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

Re: Updated Quality Manual for ISO 9001:2008

Ok:
Audited by my registrar -third party
As I said he did not write any NC's
This is what I did:
MOP/SOP/COP process map incorporating the PDCA cycle in the centre. I identified all the Processes and sub processes. There is no write up per say after this.
I went into QSP's or procedure, which are a mix of both "what" and "how" with responsibilities in each box (job function)
What baffled me was his insistence on where is your Qm?, you have not satisfied the documentation requirements. I told him my procedures reflect the intent of the standard and addressed each section. My question is this: Does the QM have to be sepearted? and then reference the procedures, which can be in a flow chart? I did for example section 5.0 like this, using decision diamonds on the left and boxes to the right which bulleted the elements onf the standard and referenced other flow charts. My manual is html interactive an online in the company.What this means is that as you click it hyperlinks you and you can pretty much start at any point and get a world tour!
Does anyone have a typical generic manual that does pass ISO 9001:2008 in a revolutionary format that people fill find value in?

Re: Updated Quality Manual for ISO 9001:2008

dmahadeo said:

Ok:
Audited by my registrar -third party
As I said he did not write any NC's
This is what I did:
MOP/SOP/COP process map incorporating the PDCA cycle in the centre. I identified all the Processes and sub processes. There is no write up per say after this.
I went into QSP's or procedure, which are a mix of both "what" and "how" with responsibilities in each box (job function)
What baffled me was his insistence on where is your Qm?, you have not satisfied the documentation requirements. I told him my procedures reflect the intent of the standard and addressed each section. My question is this: Does the QM have to be sepearted? and then reference the procedures, which can be in a flow chart? I did for example section 5.0 like this, using decision diamonds on the left and boxes to the right which bulleted the elements onf the standard and referenced other flow charts. My manual is html interactive an online in the company.What this means is that as you click it hyperlinks you and you can pretty much start at any point and get a world tour!
Does anyone have a typical generic manual that does pass ISO 9001:2008 in a revolutionary format that people fill find value in?

Click to expand...

Can you post your one pager so we can see if you have met the requirements? You may have, but we should see before giving advice. If you don't want to post it here, can you send me a PM so I can see it and comment?

Re: Updated Quality Manual for ISO 9001:2008

dmahadeo said:

Ok:
Audited by my registrar -third party
As I said he did not write any NC's
This is what I did:
MOP/SOP/COP process map incorporating the PDCA cycle in the centre. I identified all the Processes and sub processes. There is no write up per say after this.
I went into QSP's or procedure, which are a mix of both "what" and "how" with responsibilities in each box (job function)
What baffled me was his insistence on where is your Qm?, you have not satisfied the documentation requirements. I told him my procedures reflect the intent of the standard and addressed each section. My question is this: Does the QM have to be sepearted? and then reference the procedures, which can be in a flow chart? I did for example section 5.0 like this, using decision diamonds on the left and boxes to the right which bulleted the elements onf the standard and referenced other flow charts. My manual is html interactive an online in the company.What this means is that as you click it hyperlinks you and you can pretty much start at any point and get a world tour!
Does anyone have a typical generic manual that does pass ISO 9001:2008 in a revolutionary format that people fill find value in?

Click to expand...

If you do a search on take a look at the related threads or even click on the 'Post Attachments' link (green box) at the top of the page - you'll find one! There is a long thread 'Boss wants a 4 page manual' which might help too.
There is, of course, a specific requirement for a 'Quality Manual' and certain contents - not simply the procedures/processes and/or reference to them and a look up of ISO requirements. Typically a QM might also contain the QMS 'scope', any exclusions you're taking (product design?) and the Quality Policy. These tend to reside in a 'stand alone' document or section of a larger document.

How did you cover policy, scope, exclusions, etc?

Re: Updated Quality Manual for ISO 9001:2008

There are three things that must be included in the Quality Manual.

1. The scope of the qualtiy management system including details of the justification of any exclusions.

2. The documented procedures established for the quality management system, or reference to them.

3. A description of the interaction between the processes of the qualtiy management system.

It soulds like you may have only completed the last one. That is why it would help to see your quality manual.

Re: Updated Quality Manual for ISO 9001:2008

dmahadeo said:

What baffled me was his insistence on where is your Qm?, you have not satisfied the documentation requirements.

Click to expand...

You may have struck an old-fashioned auditor who is used to seeing the doco in a certain way, and hasn't the smarts or the flexibility to consider alternatives. There are some around, alas, who are particularly challeneged by anything 'different' and by online stuff and by a 'virtual' manual rather than a physical one.

Provided you have met all the requirements in the Standard, then he is wrong.

I suggest you read very closely what it says about doco in total: not just the 'quality manual', but all the bits about doco. Then, if you're sure you've satisfied all of them, take it up with their technical manager.

It's not necessarily about 'just the 1-pager' - it's the totality of your documentation! So 'just posting the 1-pager' may in fact give some people here a misleading impression.

1. Ask to discuss the issue with their tech manager. Stay objective and stick with facts, not beliefs.

2. If unsatisfactory, take it up with their boss.

Don't just roll over and do 'whatever the auditor wants' if he's wrong and it adds no value.

Do read through the other links suggested.

Re: Updated Quality Manual for ISO 9001:2008

Thank you all for your insightful comments.I did do an introduction, documented the scope, even did norm references, terms and definition. Included in the intro is a write up of the company, the 20 yrs its been around, the methodology used (process approach/team development), the exclusions (design and development since we do not design). Also a matrix showing how each element is referenced to a procedure.
What I am getting is that the auditor wants to make his work easy, he wants to see us clearly stating the "whats" in a document which he calls a "QM". which is basically substituting the "the organisation shall" for "Company XXX"that way when he comes to audit he just pulls the procedure flow chart and check for conformance. He also insisting that I STICK TO THE MINIMUM 6 PROCEDURES. I ended up with over 10. For example employees wanted to know the RFQ to product delivery cycle (I facilitated/flow charted this)and evryone uses it and we have more efficiency.It was too loose before. Simple stuff like order entry to delivery, no one was clear on the accountabilities. Unfortunately I cannot end the manual as it is proprietary. i used a COP/SOP/MOP process map I found on here

Re: Updated Quality Manual for ISO 9001:2008

This is shocking - yes, he's definitely a lazy auditor and not too bright, by the sound of it. Appalling - he's trying to force you into making your system easy and unchallenging for him to audit.

Get rid of him tout de suite. And if necessary, get rid of the certifier also.

The good news: no NC. The bad news: he's trying to push you into a non-value add, stupid activity.

1. Take it up with his boss without delay. Explain the problem, why you're not happy, provide the details. Ask for a different (competent, non-lazy) auditor to be assigned in future. Ask to see their CV in advance and scrutinise it! Refuse to have this one back. EVER.
   
2. If you get a reasonable response, then try out the new auditor. Most good certifiers respond well to reasonable criticisms and complaints - after all, they're service businesses! This auditor needs 'recalibration' and retraining! Perhaps he's been allowed to get away with this kind of cr*p for too long. It should not - repeat, should not! happen.
   
3. If you don't get satisfaction - start looking for a new certifier immediately. (It's quite easy to transfer, more so than most people realise.) Get on to it though, don't leave it until your next audit's due. Talk to at least 2, preferably 3. And explain what's happened, and why you want to swap, and ask them how they go about avoiding such nonsense, and what their response would be if it ever did. Also, look at CVs of proposed auditors!

Good luck - do keep us informed, I look forward to hearing.

But don't let this guy get away with such nonsense. It gives other certifiers and good, competent auditors an undeserved bad name too, alas.

Re: Updated Quality Manual for ISO 9001:2008

Thanks Jane.
There is more than meets the eye. I am a newbie at this company. I was working for another company for 11 yrs and then in Jan 08 it went into receivership I started at this new company one week after jan 15. This registrar is operating under a large umbrella (sorta like a franchise thing) and over the years have been "kind" to this company.They have had quite a few QA Managers over the years as well. The thing is everyone thinks "what a great job" no NC's but it does not sit well with me as I have to go against my own philosophy. I sold the President on "value added" and my launch presentation said just that ...I called it a "quality Business management system" focused on results and profitability..even went as far as to say that the word "quality" in this statement is an adjective! lol!. Now with his spin on being "conforming"..Auditor really has no "boss" he is the owner of this outfit..Hope you guys get the unspoken things here.
Unforunately I am stuck, so I will present my case and then just do what I have to do...

Re: Updated Quality Manual for ISO 9001:2008

Ye-es. Tricky situation for you.

And a prime illustration of why a one-person certifying 'company' is not a good idea. That bit of the Mouse's tale from Alice in Wonderland comes to mind:

Said the mouse
to the cur,
'Such a trial,
dear Sir, With
no jury or
judge, would
be wasting
our breath.'
'I'll be
judge, I'll
be jury,'
Said cunning
old Fury:
'I'll try
the whole
cause, and
condemn
you
to
death.'

Click to expand...

You'll guess who is 'Fury' in this case!

He's been 'kind', huh? Sure... as long as everyone does precisely what he wants. Again, this is not how it's supposed to be.

It of course comes back to what the company senior management wants: a real business management system from which they derive value? or just a certificate they can stick on the wall without too much effort... I know which is valuable and which is really a waste of time & load of old cobblers.

I can offer that when companies have taken advice to switch certifiers (not frequent, but on occasion it's been necessary), they've been blown away by how different auditors can be. 'Like chalk and cheese'; 'I know you said it would be different, but I just couldn't really believe it until this guy came along... Wow now that was a really useful audit!' are some of the things they said.

But yes, you gotta do what you gotta do and be pragmatic. And it's tough when you're new... but perhaps you can still inch toward a change? Good luck.

Re: Updated Quality Manual for ISO 9001:2008

That is exactly what I am going to do. I intend to do it on two levels. Have a manual that satisfies the auditor and develop real value procedures that make the business system work. For example, Customer complaints, it has been suggested, just hand the complaint to the relevant person and let them do the CAR. Now, we all know this is not practical as we will end up with pissed off customers, who will get no response. So I redirected the complaints in my procedure to QA to log and facilitate the CAR with the relevant persons, the QA is also the line of communication with the customer. Another one, is items found NC during manufacture, the suggestion is simply quarantine it and log it , then look at trends over time for Action. I changed this to state "based on severity impact of $$", it needs an NCR to trigger corrective action. I am also merging Lean six sigma concepts for continual improvement and as a matter of fact will be using "Lean" to drive improvements. (I have Quality engineering background)
I have "buy-in" from the top, but we need some "wins", then I can kick the Auditor to the curb.
Thanks for all the reassurance, I was beginning to think I was completely "left field" in my "interpretation" of the standard! By the way I used that word (interpretation)and it caused him to go ballistic, actually threatening to write a NC if I said it again. He claims it is "English" and if people can't understand it they should go back to school. I wanted to tell him.. so is the Bible and we have 632 denominations all with different spins on it!
Anyway peace will prevail, I have been around it Industry >23yrs and worked for Large companies like Exxon (ESSO caribbean) small companies and have always been in upper and middle management, so I think I know how to be a change agent..