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  ISO 9001/4:2000
  4.1e Monitor, Measure... Processes

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Author Topic:   4.1e Monitor, Measure... Processes
Marc Smith
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From:West Chester, OH, USA
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posted 13 January 2001 08:33 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Comments anyone?
**************************
"Leon Poels" leonpoels@lol.nietspammen.nl wrote in message
news:93f7dm$uol$1@buty.wanadoo.nl...
> Hi,
>
> I'm updating our quality system to the new standard now.
>
> In chapter 4.1e of ISO 9001-2000 it is stated that we have to "monitor,
> measure and analyse" "the processes needed for the quality management
> system and their application throughout the organization".
>
> My question now is: which processes are meant here? I can hardly imagine any
> processes needed for the QM *system* in our company; I can imagine, though,
> our production processes, but that's not what is stated here.
>
> Does anybody know for quite sure?
>
> Thanks,
>
> Leon

From: "Brian O"
Newsgroups: misc.industry.quality
Subject: Re: ISO 9001-2000 Which processes are these?
Lines: 44
Date: Sat, 13 Jan 2001 21:39:24 GMT

Leon,

I'm glad I'm not the only one who thinks that line is little vague. When I first skimmed through the standard, I thought it was odd.

After looking at 4.1 for a while, I finally saw the Note at the bottom which says that it does include "processes for management activities", which presumably includes internal audits and management reviews, and implies that they were mainly talking about production processes. This raises the question of how one "measures" an internal audit or management review.

But it seems really strange to call a production process a process "needed for the quality management system".

Brian O

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David Mullins
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posted 14 January 2001 05:53 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
My advice would be to not get hung up on anything the standard contains in clauses 4.1 or 4.2.1 as these are all encompassing statements which have detailed requirements spread throughout the standard.

In the case of monitoring, measuring, etc, a good place to start is 8.2, which is curiously titled 'monitoring and measurement'!!!!

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gutieg
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posted 15 January 2001 12:24 PM     Click Here to See the Profile for gutieg   Click Here to Email gutieg     Edit/Delete Message   Reply w/Quote
See the introduction of ISO 9004: 2000, point 0.2 Process approach. This paragraph defines and explains the concept and provide a graphical description of the model of a process-based quality management system.
What are those processes ? The sequence of inter-related tasks, responsibilities and actions needed for the organization to run with compliance to the requirements of the customers. The standard provide guidelines and "shalls" that need to be addressed.

G.G.

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Oscar
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posted 15 January 2001 04:22 PM     Click Here to See the Profile for Oscar   Click Here to Email Oscar     Edit/Delete Message   Reply w/Quote
I took an ISO 9001 transition course in August from a gentleman that sat on the commitee that rewrote the standard (TAG-76 or whatever). He explained that the processes referred to are QMS processes and not production processes. His suggestion was to prepare a flow chart of all processes in your unique QMS and then define criteria, methods, how you will measure and monitor each of the identified processes.

I don't know if this helps but I am interested in what others have to say on this subject.

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David Mullins
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posted 15 January 2001 06:08 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
A former employer had a massive amalgamation of businesses after I left, with each former company being certified/registered. Certification to 9002 was then also amalgamated by the thrid party auditor. Consequently the system/s were left to decay, with the former employers staff still using the documents written several years ago.

This would appear to be just fine under 9001:2000!

An auditor asks three questions (let's pretend):
1. What do you do?
2. where does it tell you to do it like that?
3. Show me the proof/evidence/records.

An auditee can now respond (provided we are talking about following the "SIX" procedures rule):
1. None of your business.
2. Nowhere.
3. Don't require any.

QUESTION:

So what will you include in 5.6.2 where it requires management review to include process performance and product conformity?

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[This message has been edited by David Mullins (edited 15 January 2001).]

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David Mullins
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posted 15 January 2001 08:00 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Let me take the subject of records one step further. We need to have a procedure for doc control, right? (ISO SIMON SAYS)

BUT, 9001:2000 doesn't require us to keep records of document control.

The only records required, and I've verified these against the final standard, are detailed at http://www.iso.ch/9000e/2000rev_7e.htm

Implications - a simple example:
5.3 requires that the quality policy is reviewed, but it doesn't require us to keep any records of these reviews. Hmmm.

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Alf Gulford
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posted 16 January 2001 12:13 PM     Click Here to See the Profile for Alf Gulford   Click Here to Email Alf Gulford     Edit/Delete Message   Reply w/Quote
I'm still pretty vague on the finer points of 9000:2000, particularly in the area of what documentation is required, but I always go back to the FDA philosophy: "If it isn't documented, it wasn't done." I have to believe that any ISO registrar will adopt the same viewpoint when looking for evidence of document control, management reviews or anything else.

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Ron Byrge
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posted 17 January 2001 03:28 PM     Click Here to See the Profile for Ron Byrge   Click Here to Email Ron Byrge     Edit/Delete Message   Reply w/Quote
If you do anything related to the QMS, from a Registrar's point of view, it'll need to be documented. If it isn't recorded, dated and approved...it didn't happen, and you aren't complying with 4.2.3, a thru g. If you think you are complying, then prove it to me by showing me records. *smile*

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Ron Byrge
Operations Manager
CwC Registrar, Inc.
http://cwcregistrar.com

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David Mullins
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posted 17 January 2001 05:57 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Yes - QMS - Records - Yes.

Ron, people may translate your post to mean you are advocating the hard line on documenting everything about everything.

The reality of your post is an endorsement of the 6 procedures approach, is it not?

"If you do anything related to the QMS"

Ah, but what is in the 2000 concept of a QMS? Easy:
Write two procedure, one for auditing and one for corrective action (Control of nonconformity and preventive action are generally covered in this procedure anyway).
Now write a third procedure about how you will control the first two procedures. Now put the 3 procedures in a pot with a policy and some objectives. Stir, simmer for 1 month, then serve to the nearest auditor. Now put it all on the shelf, until you need it next time, and get back to business.

2 minute QMS c/- ISO Simon Says!

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Ron Byrge
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posted 22 January 2001 02:08 PM     Click Here to See the Profile for Ron Byrge   Click Here to Email Ron Byrge     Edit/Delete Message   Reply w/Quote
What I mean is that if you change anything in the system, or the documentation that describes the system (procedures, work instructions, flow diagrams...whatever), you need to review and approve the changes, and retain records of those changes. You need to ensure the changes don't compromise the integrity of the system, and the only way to do this is to review the records you've made of the changes.
As for documenting everything about everything, that's not necessarily needed. But, if you discover a problem in a process that has historically been stable, then the records you've made will be indispensible in troubleshooting the process, hence, those records are required by inference in the new revision of the standard.
Does it spell out for you exactly what records are needed? Yes and no...you need to use your head when determining what is and isn't needed, and not try to cut corners just because the standard doesn't specifically tell you what records are needed...make the system work FOR you and not against you.

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David Mullins
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posted 22 January 2001 06:36 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Ron, you said:
"What I mean is that if you change anything in the system, or the documentation that describes the system (procedures, work instructions, flow diagrams...whatever), you need to review and approve the changes, and retain records of those changes."

Could you please direct me to the clause in the standard that requires:
1. review and approval of "anything in the system".
2. retaining records of changes.

Ron, you said:
"hence, those records are required by inference in the new revision of the standard."


Please advise if you audit based on inference. I believe you have to say it in the QMS for it to be auditable. Multiple records of a stable process are next to useless.

I prefer to take the wholistic approach with a QMS, but different organisations have different needs, so you have to be able to comprehend the most minimal approach to implementing ISO9001 before you can understand and reason why you should go any further.


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Greg Mack
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posted 08 February 2001 08:00 PM     Click Here to See the Profile for Greg Mack   Click Here to Email Greg Mack     Edit/Delete Message   Reply w/Quote
David, as far as pointing you in the direction of "review and approval" in the Standard, for a start you could look at the following clauses:

4.2.3
7.2.2
7.3.1
7.3.4
7.3.5
7.3.6
7.3.7
7.4.1
7.5.2

I consider the "verification and validation" as a "review" and "approval" activity also.

As for records, clause 4.2.4 states that you need to show "effective operation of the qms". Common sense will surely prevail here as to what a company retains and maintains as a record. The Standard cannot be expected to cover every aspect of a system and I sense you are not at all comfortable with the new approach. (The sarcasm gave it away!)
I for one applaud the new Standard as it goes a long way to helping companies shift from a "QA" perspective to a whole business management approach, which is the way it should be.
I have gladly destroyed the 1994 version!!!!

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David Mullins
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posted 12 February 2001 07:09 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
I'm sending a fax to a customer. Do I need to get it reviewed and approved?

The CEO sends a memo to the marketing department, does s/he need to have it reviewed and approved?

A project manger updates a project plan on numerous occasions in between formal project reviews, does every update need to be reviewed and approved?

The purchasing dept sends an email to a supplier requesting dates for back order items, do they need it reviewed and approved?

Do they have to keep a record of the e-mail to comply with ISO 9001:2000?

The company newsletter which provides such a powerful communication, information and reporting medium to/for staff - reviewed and approved?

Each of these things may be required to effectively run the business, but is it appropriate (indeed ethical) to apply the full letter of the standard to ever document generated to run the business?

Frank, the new employee in production, identifies an outstanding opportunity for improvement. He talks to his supervisor about it. Should the supervisor:

A. Advise Frank that he was told during his induction that he needs to raise an improvement request for that sort of thing, so he'd better do that before anyone will look at his suggestion;
B. Tell Frank that they all know about it, they've taken it to management before;
C. Write out the suggestion on the appropriate form, check it with Frank to make sure the intention is correct, and send it to the appropriate person / take action, forward a copy of the form to Frank;
D. Tell Frank to go direct to the management representative with the suggestion, otherwise he's going to have to generate a record of the conversation and get it reviewed and approved before it enters the black hole; or
E. None of the above?

Sometimes I use sarcasm, sometimes rhetoric, but mostly I try to help, even if the medium is to make people think about how they interpret requirements and the implications on the business of those interpretations.

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[This message has been edited by David Mullins (edited 12 February 2001).]

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Greg Mack
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posted 13 February 2001 04:02 AM     Click Here to See the Profile for Greg Mack   Click Here to Email Greg Mack     Edit/Delete Message   Reply w/Quote
David,

In answer to your questions above I hope these help you and everyone else in the interpretation of the Standard.

1. "I'm sending a fax to a customer. Do I need to get it reviewed and approved"?

Answer: Most likely the fax will be signed by yourself before being forwarded to the customer. I would say that your signature signifies that you have "reviewed" and "approved" the fax as to the content of the document.

2. "The CEO sends a memo to the marketing department, does s/he need to have it reviewed and approved"?

Answer: See above answer for "1." and replace "fax" with "memo".

3. "A project manger updates a project plan on numerous occasions in between formal project reviews, does every update need to be reviewed and approved"?

Answer: Your Document Control procedures should adequately cover this aspect of handling system changes. Ultimately these document changes are "reviewed and approved".

4a. "The purchasing dept sends an email to a supplier requesting dates for back order items, do they need it reviewed and approved"?

Answer: Standard requires Purchasing data to be approved and "reviewed" for adequacy.

4b. "Do they have to keep a record of the e-mail to comply with ISO 9001:2000"

Answer: If that forms a part of the way purchasing is handled and is a record of the process then "yes".

5. "The company newsletter which provides such a powerful communication, information and reporting medium to/for staff - reviewed and approved"?

Answer: I would say that the author would have reviewed this document for not only typo's but also to ensure technical content is correct. Possibly some important areas of the business and the details surrounding them may have to have an "approval" prior to release to the "general public". It is "Top Management's" responsibility to ensure appropriate communication processes are established. I would imagine that the author's Job Description, would have this "authority" documented within which would be signed by the incumbents Senior Manager - hence "approval".

I think that you have possibly overlooked some of the "reviews" and "approvals" that are within the system yet not 'formally' documented as strictly a "review and approval" process.

If Frank's business cannot process a simple suggestion for improvement effectively, I would suggest a review of their current methods to increase effectiveness.

I also like sarcasm but I would also like to help people out. So take these comments as another way of looking at what you have suggested, and mainly to help other people think from another view point.

I will look forward to future "debates" and interpretations of the standard with all.

Thanks for reading.

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David Mullins
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posted 13 February 2001 06:40 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Yes, it certainly depends which end of the spectrum of organisational maturity your company fits in to, although I would question the same person reviewing and approving documents - which is not in keeping with the interpretations provided by Standards Australia.

I'm essentially warning quality folk not to set the hurdles too high when establishing a QMS or upgrading their existing QMS, thus creating an environment for noncompliance, failure, loss of confidence and low morale.

As the company/system matures, improvements can be incorporated and control expanded (and the hurdles edged upwards). Don't raise the hurdles and just expect everyone to jump over them.

Also remember the lessons of companies like Honeywell, who considered that their normal business systems were superior to ISO 9001 anyway, but they had to have the market credibility of ISO 9001. Thus they re-structured their ISO 9001 approach to a minimal level, whilst continuing to focus on business improvement, the customer and their own vision and objectives.

Bottom line - don't hurt your company financially because of YOUR interpretation of the requirements of the new standard, and don't just accept the interpretation of your external auditor if you believe differently.

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Greg Mack
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posted 14 February 2001 05:32 AM     Click Here to See the Profile for Greg Mack   Click Here to Email Greg Mack     Edit/Delete Message   Reply w/Quote
David,

I refer back to a friend of mine who manages his own business of one employee. Currently certified to ISO 9002:1994, how do you suppose he reviews and approves his documentation?

Getting back to your quote of "although I would question the same person reviewing and approving documents - which is not in keeping with the interpretations provided by Standards Australia".

I would say that given Standards Australia's interpretation (and yours?) in relation to my friend's business it is not accurate in the slightest!

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wajnberg
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posted 10 March 2001 06:06 PM     Click Here to See the Profile for wajnberg   Click Here to Email wajnberg     Edit/Delete Message   Reply w/Quote
Ięd like to know if anyone has some clear thoughts on Marcęs initial question,( the one that originated the topic, on item 4.1).
The Guidance issued by TC 176 on Process Approach didnęt bring too much light, and this weekęs edition of Quality Digest has an article on Transition Planning that mentions a third party audit to ISO 9000:2000 on a company called MTS (I think..) where the registraręs auditor placed two non conformances on item 4.1
This goes against Davidęs reply (14 january).
Ięd really like to hear more on this topic, from registrar auditors who read this forum, if possible, giving down to earth examples)
What is really required on 4.1?

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Marc Smith
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posted 10 March 2001 06:25 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
What were the nonconformances (how were they written up - what was the 'evidence')?

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David Mullins
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posted 11 March 2001 06:47 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Hey,
I'd say the auditor has taken the easy way out. They could have been more helpful by assigning NCRs against the specific requirements.

Processes needed for the quality management system and their application throughout the organisation have been determined. NUMEROUS AREAS UNDER PRODUCT REALIZATION.

The sequence and interaction of these processes have been determined. THIS IS REQUIRED IN THE QUALITY MANUAL.

Criteria and methods needed to ensure that both the operation and control of these processes are effective have been determined. ONE EXAMPLE IS - 8.2.3 Monitoring And Measurement Of Processes.

The availability of resources and information necessary to support the operation and monitoring of these processes are ensured. RESOURCE MANAGEMENT

These processes are monitored, measured and analysed. MEASUREMENT, ANALYSIS AND IMPROVEMENT.

Actions necessary to achieve planned results and continual improvement of these processes are implemented. LOTS OF REQUIREMENTS, BUT ULTIMATELY AUDITING SHOULD TELL YOU IF THEY ARE IMPLEMENTED.

My answers are still general, (you'd have to look at the specifics of the NCR to nail done which requirement) but start pointing you towards the actual (and numerous) requirements that are contained within the standard, and are summarized in 4.1

Over to the experts....

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wajnberg
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posted 12 March 2001 03:57 PM     Click Here to See the Profile for wajnberg   Click Here to Email wajnberg     Edit/Delete Message   Reply w/Quote
Ięm sorry for the inconvenience, guys.
Marc, can you delete the two last test posts?
Letęs get back to the discussion.
Marc,
Would you please check out the article at: http://www.qualitydigest.com/currentmag/html/iso9000-2000.html
David,
In my view, the requirements of item 4.1 still need better explanation as to:
1. What is meant by "Identifying Quality Systems Processes"? Are Operational Processes needed for Product Realisation to be included or not?
2. How are you supposed to describe the "Interaction of Quality Systems Processes"?
3. What type of documentation is actually to be required?
I donęt have the replies and therefore,Ięd really appreciate to receive down to earth examples from somebody involved with tc176 or from some registrar.
After all, I just want to do things right the first time.

[This message has been edited by wajnberg (edited 12 March 2001).]

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David Mullins
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posted 12 March 2001 06:32 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
I suggest you contact your ISO member in Brazil and ascertain who the TC176 rep was. Then ask them about the meanings of 4.1

For my money the requirements of the standard start at 4.2.2. Comply with 4.2.2 to 8.5.3, and, 4.1 and 4.2.1 take care of themselves.

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juliedrys
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posted 13 March 2001 11:02 AM     Click Here to See the Profile for juliedrys   Click Here to Email juliedrys     Edit/Delete Message   Reply w/Quote
The requirements of 4.1 are general; specific requirements for these areas are all addressed in other areas of the standard (even the bit about outsourced processes, which should be addressed if you do 7.1 correctly).

As for what's meant by "the processes needed for the quality management system," it's right there in a note: "Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement." So, just about everything in your system.

As for showing the interaction of these processes, I think just about anything (a table, a flowchart, a graphical representation) would be appropriate here.

Documentation required is clearly specified in 4.2.1d which states that documentation must include "documents needed by the organization to ensure the effective planning, operation and control of its processes." This would be whatever you deem appropriate to ensure control of the processes identified in 4.1a. More for some companies, less for others.

Julie

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wajnberg
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From:Rio de Janeiro, Brasil
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posted 13 March 2001 02:06 PM     Click Here to See the Profile for wajnberg   Click Here to Email wajnberg     Edit/Delete Message   Reply w/Quote
David,
I appreciate your suggestion to contact tc176 rep in Brazil.I would have already done that if I thought that was the best way, but I thought best would be first to address to this INTERNATIONAL FORUM, to hear people from other countries, and have their interpretations. I donęt know how it was in your Australia, but here, when the 1994 revision was issued, there were many misinterpretations and it took some time to have a common sense established on the various requirements of the revised standard. This will certainly happen again with the 2000 revision.
I had read and agreed with your point of view as expressed in your post of 14 january but then, when I read the Quality Digest article, I went puzzled again, and decided to place my post.
And please, keep in mind that English is not my mother language, (somebody else has already said it in another thread). Unless you want only English speaking people participating in the forum, which Ięm sure is not the case.
Julie,
Thanks for your post.

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David Mullins
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From:Adelaide, South Australia, Australia
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posted 13 March 2001 08:02 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Dear wajnberg,
The following nonconformities were identified in the article linked in your 15 March post:

A. 4.1 General requirements: Processes needed for the quality management system and their application throughout the organization were not identified.

B. 4.2.2 Quality manual: No description existed of the interaction between the processes of the quality management system.

C. 8.2.2 Internal audits: No evidence existed that previous audit results are considered during audit planning; reporting on verification results was not included in follow-up activities.

D. 8.2.3 Monitoring and measurement of processes: Methods were not applied for monitoring processes within the quality management system.

E. 8.5.3 Preventive action: There was no documented procedure for preventive action requirements.

MY COMMENTS:
If B was corrected, A would basically be covered. A could be augmented by job description and/or a procedure (or section in the quality manual) defining responsibilities and level of authority.

C, D & E would have been identified in an audit against the 1994 version of ISO 9001.

Only my views of course. I hope this provides some clarification.

NB - I don't mind what country you're from, but I'm not much help in anything but English I'm afraid.

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Khaled El Gohary
unregistered
posted 28 March 2001 01:59 PM           Edit/Delete Message   Reply w/Quote
I beleive that clause 4.1e got a relation with clause 8.2.3 ( Mointoring and measurement of processes)which state " The organization shall apply suitable methods for mointoring and ,WHERE APPLICABLE ,measurement of the quality management system processes . So here the measurement of some processes can be very difficult so you can leave this process without measuring it but u have to mointor it.

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