What specifically must be calibrated per ISO 9001:2000?

[Eredhel]

You've opened up the fun "steel rule and tape measure debate" . We reference only ours unless they're used for "final acceptance" (might be a term you're looking for). But we tend to avoid doing some things unless we absolutely have to. And so far we've never had a complaint with reference only for in-process checks. We've thought about getting a master steel rule to set up somewhere in the future, but we haven't needed to yet.

 

[Tyler C]

Yes, I know this can be quite a difficult debate. And "Final Acceptance" was exactly what I was looking for! Thank you!

You have confirmed my thought on this. We are also looking at "reference only" for any in process checks (with a few exceptions). This is a heated debate in my company as well, should we or should we not get a "golden" ruler. We have finally settled on a "golden caliper" to use to verify other calipers with a gauge block, and we can use it to verify tapes, rules, etc.

Glad to hear you have not had any issues with this.

 

[Eredhel]

We do calibrate/verify, different language argument there , our calipers. We keep standards that are sent out yearly to a calibration lab and then do all our own in house checking of mics, calipers, et cetera. Our CMM, Comparator, and surface plates may be the only things done by an outside party.

 

[THamlett]

I went through this several years ago with a Quality Director who told us that every micrometer,caliper, gauge block, pin gauge, pressure gauge, clock, etc in the company had to be calibrated and traceable to NIST. We told him he was nuts. Only the devices that had a direct effect on product quality needed to be calibrated or if a specification required it. We had an air compressor feeding blow-off guns that had a pressure regulator and gauge but the gauge was a reference only type of device. No calibration needed.

My rule is, if a device reading is recorded on a document that some one signs, then the device needs to be calibrated.

Get yourself a lot of "Reference Only" Stickers.

 

[AndyN]

Get yourself a lot of "Reference Only" Stickers.

Better to get "Calibration Not Required". It confuses people to use "Reference Only". Why would anyone reference something if it can't be trusted?

ref·er·ence
ˈref(ə)rəns/Submit
noun
1.
the action of mentioning or alluding to something.
"he made reference to the enormous power of the mass media"
synonyms: mention of, allusion to, comment on, remark about
"his journal contains many references to railroads"
2.
use of a source of information in order to ascertain something.
"popular works of reference"

 

[ljreimer]

I tell clients during audits if they are using rulers for a measuring device for acceptance of product it should be calibrated once to verify that the cardinal markings on the ruler is correct. Future calibration is not required, only verify that that the device is still in working condition. Recalibration is not adding any value since the ruler will not produce inaccurate readings in the future.

Any monitoring or measuring device that is used to made decision to accept product at different stages of the manufacturing process needs to be calibrated if the company determines a risk in meeting customer requirements. If only calibrated devices are used at final inspection that meets the intent of the standard. However, Risk base thinking, if during the manufacturing processes inspection activities are conducted and specific product characteristics are only reviewed during these stages and not at final that could be issue if the measuring device is not calibrated.

It should also be taken into consideration the risk of identifying nonconforming product at the final stages, This could impact delivery and order fulfillment. if more effective inspection program with calibrated devices are use at earlier stages of the manufacturing process, identifying nonconforming product earlier into the manufacturing stages saves time and money.

 

[AndyN]

I tell clients during audits if they are using rulers for a measuring device for acceptance of product it should be calibrated once to verify that the cardinal markings on the ruler is correct. Future calibration is not required, only verify that that the device is still in working condition. Recalibration is not adding any value since the ruler will not produce inaccurate readings in the future.

Any monitoring or measuring device that is used to made decision to accept product at different stages of the manufacturing process needs to be calibrated if the company determines a risk in meeting customer requirements. If only calibrated devices are used at final inspection that meets the intent of the standard. However, Risk base thinking, if during the manufacturing processes inspection activities are conducted and specific product characteristics are only reviewed during these stages and not at final that could be issue if the measuring device is not calibrated.

It should also be taken into consideration the risk of identifying nonconforming product at the final stages, This could impact delivery and order fulfillment. if more effective inspection program with calibrated devices are use at earlier stages of the manufacturing process, identifying nonconforming product earlier into the manufacturing stages saves time and money.

Welcome! Could you clarify which type of audit you do, when you advise your clients - some visitors here may not realize that different "types" of auditors shouldn't be offering advice.

I understand the standard to be about prevention so I'm not certain your statement; "If only calibrated devices are used at final inspection that meets the intent of the standard." is accurate. Waiting until final to discover parts were made wrong, when the operator was using a worn-out gauge, isn't prevention.

 

[howste]

I don't know why anyone would ever measure something if there was doubt if the measuring equipment was reliable. If we don't care about in-process measurements being reliable then why should we even bother to do them?

 

[Golfman25]

I don't know why anyone would ever measure something if there was doubt if the measuring equipment was reliable. If we don't care about in-process measurements being reliable then why should we even bother to do them?

I don't think it is necessarily about reliability but trying to manage a whole lot of gages and avoiding unnecessary dings from auditors. We have all been there, on the shop floor, trying to run some part, when "Johnny" pulls out of his toolbox some gage nobody has seen in years to measure the feature. He checks it, makes a process adjustment, checks again, and hands the part off to QA for buyoff. Part is approved and production starts.

Should we make sure Johnny's gage is calibrated? Probably. Is it absolutely necessary? No, given that the buyoff is actually done by QA.

We have many gages that are calibrated, but essentially reference, on our shop floor. During setup, they will use a caliper to get a "looks good" measurement before handing off to QA who has the final say. QA will use a CMM to verify and approve. Is it a good use of resources to manage all of the "reference" gages thru calibration? Each company will have to make that decision.

 

[Rich Shippy]

Just an observation, 7.1.5.2 a gives the option of "calibrated OR verified OR both", verification is much quicker than calibrating on a lot of measuring equipment. So technically for compliance, it would appear verification is acceptable.