ISO 9001:2008 Sec 7.6 - Can we just log measurement devices as 'Pass/Fail'?

[StevePenney]

ISO 9001:2008 Section 7.6 Control of monitoring and measuring equipment.
sub-Clause 'a' states 'be calibrated or verified, or both'...

With regard to mics and calipers, the question I have is,

Can we just log the devices as 'Pass/Fail'? with no record of a reading.

Or is there the requirement to record a reading As Found - As Left ?
I do not see this in the standard, but our registrar has told us it is required?
Thanks,
Steve

 

[Kales Veggie]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Yes, it is required.

A good auditor would ask: How did you determine it passed the calibration? If it failed, how far was it out? If it failed you would want to know how far it was out and take appropriate action. Without the actual data, you cannot answer that question.

 

[Big Jim]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Yes, it is required.

A good auditor would ask: How did you determine it passed the calibration? If it failed, how far was it out? If it failed you would want to know how far it was out and take appropriate action. Without the actual data, you cannot answer that question.

I don't believe it is required. Show me the shall.

 

[Jim Wynne]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Yes, it is required.

It might be prudent, but I don't think it's required.

A good auditor would ask: How did you determine it passed the calibration?

Possible answer: "By following the calibration procedure for [device type]"

If it failed, how far was it out?

Possible answer: "It doesn't matter, failure is failure."

If it failed you would want to know how far it was out and take appropriate action. Without the actual data, you cannot answer that question.

Possible answer: "Yes I can. A decision is made at the time of calibration failure as to what the appropriate action will be, if any action is taken."

That last one assumes that there is a method for record keeping in the event of failures. If there are failures and no evidence that evaluation of risk was done, it would be a problem, but a different problem than just recording pass/fail.

 

[yodon]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Circling back around to the OP's question:

Can we just log the devices as 'Pass/Fail'? with no record of a reading.

(bold added for emphasis)

What's the objective evidence that the equipment passed?

 

[Jim Wynne]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Circling back around to the OP's question:

Can we just log the devices as 'Pass/Fail'? with no record of a reading.

(bold added for emphasis)

What's the objective evidence that the equipment passed?

I think the OP meant that the Pass/Fail status is recorded--"Can we just log the devices..."

 

[PaulJSmith]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Seems to me it really depends most on how detailed and hearty your calibration procedure and work instructions are. How they are written should determine the answer to your question.

 

[Pcool]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

ISO 9001:2008 Section 7.6 Control of monitoring and measuring equipment.
sub-Clause 'a' states 'be calibrated or verified, or both'...

With regard to mics and calipers, the question I have is,

Can we just log the devices as 'Pass/Fail'? with no record of a reading.

Or is there the requirement to record a reading As Found - As Left ?
I do not see this in the standard, but our registrar has told us it is required?
Thanks,
Steve

At the bottom of 7.6 it states:

"In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4)."

edit: I would say a record of the results are required (rather than just "pass" or "fail") according to the end of the section.

 

[Jim Wynne]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

At the bottom of 7.6 it states:

"In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4)."

edit: I would say a record of the results are required (rather than just "pass" or "fail") according to the end of the section.

The result could be pass or fail.

 

[Kevin Mader]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

As Paul points out, maybe the answer is elsewhere in the QMS records. If the cal procedure for a device reads like a validation script, maybe a Pass/Fail decision in a log (or other record) is enough. But from experience, cal houses provide the variable data along with the attribute data and the auditors are conditioned to look for it (expect it). Unless the 'script' obviates the need, I'd have the variable data ready for review.