Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:2008

Big Jim

Trusted Information Resource
#91
Re: Updated Quality Manual for ISO 9001:2008

I meant 4.2.2(b). :bonk:



I also have the understanding that there are six specifically required documented procedures, but that doesn't mean that there will be no others that are not specified in the standard.
It also doesn't mean that there will be others either.
 
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Big Jim

Trusted Information Resource
#92
Re: Updated Quality Manual for ISO 9001:2008

This doesn't come through in most of what you've written in this thread. In fact, rather the reverse.


What kinds of organisations are you auditing? In what fields? What sizes and types?

I can maybe believe a very very small organisation with a very, very low staff turnover and a very, very simple system (one process say) might have a very low need for written procedures. Or maybe perhaps an organisation with a very high degree of built-in IT/automation. Maybe. (But then, in the latter case, I'd see that the IT/automation was in fact instead of written procedures - ie, the procedure/process was defined and built-in.

But you're saying you see it frequently and very often. :confused:

I asked several auditors whose opinion I respect, and all found it quite an unusual idea, and agreed that they would (if they came across it) consider it definitely far from 'normal'.

Seems to me to be heading straight along the path of 'we know what we're doing, and once you've worked here for a while you'll know too', which isn't what I expect from a sound QMS.

:topic:
This must be one of the most responded to topics, which has explored all kinds of directions and wandered far from the OPs query. Interesting.
The types of companies varies greatly. They tend to be smaller companies with little employee turnover. They tend to have uncomplicated processes. Most have an effective quality management systems. They don't seem to have a higher NCR count than those with more conventional documented procedures.
 
X

xavierFR

#93
Re: Updated Quality Manual for ISO 9001:2008

Hello everyone,

I wouldn't like re-engage this burning topic, nevertheless very interesting. That's why I allow me to reply even one month later.

I think the opinions based on the length, size, color, visual anything which caraterise a Q manual are very sensitive because it's like the taste and color, wine to be deeply cliche. The best and often too pragmatic answer would be: TO DEPEND

We could understand that a small company, with a major workforce in the factory, few members working at the administration. To implement or manage strongly a Quality Assurance Policy could be only done with a accurate visual management, a very calm and understandable communication.

Is it possible to manage dozen managers (who love play with words and senses) as dozen of team leaders or workers (who have a natural reticence for long and complex sentences)?

Maybe to express once more this principle of TO DEPEND (the most loved answer of scientists), we can talk about HARMONY.

As an auditor, basically, if I listen to someone who introduces me a QMS complex as a rocket turbine for a small structure, I will automatically start the audit not convinced even without big defectives. On the other side, A 4 page manual for a 1000 employee company will sound too short even really visual.

The discuss about the structure and canevas is interesting. how we call the ISO 9001 or any others ... ? Standards, no? It means we should be able to find out similarities between different manuals. Obviously we will be able. Ok, I agree. But how long to make the equivalence? that's why we use key words, that's why we use chapters labels, to improve the reading.

In a suppliers selection as contractor for example, I have to read 5 manuals. How they treat the non conformance is determinant for my selection. If I can't find it quilcky in the 50 page manual, it starts badly for them.

So to resume my idea, to depend your customers, your suppliers, your employees, your direction. Even the culture interferes.

don't be extreme, start your answer by ''to depend...'' it will reduce the pain. ;)

regards Xav
 

howste

Thaumaturge
Super Moderator
#94
Re: Updated Quality Manual for ISO 9001:2008

Boy, it looks like I missed out on some lively discussion while I was on vacation last week.

Here's my :2cents: as clearly as I can state it:

I have audited hundreds of systems where there were more than 6 documented procedures. In some cases, only 6 procedures were referenced in the quality manual. In these cases I wrote a nonconformity because it didn't meet the requirements of 4.2.2b: "The organization shall establish and maintain a quality manual that includes... b) the documented procedures established for the quality management system, or reference to them..."

The audited organizations readily accepted the nonconformity because it says procedures established for the quality management system not procedures required by ISO 9001.
 
D

dmahadeo

#96
Re: Updated Quality Manual for ISO 9001:2008

ok, I visited this forum today because I just had an Audit and I did a revolutionary change to the manual that the Auditor simply could not understand. I have a one pager showing the interaction of all the processes and linkages and told him that is my quality manual. The idiot then insisted I show him my "documented" Qm!he is looking for "what" statements covering each section and if they don't line up down to the order ...as in for example the new sequence in 2008 of training, effectiveness, he sees it as a noncompliance.I even tried to tell him that effectiveness is the thing....I got zero nonconformance pending I add regurgitation to each section before my flow charts...!
 

Wes Bucey

Quite Involved in Discussions
#97
Re: Updated Quality Manual for ISO 9001:2008

ok, I visited this forum today because I just had an Audit and I did a revolutionary change to the manual that the Auditor simply could not understand. I have a one pager showing the interaction of all the processes and linkages and told him that is my quality manual. The idiot then insisted I show him my "documented" Qm!he is looking for "what" statements covering each section and if they don't line up down to the order ...as in for example the new sequence in 2008 of training, effectiveness, he sees it as a noncompliance.I even tried to tell him that effectiveness is the thing....I got zero nonconformance pending I add regurgitation to each section before my flow charts...!
Bummer! I sympathize with your frustration.

Weekends are slow times here in the Cove. This is a hot button issue which is sure to arouse interest once the regulars come back after a weekend of recreation.

One thing I'm sure will come up is the question of whether the Audit was internal or external. If external, was it a third party registrar or a customer's auditor? The answer to the kind of audit and the difference between third party registrar audits and customer audits will make a big difference in your approach to relieving or resolving your frustration.

Come back from time to time to check on responses.
 
J

JaneB

#98
Re: Updated Quality Manual for ISO 9001:2008

Bummer, indeed.

As Wes said, can you provide some more info about the audit internal/external? certification/surveillance, etc?
And what specifically was the wording of whatever is requested/expected? What clause/s were quoted that you supposedly did not meet?
 

Paul Simpson

Trusted Information Resource
#99
Re: Updated Quality Manual for ISO 9001:2008

ok, I visited this forum today because I just had an Audit and I did a revolutionary change to the manual that the Auditor simply could not understand. I have a one pager showing the interaction of all the processes and linkages and told him that is my quality manual. The idiot then insisted I show him my "documented" Qm!he is looking for "what" statements covering each section and if they don't line up down to the order ...as in for example the new sequence in 2008 of training, effectiveness, he sees it as a noncompliance.I even tried to tell him that effectiveness is the thing....I got zero nonconformance pending I add regurgitation to each section before my flow charts...!
I am making the (dangerous) assumption that this is a third party audit.

I hope you told your auditor to go take a hike? Depending on how far you want to take this and there are plenty who would not want to take up this particular challenge! :notme:
  • Reject the NC the auditor left you. If you signed it withdraw your acceptance of it
  • Complain to the registrar that the NC should never have been raised
  • If you get no joy from the CB compalin to their accreditation body

BTW do make sure you have your facts right and the manual you presented does address all the requirements in the relevant clause - 4.2.2 :D
 
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S

Sweetsue28uk

Re: Updated Quality Manual for 9001:2008

Hi

I am currently writing my quality manual and I am totally new to this area of work. Would you be able to send me what you consider "a worthwhile" manual because I am concerned that I am basing mine on the standard even though the processes I am writing highlight how the company works. I have only just completed control of documents and records so I have a long way to go.

Thanks

Sue
 
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