... :agree: