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ISO 9001:2008 Sec 7.6 - Can we just log measurement devices as 'Pass/Fail'?
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ISO 9001:2008 Sec 7.6 - Can we just log measurement devices as 'Pass/Fail'?
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Some Related Topic Tags
7.6 - control of monitoring & measurement devices, calibration (general topics), calibration verification, calipers, iso 9001 - quality management systems, micrometers
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  Post Number #1  
Old 20th March 2013, 11:02 AM
StevePenney

 
 
Total Posts: 8
Question ISO 9001:2008 Sec 7.6 - Can we just log measurement 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

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  Post Number #2  
Old 20th March 2013, 12:30 PM
Kales Veggie's Avatar
Kales Veggie

 
 
Total Posts: 1,017
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.
Thank You to Kales Veggie for your informative Post and/or Attachment!
  Post Number #3  
Old 20th March 2013, 02:57 PM
Big Jim

 
 
Total Posts: 2,906
Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Quote:
In Reply to Parent Post by Kales Veggie View Post

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.
Thanks to Big Jim for your informative Post and/or Attachment!
  Post Number #4  
Old 20th March 2013, 03:21 PM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,217
Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Quote:
In Reply to Parent Post by Kales Veggie View Post

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

Quote:
In Reply to Parent Post by Kales Veggie View Post

A good auditor would ask: How did you determine it passed the calibration?
Possible answer: "By following the calibration procedure for [device type]"
Quote:
In Reply to Parent Post by Kales Veggie View Post

If it failed, how far was it out?
Possible answer: "It doesn't matter, failure is failure."
Quote:
In Reply to Parent Post by Kales Veggie View Post

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.
Thank You to Jim Wynne for your informative Post and/or Attachment!
  Post Number #5  
Old 20th March 2013, 04:05 PM
yodon

 
 
Total Posts: 1,158
Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Circling back around to the OP's question:

Quote:
In Reply to Parent Post by StevePenney View Post

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?
  Post Number #6  
Old 20th March 2013, 04:39 PM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,217
Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Quote:
In Reply to Parent Post by yodon View Post

Circling back around to the OP's question:

Quote:
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..."
  Post Number #7  
Old 20th March 2013, 05:31 PM
PaulJSmith's Avatar
PaulJSmith

 
 
Total Posts: 562
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.
Thanks to PaulJSmith for your informative Post and/or Attachment!
  Post Number #8  
Old 20th March 2013, 07:24 PM
Pcool

 
 
Total Posts: 25
Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Quote:
In Reply to Parent Post by StevePenney View Post

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.
Thank You to Pcool for your informative Post and/or Attachment!
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