ISO 10012, ANSI/NCSL Z540, ISO 17025 reference meet ISO 9001 7.4.2 (a) intent?

R

rlyke

For purchasing documents for calibration services, does a reference in a Supplier Quality Requirements Manual to ISO 10012,
ANSI/NCSL Z540, or ISO 17025 meet the intent of ISO 9001 clause 7.4.2 (a): "Purchasing information shall describe the product (or service in this case) to be purchased, including, where appropriate, a) requirements for approval of product, procedures, processes, and equipment....."?

There is some discussion in my organization as to whether this is sufficient. If the PO only states "Provide calibration services" but also has a reference to the SQR provided to the vendor and we have no other specific requirements or acceptance criteria defined, does this reference meet the intent of clause 7.4.2?
 

qusys

Trusted Information Resource
For purchasing documents for calibration services, does a reference in a Supplier Quality Requirements Manual to ISO 10012,
ANSI/NCSL Z540, or ISO 17025 meet the intent of ISO 9001 clause 7.4.2 (a): "Purchasing information shall describe the product (or service in this case) to be purchased, including, where appropriate, a) requirements for approval of product, procedures, processes, and equipment....."?

There is some discussion in my organization as to whether this is sufficient. If the PO only states "Provide calibration services" but also has a reference to the SQR provided to the vendor and we have no other specific requirements or acceptance criteria defined, does this reference meet the intent of clause 7.4.2?

The response is yes if in the Supplier quality requirement manual there are clear in indication of what you expect from the supplier in terms of quality by purchasing that service and be sure that the supplier performance is in line with the set requirements.
To go the practical case you mention, did you establish the release time of the service? Did you establishe how they will provide you the documentation of the performed service? Did you request the to be ISO 17025 certified? Are they use traceable standards?
These are only some questions that should be addressed in the Purchase Order or in the Contract.
hope this helps:bigwave:
DId you do? Are thery reported in SQR?
 

AndyN

Moved On
For purchasing documents for calibration services, does a reference in a Supplier Quality Requirements Manual to ISO 10012,
ANSI/NCSL Z540, or ISO 17025 meet the intent of ISO 9001 clause 7.4.2 (a): "Purchasing information shall describe the product (or service in this case) to be purchased, including, where appropriate, a) requirements for approval of product, procedures, processes, and equipment....."?

There is some discussion in my organization as to whether this is sufficient. If the PO only states "Provide calibration services" but also has a reference to the SQR provided to the vendor and we have no other specific requirements or acceptance criteria defined, does this reference meet the intent of clause 7.4.2?

Not really! It's a place to start in terms of selection criteria, but not on what you want of the service. If you are contracting out calibration services, what do you want them to do? In the past, we drew up a calibration specification for the equipment and even had the lab contact us the moment they found an out of tolerance condition, since we wanted to respond quickly to such an issue.

It's no different to using a supplier who is ISO 9001 certified, you still have to give them specs to work from!
 
R

rlyke

AndyN,

Thanks for your response, it is exactly in line with what my position is. I believe our SQR references only provide the criteria for supplier qualifications but does not provide clear direction on what we expect from the calibration service. At a minimum, I believe that our PO documents or the SQR needs to have a statement along the lines of "Calibration vendors must perform calibrations in accordance with nationally accepted methods / procedures and acceptance tolerances must be in accordance with manufacturer's recommendations unless specified otherwise." Best case would be to provide the vendor with a device listing and required acceptance tolerances. Our calibration vendor is A2LA accredited to ISO 17025 and calibration certs all have the appropriate information, so I'm thinking the above is the only thing we need to do to close the gap. Thoughts?
 

qusys

Trusted Information Resource
AndyN,

Thanks for your response, it is exactly in line with what my position is. I believe our SQR references only provide the criteria for supplier qualifications but does not provide clear direction on what we expect from the calibration service. At a minimum, I believe that our PO documents or the SQR needs to have a statement along the lines of "Calibration vendors must perform calibrations in accordance with nationally accepted methods / procedures and acceptance tolerances must be in accordance with manufacturer's recommendations unless specified otherwise." Best case would be to provide the vendor with a device listing and required acceptance tolerances. Our calibration vendor is A2LA accredited to ISO 17025 and calibration certs all have the appropriate information, so I'm thinking the above is the only thing we need to do to close the gap. Thoughts?

Hi rlyke,
appreciated your thanks.
What you wrote go towards my suggestion of the previous post.
In fact, if you do not clear specify the requirment for the calibration service in SQR, you shall have them in other parts, i.e PO or contract/
The requiment of IS0 17025 to be mentioned in PO is ok as well as the other you wrote.
Another suggestion is to specify how you will monitor its performance as well as other quality criteria ( cost, poor quality, specification etc...)
see you:bigwave:
 

Hershal

Metrologist-Auditor
Trusted Information Resource
For purchasing documents for calibration services, does a reference in a Supplier Quality Requirements Manual to ISO 10012,
ANSI/NCSL Z540, or ISO 17025 meet the intent of ISO 9001 clause 7.4.2 (a): "Purchasing information shall describe the product (or service in this case) to be purchased, including, where appropriate, a) requirements for approval of product, procedures, processes, and equipment....."?

There is some discussion in my organization as to whether this is sufficient. If the PO only states "Provide calibration services" but also has a reference to the SQR provided to the vendor and we have no other specific requirements or acceptance criteria defined, does this reference meet the intent of clause 7.4.2?

ISO/IEC 17025:2005 accreditation for a cal lab meets all applicable requirements of ISO9001, according to the agreement between ILAC and IAF.

You should request the accredited calibration and uncertainties to assure that the certificate meets all requirements of ISO/IEC 17025:2005 and ILAC.
 
L

lday38

Does a company who wants to be certified to ISO 9000:2000 have to use a calibration service who is registered to the 17025? I thought so.

Would it make a differance for electrical test equipment?

Thanks

Linda
 

qusys

Trusted Information Resource
Does a company who wants to be certified to ISO 9000:2000 have to use a calibration service who is registered to the 17025? I thought so.

Would it make a differance for electrical test equipment?

Thanks

Linda

I think that it is not a requirement of ISO 9001, while it is a requirement of ISO TS 16949 , applied to the usage of the external lab.:bigwave:
 

AndyN

Moved On
Does a company who wants to be certified to ISO 9000:2008 have to use a calibration service who is accredited to the ISO/IEC17025? I thought so.

Would it make a difference for electrical test equipment?

Thanks

Linda

Linda, not have to, but, let's put it this way: Do you need to trust the results of the readings from the equipment? Is it important to know the accuracy of the calibration, compared to the values you are measuring? If so, your best option IS to use an accredited lab...
 

qusys

Trusted Information Resource
Linda, not have to, but, let's put it this way: Do you need to trust the results of the readings from the equipment? Is it important to know the accuracy of the calibration, compared to the values you are measuring? If so, your best option IS to use an accredited lab...

Andy, thanks for having elaborated and for the precision.
In fact , if you use primary standard to calibrate equipment and you send them outside, you should guarantee the traceability and this is done by accredated lab.
However, I would like to ask to Linda more details for this calibration.
For example, is it done by the manufacturer of the gauge or by the vendor of the equipment? In this case, this could be an assurance too:bigwave:
 
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