ISO 9001:2000 transition - Document and Process Discussion

[Paul Simpson]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

I'm going to shortcut and just say I agree with everything you say Cliff. There is a persistent problem however. There are so many indicators in ISO that would clearly say that the six references to the contents of six different procedures have nothing to do with how many procedures you must have.

On the contrary they tell you exactly how many procedures you must have but nothing about how many you should have. Only your own organization - or its consultant - can help you with that.

1) Given the history of the standards the authors are not about to take the stand of telling us how to structure our documented system. I am so positve the authors would never put them selves in the position of being able to be accused of telling us we only need six procedures.

Absolutely. They have placed the responsibility for deciding the level of documentation on the user.

Whereas in the bad old days a 3rd party auditor could raise a noncompliance because you didn't have a documented procedure (that you would never refer to but that you had to keep updated) now the shoe is on the other foot - you decide on the level of documentation and the auditor has to identify where the system is not working because a procedure is missing.

2) The very first requirement in the standards

"4.1 The organization shall...document...a Quality Management System...in accordance with the requirements of this International Standard."

Would clearly imply the entire QMS is to be documented, all requirements.

There is no clear implication as far as I am concerned.

All this requirement says is you have to have (as a minimum) a quality manual meeting the requirements of 4.2.2 (see many other threads re the one page quality manual), a minimum of six procedures and records that show the system is effective. That is your documented system. Oh, and any other procedures you believe are required to manage your organizations wrt quality - could be zero, could be thousands.

3) 4.1.a tells us to identify the processes needed for the QMS. It doesn't say anything like "use the six processes we have identified for you."

No, it says identify your processes. The only documentation requirement for processes is that in your manual you describe "the interaction between the processes of the quality management system." You may do more. You may document controls, measures. These could be linked to objectives, targets etc.

It is up to you.

4) The NOTE at the end of 4.1 where it says processes needed for the QMS should include management (5.0) resources (6.0) Product realization (7.0) and Measurement (8.0) is ISO's way of saying "be sure to include all the requirements of this standard the same way they did with the very first shall in the book at 4.1.

Your interpretation and if it works for you then good luck but that does not mean that everyone has to do it this way.

Taking part of the first area as an example a classic area - management review clause 5.6. If I have a management review agenda that shows I plan to cover all the input requirements of clause 5.6.2. The records of management review clearly show that the agenda is covered properly and when I interview the senior management team they are all clear as to what they are doing and why.

The minutes go on to show what they are doing as an action plan and it covers all the requirements of 5.6.3 and at the end of the minutes there is a next planned date ....

..... why have a procedure?

5) If we held to the belief that only where the word "documented" appears do we need to have a document then we would not have to document our level one Quality Manual. The word documented does not appear in 4.2.2

The quality management system documentation shall include
........b) a quality manual,

Can it get any clearer than that?

The evidence just goes on and on. I have no idea why it seems to be so difficult to so many. It's like we are reading only those six inclusions and not trying to understand at all.

We are all trying to understand the requirements and pass on good advice in the Cove. Only by understanding can we pass on this knowledge to others - otherwise we just muddy the water.

You are absolutely right; the effective system will include the minimum documentation required to get the job done. The general concensus that all we need are six procedures is not right. No flexibilty, no freedom, no individualism; the entire QMS must be documented to fit your organization and your system.

The only consensus is that there are 6 mandatory requirements for procedures. How many are needed is up to the organization. Some people combine two requirements in one procedure - e.g. document control and records or non conforming control and corrective action. It could be 3 / 4.

Ultimate flexibility I would say.

 

[Gary E MacLean]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

This thread, or any of them for that matter, shouldn't appear to be as militant as this one does; particularly when I appear to be on the losing side.

The only real point I have been trying to make is that I believe the six references to documented procedures are only references to what should be in those documented procedures were you to write them. Of course, with so much left up to interpretation it is difficult to come to a full concensus.

It's just that it doesn't seem, with the emphasis turning away from documentation, that ISO would want a documented procedure on 4.2.3 and 4.2.4 but not want one on anything in 5.0, 6.0 or 7.0. Now that is simply an interpretation but it raises questions.

 

[Paul Simpson]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

This thread, or any of them for that matter, shouldn't appear to be as militant as this one does; particularly when I appear to be on the losing side.

There is no winning or losing side - just opinion. Covers like me may seem a little vexatious only because we have been here before ... many times. So to have to post again on the same topic seems a little tiresome .... personally I only rise to the bait occasionally.

The only real point I have been trying to make is that I believe the six references to documented procedures are only references to what should be in those documented procedures were you to write them. Of course, with so much left up to interpretation it is difficult to come to a full concensus.

The idea of the standard is that it can be applied to a huge range of types and sizes of organizations. One size definitely does not fit all. The topic of levels of documentation has been covered here ad infinitum and the auditors now have to assess documentation levels rather than just blanket: "You need a procedure."

It's just that it doesn't seem, with the emphasis turning away from documentation, that ISO would want a documented procedure on 4.2.3 and 4.2.4 but not want one on anything in 5.0, 6.0 or 7.0. Now that is simply an interpretation but it raises questions.

If I had my way ISO would take out any requirement for documented procedures and leave it totally up to the organization to decide if their document control procedure (for example) was robust enough without writing it down. Still .... when they invite me on the committee!

 

[CliffK]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

If I had my way ISO would take out any requirement for documented procedures and leave it totally up to the organization to decide if their document control procedure (for example) was robust enough without writing it down.

Paul, I like it. If we petition our respective reps to TC 176 ...

 

[Gary E MacLean]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

There is no winning or losing side - just opinion. Covers like me may seem a little vexatious only because we have been here before ... many times. So to have to post again on the same topic seems a little tiresome .... personally I only rise to the bait occasionally.

I can understand and personally relate to the redundancy of repeating oneself. But, if you expected not to repeat some, wouldn't you actually be asking new covers to please not be...new? Either that or you would expect new covers to go through the effort of reading every single post that has ever been posted and remembering to "..OK, not that one again..." Or maybe you would be sending a message that you feel your cove group is just right the way it is and you do not need "new" covers.

I regret, for your sake, having stumbled upon the Cove during random surfing but I did, I can't take it back. It's a very interesting site, very challenging and it provides, well, a "forum" with which to expound upon those things I or you think we know something about. And if I were to exercise the "flexibility" all would seem to support then different opinions should be expressed and even practiced. Admittedly, mine is different at times.:mg:

The topic of levels of documentation has been covered here ad infinitum and the auditors now have to assess documentation levels rather than just blanket: "You need a procedure."

I sense that any site similar to this one on any topic will cover certain "Hot" topics ad nauseum. Its inevitable, it's the circle of forum life. Old timers move on and new ones emerge. Membership in forum sites is a very dynamic thing, changing constantly. Even the window shopper will throw something out for all to re-hash and maybe the shopper will never return.

I think it is a burden of the forum approach that subjects will arise, be beaten to smithereens, fall back then arise again with a new member only to be discussed once more and thrown back and then again and again. There will always be new Quality people looking for the fast answer rather than being told "we've discussed it - go read the post from '05". I know I have responded, in different situations in real life, to the same question dozens of times but I seldom refer the asker to my lecture of last year, or my book from '93, or the discussion we had several months ago - I just strap it on and try to answer this person's personal query once again.

If I had my way ISO would take out any requirement for documented procedures and leave it totally up to the organization to decide if their document control procedure (for example) was robust enough without writing it down.

Now that I like. No reference to procedure, documented or otherwise. Just "write it down if you need it." "Smoke 'em if you got 'em" kind of thing.

I hope, not to your chagrin, but I will probably be around, on the forum, a while simply because it is stimulating to share thoughts and ideas with other professionals; especially with those who have the experience and knowledge to share back.

I may bring up an old discussion from time to time also. I won't do this out of spite or just to frustrate you but out of ignorance because I probably will not attempt to read and study every post that has been posted on the cove thus I will not have full knowledge of the past. But, if I bring it up I am certain there will be other new covers who will be able to share their thoughts and ideas without experiencing the frustration of redundancy and repetition....and the cycle goes on.................

 

[JaneB]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

Individualism, freedom and flexibility belong in personal life not necessarily in industry.

Well, that's a whole other topic. But to shorten, I was referring to those for businesses & organisations, in this instance.

The Standard says what, not how. Each organisation has the freedom and the flexibility to determine how to apply it.

Some times total freedom really does not work to the best in all circumstances.

I did not demand total freedom in all circumstances, and don't. YOu're misinterpreting. I do demand that each organisation and business has the freedom to seek to understand and apply ISO 9001 to them. To suit them. They must of course meet all mandatory requirements. They do not and should never be required to do it only in one way.

Hmmmmm, put that way it sounds more like a communistic state.

Funny that, isn't it?

standardization in certain activities is the only way software packages for instance, could ever be developed; MiniTab for instance, calibration software, SPC software, my gosh even windows. Yes, some things need to be done the same way, every time, universally.

Well, yes. Of course!!! I already acknowledged this.

The challenge is in where you insist on standards and where you don't/aren't necessary.

Think of driving laws: they insist on speed limits, stopping at signs, how to make turns etc. All good stuff. They do NOT insist that you all go to the same destination, the same way, every time. (Yeah, I know the analogy breaks down fairly quickly, so don't pick it to pieces.) Or building standards. Floors must be capable of bearing X load, roofs ditto. They don't insist on all houses having 2.5 bedrooms, 2 bathrooms, a living area of 5 squares, etc etc.

Thank you so much for your vivid review of my postings, it reminds me of the 'flexibility' we all have in our activities.

You're welcome. My business mission fulfilled.

 

[Gary E MacLean]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

You are a funny gal JaneB

I seriously do appreciate your "in my face" approach to getting your point across

It really is all good. Many things get exposed in discussions such as this. Without opposition there is no cooperation:truce:

Thank you for the words of wisdomI will take them and use them well.

 

[Sidney Vianna]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

Would clearly imply the entire QMS is to be documented, all requirements....

That is why the TC 176 authored N525 - Guidance on the Documentation Requirements of ISO 9001:2000
One can still disagree with the TC 176 about what ISO 9001 requires. But most people would tend to abide by it's "guidance". Heck, some people still believe that there should be no taxation...

 

[Gary E MacLean]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

Sidney, Sidney, Sidney...........

Of everything I have read in this and other posts, of everything I have said in this and other posts, nothing has carried the value your simple little link did for me. Perhaps because of my line of work I should have known of its existence but I didn't. Nobody else has ever said anything about it either.

In one short post you have reversed a career of belief and direction. I have a great deal of work to do to fix the wrongs I have concocted.

It may seem like not so much but all I ever wanted was someone in authority to say what I did not want to hear - they do just that in this publication you have linked us to.

Thank you so much for clearing up something that has been a festering puzzle in my side for many long nights and days. just like that - I have been redeemed.



Clearly the singular most important and effective post I have yet read or posted on Elsmar Post!!!!!!!!!!

 

[AndyN]

Re: ISO 9002:1994 to ISO 9001:2000 conversion (transition)

Yeah I read what Gary said about elongating posts etc., but here goes......

The 6 required procedures are not 'processes':mg: There's no input to or output from them.......

They need to be documented procedures because they are not 'institutional' to most organizations - we (generally) don't know how to do a good job of controlling documents, records, how to deal with non-conforming product, or how to do internal audits, we suck at corrective actions and who the heck knows how to prevent problems..............and everyone (pretty much) has a finger in all of them. They have no 'natural' process ownership, either.

The 'processes' required by the organization are (for the most part) fairly robust, since the organization likely has someone who knows that part of the business and in some way or other has control - but it may not be documented, there may not be a defined objective or measurement associated with it, but it is implemented.

The procedures run across, through and over to support these processes (a bit like the weave and weft of cloth). If they are not well integrated into the system the others will, eventually, fall apart.

So, my assertion is; they have to be documented procedures for everyone to do the 'right thing', but the business processes can be documented in other styles, checklists, process maps, flows etc. Also, who wants to measure those 6 things? Not me! What's that important about a measurement for documents, records etc.??

SO, have the 6 as documented procedures and keep them simple for everyone, in a user friendly format so they're not frightened off.