ISO 9001:2000 transition - Document and Process Discussion

[Jim Wynne]

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

I do like your additional discussion but rather favor my interpretation. Even if ISO is saying you must have these six plus whatever else you want would they actually leave out Management Review, Competence/Awareness & Training, Maintenance, Quality Planning, Contract Review and even the one they name a process - Purchasing, in favor of what documents you need to issue and how do you control records? Without some of those in 5, 6 & 7 you don't even have a system.

It's not "whatever else you want"; it's whatever else is necessary. On top of that, you can have whatever else you want, but if "whatever else" is a documented part of your QMS, it's auditable, notwithstanding the requirements of the standard. The whole idea behind the Big Six is to say, "Here's what's absolutely mandatory--the foundation of the QMS," and the implementation is expected to include documents and processes needed by a specific business to support the system. I reiterate--the standard doesn't say that only six documents are necessary. As you point out, records (e.g.) are a type of document, and some are mandatory, such as records of contract review and management review. Where processes have been established in support of the QMS, it's expected that they'll be documented as well. The documentation produced will expand in direct proportion to the degree of pedantry and legalism invoked in interpretation of the standard (can I call this Wynne's Law?). Less is more, so long as the requirements are met, and the resulting system is efficacious.

Then, I have produced process maps that included 4.2.3 and 4.2.4 as prcesses and got shut down big time by two individually independent registrars. Yet, they are both members of the six "Documented documents (processes) you refer to.

I can't account for the opinions of auditors, but I doubt that if I documented any process that I felt was important to the operation of the system that I would allow any auditor to shut it down.

I don't know Jim, sounds just a bit frail - don't you think?

Not "frail." Lean.

 

[Gary E MacLean]

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

Yes, lean, a much better term and a much more intense discussion. I will save my point of view for some other lazy afternoon

Not six documents but six procedures. I thought the claim was that six procedures were referenced therefore only six procedures are required. Records of course are documents and must be available for many things but a record is generally not thought of as a procedure.

This is great fun but exhausting Jim, let's just say I'm right and fold it upjust kidding.

Like I said; ten interpreters, ten interpretations. The interpretation area seems to be one area we, as a group of quality professionals, will always have a tough time getting past. Wouldn't it be grand if we could just all come together on something and be able to issue pads of say, a problem response document that is universal and everyone can and does use the same one?

Nirvana, paradise, fantasy? Yeah, I think so.

Thanks to you and all for a very invigorating exercise

 

[Britman - 2012]

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

I am starting this process and I am semi unfamiliar with both standards. I am learning as I go, but I thought I would toss this out here and get everyones feedback about their experiences with the conversion.

If there are any pointers you may have to help me along the way I would greatly appreciate it.

Thanks,
Zach

Zach, have attached an approach I have taken, company consists of 30 people, therefore its based on "size, activities and competence of personnel".

It highlights the mandatory "documented procedures", however we have 7, documenting additional processes as "work instructions" - Corrective & Prevention combined

The 6th & 7th is "People, Competence, Awareness, Skills" - covers "Resource Planning" & Management Responsibility.

The methods and number of procedures is up to your company, however in all that you do - "keep it simple" - hope it helps

 

[jzh797s]

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

This will help immensely!

Thank You Britman!

 

[JaneB]

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

The documentation produced will expand in direct proportion to the degree of pedantry and legalism invoked in interpretation of the standard (can I call this Wynne's Law?).

If you wish, though clearly there's a cultural divide, as down here I call it the Law of Proliferating B*S*

 

[JaneB]

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

Yes, lean, a much better term

Much.

Not six documents but six procedures. I thought the claim was that six procedures were referenced therefore only six procedures are required.

Fine point, & not to be pedantic, but it isn't true that you 'have to have' six procedures for the mandatory areas.

Yes, the Standard says a 'documented procedure shall be' in 6 specific areas. It does not say thou shalt have 6 procedures. For example, in some organisations - where it was appropriate - we had a single procedure to cover nonconformity, corrective and preventive action. In some we had a single procedure covering both document and records management. Some manufacturing facilities would turn purple at those ideas. But many of the service organisations I work with turn equally pale with horror at some things that make sense in manufacturing, but not for them & their context.

The interpretation area seems to be one area we, as a group of quality professionals, will always have a tough time getting past.

Hmm. Tough? Interesting, say I. Challenging, yes. Lawyers argue about the interpretation of points of law, accountants debate the 'right' way to do other things, etc. Try getting a bunch of doctors (or nurses) to agree on a single way to do certain things!

It's part of a profession! Why this desire to have The One Single Right Approach for Everything? To me, that's a horrible idea. And antithetical to values I hold dear, like individualism, freedom, and flexiblity.

I say: it's a 'generic' Standard for a reason. It says what, not how. And applying it & fitting the 'how' sympathically and intelligently to individual organisations is where the skill & joy & pleasure & challenge is.

Wouldn't it be grand if we could just all come together on something and be able to issue pads of say, a problem response document that is universal and everyone can and does use the same one?

Gee yeah... and wouldn't it be nice if we all drove the same car? Ate the same meal? Read the same book? Wore exactly the same clothes? Built houses to the same pattern? Sounds like a nightmare to me.

I like standards & standardisation. But only to a point.

 

[Gary E MacLean]

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

Much.

Fine point, & not to be pedantic, but it isn't true that you 'have to have' six procedures for the mandatory areas.

Thank you JaneB for supporting my contention. It's the 'have to have' that has always stuck in my craw.

Hmm. Tough? Interesting, say I. Challenging, yes. Lawyers argue about the interpretation of points of law, accountants debate the 'right' way to do other things, etc. Try getting a bunch of doctors (or nurses) to agree on a single way to do certain things!

Interesting that tough and challenging are both synonyms for one another. Perhaps they may mean somewhat the same thing. Whatever, I agree with your use of challenging as well.

It's part of a profession! Why this desire to have The One Single Right Approach for Everything? To me, that's a horrible idea. And antithetical to values I hold dear, like individualism, freedom, and flexiblity.

Individualism, freedom and flexibility belong in personal life not necessarily in industry. Yes, I know that is an entirely unacceptable point of view. However, my having that view fits within your boundarys of "freedom." A consultant once told me that the simple definition of housekeeping is putting something back where you got it, not putting it back where you would like to put it. Some times total freedom really does not work to the best in all circumstances.

Gee yeah... and wouldn't it be nice if we all drove the same car? Ate the same meal? Read the same book? Wore exactly the same clothes? Built houses to the same pattern? Sounds like a nightmare to me.

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

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

 

[CliffK]

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

Sorry for jumping in so late. This discussion has been boiling along and I've missed a lot of interesting stuff. Let me present a contrarian view.

I do like your additional discussion but rather favor my interpretation. Even if ISO is saying you must have these six plus whatever else you want would they actually leave out Management Review, Competence/Awareness & Training, Maintenance, Quality Planning, Contract Review and even the one they name a process - Purchasing, in favor of what documents you need to issue and how do you control records?

The quality system must fit the task at hand. The cited processes (management review, contract review, etc.) can usually be accomplished with a minimum of documentation. An effective system will contain this minimum, and nothing more. The effective system will present the necessary information in a usable and accessible way.

The formalism, formality and general bureaucracy that usually accompanies a set of documented procedures is a huge time waster.

 

[Gary E MacLean]

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.

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.

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.

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."

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.

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 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.

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.

 

[Jim Wynne]

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

If you wish, though clearly there's a cultural divide, as down here I call it the Law of Proliferating B*S*

Because yours is much more descriptive, I humbly defer.