Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540?

BradM

Leader
Admin
Well... interesting question.

To me, your customer is mandating something from you. You either produce it, or tell your customer to go somewhere else.

If you are going to meet the requirements, then whatever vendor you use would need to demonstrate compliance to one of those three requirements. Like the others said, ISO 17025 is more robust, but costs more. Is your customer willing to pay extra for ISO 17025?

I guess in the end, you get what you pay for. :)
 
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MGMTREP

We now have exactly the same requirement from one of our customers. We have chosen to meet the requirements of 10012, but I would like get quotes from consultants in the Chicago area to assist us with this. Web searches have produced no clear llinks. If anyone can provide leads, please contact me through Personal Message tool- Thanks!
 
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MGMTREP

Thanks Big Jim. I already purchased a copy and my reason for seeking a consultant has to do with time, not difficulty.
 
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Bob Mackie

Hi Hershal, this is my first time on the cove. Please excuse me from jumping in at this point. I have a question regarding ISO9001:2008 clause 7.6 regarding organizations carrying out in house calibrations. ISO 9001:2008 does not refer to what standard the calibrations should conform to. If I sent out test equipment to an external cal lab certified to ISO17025 I would expect the item would be calibrated to that standard, therefore, I would also expect an organization carrying out in house calibrations to conform to the same standard. How do organizations make the link to 17025 from clause 7.6?
 
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AshleyE

Hi Hershal, this is my first time on the cove. Please excuse me from jumping in at this point. I have a question regarding ISO9001:2008 clause 7.6 regarding organizations carrying out in house calibrations. ISO 9001:2008 does not refer to what standard the calibrations should conform to. If I sent out test equipment to an external cal lab certified to ISO17025 I would expect the item would be calibrated to that standard, therefore, I would also expect an organization carrying out in house calibrations to conform to the same standard. How do organizations make the link to 17025 from clause 7.6?

Hi Bob.:bigwave:

The standard states "Where necessary to ensure valid results, measuring equipment shall (a) be calibrated or verified, or both..."

So if you are an 9001:2008 company, you need to establish a process appropriate to your organization for calibrating or verifying your equipment. There is no requirement in ISO9001 to tie into 17025 for in-house calibration. If you cannot verify or calibrate in house, that's when you would send the equipment to a certified cal lab.

But if your customer is requiring calibration certified to 17025, as discussed here, that is a different matter.

Quality System requirements come from three places: the standard, the customer, and your documentation. Hope that helps.
 

Jim Wynne

Leader
Admin
Hi Hershal, this is my first time on the cove. Please excuse me from jumping in at this point. I have a question regarding ISO9001:2008 clause 7.6 regarding organizations carrying out in house calibrations. ISO 9001:2008 does not refer to what standard the calibrations should conform to. If I sent out test equipment to an external cal lab certified to ISO17025 I would expect the item would be calibrated to that standard, therefore, I would also expect an organization carrying out in house calibrations to conform to the same standard. How do organizations make the link to 17025 from clause 7.6?

Welcome to the Cove. :D

I'm not sure what you're trying to find out. Are you referring to internal calibration activities, or those of suppliers? There is no link between 7.6 and ISO 17025. You can set whatever requirements you want to set as far as calibration is concerned, and likewise you can impose those requirements on your suppliers. Most people seem to think that 17025 is overkill for internal calibration unless there's a lot of calibration going on, and accreditation/compliance somehow adds value to the operation.
 

BradM

Leader
Admin
Hi Hershal, this is my first time on the cove. Please excuse me from jumping in at this point. I have a question regarding ISO9001:2008 clause 7.6 regarding organizations carrying out in house calibrations. ISO 9001:2008 does not refer to what standard the calibrations should conform to. If I sent out test equipment to an external cal lab certified to ISO17025 I would expect the item would be calibrated to that standard, therefore, I would also expect an organization carrying out in house calibrations to conform to the same standard. How do organizations make the link to 17025 from clause 7.6?

Hello Bob! Welcome to the forum!:bigwave:

I'm certainly not Hershal, but I was intrigued with your question.

So you have an in-house calibration lab. Is this lab 1) accredited to the 17025:2005 standard? Or 2)are they performing work within the ISO 9001:2008 guidelines?

If it is 1, they need to be having an ISO17025 accredited labs calibrate their higher-order standards.

If it is 2, then the choice of calibration labs for their higher order standards should be outlined within their quality system. This may involve maintaining an approved vendor list with the selected vendors. However, I would not dismiss seeking, evaluating, and utilizing competent vendors. I would recommend using ISO 17025 accredited labs, whether they are mandated or not.

Bob, I'm not sure if I got anywhere near your query, or just made it worse. :D
 

BradM

Leader
Admin
Sorry Jim. I cross-posted with you. :D

Welcome to the Cove. :D

I'm not sure what you're trying to find out. Are you referring to internal calibration activities, or those of suppliers? There is no link between 7.6 and ISO 17025. You can set whatever requirements you want to set as far as calibration is concerned, and likewise you can impose those requirements on your suppliers. Most people seem to think that 17025 is overkill for internal calibration unless there's a lot of calibration going on, and accreditation/compliance somehow adds value to the operation.

True. However, there is still some value in choosing the accredited labs, as it reduces the vendor evaluation effort. The justification/ supplier evaluation is significantly easier with an ISO17025 accredited vendor. :)
 
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