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TS16949 Clause 7.6.3.1 - Internal laboratory - Facility shall have a defined scope

R

roder - 2012

#1
Internal laboratory - facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality mgt system documentation. The laboratory shall specify and implement , as a minimum, technical rqmts for -adequacy of the laboratory procedures, -competency of the laboratory personnel, -testing of the product, capability to perform these services correctly, traceable to the relevant process stds(such as ASTM, EN, etc.), and -review of the related records.

- My question is....Does calibration of instrument based on manufacturer's manual requires compliance/traceability to process standards (standard methods)?
 

Jim Wynne

Super Moderator
#2
roder said:
Internal laboratory - facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality mgt system documentation. The laboratory shall specify and implement , as a minimum, technical rqmts for -adequacy of the laboratory procedures, -competency of the laboratory personnel, -testing of the product, capability to perform these services correctly, traceable to the relevant process stds(such as ASTM, EN, etc.), and -review of the related records.

- My question is....Does calibration of instrument based on manufacturer's manual requires compliance/traceability to process standards (standard methods)?
Assuming that there are no other relevant standards (ASTM, e.g.), the manufacturer's manual would be the "relevant process standard" in this case.
 
D

David T

#3
So to follow that thought, is the manufacturer qualified to service and calibrate the instrument themselves. I am seeing a big circular loop between 7.6.3.2 NOTE 2 ...
calibration services may be performed by the equipment manufacturer... requirements in 7.6.3.1 have been met.
This comes back to being accredited to ISO17025 and having a complete lab scope, etc. I have manufacturers who can service my instruments but refuse to provide a lab scope because 'they are not laboratories, they are manufacturers'. In most cases, they are registered to ISO9000
 
V

vanputten

#4
Hello David T:

I get the same unimformed, crap answer. Check the definiton of laboratory in TS. We all should be aware and use the definitions in ISO 9000:2005 and TS.

An OEM that provides test, calibration, or inspection service is a laboratory. I see nothing in all of 7.6.3 that is cyclical. If the OEM is providing test, inspection, or cal service, then they need to meet the requirement of 7.6.3.1.

And the OEM can provide this service if a qualified (ISO 17025 accedited) lab is not available. The OEM has to be the only available source and there are no ISO 17025 labs available to do what it is you need.

There is also the option of contacting all auto cusotmers to get a waiver.

And to add confusion, per the Foreward of TS, "Paragraphs marked Note are for guidance in understanding or clarifying the associated requirement."

So many people never read all of ISO 9000:2005, ISO 9001:2000, or TS 16949:2002.

Finally, the bigger question is what value does all of this give the auto indusry? I say just about zero.

Regards,

Dirk
 
D

David T

#5
Thanks for your comments.

So, if I read your note correctly, we poor Tier 2/3 suppliers are stuck between a rock and a hard place.

We have a standard which requires our calibration agencies, including OEM, to either register to ISO17025 or follow the spirit enough under ISO9000 to be physically audited to a standard they don't subscribe to and pass with our permission (who are also not required to register to 17025) and/or our customer's waiver

and our OEM suppliers who are capable of making a instrument which may cost up to a $1M or more but who don't have a lab scope, and refuse to generate one.

and where I own tooling and instruments which need to be certified as as calibrated and annually checked by the manufacturer and confirmed as conform to OEM specifications

and a registrar who says all my service agencies for metrology calibrations must have a lab scope.:lmao:

Using this logic, why stop with metrology tools? All production equipment which is purchased to manufacture an automotive product and is measured to conform to OEM performance standards and customer requirements list (my requirements), must be built be an organization with a 'laboratory' and a 'laboratory scope' sufficient to pass ISO17025.

Anyone have any experience of using an OEM's process-control plan as their 'laboratory scope'?
 
V

vanputten

#6
Hello Dave T:

I do not understand everything you wrote. Keep in mind that the "customer" is always the automotive customer of the organization (your orgainzation) seeking TS certification.

I am not sure what you mean by the following: "follow the spirit enough under ISO9000 to be physically audited to a standard they don't subscribe to and pass with our permission (who are also not required to register to 17025) and/or our customer's waiver"

Your customer may assess your suppliers. That is one option. See Note 1 of 7.6.3.2. Keep in mind Notes are for guidance.

Your choices:

Suppliers are ISO 17025 accredited and the service they provide is within the scope of accrediation

Have your customer assesses your suppliers ability

Ask auto customers for a waiver

If no accredited lab exists and the supplier is the OEM, then the OEM must meet the requirments of 7.6.3.1 (But only if there is no accredited lab available.)

We have an OEM supplier of machines that are millions of dollars each. Each! They will not accept the above as our requirements of them.

Not sure what you are saying here either: "and where I own tooling and instruments which need to be certified as as calibrated and annually checked by the manufacturer and confirmed as conform to OEM specifications"

I am not sure how the manufacturer or OEM applies in your statement. If you do your own cal, then you have to meet the requirements of 7.6.3.1.

Please make sure you know the definitions of "customer", "organization", and "supplier". Internal lab requirements only apply to the "organization."

All of 7.6.3 applies to test, inspection, and calibration and the providers of that service.

It is not that hard to find ISO 17025 accredited labs for what you need unless you have a very specific piece of equipment.

Lab scopes appear to be specific things. Go to the a2la.org website and do some searches. All of the accrediation certificates include a lab scope. A control plan would be something different than what I have seen as lab scopes.

Regards,

Dirk
 
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