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View Full Version : 4.1 General Requirements and Transition Training


Oscar
24th July 2000, 05:15 PM
I just returned from a Transition training class. This course emphasized the requirements of clause 4.1 which requires establishing, documenting, implementing, maintaining, and continually improving the QMS. The instructor suggested a flow chart as a method for defining the QMS your company uses and them expanding the chart to include criteria, methods, information, etc. and all requied by this clause. I would appreciate any comments relative to this area of the DIS soon to be FDIS.

The instructor identified this area as a key change in the standard and a good starting place for ensuring compliance to the revised standard.

Thanks

Marc
10th September 2000, 11:13 PM
I missed this one in the fray somehow..

Anyway, I dont agree that there is much difference in the 4.1 requirements. You say: "...This course emphasized the requirements of clause 4.1 which requires establishing, documenting, implementing, maintaining, and continually improving the QMS."

Did they cite specifics? Only continuouus improvement is 'strengthened'.

I agree with flow charts. They're the way to go.

Oscar
11th September 2000, 04:33 PM
We are currently registered by Det Norske Veritas (since 1994) so I have been waiting for information from them relative to the new standard and any interpretation that may be forthcomning.

Marc
11th September 2000, 07:36 PM
I would be surprised if you have to make any serious changes in your systems.

Take a read through -- Temp doc is gone -- and see if this answers some questions.

Let me know if you have any problem getting the document. It's on a test server here at the office -- not on the site server which I run my site on.

I would like to hear from others about the transition issue.

NOTE: This document is a 'temporary' document - I'll keep it posted for a few days, but it may not be there come the weekend.

[This message has been edited by Marc Smith (edited 11 September 2000).]

Marc
11th September 2000, 10:59 PM
By the way, check out ISO-Transi-N474.doc

It should be in Elsmar Cove Free Files Directory (http://Elsmar.com/pdf_files/)

Laura M
11th September 2000, 11:22 PM
Link worked. Doc looks interesting. I'm going to print it and see. I have customers that are interested in being QS9000 but know about ISO9000:2000. Want to plan on a 2001 audit, so QS kind of restricts to ISO 9000:1994

Go Browns!!!!!

Laura

Oscar
12th September 2000, 01:28 AM
This course emphasized that the new standard is structured to be business based rather than a quality standard. The new standard really tells companies how to run their business and 4.1 is the beginning point for this transition. The instructor recommended the flow charts be part of the Quality Manual as well as criteria, methods, objectives, measuring and monitoring, etc.

Any discussion would be appreciated.

Thanks

Marc
12th September 2000, 01:40 AM
Yeah - good rhetoric (changing from a quality standard to a business standard). Well, the bottom line is the basic requirements have not changed. 4.1 is just general requirements in the new 'standard'. If you are currently registered, you should have all this stuff already. Are you registered now or are you intending to register in the future? What's your current status?

Oscar
26th September 2000, 10:49 AM
Marc, thanks for the links they were helpful and good reading.

Alf Gulford
18th October 2000, 11:43 AM
This seems like as good a place as any to ask what might be a very dumb question.

Will we be required to audit 4.1 and 4.2 in ISO 9000:2000?

I'm just now starting to really consider what I'll be faced with when the new standard is released. Not only do these two paragraphs seem like high level overviews of requirements, but everything I read about changes refer to the 'four main sections' of the new standard, referring to numbers 5 through 8. The second sentence of 4.1 even seems to segregate these items from #s 5-8.

I also have heard that parts of #5 are going to be put into #4, which may make that section more significant, but aside from that, and back to my question: Are #s 4.1 and 4.2 intended to be directly auditable?

I always appreciate feedback from this group.

Thanks. Alf

Oscar
18th October 2000, 12:34 PM
Alf, my understanding from the training sessison was that 4.1 and 4.2 are very auditable and some of the major differences in the new standard. I would like to hear other comments relative to this issue also.

Marc
19th October 2000, 01:08 AM
I don't have a copy of the FDIS but the differences are cited in Changes in FDIS 9001:2000 (http://Elsmar.com/ubb/Forum15/HTML/000100.html)

If these are correct, the movement of some stuff like document control to section 4 ensures there is no question - section 4 is (will be) auditable.

Ferric
14th June 2001, 06:26 AM
Hello all,

I'm new to this forum, found it invaluable.

I am in the process of rewriting our '94 ISO doc to be inline with the 2000 revision. I am having some difficulty with regards to section 4.0 viz 4.1 General Requirements. Could someone kindly advise me what is the best way to document the requirements of this section?

From what I read, I'm thinking out loud that I should deploy a QFD process that addresses sections a) through f) for the product(s) that we manufacture. I hope this section can be addressed in some easier way. Am I intepreting this section correctly? Any examples?

Also with regards to section 5.4.1 Quality objectives. Wouldn't Quality objectives be addressed in section 4.1 via QFD planning?

Currently our Quality Planning is written similarly to a FMEA process where we list out the steps in a manufacturing process, identify suitable controls/rating etc for each step/process and based on these ratings action plans are identified. Would FMEA fit/address this requirement in section 4.1?

All questions really,
Thanks in advance.
Ferric

Marc
20th June 2001, 03:20 PM
I don't know how your quality manual looks now, but all I've done is to use the new standard and put in the appropriate references. A day's job. If you have included a bunch of extra stuff in your quality manual you might have some serious work to do.

4.1 General Requirements is just the stuff in the rest of the sections - a sorta listing.

-> I'm thinking out loud that I should deploy a QFD process
-> that addresses sections a) through f) for the product(s)
-> that we manufacture.

No need for QFD. You have to have a 'quality plan. I believe we just posted one - It's posted as: Quality_Plan.doc in the pdf_files directory.

-> Also with regards to section 5.4.1 Quality objectives.
-> Wouldn't Quality objectives be addressed in section 4.1
-> via QFD planning?

Remember that 4.1 is a listing of stuff in other sections. E.g.: "c Determine criteria and methods needed to ensure that both the operation and control of these processes are effective,"

This talks about criteria and methods of control. It comes into play where we discuss how checks are decided upon such as content of audits performed (eg. Customer Service Audit Form). A ‘process audit’ is one methodology. The audit criteria is the audit content. Note that both effective and control are key words here.

I'd go into more detail here but it's all discussed in detail (of course) in my Implementation and Upgrade Guide - sentence by sentence. Bottom line to answer your question is, however, some things are addressed in different places. To interpret 4.1 you have to also see 71. and 5.4.2 a, for example.

-> Currently our Quality Planning is written similarly to a
-> FMEA process where we list out the steps in a
-> manufacturing process, identify suitable controls/rating
-> etc for each step/process and based on these ratings
-> action plans are identified. Would FMEA fit/address this
-> requirement in section 4.1?

Sounds like it part of the bill, at least.

Do you have a diagram or flow chart or other representation of your overall quality system?

Jim Biz
7th September 2001, 02:20 PM
Two opening wonderments?? Maybe it's just Friday....

1) Rumor has it that formal training to the 2000 transition for MR Reps & internal auditors wiill be "Strongly encouraged" and/or actually required by many registrars -

Is there anyting "official" from anywhere on this yet? - or is it an individual registrar decision?

2) I am currently being Fax spammed by many training bodies - which is not unusual but AIAG has faxed a training course announcement stating
"This one day course provides an overview to develop participants understanding of the "NEW OPTIONAL ISO/TS 16949" Satisfying requirements for AVSQ/EAOF/QS9000/Vda6.1

Am I confusing myself :confused: with the wording - or is there really a NEW OPTIONAL ISO/TS program.

:o

Regards
Jim

Marc
7th September 2001, 03:00 PM
> 1) Rumor has it that formal training to the 2000
> transition for MR Reps & internal auditors wiill be
> "Strongly encouraged" and/or actually required by many
> registrars -
>
> Is there anyting "official" from anywhere on this yet? -
> or is it an individual registrar decision?

I've gone through 2 registrations to the 2000 version and neither registrar mentioned anything about this. So far as I know, nothing is 'official'.

> 2) I am currently being Fax spammed by many training
> bodies - which is not unusual but AIAG has faxed a
> training course announcement stating "This one day course
> provides an overview to develop participants understanding
> of the "NEW OPTIONAL ISO/TS 16949" Satisfying requirements
> for AVSQ/EAOF/QS9000/Vda6.1

I think this comes from Ford/GM/Chrysler saying 16949 is now 'optional' - instead of QS-9000 registration. We all know that QS-9000 is essentially dead anyway.

Training and certification programs are getting way out of hand. :rolleyes:

rsalinger
18th September 2001, 03:34 PM
There surely are a lot of people drawing income from transition training out there! The level of training actually needed can vary from the 14 hour requirement by RAB for its accredited auditors, both up and down. I'ver taken one of these 14 hr approved courses and while it was useful, it may well be overkill for internal auditors and other ISO-involved folks who are not trying to maintain an auditing credential.

One very economical approach is to have your consultant (if you are using one) present in-house training. If you are lucky, this might be possible for just the normal day rate. That's be a bargain compared to $200 + per person to attend an outside course. I hope this isn't too much blatant self-promotion, but I do offer that option to my clients, and I suspect there are others too.

Marc
18th September 2001, 04:10 PM
> One very economical approach is to have your consultant
> (if you are using one) present in-house training.

I have done a lot of internal training during implementations - in large part that's where the 'Guide File Sets' I sell here originated. I charged my daily rate plus materials (you have to print up manuals, etc.)

I haven't addressed transition training for company personnel because I don't see it as an issue for any of my past clients. If the original implementation was done well, the transition is not that big a deal. The 2 upgrades I have gone through were really simple and took less than a week.

For auditors, it's a bit different as they address the audit somewhat differently than before.

gpainter
29th October 2001, 08:59 AM
We have had no requirement from our registrar on required training and should not have any. How we train our people is up to us and as long as it is efffective there should be no gripes. I know many registrars help sponser training and probably get rewards from this.

Cheryl
31st October 2001, 01:56 PM
GM has set some guidelines concerning Internal Auditor requirements.

4.1.3 Internal Audit

Internal auditors should be qualified as recommended in ISO 10011-Part 2 as a minimum


Our registrar is "implying" that official training will be required.

Marc
3rd November 2001, 08:55 AM
Originally posted by Cheryl

GM has set some guidelines concerning Internal Auditor requirements.

4.1.3 Internal Audit

Internal auditors should be qualified as recommended in ISO 10011-Part 2 as a minimum

Our registrar is "implying" that official training will be required.Welll, that was a money thing in my opinion - an ASQ / AIAG drive spearheaded by Dennis Arter. QS in it's heyday was a lot more 'internal auditor' sensitive. They wanted, as I understand it, to make internal auditor certification mandatory.

ISO has always been more of a do-it-yourself approach. Normally at least someone goes through auditor training (such as the lead auditor course). Sometimes it's the Management Rep or Quality Manager. They come back and train their people - or in bigger compnies may have formal classes of many people. I generally give internal auditing classes at client facilities which plan to have their own internal auditors. QS or ISO.

Also see: ISO 10011 Dead - 19011 Is Released - A summary of differences (http://Elsmar.com/Forums/showthread.php?t=2332) and Is ISO10011 Dead? (http://Elsmar.com/Forums/showthread.php?t=2398)

Raffy
4th November 2001, 05:34 AM
Hi Everyone,
We as a group did undergo training for the ISO9001:2000 training, however we weren't able to continue to upgrade to the transition. It didn't materialize due to the lack of time.
Raffy

Marc
4th November 2001, 05:48 AM
How about some details of the training. How long? What did they really say (bottom line)? Who gave the training? Did you find it of value?

Raffy
6th November 2001, 07:48 AM
We'll the training on ISO9000:2000 is about the 8 Quality Management Principles, its importance and how it was been merged to the new ISO standard. The same that was been published in the ISO online (www.iso.ch), as I compare the documents that was been discussed to us almost the same. I think the one who conducted the training also based his discussion on that website. Transition training takes about 1 day.
We have an introductory for the ISO9K:2K, Documentation and Record Management. It tackles on how to control the documents, softcopy and hardcopy.....but It didn't fully dicussed. And Internal/External Auditing Course based on ISO9K:2K. Actually this is a Package of three.....
The training was given by a consulting firm.
Value.....hmmm in my opinion, there were so many things that lack on the package. Some things were not clearly discussed :confused:.
An example of that is the Objectives and Targets. I've read the ISO14000 file in the free pdf. It did come from ISO14000. Since were not an EMS certified. We couldn't catch up on how are we going to used this, but with the help of file that I've read. It is now clear to me. Thanks to you Marc.
Plus with the existence of this forum, It helped me a lot on different areas. :)
IMHO, for those who would suit up for Training for Transition must read some thread on this forum, which would help and a great value. :)
Raffy

gpainter
6th November 2001, 09:05 AM
I attended a two day transition course (16 hours) presented by Reciprocal International LLC. Topics covered include:

Comparison of 94-00
Process model
Review of the 9001-2000 standard (brief)
Conversion options
Key process model
Change
Document compression
Work sessions
Questions and answers
For the money spent and the info gained on my part it was very valuable.

Marc
28th July 2002, 10:51 PM
Has anyone done a transition course lately? Who's doing them and what's the cost? Is it worth the time?

barb butrym
29th July 2002, 11:09 AM
one of my clients wanted a new "voice" and invited a small consulting group (somebody in management knew the owner) from Rhode Island in to do the transisition auditor training, and invited me to attend as thier internal lead auditor (gratis).

Well, it was most disappointing. it was 2 days.....they read the standard, talked about it like it was this huge monster to conquer, and all of the work they would need to do (selling their services, i believe)..told me nothing.....taught the others to fear the standard and the work ahead of them. All theory no facts, no practical application at all. Almost made me want to go ahead and prepare one, against my principal theory that its not necessary, not that many changes...etc......his presentation was no more than the words from the standard posted....and a "change is difficult" exercise. I fought the urge to question most of his presentation, but by day two..........I became a doubting Thomas and made his life a bit miserable...sorry to say....oh well...what good is a mouth if you don't use it?

summary:
A good internal auditor training is more than enough. Don't make this more difficult than you have to. A quick awareness training is a good tool...but don't go broke on it. Your consultant can do it with the "ok, the auditor is coming......here is what he is looking for when he talks to you" session.

juliedrys
30th July 2002, 12:05 AM
My company offers RAB-Approved ISO 9001:2000 Transition Training.

This is the 2 day training required for RAB-Certified auditors to maintain their status; however, only about 5% of my students have been RAB auditors. Most are QA Managers, management reps, internal auditors, or others who have been tasked with driving the transition process.

Several months before I developed the class, I attended an approved course offered by a large and fairly reputable training/registration company. My opinion is that this course was just barely adequate. There were too many people in the class for any real learning or discussion to take place, the course material was weak (copies of powerpoint slides), and the instructor was obviously a hired gun, not the author of the material.

Our course (taught exclusively by me) is never much larger than 5 or 6 students, and the course material is quite comprehensive.
Ok, now this sounds like a commercial. But I am very proud of this class, because I think it offers a real opportunity to study and discuss the standard. We don't just read the words. My experience with ISO 9000 has taught me that all of my knowledge is incomplete: the more I study and discuss it, the more I learn. This is the approach I take in the class, and it's great fun.

We cover the 8 principles, the requirements of the clauses (focusing on the new requirements, also what an auditor might look for as well as some suggestions for implementation), and a short bit about auditing methodologies.

I think the difference between a good class and a great class is the instructor. I am passionate about this topic, and it comes through when I teach.

**END OF COMMERCIAL**

That being said...I don't think that this class should be "required" for internal auditors. I did a one-day class today for a team of internal auditors who just wanted me to focus on the differences, and some of the new interpretations. For the general employee, an awareness training is plenty, and in some cases not needed at all.

This class is ideal, however, for people who truly want to understand, dissect and discuss the new standard. I'd be happy to answer anyone's questions about the course or provide student testimonials if requested.

Also, it's taught (publically) in a rather beautiful part of California, at a Country Club. Very cool.

Julie Drysdale
BSA