I'm setting up a quality management system from scratch - to do this effectively will need more than the six mandatory procedures requried by ISO9001:2000. Although the new standard is promoted as being easier and less bureaucratic than the previous version, my own feeling is that lacks clarity. This means that it's interpretation and implementation can be very varied and possibly end up producing a more complicated management system than the old version.

Or am I showing a lack of understanding here?

Brian

I'm setting up a quality management system from scratch - to do this effectively will need more than the six mandatory procedures requried by ISO9001:2000. Although the new standard is promoted as being easier and less bureaucratic than the previous version, my own feeling is that lacks clarity. This means that it's interpretation and implementation can be very varied and possibly end up producing a more complicated management system than the old version.

Or am I showing a lack of understanding here?

Brian


No, Brian, you do understand.

There is a tradeoff here. In exchange for the clear cut "shalls" of the 1994 version, where you could "check off" required documents, etc., the 2000 version requires more thought be given to what makes a given system "tick"., IMO. Less user friendly? Maybe, but the 2000 version gives us the latitude ( and responsibility) to decide what works for our unique situation(s).

Possibly creating a more complicated management system? Maybe, but let's hope that the increased complication is brought upon us by increased upper management involvment and input.

You say that the QMS you are working on is "from scratch". If the QMS, and not the company itself, is "from scratch" (in other words the company has been in business for a while), then I would strongly suggest that you look at what is in place now. Chances are that you already have many of the pieces of a QMS in place, they just are not organized as such. Have you done a gap analysis?

Hope this helps.

Craig H.

Craig provides excellent advice! :applause:

Instead of creating a comprehensive system, and then paring it down to the necessary elements, describe your present system (using flowcharts, etc.) and see if it meets all of the ISO9K2K requirements (gap analysis) - adding ONLY WHAT IS NEEDED (in a value added manner if possible) to meet the requirements.

FWIW I do think that the 1994 version was easier to understand and implement. I think either version can be used as a guide to create a great QMS.

... This means that it's interpretation and implementation can be very varied and possibly end up producing a more complicated management system than the old version.

Or am I showing a lack of understanding here?
No, I think you understand it perfectly well, because I agree: I really believe the 1994 version was easier... If you happened to be the one building or auditing a QMS, that is... You could tick the clauses off one by one and get it done, without too much concern about how the different parts worked together.

Today, you have to create a system describing the interaction of your processes. A system that can be tailored to your organizations needs and therefore probably serves the users better.

/Claes

Craig's advice is excellent. I would contemplate whether "easier" means "better." I believe the 2000 version is producing "better" quality systems.

I agree as well. I am in the process of building a new system based on the requirements of the new standard and have found that the new standard forces you to think about the process you are implementing rather that just implementing them because ISO says so.

I also agree that you should document your current practice and build from there. It is much easier to get buy in/support if you start with current practice and improve upon it by making things easier/faster/better for all involved. You will probably be pleasantly surprised by how many of the requirements your organization is already meeting. After all much of the standard is just business common sense.

No, Brian, you do understand.

There is a tradeoff here. In exchange for the clear cut "shalls" of the 1994 version, where you could "check off" required documents, etc., the 2000 version requires more thought be given to what makes a given system "tick"., IMO. Less user friendly? Maybe, but the 2000 version gives us the latitude ( and responsibility) to decide what works for our unique situation(s).

Possibly creating a more complicated management system? Maybe, but let's hope that the increased complication is brought upon us by increased upper management involvment and input.

You say that the QMS you are working on is "from scratch". If the QMS, and not the company itself, is "from scratch" (in other words the company has been in business for a while), then I would strongly suggest that you look at what is in place now. Chances are that you already have many of the pieces of a QMS in place, they just are not organized as such. Have you done a gap analysis?

Hope this helps.

Craig H.


Craig - thanks for your comments

The belief I have is that the requirements (e.g. for contract review and calibration) are clearly stated in the old standard and visible to all - but not as clear in the new one. The interpretation of the new standard requires "experts" and makes the requirements less accessible to everyone else. This could result in a more complicated management system and less understanding from senior management.

The QMS I'm working on is from scratch in that the company is a small one with a number of informal, back of the envelope procedures. While they are close to the requirements of the standard as I diagram them below, I do think that the old standard was better in communicating what was needed for an effective company. The problem was in the interpretation and application of the standard.

http://www.sanguma.com/articles/iso9k_2k_1pg_small.jpg


Brian

That is an unusually clear and informative illustration... Well done Brian..:applause: Would you mind if I nick it for internal use over here?

/Claes

That is an unusually clear and informative illustration... Well done Brian..:applause: Would you mind if I nick it for internal use over here?

/Claes

Thanks Claes - you're very welcom to use it - a better quality pdf version is attached

Rgs

Brian

Thanks Claes - you're very welcom to use it - a better quality pdf version is attachedGreat. Thank's. I nick everything I can use here :D I'll have to translate it though.

/Claes

The belief I have is that the requirements (e.g. for contract review and calibration) are clearly stated in the old standard and visible to all - but not as clear in the new one. The interpretation of the new standard requires "experts" and makes the requirements less accessible to everyone else. This could result in a more complicated management system and less understanding from senior management.

The QMS I'm working on is from scratch in that the company is a small one with a number of informal, back of the envelope procedures. While they are close to the requirements of the standard as I diagram them below, I do think that the old standard was better in communicating what was needed for an effective company. The problem was in the interpretation and application of the standard.

Brian

Brian,

I have to disagree with your comment that "the new standard requires "experts" and makes the requirements less accessible to everyone else". I believe that the requirements (though re-organized) are still there. As an example, 7.5.1 requires "the availability of work instructions, as necessary" (a requirement for both manufacturing and service organizations).

The beauty of the new version of the standard is that it now allows you the freedom to "control" those areas with the use of work instructions, formal/defined training, flow charts, movies, etc. (which BTW I have seen done in order to meet the "old" version as well).

I just spent the past year coordinating the development (and certification) of a QMS from scratch for a strictly service oriented organization, and had no problems defining, and gaining support for, needed work instructions (and other controls).
:2cents:

No, I think you understand it perfectly well, because I agree: I really believe the 1994 version was easier... If you happened to be the one building or auditing a QMS, that is... You could tick the clauses off one by one and get it done, without too much concern about how the different parts worked together.

Today, you have to create a system describing the interaction of your processes. A system that can be tailored to your organizations needs and therefore probably serves the users better.

/Claes


And this is where the knowledge and business understanding of the quality manager/senior managenent and external auditors comes in - the old standard clearly defined the elements of the QMS - the clever bit was putting them all together as a working system with effective handover from different functions. The 94 standard could be easily used as a checklist - but this approach did not have to be taken. Perhaps the selling of certification influenced companies to take the checklist approach without any real intention of improving quality.

Brian

. Perhaps the selling of certification influenced companies to take the checklist approach without any real intention of improving quality.

Brian

Exactly. The new standard makes us decide where to best place our efforts, and where we can place less emphasis.

Sure, it is more difficult to reconcile a QMS with the new standard, and I expected a really good series of fights with our external auditor the first time around with ISO 9001:2000. We didn't have any. Our positions were thought out, and, guess what? The system works.

If someone wants "window dressing", a certificate for a certificate's sake, than ISO 2001/2:1994 is the standard for them. ISO 9001:2000 requires more up-front thought, IMO. That said, if the intentions are right, either standard can be used as a starting point for a good, even excellent, QMS.

Was that worth 2 centavos?

Craig

And this is where the knowledge and business understanding of the quality manager/senior managenent and external auditors comes in - the old standard clearly defined the elements of the QMS - the clever bit was putting them all together as a working system with effective handover from different functions. The 94 standard could be easily used as a checklist - but this approach did not have to be taken. Perhaps the selling of certification influenced companies to take the checklist approach without any real intention of improving quality.

Brian

Brian

Surely the real need was for "business experts" first to define a management system which was of benefit to the organisation, and then to ensure that it also met the requirements of the 94 standard? You suggest that the 94 standard defined the elements of the QMS. I disagree - it defined criteria to be met when you assessed a QMS. Unfortunately, c95% of the 94-style QMSs I have seen parrotted the sections of the standard and were of no earthly use to the average member of staff who had the misfortune to pick them up.

There was seldom any attempt to look at the business as a whole, nor to focus on how it met its objectives. That is why ISO9K got a bad name - and perhaps why the new version is less prescriptive?

ISO 9001:1994 more user friendly than ISO 9001:2000?

From an implementation standpoint, yes, the old version was much easier to follow. Why? Because life is a lot simpler when we are told what we need to do.

ISO 9001:2000, as has been discussed, allows us a bit more flexibility when it comes to documenting what we do. Does this make it harder? At first, I was tempted to say yes, but by sheer coincidence a coworker joined me who will shortly be transferring to a sister facility where she will be responsible for implementing their ISO 9001:2000 programme. As I sat with her and started giving her some thoughts on where to start, I realized that it isn't all that more cumbersome. In fact, it may almost be easier! Why?

Because (yes, I know, bad grammar) we get to document truly what we do...and the sequence in which we do. Welcome to the world of processes. What could be more simple?

The advice on doing a Gap Analysis is exactly what I recommended to my coworker...even offerred to help her out with it as her knowledge is all on the 1994 version and it will take her some time to get up to speed on the the 2K version.

She laughed and said nothing was in place there. I disagreed...after all, the company is still in business. Surely there are some processes in place...the trick is determining if the processes are consistent between crews and are they effective/efficient.

The process-approach to the new standard is, in my opinion, more user-friendly. What could be nicer to see than how my outputs can impact (i.e., be the imputs) for someone else. From an implementation standpoint, I have been thrilled to see my coworkers realize that they don't work in a static environment...when they suddenly realize that their job impacts someone else, when they see how their actions impact others...now that's user-friendly!