ISO 9001 vs Procedure

Calibrationian

Starting to get Involved
Good day Sirs,

Just curious since ISO 9001 and 14001 is nearing, we have on our procedure which limits the scope of our Control on Monitoring and Measuring Equipment.

"Monitoring and Measuring Equipment that are consigned by the customer which have direct bearing to the product quality but are controlled and calibrated by the customer or are waived from calibration by the customer are not subject to the provision in this procedure."

will ISO 9001 override us on this procedure and require us to still monitor the equipment controlled by our customer?

Pardon for the ignorance, I'm still new in an In-house Calibration of a Manufacturing Company and I am interested...

Thanks...
 

ChrisM

Quite Involved in Discussions
You need an agreement in place with your customer.
They may require you to arrange calibration, or they may arrange it (e.g. by swapping out items of measuring equipment that are on loan to you).

Is your text in bold above the wording in the contract/agreement with your customer?
 

Randy

Super Moderator
Good day Sirs,

Just curious since ISO 9001 and 14001 is nearing, we have on our procedure which limits the scope of our Control on Monitoring and Measuring Equipment.

"Monitoring and Measuring Equipment that are consigned by the customer which have direct bearing to the product quality but are controlled and calibrated by the customer or are waived from calibration by the customer are not subject to the provision in this procedure."

will ISO 9001 override us on this procedure and require us to still monitor the equipment controlled by our customer?

Pardon for the ignorance, I'm still new in an In-house Calibration of a Manufacturing Company and I am interested...

Thanks...
What's all this got to do with 14001?
 

Big Jim

Admin
Good day Sirs,

Just curious since ISO 9001 and 14001 is nearing, we have on our procedure which limits the scope of our Control on Monitoring and Measuring Equipment.

"Monitoring and Measuring Equipment that are consigned by the customer which have direct bearing to the product quality but are controlled and calibrated by the customer or are waived from calibration by the customer are not subject to the provision in this procedure."

will ISO 9001 override us on this procedure and require us to still monitor the equipment controlled by our customer?

Pardon for the ignorance, I'm still new in an In-house Calibration of a Manufacturing Company and I am interested...

Thanks...

That doesn't look like a sound reason to claim nonapplicability. I'm guessing that is what is meant by waving the requirement. It would appear that you still need to meet the requirements of 7.1.5 even if you customer doesn't require you to do so. There is nothing wrong with the customer helping you with it though. That could be accomplished by them providing a record of their calibration.

A customer can require you to do things beyond what the standard requires, but they can't require you to not do things that the standard requires.
 

Calibrationian

Starting to get Involved
You need an agreement in place with your customer.
They may require you to arrange calibration, or they may arrange it (e.g. by swapping out items of measuring equipment that are on loan to you).

Is your text in bold above the wording in the contract/agreement with your customer?
Would an e-mail suffice for this, or an actual signed agreement is needed?...
The bold text was specified in our procedure but I have not yet seen the actual contract if there is any, since it could have been made way before my superior existed here...

Technically, the customer is already in control of the instrument calibration, and they also conduct their own in-house calibration by swapping the instruments with their own spare.
 

ChrisM

Quite Involved in Discussions
Would an e-mail suffice for this, or an actual signed agreement is needed?...
The bold text was specified in our procedure but I have not yet seen the actual contract if there is any, since it could have been made way before my superior existed here...
One of the reasons why agreements in emails are generally not held to be "enforcable" is just this - the person involved leaves, emails are locked and nobody else can find out what was supposedly agreed. It needs to be in a signed agreement/contract
 

dwperron

Trusted Information Resource
Good day Sirs,

Just curious since ISO 9001 and 14001 is nearing, we have on our procedure which limits the scope of our Control on Monitoring and Measuring Equipment.

"Monitoring and Measuring Equipment that are consigned by the customer which have direct bearing to the product quality but are controlled and calibrated by the customer or are waived from calibration by the customer are not subject to the provision in this procedure."

will ISO 9001 override us on this procedure and require us to still monitor the equipment controlled by our customer?

Pardon for the ignorance, I'm still new in an In-house Calibration of a Manufacturing Company and I am interested...

Thanks...
Your clause is tough to read, so interpretation will be an issue....

Not all measurement and test equipment needs to be calibrated. If the determination has been made your organization that equipment used must be calibrated for a particular process then it must be calibrated. If your customer is providing the equipment being used it still must be calibrated, it doesn't matter who calibrated it but it must be calibrated. You can choose to leave such customer provided equipment out of your calibration recall program (since you are not responsible for the calibration of their equipment), but that will leave you vulnerable to using uncalibrated equipment since it is not on your recall list. That would be a finding against you, not your customer.
 

Calibrationian

Starting to get Involved
That doesn't look like a sound reason to claim nonapplicability. I'm guessing that is what is meant by waving the requirement. It would appear that you still need to meet the requirements of 7.1.5 even if you customer doesn't require you to do so. There is nothing wrong with the customer helping you with it though. That could be accomplished by them providing a record of their calibration.

A customer can require you to do things beyond what the standard requires, but they can't require you to not do things that the standard requires.
This is a very good point and I agree with this.

In a different circumstance, we as a calibration team, provide a master list of all the instruments being calibrated internally/externally and are stable.
However, with a particular customer, they pull-out their own instrument and replace it with other spare instruments which messes up the Master list. They do this in a very frequent manner (almost 10-15 instruments per week are replaced) and there is no assurance that the instrument they pulled out will ever be returned.

I am looking for a way to exclude them in our Master list since our Test Engineers with direct contact with that customer have their very own Master list of instruments for that account and the control of calibrating the instrument already belongs to the Customer even in their financial budgets for calibration. Would this still satisfy 7.1.5? Provided that the Test Engineers have the Calibration Certificates.
 

Calibrationian

Starting to get Involved
Your clause is tough to read, so interpretation will be an issue....

Not all measurement and test equipment needs to be calibrated. If the determination has been made your organization that equipment used must be calibrated for a particular process then it must be calibrated. If your customer is providing the equipment being used it still must be calibrated, it doesn't matter who calibrated it but it must be calibrated. You can choose to leave such customer provided equipment out of your calibration recall program (since you are not responsible for the calibration of their equipment), but that will leave you vulnerable to using uncalibrated equipment since it is not on your recall list. That would be a finding against you, not your customer.
To be fair, the customer calibrates the instruments themselves and they do not miss anything. The problem lies with a provision in our procedure where we keep a list of their instruments and monitor their calibration due dates.

We don't even calibrate them nor send them outside for calibration. Its the Test Engineers and Test Support Groups that coordinate the instruments with the customer. Calibration Certificates are also from the customers.

Is there any chance that we can transfer this responsibility of keeping track of their instruments from our team to the Test Engineers?
 
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