ISO 9001:2000 transition - Document and Process Discussion

[Gary E MacLean]

Re: ISO 9002:1994 to ISO 9001:2000 conversion

Hello all,

I am amazed at the response so quick. Thank you all for that!

I have purchased the $1000 development packet from "The 9000 Store". I believe this has it all, but as I have said I am JUST stepping into this and starting a Gap analysis. It is a bit overwhelming for someone with no experience in this field. Is there somthing else I need to purchase?

To address Stijloor, our current status is dorment.

Thank you,
Zach Hardt

Zach...step back slowly --- OK? Carefully now, look at what you have and what you are facing. Slow down and think this through.

I would be the last one to say please don't spend money with an ISO professional, I consider myself one. I know there are many other consultants, trainers and professionals on this very site who feel the same way, but you gotta take it easy.

Your first seemingly well spent $1000 dollars could probably have gotten you so much further with one of the experts on this site than it will with a set of cookie cutter documents. Your best bet, though maybe most work, is to develop the processes and documents yourself. There has to be at least one person in your company who knows every process and document, fortunately or unfortunately that one person will be you. If you are integral to the development of every one of them you will know them - believe me.

You have already purchased the packet so work with it as best as you can but take advantage of the Cove here and just ask. When someone thinks they know something they are just so eager to share it - go ahead ask me

Also, take note of the increasing agreement on your gap analysis activity - if you ask you will get the answer but if you don't use the answer how far did you come?

You have an ominous task ahead of you but one that will both benefit and edify at the same time. Both you and your company stand to gain so much more from this process if you just get in there and do it.

Good luck - keep asking - all the way - OK?

GMAC49

 

[CliffK]

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

What is the purpose for doing ISO 9000? What is the desired outcome?

Why did the last effort go dormant, and how long ago?

How much ISO awareness is left over from the prior effort? Who is still around from that time?

How big is your organization, what resources do you have available, who is driving ISO 9000, how much support do you have?

How well do you know the organization? You will know it very well before you are done.

I agree with Gary MacLean about the generic documents. You have some organizational work to do before you start cranking out manuals. If you don't do the organizational work, the system will end up being yours alone, not something that belongs to the company. Believe me, you do not want this outcome.

Don't spend any money on software, either. Introducing it at this point will create tons of extra work.

I agree with the suggestions that you start with training (I, too can help with this.) You need to know the requirements of the standard and others need to know what to expect as the project progresses.

I don't necessarily agree with the "throw everything out" approach, though. You may be able to salvage many work instructions. You may also find usable procedures among the artifacts from the previous effort. Examples included document control, control of records, calibration, internal audit, nonconforming product and a few others. But learn the requirements before you begin to evaluate any such documents.

Learn the attitudes of those around you. If they are supportive, you have a simpler task ahead of you. If negative or cynical, it is not a cause for discouragement but it does indicate that you will have to do some work to turn those attitudes around.

Be wary of cookie-cutter approaches. Be wary of promises of quick results.

Keep it simple. Make sure it addresses real problems.

Feel free to contact me off line if you want to discuss further.

Cliff

 

[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

Good advise as always from the Cove, take it steady, base your approach on clause 4.2.1 - note 2

The extent of the quality management system documentation can differ from one organization to another due to
a) The size of the organization and their of activities
b) The complexity of processes and their interactions, and
c) The competence of personnel

This section has enabled myself to maintain a lean, slim and user friendly system.

What size and business are you operating in?

 

[Coury Ferguson]

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

You may also want to review this current discussion:

Overhaul QMS or start over? How do you decide?

This might give you a little more information that might help.

Everyone has provided good direction regarding the Gap Analysis. It would almost be a waste of time, valuable time.

You have your work cut out for you. There are some/major differences between the 1994 and 2000 version. The major one is the ISO9002:1994 version didn't encompass design requirements, and the ISO9001:2000 has incorporated it, however it can be excluded.

The best recommendation that has been given is to start new from the ground up, however, if Top Management prefers the current system (apparently since it is dormant, they don't) stick with. There is nothing that I recall in ISO9001:2000 that doesn't allow the intense paperwork that ISO9002:1994 required.

The easiest, not necessarily the right/correct choice (not the way I would do it), to change would to take the existing procedures and reduce them to the minimum of 6, exclude the Design aspect and tailor it specifically to the Company's business.

It really is the Company's choice. I reiterate the fact that everyone needs to be involved in this task. Don't take it upon yourself, in my opinion.

 

[Gary E MacLean]

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

Oh Coury

Everything was going so good. Your explanation was on the money, good sound advice then you slipped into the old "Only need six" trap. We should all know what that refers to; the six mentions of documented procedure throughout the standard; 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.1, 8.5.2. Poof we have our entire QMS Quality maagemet System if we issue those six magical procedures.

Somehow, those who of that understanding missed the whole of clause #4

4.1 "...shall establish, DOCUMENT, implement and maintain a QMS ... in accord with this International Standard."

NOTE: Processes needed for the QMS should include processes for management (5.0), provision of resources (6.0), Product realization (7.0) and measurement (8.0)

If we just do the six we are saying this is our QMS, nothing on management, resources or product realization is in our QMS.

No, please don't reduce any system to the meager six referenced procedures - you will regret it.

GMAC49

 

[Coury Ferguson]

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

Oh Coury

Everything was going so good. Your explanation was on the money, good sound advice then you slipped into the old "Only need six" trap. We should all know what that refers to; the six mentions of documented procedure throughout the standard; 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.1, 8.5.2. Poof we have our entire QMS Quality maagemet System if we issue those six magical procedures.

Somehow, those who of that understanding missed the whole of clause #4

4.1 "...shall establish, DOCUMENT, implement and maintain a QMS ... in accord with this International Standard."

NOTE: Processes needed for the QMS should include processes for management (5.0), provision of resources (6.0), Product realization (7.0) and measurement (8.0)

If we just do the six we are saying this is our QMS, nothing on management, resources or product realization is in our QMS.

No, please don't reduce any system to the meager six referenced procedures - you will regret it.

GMAC49

Gary,

I really don't think I fell into the trap of 6 required. Here was my statement (emphasis added):

The easiest, not necessarily the right/correct choice (not the way I would do it), to change would to take the existing procedures and reduce them to the minimum of 6, exclude the Design aspect and tailor it specifically to the Company's business.

I was just providing a simple way, to make the transition. If you read in the majority of my posts regarding the 6 minimum procedures, you will find that I have not said to stay with the 6. They are only the minimum requirements of the standard.

Any critical process should be documented.

 

[Gary E MacLean]

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

Of course if there are ten interpretors there are ten interpretations. But the one interpretation about the minimum of six procedures has always puzzled me. Perhaps you could help clear my confusion up.

I read in 4.1 where it says to document my QMS not just six procedures, but my QMS. If I use ISO 9000 to find out what QMS is I find out it is that collection of documents that defines the way I address and satisfy the International Standard. Can I really do that with just the six referenced procedures? In addition the six procedures that the standard happens to reference do not address clause 5, 6, or 7 at all. Do those three clauses not belong in my QMS?

Were we to accept that the intent of ISO was to identify a minimum QMS consisting of only six procedures fwe would be saying our QMS consists of only documents and records (4.2.3 & 4.2.4) directions on how to audit the nonexistent QMS (8.2.2), how to take care of bad stuff (8.3) but wait we haven't made anything yet, and how to apply corrective and preventive action (8.5.1 & 8.5.2) to that bad stuff that really was never made in the first place.

My confusion comes from how does the reference to six procedures become the minimum requirements when throughout the standard there are numerous words that would imply something must be documented. In fact this interpretation would suggest that our quality manual does not have to be documented (the word document is not used in clause 4.2.2: Quality Manual.)

I prefer to confront the "Minimum 6" by saying this is where ISO saw an important opportunity for all organizations. So important was that opportunity and so problematic had systems of the past been that they felt they just had to identify things that must be included in the documented procedure being issued for those specific areas. Not necessarily that a documented procedure had to be issued but "when you do issue your procedure for this clause, because we know you are going to document your entire QMS, remember to include....."

I am sure I am way off track as regards the orign of this thread and I really didn't mean to upset things, but that one assumption on the part of so many people that there is a minimum six procedures out there, has always jerked me the wrong way.

Anything you could offer to support those six references having exclusive priority over all the other references in the standard and that a QMS really can be defined with those six, would be greatly appreciated. If it is true, then I would certainly want to be convinced it is.

Thanks for your patience

GMAC49

 

[Jim Wynne]

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

I read in 4.1 where it says to document my QMS not just six procedures, but my QMS. If I use ISO 9000 to find out what QMS is I find out it is that collection of documents that defines the way I address and satisfy the International Standard. Can I really do that with just the six referenced procedures? In addition the six procedures that the standard happens to reference do not address clause 5, 6, or 7 at all. Do those three clauses not belong in my QMS?

We've talked about this before; the confusion stems from use of the word "procedure" which, depending on context, can refer to either a document or a process. Because the Big Six are referred to in the standard as "documented procedures," the word "procedures" in this context is synonymous with "processes." "Documented documents" would make no sense. So what the standard calls for is six documented processes, plus whatever other documentation (including records) and processes are necessary to support the functioning of the system. Nowhere does the standard say that only six documents are required; there are six mandatory processes that must be supported by documentation.

 

[Gary E MacLean]

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

We've talked about this before; the confusion stems from use of the word "procedure" which, depending on context, can refer to either a document or a process. Because the Big Six are referred to in the standard as "documented procedures," the word "procedures" in this context is synonymous with "processes." "Documented documents" would make no sense. So what the standard calls for is six documented processes, plus whatever other documentation (including records) and processes are necessary to support the functioning of the system. Nowhere does the standard say that only six documents are required; there are six mandatory processes that must be supported by documentation.

That is a new take on an old debate - for me anyway. I like it - it does help further define this situation. I've only recently joined the cove and have not taken the liberty of reviewing old threads as yet so I would have missed any earlier discussions on this topic.

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.

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

 

[Coury Ferguson]

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

Of course if there are ten interpretors there are ten interpretations. But the one interpretation about the minimum of six procedures has always puzzled me. Perhaps you could help clear my confusion up.

See ISO9001:2000 maybe this might clear the air.

NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is
established, documented, implemented and maintained.
NOTE 3 The documentation can be in any form or type of medium.

We've talked about this before; the confusion stems from use of the word "procedure" which, depending on context, can refer to either a document or a process. Because the Big Six are referred to in the standard as "documented procedures," the word "procedures" in this context is synonymous with "processes." "Documented documents" would make no sense. So what the standard calls for is six documented processes, plus whatever other documentation (including records) and processes are necessary to support the functioning of the system. Nowhere does the standard say that only six documents are required; there are six mandatory processes that must be supported by documentation.

I agree with you here Jim.