Exclusions to ISO 9001:2015

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Richard W

#1
HI All.

I want to make calibration of measuring devices an exclusion from our system.

last time the auditor was happy with this, as whilst we have a couple of scales, they are used for postage and do not affect the quality of the products (we do not actually manufacture anything)

What is the best way of doing this, I was thinking of simply having a small exclusions sections, with juts this one in a at the moment giving my reasons for excluding it.

Thanks

Richard
 
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Ninja

Looking for Reality
Trusted Information Resource
#2
Re: Exclusions to ISO 9001

I would think you would find it easier to NOT exclude calibration.
Write a one page calibration document saying that all measuring devices that can affect the quality of products shall be calibrated.

Then note each of your two measuring devices as unrelated to product quality (if they truly are unrelated).

Should take you about 30 minutes...no exclusion needed.

Do you truly not measure anything with any type of gage?
 
R

Richard W

#3
Re: Exclusions to ISO 9001

thanks , that's a good idea, and will prevent a massive amount of work in the event of me needing to add something which is relevant. And No - we don't measure anything, its a bit like Amazon, we sell products but don't make them..........
 

Kronos147

Trusted Information Resource
#4
Re: Exclusions to ISO 9001

thanks , that's a good idea, and will prevent a massive amount of work in the event of me needing to add something which is relevant.
I audited a company that was in a similar situation, and had excluded calibration. However, they just bought some stuff before the audit to "check" the quality of outsourced production, as a method of acceptance prior to shipping.

It earned them a major nonconformance. :(

Better to have, just in case!
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Re: Exclusions to ISO 9001

ISO 9001:2015 FAQ.

Are organizations still allowed to exclude requirements of ISO 9001?
ISO 9001:2015 no longer refers to “exclusions” in relation to the applicability of its requirements to the organization’s quality management system. However, an organization can determine the applicability of requirements. All requirements in the new standard are intended to apply. The organization can only decide that a requirement is not applicable if its decision will not affect its ability or responsibility to ensure the conformity of products and services and the enhancement of customer satisfaction.
 

Eredhel

Quality Manager
#6
Re: Exclusions to ISO 9001

I haven't had a chance to dig in to the new ISO 9001:2015 update as much as I'd like but I do notice this:

"When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be..."

The bold seems to leave it up to the organization's actual needs. That's just a quick search though, I've only just started ramping up our update path.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Re: Exclusions to ISO 9001

The bold seems to leave it up to the organization's actual needs.
Not really. Do not underestimate the importance of the ISO 9000 definition of the term "requirement". If your customer (or another relevant stakeholder) expects measurement traceability, even though they have not explicitly required it, it is a requirement.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
Instead of citing exclusions which have in some cases have been questionable, ISO 9001:2015 wants a system scope statement that identifies which elements do not apply and explains why. This should not be a complex matter but is important to "draw a box" around what is auditable in order to make justifiably clear what is not.

What we could ask ourselves is: (I didn't find a regulation in my search so unless part of your customer requirements includes adequate postage, so...)

Are the items being mailed to customers?
What is the potential result of inadequate postage?

If you decide you must calibrate the scales (in almost all cases I would not be asking for that, but would apply the requirements to only that which provides final acceptance results data for customers or is part of a critical process), I would first compare the cost of doing it yourself using available process and traceable weight standards - which of course also need to b verified on some reasonable frequency because weights do change over time.
:2cents:

I am not affiliated with TechGuy.
 

Colin

Quite Involved in Discussions
#9
Lets not fall into the trap of finding a way to meet a requirement when it doesn't really apply. I am with your previous auditor, calibrating the mail scales is not necessary for you so explain it in the manual (or somewhere else if you have done away with the manual).
 
R

Richard W

#10
thanks all.
I have written the process along the lines of .... "When it is necessary we will do it, at the moment it is not" so I have a process to show we have thought about this, justified why we do not calibrate, and it is there in the case of us ever needing it"
 
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