Audit Observations - Is there a requirement to Respond to Observations?


Fully vaccinated are you?
Saw this. Any coments here?

From: "David Jenkins"
Newsgroups: misc.industry.quality
Subject: Registrar comments

Date: Mon, 15 Apr 2002 20:09:51 GMT
Organization: Shaw Residential Internet
Xref: sn-us misc.industry.quality:16278

Just wondering if anyone else has observed this from an auditor on an ISO
9001:2000 registration audit?

They found one minor nonconformance and made a 'comment' on three other
issues. They are trying to insist that we respond to these 'comments' as
well as the nonconformance before confirming registration. On being
challenged as to whether these comments were really 'minor or
potential-minor nonconformances' they replied no - they were justs things
they would like to see changed: they could not point to non-complience with
the standard.

I've been through a fair number of ISO audits with our clients, but have
never run across this behavior before. Anyone else seen this?

David Jenkins
White Rock BC

Randy Stewart

Unfortunately, yes. One of the sites I use to be responsible for received a minor during the next audit because we didn't respond to the OFI. However, 1 incident out of all the audits in the past 6 years isn't a bad percentage.


M Greenaway

I have never experienced this, and find it quite alarming.

However what you could do is document it in your CA system, conduct an investigation, come to the conclusion that you cannot identify that there is any non-compliance (which your auditor must agree with), and then close the CA with 'no-action'.

Unless of course you really want to go to war on it, in which case tell the guy to ............. off


Quite Involved in Discussions
Our Registrar does not require a response on Opportunity for Improvements. They are also not allowed to write an OFI during a registration. File a grievance with the registrar


How do you define "respond"?

All "observations" need some form of response, if only to say that nothing will be done. If that is what the registrar is looking for; evidence that you considered the observation, then great. If, on the other hand, the registrar is looking for you to “fix” the observation, then I would have an issue. If it requires “fixing” it should be a nonconformance, not an observation. If the situation is conforming, then not “fix” should be required.


Super Moderator
Trusted Information Resource
Guess I can't say how kosher these opportunities for improvement and responses are, but here is what I have done in the past.

We have welcomed any and all observations pertaining to opportunities for improvement. We also let our registrar know that while we welcome them, we may not choose to do the exact things that the auditor is looking for, we will do what is best for us. Our registrar has never required a formal action plan for OFIs. We do (quality team members) sit down with the auditor prior to the closing meeting and discuss them. We may come up with a plan right there, or not. But at least the auditor knows we are aware, and will keep them in mind. Usually these improvement opportunities lead to the next surveillance audit, and they give us a chance to maybe take care of a potential problem before it happens. Obviously, if they were in nonconformance now, we'd get a finding. Usually it is just a feeling from the evidence collected in the current audit that there is a potential for nonconformance down the road.

I don't know, maybe we are pretty naive, but we like to partner with our registrar and keep everything pretty low-key and friendly.

Jim Biz

Two way situation

I've seen this happen in two different situations

1) auditor "using" an improvement as a warning
(ie explaining that although it is wiitten as a "Suggestion" if nothing changes by the next visit - I'll find a way to write a nonconformance for it.....

2) Auditor Using improvement suggestins to "mold" the clients system to his viewpoint. Ie your system would be better in my opinion if you did this or that........

Of course the auditor that explains "this is what I think and you can take it and run with it OR ignore it completley is correct.


Trusted Information Resource
my experience

During our initial audit, our registrar found some OFIs. They included them in their report, but did not require a written response. We did have 3 minors written, and we had to respond to those before we received our certification.



Oh yeah

One additional thing I forgot, for some reason SteelMaiden's post reminded me of it. If an observation points to something that would be of benefit, then without a doubt follow-up, regardless of whether the registrar says you have to.


Two out of the three Registrars I have used required responses to Observations.

Both described it as being a warning about a future finding.
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