Please review my ISO 9001 Quality Manual and Registrar comments

[Jim Wynne]

Re: Please review my ISO-9001 QM and registrar comments

Jim -

what if I just include the word "scope" in the first paragraph of section I?
It's got "where", "what", and "how"... maybe another slight rephrase to add "why"?

What about "who"? You need to say what (and to whom) the QM applies--is it your whole business? Just the processes explicitly cited in the manual? Do the requirements apply to all employees?

 

[qualitychic]

Re: Fellow Mods - would you please review my QM

That sounds like your registrar has some issue themselves. They should evaluate their auditors to make sure that they are equally competence.

 

[ScottK]

Re: Please review my ISO-9001 QM and registrar comments

Got responses back to my comments on his concerns.

he keeps referencing paragraph 0 on the process approach and is insisting I need a "terms and definitions" point in the manual. I think I'll stand my ground on that one.

honestly - most of this stuff is easy to fix and make him happy even if it's not really required.

The good news is it looks like I'll get to re-write our quality policy.

I have always been of the opinion that the QMS starts with clause 4.
Anything prior to that is guidance or about the standard itself.

 

[Icy Mountain]

Re: Fellow Mods - would you please review my QM

oh yeah - I'm doing well. And yourself?
you know... on other boards where my nick is still "discordian" they shorten it "disco"... I was a punker during the disco era.

My mental shorthand for your tag was always "discord". I saw this new guy posting with your avatar but it only took me a couple of posts to realize that it was the samo-samo with a new name.Unfortunately, I start a 9 day vacation in about 30 minutes so I'm finding it hard to stay on topic.

 

[ScottK]

Re: Please review my ISO-9001 Quality Manual and Registrar comments

I AM FURIOUS

Just got an official report of the registrars QM review... 5 days before they're supposed to be here. And the reviewer is on vacation until then.

Trying to calm down now but it seems to me that our registrar thinks that the QM should be way more than an outline of the QMS and therefore is assuming everything is missing.

I will post their report after I remove company names and such.

 

[ScottK]

Re: Please review my ISO-9001 Quality Manual and Registrar comments

Here's the report.

Any feedback is appreciated.

(I also modified the manual to clarify the scope of the QMS and add a description of the interaction of the processes, I won't bore you with that)

(removed attachment - left it up long enough)

 

[Randy]

Re: Please review my ISO-9001 Quality Manual and Registrar comments

I dunno, but looking at the report I'm relieved it ain't us...............

Just a quick glance at what you recieved raises a couple of questions about the "auditing" and "competence".

The pieces about President's signature and lack of organizational chart are kinda wierd. Unless you require a signature, who really cares? You also indicated that there is an org chart, but it's not in the manual and doesn't have to be there is a reference to a document instead.

The whole thing seems to be messed up.

 

[ScottK]

Re: Please review my ISO-9001 Quality Manual and Registrar comments

I dunno, but looking at the report I'm relieved it ain't us...............

Just a quick glance at what you recieved raises a couple of questions about the "auditing" and "competence".

The pieces about President's signature and lack of organizational chart are kinda wierd. Unless you require a signature, who really cares? You also indicated that there is an org chart, but it's not in the manual and doesn't have to be there is a reference to a document instead.

The whole thing seems to be messed up.

the real kick in the nuts is that up front, months ago, I emailed the manual and said "here's the manual, I'm keeping it minimalist, do you want the all the documents that are referenced?"
Then answer was "no, just the manual."
I think that's what it comes down to - they need to see all the support procedures to really make any sort of judgement.

And am I wrong in finding it unprofessional that I sent them the QM in May, the auditor responded in Mid July - then went on vacation for 4 weeks leaving the final communication with his boss, who responded a week before the audit with the above and saying he's now going on vacation as of today.

On a positive note, we just had a third party audit from a guy who's probably been doing ISO and FDA auditing longer than just about anyone here and his feedback at the end of the audit was "very impressive system, you should breeze through registration".

 

[progressive post]

Re: Please review my ISO-9001 Quality Manual and Registrar comments

Hi,
our pleasure joining this discussion.
the manual is brief and incomplete with shortcomings pointed out by many and regisrars final note.
some of the additional notes from our end are as follows
interaction of process to be loud and clear to breed confidence in any one who or runs through /refres your manual.
QMS effectiveness depends on involvement and participation.Quality representative sounds like quality incharge and is viewed as policing person.management representative(QMS) would be right term,in our opinion,if not wrong.
clause references missing(hope it was not preliminary draft)
connectivity,identification,traceability,though not mandatory are the life line for flawless performance and effectiveness.manual does not give clear clue to these.
quality organisation is different than organisational structure-it is unclear how system beeps for effectiveness on continual basis in the complete relisation cycle.
registrars have some times divergent views and expectation from system and manual.but the fact that documentation is a business in black and white,probably QMS 9001:2000 international standards quality requirements needs to be adequate and understandable by the complete supply chain and the all associated with product realisation cyle.
auditable objectives,action plan in place to achieve them and provision to review to upgrade is one of the prominant essense,that may draw your attention during audits.
management review frequency is another bothering factor.any way either before or after the audit-it is once in a year in your case, one gets a feeling that management commitement takes a back seat.
excuse me for frank comments.high regards for the upfront approach with which you have clarified your position.we all wish that QMS in your organisation be more and more effective-a bonaza for the team.
one more angle, though out of the scope of this discussion, is how much your people adore it and their contribution to upgrade , revise or review the connected documents.you will know the best to draw real satisfaction.
system again is not only for them who are in your organisation for pretty long tine but also for them who join fresh and get a message to be serious and committed to your quality objectives.
regards again.progressive post.
appreciation sends a wave of joy but points for improvement builds futture prospects.
Thanks that you are also giving more learning to all of us who participate to your cause.

 

[CliffK]

Re: Please review my ISO-9001 QM and registrar comments

Just a suggestion, you may want to soften your response a bit seems very combative. Other than that it looks good. Read it and see how you would feel if this was a response you received from one of your suppliers. JMHO

You're not the supplier. You're the customer. An irate one, at that and with a legitimate beef.

I am assuming that your contract with the auditor clearly states that the audit criteria shall be ISO 9001:2000. The presence of reference documents in the registrar's report makes me nervous on that point. If the reference documents are part of the criteria and noted in your contract, you may be in for a very bumpy ride.

Of course, if you thought you were contracting for an audit to ISO 9001:2000 and all this other stuff gets dragged in because it's "what they do," then it's probably time to cry foul, call the whole thing off and start negotiating about liquidated damages. I would take an initial position of $0.00, on the basis of misrepresentation.

If they claim to be auditing according to ISO 9001:2000 only, more communication about the report needs to take place before the audit. The review report is not really clear about the concerns cited. It leaves me wondering if the guy believes he has uncovered deficiencies or is merely giving himself reminders of things to look at during the audit. If he thinks his comments represent deficiencies, then he has demonstrated an absence of competence to perform an audit to ISO 9001:2000. Were I in your shoes, I would try to put a halt to proceedings until the registrar agrees to supply an auditor that knows the standard and will abide by it.

All that said, I have a further concern: the reviewer seems to expect one of those document-heavy, bureaucratic abominations that sometimes pass for a system. I caught his comment about wanting to see a documented link between providing resources and enhancing customer satisfaction. I fear that, in addition to the link, he will expect to see documented evidence that you have, in fact, provided resources to enhance customer satisfaction and documented evidence to show that the provided resources actually have enhanced customer sat. Oh yeah, and a measurement to prove that it's so.

I guess if it gets too bad you can show them off the premises and write a supplier corrective action to the registrar for failing to deliver contracted services. And by the way, withhold payment until they deliver the service contracted.

For what it's worth, that's the course I would pursue. Good luck and let us know how it turns out.

Cliff Kachinske