ISO 'major' vs 'minor'

Randy

Super Moderator
Incorrect, there is a requirement to classify, and prescribed classification is noted to include major, and conversely minor. See the requirements from ISO 17021-1 I posted, which is normative to accredited certification bodies.
I know this from the 13485 scheme, but as it is in ISO 17021-1 it applies to all schemes.
Yes, an 99.99999999% of people do not have access to 17021 mainly because it does not apply to them, only CB's need it and care.
 

Big Jim

Admin
Yes, an 99.99999999% of people do not have access to 17021 mainly because it does not apply to them, only CB's need it and care.

I disagree that only CB's care. Some want to understand how they are evaluated, and they are often frustrated when they learn there is more than the standard they are registered to. I personally am offended when there are additional requirements that are shrouded / hidden.
 

Golfman25

Trusted Information Resource
I disagree that only CB's care. Some want to understand how they are evaluated, and they are often frustrated when they learn there is more than the standard they are registered to. I personally am offended when there are additional requirements that are shrouded / hidden.
Face it, you're not a member of "the club." :)

I agree. There is nothing more frustrating than sitting in a audit and having the audit pull out the secret book to ding you on something.
 

Jean_B

Trusted Information Resource
They shouldn't ding you on 17021-1 stuff, though 17021-1 requires them to arrange some stuff with you through contract (and thus known to you).
Probably it's the fact that through applicable regulations other standards become applicable as well. Harmonization, market access requirements etc.

As they need to be specific to which requirement you are not conforming with you can challenge them on explaining it in the statement of the nonconformity.
You can ask interpretation or appeal officially.
In such cases elsmar is an excellent avenue to share and ask support. We love a good puzzle/laugh.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
They shouldn't ding you on 17021-1 stuff, though 17021-1 requires them to arrange some stuff with you through contract (and thus known to you).
Probably it's the fact that through applicable regulations other standards become applicable as well. Harmonization, market access requirements etc.

As they need to be specific to which requirement you are not conforming with you can challenge them on explaining it in the statement of the nonconformity.
You can ask interpretation or appeal officially.
In such cases elsmar is an excellent avenue to share and ask support. We love a good puzzle/laugh.
Opening meetings for CB audits are supposed to include explanations of major and minor. If we forget to do this while on an ANAB witness audit we will receive a nonconformity for not adhering to 17021-1.

As for trickling down, we here have of course discouraged that practice many times.
 

Jean_B

Trusted Information Resource
Opening meetings for CB audits are supposed to include explanations of major and minor. If we forget to do this while on an ANAB witness audit we will receive a nonconformity for not adhering to 17021-1.

As for trickling down, we here have of course discouraged that practice many times.
True points too.

As for trickling down I don't know specifically what you mean.
Does it pertain to the suggestion to come here to seek understanding?
I've always learned a lot from the cases shared on elsmar (probably more than I got from any training, yet less than direct lived experience), and tried to give back when not blocked under NDA or copyright.
 

Randy

Super Moderator
Opening meetings for CB audits are supposed to include explanations of major and minor. If we forget to do this while on an ANAB witness audit we will receive a nonconformity for not adhering to 17021-1
Yep, but I've been to a few where that doesn't happen. Why? Dunno

And the ANAB thing, you betcha, but not during one of mine and I've had a dozen or so.

There is nothing more frustrating than sitting in a audit and having the audit pull out the secret book to ding you on something.
That's when you stop it and ask the person to depart......There are no secrets!

Here's a copy of a generic Opening/Closing Meeting checklist I used way back when I was teaching courses and use for myself as a personal refresher/record to this day.
 

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Jen Kirley

Quality and Auditing Expert
Leader
Admin
True points too.

As for trickling down I don't know specifically what you mean.
Does it pertain to the suggestion to come here to seek understanding?
I've always learned a lot from the cases shared on elsmar (probably more than I got from any training, yet less than direct lived experience), and tried to give back when not blocked under NDA or copyright.
What I meant by trickling down is applying the major/minor in site internal audits. We've been known to discourage that here for various reasons, mostly because it can be hard to apply it consistently among auditors.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Yep, but I've been to a few where that doesn't happen. Why? Dunno

And the ANAB thing, you betcha, but not during one of mine and I've had a dozen or so.
I haven't received a nonconformity for this during my witness audits, maybe because I always included it in the opening meeting. It's in a checklist we use to make sure it always gets included. It's no good to leave such a thing to question.
 

Golfman25

Trusted Information Resource
Opening meetings for CB audits are supposed to include explanations of major and minor. If we forget to do this while on an ANAB witness audit we will receive a nonconformity for not adhering to 17021-1.

As for trickling down, we here have of course discouraged that practice many times.
After a while “opening meetings” are simply a waste of time. New auditor, sure. But after two or three people’s eyes glaze over. Been certified for 20+ years, don’t really need an opening meeting these days. Just get to the point. :)
 
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