Calibration Purchasing Information - TS 16949 Audit Finding

#31
This is from ISO-17025 and should clear this up.

5.5.8 Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be
labeled, coded or otherwise identified to indicate the status of calibration, including the date when last calibrated
and the date or expiration criteria when recalibration is due.
5.5.9 When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory shall
ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before
the equipment is returned to service.
5.5.10 When intermediate checks are needed to maintain confidence in the calibration status of the equipment,
these checks shall be carried out according to a defined procedure.
5.5.11 Where calibrations give rise to a set of correction factors, the laboratory shall have procedures to ensure
that copies (e.g. in computer software) are correctly updated.
5.5.12 Test and calibration equipment, including both hardware and software, shall be safeguarded from
adjustments which would invalidate the test and/or calibration results.
It might, but it doesn't have (much or even anything) to do with equipment being sent to another lab (which isn't accredited to 17025) for calibration...........
 
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#32
Thanks Andy:

Here is section 4.5

Word for word.

4.5 Subcontracting of tests and calibrations

4.5.1 When a laboratory subcontracts work whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question.

ISO/IEC 17025:1999(E)
6 © ISO/IEC 1999 – All rights reserved

4.5.2 The laboratory shall advise the client of the arrangement in writing and, when appropriate, gain the approval of the client, preferably in writing.

4.5.3 The laboratory is responsible to the client for the subcontractor’s work, except in the case where the client or a regulatory authority specifies which subcontractor is to be used.

4.5.4 The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question.
 
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howste

Thaumaturge
Super Moderator
#33
Thanks Andy:

Here is section 4.5

Word for word.
All of 4.5 has already been quoted word for word in post 20 of this thread, along with 5.10.6. Can you help me to understand the point you're trying to make?

By the way, you're quoting an outdated version of ISO 17025. The 1999 version was replaced with a new version in 2005. Fortunately in this section, the only change was replacing "client" with "customer."
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#34
I agree that the lab must inform the cusromer of sub-contracting.

My question is the following: If someone send me a spectrum analyzer which is not on my scope and I send it out to another lab, am i Sub-contracting?
Yes, that is sub-contracting per 4.5.1 as it pertains to your customer. As to whether you can your accreditation logo on the cover, check with your AB, as they have to give the final word on that.
 

Raffy

Quite Involved in Discussions
#35
Hi howste,
Thank you very much.
I already sent them an 8D format for their corrective and preventive action through our Purchasing Department. Luckily, we haven't pay them yet because of the problem that we encounter. Purchasing hold the payment.

With regard to your clarification, it was calibrated by another company, what they claim is the Authorized Calibration Service Providers (CSP) of the Manufacturers. They even sent us the copy of the Letter of Authorization from the Manufacturer that the CSPis their duly assigned and certified CSP by the Manufacturer.

Best regards,
Raffy

I would definitely ask them for a corrective action. As you can see, others agree with what I said about the 17025 requirement to notify you in writing.

Just for clarification - was the calibration done by the manufacturer, or another company authorized by the manufacturer? The first case is acceptable, the second is not.
 

Raffy

Quite Involved in Discussions
#36
To everyone,
The equipment that was calibrated by the authorized calibration service provider by the manufacturer was put on hold due to the problem. Any suggestion what we should do to the equipment? Please advise.
If the answer is re-calibration, we can't find any ISO17025 certified that will calibrate our equipment locally here in the Philippines...
If the answer we can use it, how are we going to document and put the said process in our system? What should we answer to our Certifying Body with regard to this issue. please advise.
Thank you very much in advance for the usual prompt attention you'll give to this request.
Best regards,
Raffy
 

howste

Thaumaturge
Super Moderator
#39
Hi howste,
No automotive customers were affected.
Raffy
If no automotive customers have product affected by the equipment, then it's outside the scope of the TS 16949 requirements. If this is the case, then there is no problem.

3rd party TS auditors are only allowed to audit TS 16949 requirements on processes (including equipment) and products that affect automotive customers.
 

Raffy

Quite Involved in Discussions
#40
Hi Howste,
Woh, what a relief...for all of us... now, I had a clearer picture that I need to make a provision in our procedure with regard to equipment that are being sent outside for calibration that have no automotive customers that they need not to be ISO17025 Certified. I think we overkill the requirements of TS16949 on External Laboratory.

Thank you very much...:thanx:
Best regards,
Raffy

If no automotive customers have product affected by the equipment, then it's outside the scope of the TS 16949 requirements. If this is the case, then there is no problem.

3rd party TS auditors are only allowed to audit TS 16949 requirements on processes (including equipment) and products that affect automotive customers.
 
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