Control of Monitoring & Measurement Equipment - ISO 9001:2008, Clause 7.6 c)

R

RRder

#1
In this clause, the last word is "status". I do not find a definition in ISO 9000:2005 for this word. We use Gage Trak to maintain control of our measuring instruments and in the past have found that in our working environment, that calibration labels fail to remain on the gages when being handled and used at the machines. The gages are all serial numbered within our GT system. We maintain as long as the gages have been issued from our QA lab and are properly maintained in GT, the labels are not necessary. The operators using the gages are responsible for notifying and returning any defective gage to the QA lab. The QA Manager maintains the GT system and updates/monitors calibration status therein daily based on the condition of the gages when returned from the shop floor.
Our 3rd party auditor contends that the ISO standard's intention is that the gages must have the labels attached to indicate the "status" (condition or state of being). We maintain that GT does this for us if proper protocol is practices on the shop floor.

In a pristine environment, I can understand the labeling, but in ours with materials that melt the adhesive, compounded by the handling, the labels soon become removed.

The question:
Per the Standard, can we legally continue without having the labels on the gages if the Gage Trak system is working by indicating the condition, stated interval for next calibration/verification, and issues a notification? :confused:
 
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Stijloor

Staff member
Super Moderator
#2
Re: ISO 9001:2008, Clause 7.6 c)

In this clause, the last word is "status". I do not find a definition in ISO 9000:2005 for this word. We use Gage Trak to maintain control of our measuring instruments and in the past have found that in our working environment, that calibration labels fail to remain on the gages when being handled and used at the machines. The gages are all serial numbered within our GT system. We maintain as long as the gages have been issued from our QA lab and are properly maintained in GT, the labels are not necessary. The operators using the gages are responsible for notifying and returning any defective gage to the QA lab. The QA Manager maintains the GT system and updates/monitors calibration status therein daily based on the condition of the gages when returned from the shop floor.
Our 3rd party auditor contends that the ISO standard's intention is that the gages must have the labels attached to indicate the "status" (condition or state of being). We maintain that GT does this for us if proper protocol is practices on the shop floor.

In a pristine environment, I can understand the labeling, but in ours with materials that melt the adhesive, compounded by the handling, the labels soon become removed.

The question:
Per the Standard, can we legally continue without having the labels on the gages if the Gage Trak system is working by indicating the condition, stated interval for next calibration/verification, and issues a notification? :confused:
There a quite a few threads about "Labels on Gages."

Look here.

As an auditor, I still would like to know how you identify the (measuring and testing) equipment.

Stijloor.
 
#3
Re: ISO 9001:2008, Clause 7.6 c)

One way I've seen this done is to list (by gauge i.d) each gauge used at a work station - often on a board - and put the status by each i.d. This also helps with tracking those which 'walk'...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Re: ISO 9001:2008, Clause 7.6 c)

The question:
Per the Standard, can we legally continue without having the labels on the gages if the Gage Trak system is working by indicating the condition, stated interval for next calibration/verification, and issues a notification? :confused:
The answer: YES.
Our 3rd party auditor contends that the ISO standard's intention is that the gages must have the labels attached to indicate the "status" (condition or state of being).
Your external auditor is having a hard time with the "open mindedness" aspect of auditing. Just because stickers/labels are the norm, it does not mean they are required in the ISO 9001 standard. I have seen organizations applying color (paint) dots to I,M&TE. Each color signified that the device should be recalled at the end of a quarter, just to make it easier for the operators to know when to turn them in, in case the recall notice was missed. But the standard is very clear; the device must have an identification which enables the determination of the calibration status. A serial number certainly serves that purpose.
 
Last edited:
D

Duke Okes

#5
Re: ISO 9001:2008, Clause 7.6 c)

Your 3rd party auditor is full of something, and it's not knowledge of how to interpret the standard.

As long as the gage is uniquely identified (e.g., serial number) a person can take this number to the calibration database and find out what the status is. They could do this by phone ... by having a printed list of gages used in the area ... etc.

If the auditor pushes it file a customer complaint!
 

Big Jim

Super Moderator
#6
Re: ISO 9001:2008, Clause 7.6 c)

I agree with the others posters that what you are doing meets the requirements of the standard.

An additional solution could be to have a calibration status sticker on the storage container for the piece of equipment and to keep the storage container in close proximity.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Down side of ISO9001 audits unless it has changed in the last 8 years, is that the auditor does not have to have a background in what s/he audits. Radical difference from an accreditation assessment where the assessor MUST have a similar background or training, which would have avoided that issue.

I faced it when I dealt with ISO9001 in a manufacturing facility, as Staff for the company.

Where it is not practical to apply stickers or other indication, it is not practical and should not be done. You need to have the information available at short notice; that is not the same as a sticker on the instrument. BTW, try to get a sticker to stay on calipers that are often covered in hydraulic fluid.

Hope this helps.
 
#9
Down side of ISO9001 audits unless it has changed in the last 8 years, is that the auditor does not have to have a background in what s/he audits. Radical difference from an accreditation assessment where the assessor MUST have a similar background or training, which would have avoided that issue.
ISO 9000 (etc) auditors have always been (broadly) qualified by SIC/NAICS or similar coding. With the advent of ISO/IEC 17021 they also have to be competent.

The issue of stickers is more one of bias, inexperience or something similar, but when (some) clients choose their CB on lowest price, and (some) CBs choose auditors in a similar manner - this is the kind of thing you have to deal with!
 
U

Umang Vidyarthi

#10
In this clause, the last word is "status". I do not find a definition in ISO 9000:2005 for this word.
7.6 .....Where necessary to ensure valid results, measuring equipment shall....c) "have identification in order to determine its calibration status."..
You have isolated the word 'status' where as the standard is talking about the 'calibration status'. Reading in continuity:

"Where necessary to ensure valid results, measuring equipment shall have identification in order to determine its calibration status."

You are required to have some 'identification' through which the 'calibration status' can be determined.

We use Gage Trak to maintain control of our measuring instruments and in the past have found that in our working environment, that calibration labels fail to remain on the gages when being handled and used at the machines. The gages are all serial numbered within our GT system. We maintain as long as the gages have been issued from our QA lab and are properly maintained in GT, the labels are not necessary. The operators using the gages are responsible for notifying and returning any defective gage to the QA lab. The QA Manager maintains the GT system and updates/monitors calibration status therein daily based on the condition of the gages when returned from the shop floor.
The tracking system you are using suffices to show the 'calibration status'.
Our 3rd party auditor contends that the ISO standard's intention is that the gages must have the labels attached to indicate the "status" (condition or state of being). We maintain that GT does this for us if proper protocol is practices on the shop floor.

In a pristine environment, I can understand the labeling, but in ours with materials that melt the adhesive, compounded by the handling, the labels soon become removed.
The auditor's contention is not right. Ask him to show the 'shall'. The standards are not asking for 'Labels' as a must. A majority of people find the use of 'labels' convenient, since the information of 'calibration status' comes in handy, on the spot and saves the headache of rummaging through the data. This is a popular system, but can not be converted into a rule at the whim of an auditor. You should contest it.
The question:
Per the Standard, can we legally continue without having the labels on the gages if the Gage Trak system is working by indicating the condition, stated interval for next calibration/verification, and issues a notification? :confused:
Yep. You can continue without labels if your gauge track system is able to show the 'calibration status'. If it is not practical to have labels, it is practical not to have labels.

Umang :D
 
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