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  Compliance With 9K:2000

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Author Topic:   Compliance With 9K:2000
John C
Forum Contributor

Posts: 134
From:Cork City, Ireland
Registered: Nov 98

posted 29 December 2000 07:32 AM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message   Reply w/Quote

Cove Contributors,

A current client wants me to put together a plan for upgrade of his system to ISO 9000:2000. I hadnāt done any work on the new version, having waited until the final draft was out before spending effort on it and now I see it has presented me with something of a quandry;
My impression from various sources was that there would be few changes necessary - the general opinion seemed to be that if you qualified for Ī94 then you would qualify for Ī2000 without much re-documentation. Certainly, my view of Ī94 and the developerās approach to the subject led me to think that this would be the case.
Now Iāve looked in detail at some of 2000, I see a new approach. A lot of things which were assumed or implied before, are now written down as specific requirements. My conclusion is that we need a considerable documentation effort to upgrade.
My Īquandryā is that the rest of the world might not see it like that.
I think it is quite possible that these requirements, that I see as specific, will go on being seen as Īassumedā and that little will be done to come up to the new level and that registrars will accept it that way and go on as before.
Let me give an example;
In the 2000 version section 4.1 there are 9 requirements, including a) to f) plus a note. The first line and the note, indicate that procedures are required to cover requirements for section 4 and, as in any audit, the auditor is likely to ask were you doing the right thing and have you evidence of doing it. As I see it, each of these requirements is specific, individual and open to these questions from a registrar auditor; ĪHave you done this? Where is it documented? Tell me how you did it? Can you show me evidence (ie; quality records) that you have done it.ā

In the appendix showing correspondance 2000 to Ī94 it states that this 4.1 corresponds to 4.2.1 of ISO 9001:ā94. But, in fact, the old version asks for only 3 specific responses, ie; Īdocument, etc a DMS, prepare a QManual, refer to the procedures and outline the structure of the quality system.
The old version does not ask for continuous improvement. It does not ask us to Īidentify the processes needed and their applicationā, which I see as asking for a process of identifying the correct ones and a means of providing evidence. It does not ask us to determine the sequence and interaction (quite a different thing from Īstructureā. Nor does it ask for what I consider to be the best and biggest question of all; ĪDetermine criteria and methods to ensure implementation and control is effectiveā. Thatās the $64000 question (or requirement). A whole lot of thought and good work would go into that one to come up with a valid answer.
Similarly; ĪMonitor, measure and analyse these processes; Implement actions to achieve planned results, continuous improvement. The final requirement, ĪProcesses needed for QMS including management, resources, product realisation and measurementā, leaves us open to be written up on any significant process that isnāt documented.

I hoped that this new approach would only apply to section 4, but as I go on, I see the same type of specific requirement appearing where, before, the method was assumed and the end product was all that was asked for. It seems like a totally new standard to me.

Iād like to hear comment on this issue. How far do people think we have to go? Is my comment valid? practicable? likely to be the right and the effective way to deal with things?

My own view is that it is right to read into it these specific requirements. They have always been part of the response to the standard, as I saw it, but not specified. However, since I object to the restriction and the problems likely to arise from registrars, I do not approve of their appearance in the 2000 version.

What do you think?
thanks and rgds,
John C

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Posts: 24
From:La Mesa, CA, USA
Registered: May 99

posted 29 December 2000 05:52 PM     Click Here to See the Profile for stefanson   Click Here to Email stefanson     Edit/Delete Message   Reply w/Quote
In response to your questions:
1. There's an excellent article on auditing to the ISO 9001:2000 version in the May 99 issue of Quality Progress. Let me know if you need a copy.
2. Registrar [and other] auditors will have to focus on evidence of effectiveness, the evidence being key metrics showing progress towards quality goals and targets (e.g., OTD, FTY, COQ reduction, etc., whatever makes good business sense in the eyes of your customers and other stakeholders, and other evidence of compliance e.g., listening to auditees, observing people working, and quickly understand what the organization is doing, not what the 3rd party auditor thinks they should or must be doing) and evidence of action taken when trends indicate you're not making progress (showing trends over time began to show progress).
3. Auditors must stop looking for mismatches between documented procedures and practices. Your QMS needs to be able to quickly adapt to changing business conditions. Note that only 6 requirements require documented procedures.
4. I was able to audit more than 650 organizations over the past 10 years. During 2000 I saw several organizations either converting to electronic documentation, corrective action, change control, etc., or starting their systems that way from the start of the ISO/QS/AS process. What a great way to streamline and simplify a typically over-documented, detailed and tedious non-value added way of keeping a certificate on the wall! [and it gives 3rd-party auditors (many of whom have never worked in a factory) a field day for writing frivolous non-value-added CARs for mismatches between practices and documented procedures]. However, during a 4 day TL 9000 class last week I asked the consultants (Excel Partnerships) if they had also seen any recent digital approaches to Quality Management Systems. They told me Control, an Enterprise Management Process software tool, was the best they'd ever seen, and I agree 100%! I've seen it work and highly recommend considering it. I didn't have a chance to search The Elsmar Cove Forums, but if you don't already know about it you can learn about and download a free demo from this site:

Good luck!

[This message has been edited by stefanson (edited 29 December 2000).]

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA

posted 01 January 2001 07:08 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I don't know if this will help. I personally think you're reading too much into the 'new' requirements. In December the 3rd company I have done to the DIS registered without a problem. The implementation was not significantly different than to the 'old' standard. Before you say "Yeah, but you were audited to the old version..." you should know we were audited to the quality manual as well which was written to the DIS (the last one to the FDIS).

On the other hand, I offer the following:
Newsgroups: misc.industry.quality
Subject: Re: ISO 9001:2000
Date: Mon, 1 Jan 2001 21:58:51 -0000

> > Dave & Rachael wrote in message
> >
> >
> > How did the ISO9000:2000 audit differ from an ISO9000:1994 audit? My
> > assessment body is still considering [at the start of December 2000] how to
> > audit against the new standard.

> David Tan wrote in message
> news:92mcfb$hd5$
> Interestingly enough, the audit is very much different from the old ISO
> which stresses on COMPLIANCE. I always remembered "say what you do and do
> what you say". This rule of thumb seems to be lesser of importance. The
> new emphasis was very much on EFFECTIVENESS. By doing what you say is not
> good enough, the bottomline is "IS IT EFFECTIVE?" . Does it help the
> organisation to gain more customers, keep customer's happy, achieve business
> goals? Lastly, how can you tell how good or how far off ? Systems must be
> in place to monitor and assess the effectiveness of processes. The only way
> to be able to distinguish effectiveness is to be able to measure it and best
> of all matched against certain set benchmarks.
> Finally some key words that summarises the new ISO - Commitment, Customer
> focus, Continual Improvement, Effectiveness.
> In essence, the 9000:2000 makes more business sense and I believe would
> steer organisation towards a better customer focused, better managed
> organisation.

Starting to sound strange...

[This message has been edited by Marc Smith (edited 01 January 2001).]

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John C
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Posts: 134
From:Cork City, Ireland
Registered: Nov 98

posted 02 January 2001 05:32 PM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message   Reply w/Quote
I've finished my first review of '2000;
Not including the Design Section (working from 9002 basis), I've identified 45 requirements that I consider new. I admit that I always regarded virtually all of the 45 as necessary for a DMS, but they are not in 9002. How they translate in terms of what is in the a typical system compliant with 9002, I can't say. I don't have the same concerns as I had at first sight regards the new stuff in there; It drives right through from the Policy to the final review, keeping focus on the customer and on improvement and most of the differences are in these two areas - which were almost ignored in 9002 - so that's ok.
But, my 45 new requirements came in a total of only something over 150, so it's a pretty significant difference. (I'm not saying there's only 150 requirements - it's just the way I grouped them, everyone would have their own figure)
I think I'd find a good few ommissions in an average '2000 system unless people are a lot cleverer and dedicated than I give them credit for.
As regards, effectiveness; This word comes in quite a lot but I don't believe it can be very relevant in terms of measured improvement - we do have to maintain objectiveness in auditing. How can you judge the effectiveness of an improvement of 4.3%? How can you judge the validity of the percentage of effort directed into the measurement of effectiveness? (This new standard might tend to require a team of quality professionals, but I don't think we're going to get them whether we decide we need them or not) It would take either an exceptionally bad, or an exceptionally good system to turn that sort of data into objective evidence. I think it is going to be a case of addressing the issues, having a process that can be seen to be working, and leaving it at that.
Anyway, that's all very well but, what about my 45 new requirements? Has anyone else seen any? Real, spelled out ones, that is, not just opinions.
Are we going to be audited against the standard or against registrar's and auditor's ideas about what we should be audited against?
rgds, John C

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Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 10 January 2001 06:14 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Hello John

I have been drawn to this particular post several times like a moth to a flame, as i know from previous discussions that any response is likely to be completely opposite to your preferred method of work. But what the hell, it cant hurt to look at a problem from many different angles, even if they do seem obtuse.

I seriously beleive that the new ISO 9000 is an improvement over the last version, because it requests more precisely concepts that have a chance to add value to a company. ie Customer Satisfaction, Process Measurements, Company Objectives etc.

Yes it is true that if a company was committed to enthusiastically implementing the full INTENT of ISO 9000:1994 in the first place, then there shouldnt be any major differences. I just havent met many of these companies.

The new ISO simply supports better anybody who is seriously having a go at implementing Best Practise in an organisation.

Thats the background. So how have i changed my approach when implementing the new ISO 9000:2000?.
NOT AT ALL. My approach is absolutely the same as before. I work from the point of view of what does the company need. What is the Value Chain, what are the Critical Processes needed to make this company successful (and rarely are they the same as the required processes from ISO) and then define them and improve them.

After having done all this i then go to the Standard and see how far away we are. If something is missing that can add value for the company, i am angry at myself for the oversight and i include it. If something is missing that doesnt add value i gird myself for a fight with the auditor.

However i am always surprised after building a system that the company needs just how close it is to the intent of ISO.

My point is why not try to approach the company from the point of view of what do they need to be successful, not what are the ISO 9000 requirements. Dont read too much into the Standard itself. my experience is that an auditor can differentiate between a company that is systematically striving for Best Practise and a company that is trying to pull the wool over their eyes. I suppose the risk is that you could meet a pedantic auditor who simply quotes the Standard chapter and paragraph at you, but in this case i would change the auditor instead of the system.



Andy B

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Posts: 46
From:Ontario, Canada.
Registered: Nov 2000

posted 10 January 2001 07:32 AM     Click Here to See the Profile for WALLACE   Click Here to Email WALLACE     Edit/Delete Message   Reply w/Quote
I agree with Andy regarding reading too much of the requirements of the standard, the value added aproach to business practices are more important to organizational development, However,Management commitment, document control, records and training remain the backbone of any quality system.

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Posts: 13
From:Laredo, Texas
Registered: Jan 2001

posted 11 January 2001 01:15 PM     Click Here to See the Profile for gutieg   Click Here to Email gutieg     Edit/Delete Message   Reply w/Quote
A new paradigm is born so -most of us are going back to zero. Naturally, we resist the change - some people I know memorized and can recite almost all of the 1994 version. Many of us are taking steps so quickly and started working on the changes, when more time to study, understanding and reflexion is needed to assimilate the new model. The two most important features of the new model are related to the customer and continual improvement. The steps I am starting to take are:

1. Read the new standard completely once.This should include the ISO 9000 and ISO 9004 documents, and of course the ISO 9001.
2. Read it again, this time making notes as you go, on ideas. Brainstorm with people from different departments.
3. Analyze the process, as if iso 9000 version 1994 never existed. Concentrate on the value chain and the process flows and interactions.
4. Identify processes, products and documents that are providing real help, value, and support to the people; and those who don't.
5. Define new processes, with two objectives in mind, first, provide a healthy and valuable quality system and second, to comply with the new ISO 9001:2000.
6. Only after those six steps, make a plan to document the sistem, that is, what, who, when and why to do it. Some useful documentation identified in step 4 can be used, changing the identification to align it with the new clauses and making any necessary changes.
7. Implement the system. Phase out all of the now obsolte 94 based system.
8. Audit internally and then with a certified outside auditor before the certification audit with the new standard takes place.

In my opinion, this is an opportunity to review and redefine our approach to quality, it may be better to go one firm step at a time. Some people already wrote manuals and procedures based on the drafts, and the standard has important changes even from the final draft. Get your copy of the standards and dump the previous drafts - the standard eliminated a lot of jargon and confusion in the redaction.

Good luck in your efforts to make a professional and sound transition !

Gus Gutierrez

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Posts: 51
From:Vernon Hills, IL, USA
Registered: Apr 2000

posted 25 January 2001 10:11 PM     Click Here to See the Profile for isodog   Click Here to Email isodog     Edit/Delete Message   Reply w/Quote
listen to me,

Train your management in ISO 9000:2000

Train your internal auditors (thoroughly) in ISO 9000:2000

Train your employees in ISO 9000:2000

Audit your quality management system ( 2 cycles)

Tell your auditor you are compliant with ISO 9000:200 and you need to be audited to that standard.

What could be simpler?

I would be happy to help with any of these steps (

Dave Taylor

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