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7.6.3 Internal or External Laboratory? Measuring instruments used in production

Peters

Quite Involved in Discussions
#1
The company makes transition from ISO 9001 certification to ISO/TS 16949 certification. Company has doubts concerning laboratory calibrating measuring instruments used in production.
The company has a holding structure, and the laboratory is a subsidiary company (the same address), which has so far not been covered by an ISO 9001 and the lab was not included in the ISO 9001 certification audits. The laboratory is not accredited.

Question - How to solve this during the certification of ISO / TS 16949?

In my opinion, there are 3 possible solutions:

1.Laboratory accreditation (difficult in a short time)

2.Acceptance from all automotive customers (theoretically possible)

3.Decision that laboratory located in the subsidiary company is an INTERNAL laboratory and cover this activity during the certification audit (see section 7.6.3.1 - Internal Laboratory), although formally it is another company that will not be shown on the certificate (is it possible?).

What do you think about it?
 
Last edited:
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R

rclanzillotto

#2
Not sure what 2 means. I would think 3 is a viable option if your organization chart shows connection between your top managment and the subsidiary. If not they are essentially a supplier of yours. IMHO. Best, Rich
 

howste

Thaumaturge
Super Moderator
#3
Even if the lab is a separate company, you can list it as a support site for the manufacturing site. This site would need to appear on the certificate.
 

Stijloor

Staff member
Super Moderator
#4
The company makes transition from ISO 9001 certification to ISO/TS 16949 certification. Company has doubts concerning laboratory calibrating measuring instruments used in production.
The company has a holding structure, and the laboratory is a subsidiary company (the same address), which has so far not been covered by an ISO 9001 and the lab was not included in the ISO 9001 certification audits. The laboratory is not accredited.

Question - How to solve this during the certification of ISO / TS 16949?

In my opinion, there are 3 possible solutions:

1.Laboratory accreditation (difficult in a short time)

2.Acceptation from all automotive customers (theoretically possible)

3.Decision that laboratory located in the subsidiary company is an INTERNAL laboratory and cover this activity during the certification audit (see section 7.6.3.1 - Internal Laboratory), although formally it is another company that will not be shown on the certificate (is it possible?).

What do you think about it?
Peters,

If you treat them as your internal lab, then they need a scope statement and will be included in the audit.

If you consider them an external lab, then they need to be accredited to ISO 17025.

Either way, you can not ignore them.

Stijloor.
 

qusys

Trusted Information Resource
#5
Agree with Howste.

Another possibility could be consider it as an outsourced service : also in this case the organization that is pursuing the ISO TS certification has to demonstrate to control it, looking and monitoring the process that Lab performs.

Even if the lab is a separate company, you can list it as a support site for the manufacturing site. This site would need to appear on the certificate.
 
V

vanputten

#6
How many automotive customers do you have? If it is only a few, and you have a mutually beneficial relationship with the few automotive customers, then option #2 may be the least painful and easiest to attain. Otherwise I would go with #3 and ensure the lab meets the requirements for an internal lab and make sure you list the lab within the scope of the QMS.
 

Peters

Quite Involved in Discussions
#7
Thank you!
Have you ever seen an example of Formal Customer Acceptance for use of external lab without accreditation?
 
V

vanputten

#8
I have never seen a Formal Customer Acceptance document. I assume it is as simple as asking the customer, "Is it okay if we use lab blah, blah blah for calibration?" I think you would have to provide some data as to why you think they are acceptable. You might have to explain why you are asking. The lab is not ISO 17025 and is not an internal alb, therfore, per TS 16949, you are asking for their approval to use lab blah, blah, blah for calibraiton of devices that determine the product's conformance to requirements.
 

Jim Wynne

Staff member
Admin
#9
Thank you!
Have you ever seen an example of Formal Customer Acceptance for use of external lab without accreditation?
The "formal" part just means that it's in writing and written by a person who has the authority to accept your proposition.
 

howste

Thaumaturge
Super Moderator
#10
Thank you!
Have you ever seen an example of Formal Customer Acceptance for use of external lab without accreditation?
I've seen them a few times. The ones I've seen have always been letters. In some cases it's been authored by the customer, in some cases it's been authored by the supplier and approved by the customer. It's probably easiest to get if you to write the letter (similar to what vanputten wrote) and ask them to approve it.
 
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