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Author Topic:   Self Declaration to Standard II
Marc Smith
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From:West Chester, OH, USA
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posted 18 April 2001 08:52 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Continued from: https://elsmar.com/ubb/Forum9/HTML/000049.html

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Greenraisin
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Posts: 13
From:West Chester, OH, USA
Registered: Feb 2001

posted 18 April 2001 10:00 AM     Click Here to See the Profile for Greenraisin   Click Here to Email Greenraisin     Edit/Delete Message   Reply w/Quote
We are ISO 9001 and 14001, (among others), certified and we did so because 9000 certification is a requirement to sell in the European Union, (EU). It is a requirement that the certification come from a recognized source. How that plays out if you don't sell internationally, or at least to the EU is another thing, but I assume the registrars will certainly want to continue being the only ones authorized to certify as it is in their best interest to control the market! Being compliant to a standard is one thing; being certified is another and there will always be issues with the certification process and "authorized" registrars.

One way to ensure that you are getting a decent registrar is to follow one of the basic tenets of 9000, which is to evaluate your supplier. The registrar is a supplier (of your certification). When we pulled that on our Registrar, they could only stare at us and let us do what we felt we needed to do! It was rather humorous to see their reaction, but they really had no leg to stand on as we were just complying with the very standard that they were certifying us to! I would suggest, as Marc has stated, that ISO9000 is not only a standard, but also a business model that really makes good sense if it is truly the basis of your quality system. Donât do it just to say you are certified, although itâs becoming more and more "required" as a condition of doing business. Do it because it is a good model for structuring your business. Even if you "have to do it", take the approach that a good look at what you do and why you do it can only result in an improvement in the way you operate. Personally, I like ISO 9000 1994 better than the 2000 version and suggest that you structure your system on the older version, as it is more of a structured approach, as opposed to the 2000 version, which is more management philosophy after the system is built, (In my opinion!). We do medical devices and have a lot more standards and regulations to comply with, but ISO9000 really helped us move our business forward as we focused on each section of the standard and looked at how all of our "processes" should link in a flow, which we really hadnât done in the past.

ISO9000 is a process flow model. Not a manufacturing process, but a business model process. If any one is interested, I have developed a Power Point presentation that shows how each element of ISO9000 fits in with a specific function of a business, regardless of the service or product provided. Once I "saw" that it wasnât just a compilation of different subjects, but a flow, I could really see the strength behind the standard. Our registrar and the several consultants we used to set up our system never presented the standard that way and that was a disservice to us as it allowed us to approach the conversion with a less than full understanding of the strength of the system.

Sorry for going on so long. I have lots of scar tissue to show from setting up the system, implementing it, and more importantly, maintaining, it. Any system that is developed but not followed is just busy work and is actually a liability. Make it work for you! Once you understand the model, you will see that its structure can definitely help to optimize your quality system, regardless of what your business is.

My last comment is this: If you are going to convert to an ISO 9000 based quality system, MAKE SURE YOU SELL IT FIRST TO MANAGEMENT AND THAT IT IS DEVELOPED AND IMPLEMENTED FROM THE TOP DOWN. If they donât understand it and support it, you will not realize the benefits of the strengths of the model, AND, you will not be compliant with the spirit of the standard, which requires management to know, understand, and be an integral part of the system!

------------------
See you down life's highway!

Eric

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Randy
Forum Wizard

Posts: 228
From:Barstow, CA, USA
Registered: Jun 1999

posted 19 April 2001 08:47 AM     Click Here to See the Profile for Randy   Click Here to Email Randy     Edit/Delete Message   Reply w/Quote
Hey Carl....we need a name for our company.

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energy
Forum Contributor

Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 19 April 2001 11:16 AM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
How about Dewey, Screwem & Howe?

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CarolX
Forum Contributor

Posts: 108
From:Illinois, USA
Registered: Jun 2000

posted 19 April 2001 01:03 PM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote
how about

Certs-R-Us

or

The Ben Dover Company

any other ideas?
CarolX

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Carl
unregistered
posted 19 April 2001 02:27 PM           Edit/Delete Message   Reply w/Quote
Greenraisin,

You had me going until the end there with that "Spirit of the standard" baloney.

There is no such thing as the "spirit of the standard" That is like saying "well officer, I know that I had several driving offeses back there, but can you let me go because I am trying to meet the spirit of the law" You either conform/comply, or you don't. The Registrar cop can give you a ticket for doing 62 in a 50, but likely he will not because:
1. Everyone else is going 65 - 70 (and he is not giving them tickets either)
and
2. You are paying his salary

If we treated our registrars as our suppliers, none of them would be in business because many companies now require their suppliers to be ISO registered. As I know it, registrars are not ISO registered, thereby making the company not compliant to the standard because they are allowing a supplier to continue without being registered.

I keep hearing that the EU requires ISO registration too, but I am beginning to be quite skeptical of that statement. The Japanese don't buy into ISO nearly as much and there is PLENTY of trade going on between them and EU. The major Japanese auto makers are not QS registered and you see PLENTY of Toyotas, Nissans etc. driving over there. Hmmmm. I think someone is pulling a fast one! Let's see, where did ISO originate?


You do give sound advice on working with the standard and registrars. Thanks.

I like both the standards, 1994 probably moreso, but when you get right down to it, it is actually pretty sad. The standard is nothing more than a replacement for common sense. Name one thing in either the 1994 or the 2000 revision that does not have a common sense business practice root.

Company Names?

How about:
Sent Past Corp?
Smart Enough Not To Pass Along Savings to Certification Organizations / Registrars Profits?.

Too long?

How about REACH Registration?
Registrars Enabling Affordable Certification Help?

OK, OK, mine stink, let's see some others.

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 19 April 2001 02:49 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
->There is no such thing as the "spirit of the standard"
->That is like saying "well officer, I know that I had
->several driving offeses back there, but can you let me go
->because I am trying to meet the spirit of the law" You
->either conform/comply, or you don't. The Registrar cop can
->give you a ticket for doing 62 in a 50, but likely he will
->not because: 1. Everyone else is going 65 - 70 (and he is
->not giving them tickets either) and 2. You are paying his
->salary

Were all the ISO 9K requirements as clear and concise as the example of a speed limit law you would be correct. I use the phrase "...meet the intent..."

->If we treated our registrars as our suppliers, none of
->them would be in business because many companies now
->require their suppliers to be ISO registered.

Pity be the company which requires all of its suppliers to be ISO 9K registered. I'm not convinced ISO 9K registration should be a requirement in any purchase.

I disagree. Registrars are suppliers and should be treated as such.

For you folks taking about self registration, somewhere betwen US$10K and US$20K will buy you what you need to do 'real' registrations. They're multiplying like rabbits. You, too, can be part of the gold rush!

->I keep hearing that the EU requires ISO registration too,
->but I am beginning to be quite skeptical of that
->statement. The Japanese don't buy into ISO nearly as much
->and there is PLENTY of trade going on between them and EU.
->The major Japanese auto makers are not QS registered and
->you see PLENTY of Toyotas, Nissans etc. driving over
->there. Hmmmm. I think someone is pulling a fast one! Let's
->see, where did ISO originate?

I agree that ISO 9K has become a sales gimmick for the most part. And QS has never been anything more than a cost shift.

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energy
Forum Contributor

Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 19 April 2001 02:55 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
Ajax Manufacturing is committed to improving our Quality Management System to meet or exceed the goals of ISO 9000:2000 compliance, anticipating our customers needs and providing total Customer satisfaction. Ajax Manufacturingâs Quality processes represent continual improvement to eliminate defects, enhance service and delivery and provide quality product through superior design and workmanship. At the top levels and throughout the entire company, our priority is to be recognized as having the highest level of Quality attainable in our industry.
Well, I do declare.


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CarolX
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Posts: 108
From:Illinois, USA
Registered: Jun 2000

posted 19 April 2001 03:46 PM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote
Marc,

You hit the nail on the head..

Quote:
"I agree that ISO 9K has become a sales gimmick for the most part"

My boss will tell you right out that we persued certification only because new customers wouldn't talk to us unless we were certified. Our current customers could care less because we deliver good parts, on time, at a reasonable cost. We couldn't expand our customer base without the certification. So it has become a sales gimmick. Our system was so close to the ISO requirments that we achived certification in less than 6 months (and during that time I was out for 6 weeks on maternity leave).
Sorry if I am blowing my own horn a little, but you either got it, or you don't. Customers don't crash down your doors because of a little piece of paper. A good reputation will do that.

And so I ramble.........

CarolX

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Carl
unregistered
posted 20 April 2001 11:09 AM           Edit/Delete Message   Reply w/Quote
Marc,

You make some good points. I disagree with some of them, but I respect your opinion nonetheless.

I have come to beleive the standard IS clear and concise. You are either doing what it states or you are not.

You use the phrase "Meet the intent" What is that? I do not remember reading anything about "Meeting the Intent" in the standard. That is precisely how we as quality professionals get into trouble. As soon as you introduce subjectivity, you lose control. Your perception of meeting the intent could vary greatly from mine. How much do you have to meet the "Intent" to be registered? 51%? 80%?

I say no, You need to meet it 100%.

The "Intent" of the standard is that you follow it.

The "intent" of the RAB is that you hire a registrar and pay them. Maybe a consultant or two if they can scare you enough.

How do you differentiate between the suppliers which need to be ISO certified? What do you accept in lieu of registration? If you accept ISO registration OR an audit performed by your company, that would fit in nicely with self declaration, would it not? What criteria did you use to accept your registrar? Did you use the same criteria for ANY other supplier to your company?

I agree, Registrars are absolutely suppliers, but I have not seen one company that truly treats them as such.

Is true self registration ever going to become a reality? Probably not, but let me tell you, a piece of paper is not going to do diddly for your product quality, and it is going to cost you a WHOLE LOT MORE than $10K - $20K by the time you are done. Initial registration is just the start. Two audits annually are going to cost you $15K by the time you are done paying for the audit days, cert fees, someone's wages to babysit the Registrar, hotel and meal expenses, etc. EVERY YEAR, year after year.

What is the difference between a company that complies to the standard but is not registered, and a company that has the cert hanging on the wall just to gain a business advantage? The first company has a bunch more money in the coffers to pass on to the customer in savings and to put towards preventive action and process improvement.

It is a money making machine, cleverly developed and executed. Does anyone know of a company that actually had their registration pulled during an audit? Not non-conformances that were fixed by the next audit, I am talking about pulling the cert down off the wall and having to notify your customers. There might be a couple, but they are few and far between my friends. Getting a certification takes one thing.

Money.

Virtually every registered company did so to increase their marketability, not to enhance their Quality Management system. If you wanted to enhance your QMS, you could buy the standard for $40.00 and implement it yourself. save a whole lot of money.

Carl-

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Al Dyer
Forum Wizard

Posts: 622
From:Lapeer, MI USA
Registered: Oct 2000

posted 20 April 2001 11:35 AM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
More logs on the fire and am posting because this is not an ISO specific topic.

In QS-9000 the word "SHALL" is a requirement. The word "SHOULD" means you must be able to show the approach meets the intent of QS-9000. (Page 1 3rd Edition)

I don't have the energy to go into the terms "typical", "example", or "as appropriate"

Convoluted? Yes

Intent? Just try to get an answer from the RAB or B3. My requests to them are at the best, wavering.

ASD...

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 20 April 2001 12:11 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Al makes my point pretty well. You can, for example, stand back and read where it says something like "...The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard..." Sounds streight forward and simple, yes? Well, there are 1000 and 1 ways to design a system which will comply.

->I have come to beleive the standard IS clear and concise.
It is clear to you with respect to your business and such. And, of course, you've now been studying it for a while and better understand the intent. Even calculus makes sense after a few semesters of it. Well most of it does.

If interpretations were not a significant issue with ISO 9001 this forum would not exist. If all this was as easily understandable as you believe, there would be no visitors here. No posts. No questions. The vagueness of ISO 9K (not to mention QS-9000) is good, but it is the root of the issue under discussion.

->How do you differentiate between the suppliers which need
->to be ISO certified? What do you accept in lieu of
->registration?

Please explain why you would want to require a supplier to be registered before you would buy from them. Include what you believe you will gain.

->I agree, Registrars are absolutely suppliers, but I have
->not seen one company that truly treats them as such.

And your point is?

->What is the difference between a company that complies to
->the standard but is not registered, and a company that has
->the cert hanging on the wall just to gain a business
->advantage? The first company has a bunch more money in the
->coffers to pass on to the customer in savings and to put
->towards preventive action and process improvement.

Maybe, maybe not. Presence or absence of a cert does not correlate to financial reserves (I don't know this but I'd bet on it) nor does an abundance of cash have an influence on savings passed on to the customer (which in reality, other than in automotive where Ford, GM and Chrysler essentially force a company to open their books to them, this never happens) and to put towards preventive action and process improvement. But - all in all I believe I understand the intent of your statement - certificate is a total waste except as a marketing tool.

->Virtually every registered company did so to increase
->their marketability, not to enhance their Quality
->Management system. If you wanted to enhance your QMS, you
->could buy the standard for $40.00 and implement it
->yourself. save a whole lot of money.

Yes, yes, yes!

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ISO GUY
Forum Contributor

Posts: 81
From:Rochester, NY
Registered: Jan 2000

posted 20 April 2001 12:39 PM     Click Here to See the Profile for ISO GUY   Click Here to Email ISO GUY     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by Carl:
Marc: How do you differentiate between the suppliers which need to be ISO certified? What do you accept in lieu of registration? If you accept ISO registration OR an audit performed by your company, that would fit in nicely with self declaration, would it not? What criteria did you use to accept your registrar? Did you use the same criteria for ANY other supplier to your company?

I agree, Registrars are absolutely suppliers, but I have not seen one company that truly treats them as such.


Carl,
The company I work for treats our Registrar as a supplier, we have them on our approved supplier list, there was a whole process we went through before we choose them as our registrar. Is your company ISO certified, if so is your Registrar on your approved supplier list? When I do Registration Audits and I am auditing purcahsing guess what I make sure that the Registrar is on the approved supplier list, if not they would get an NC.

Is true self registration ever going to become a reality? Probably not, but let me tell you, a piece of paper is not going to do diddly for your product quality, and it is going to cost you a WHOLE LOT MORE than $10K - $20K by the time you are done. Initial registration is just the start. Two audits annually are going to cost you $15K by the time you are done paying for the audit days, cert fees, someone's wages to babysit the Registrar, hotel and meal expenses, etc. EVERY YEAR, year after year.

As far as expenses go maybe you should look for a different Registrar not all of them charge that much.

It is a money making machine, cleverly developed and executed. Does anyone know of a company that actually had their registration pulled during an audit? Not non-conformances that were fixed by the next audit, I am talking about pulling the cert down off the wall and having to notify your customers. There might be a couple, but they are few and far between my friends. Getting a certification takes one thing.

Yes I do know of a few companies that had the Certificate suspended and pulled guess what I was the one who made the recommendation. I agree it is very difficult to get your ISO cert. pulled but it does happen.


Virtually every registered company did so to increase their marketability, not to enhance their Quality Management system. If you wanted to enhance your QMS, you could buy the standard for $40.00 and implement it yourself. save a whole lot of money.

If that is the only reason they did it, then I would have to say they dont really support quality they are just paying lip service. This I know from experience becuase I have fought till I am blue in the face with our Executive Committee about the lack of support they give the system, well it has come back to bite them, during our last Audit the Registrar pointed out all the flaws that I did in the past, they have never been addressed and we have been duely warned that if it is not fixed, when the come back in 6 months we will have our cert. pulled, this would kill the company I work for the lose of business would shut the doors. Once the clients get wind that the cert. is pulled they to will pull their business.

*****************
Edited to end the 'quote' portion properly.

[This message has been edited by Marc Smith (edited 29 April 2001).]

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Carl
unregistered
posted 20 April 2001 01:53 PM           Edit/Delete Message   Reply w/Quote
Marc,

Actually I think Al makes my point pretty well.

First he is quoting QS9000 not Q9001. Q9001 makes no such statements. "Shall" is pretty clear in any language. I would avoid "should" like the plague.

Second He freely admits he cannot get an answer to the question of defining "Intent" from the RAB.

I guess I do have some advantage having been exposed to the standard, however the new revision is pretty new to me also.

I think Marc makes a good statement that there are 1000 and 1 ways to design a system which will comply. I guess my point is that all 1000 and 1 should be acceptable as long as you have evidence that they comply. Why should subjectivity rule the outcome?

As to the rest:
Most companies use the fact that a supplier is registered as criteria to include them on their approved supplier list.
Proof that they have a functioning Quality Management System.
What do I think you gain by doing that? NOTHING.
But I would be interested to find a company that did not use it as one of the criteria and it is acceptable as such to the registarars I have worked with.


Intent and subjectivity should be removed as much as is possible and I guess the upsetting thing is, I don't see that trend occuring during Registration audits.

BTW. My present company is not registered. (I have only been here 4 months) I will have them "meeting the intent" and compliant "to the spirit of the standard" by August. I have been through ISO 9001 1994 rev. 3 times as Quality Manager and Management Representative and once as a consultant. I am also an ASQ CQMgr.

I have suggested to Management that we "live the standard" for as long as possible without becoming registered. Some companies unfortunately do not have that luxury.

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Greenraisin
Forum Contributor

Posts: 13
From:West Chester, OH, USA
Registered: Feb 2001

posted 23 April 2001 02:03 PM     Click Here to See the Profile for Greenraisin   Click Here to Email Greenraisin     Edit/Delete Message   Reply w/Quote
Good discussion!

Carl, my comment about meeting the intent was directed at management and their support of an ISO9000 based quality system. It is very easy, and many times reality, that a system is put into place that complies with ISO9000 requirements, WITHOUT management being totally committed to the continuous improvement and customer satisfaction. They do what they are told to do by some quality person and that suffices as Management Review, etc.. The results of the quality system are compliant to the standards, but my point was supposed to be that the intent of the standard is not to just show that you met some criteria, it's to continuously improve your results and take care of customer needs. Without management buying into that philosophy rather than to "just be compliant to whatever we need to be to get our certification", the intent will never be met.

That's all I was trying to say. I agree that compliance is either there, or not, but philosophical thinking is hard to gather objective evidence to support it!

Also, I was referring to the CE mark to be able to sell in the EU. I'm not sure of the universal applicability, but do know that to sell medical devices, one must have the CE mark on it. To get that, you must comply to the Medical Device Directive (MDD), and that requires ISO9000 certification. The MDD is an EU based requirement and is very strict and focused purely on medical devices, whereas ISO9000 is applicable to anything from medical devices to manhole covers!

Finally, I agree that ISO certification is getting out of hand and many businesses are getting it just for the perceived marketing advantage it may get them. In my opinion, it diminishes the value for everyone if it gets issued to anyone by some of the less than honest registrars. Kind of like everyone getting into the hall of fame just because they played the game!

Have a great day!

------------------
See you down life's highway!

Eric

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Randy
Forum Wizard

Posts: 228
From:Barstow, CA, USA
Registered: Jun 1999

posted 23 April 2001 09:32 PM     Click Here to See the Profile for Randy   Click Here to Email Randy     Edit/Delete Message   Reply w/Quote
Management will support anything that doesn't cost too much, is easy, , makes them look good and turns a profit. When these factors are missing, forget it.

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Dan Larsen
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Posts: 137
From:Sussex, WI
Registered: Feb 2001

posted 26 April 2001 05:59 PM     Click Here to See the Profile for Dan Larsen   Click Here to Email Dan Larsen     Edit/Delete Message   Reply w/Quote
Carl,

We all may be one step behind the leader here...got this from a client asking my opinion. It seems this outfit is listed as a registrar without accrditation: "QAS is an independent body and does not subscibe to the conventional accreditation network." But they are a "key member of the British Quality Foundation (BQF) of the U.K."
http://www.quality-assurance.com/

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 26 April 2001 06:31 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
My question would be what value it having a 'registrar' who "...does not subscibe to the conventional accreditation network..."

I thought the idea was to self-certify to save $. If you're still paying a company to evaluate your company, what is the 'up' side? Are they easier? Cheaper?

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Carl
unregistered
posted 27 April 2001 10:44 AM           Edit/Delete Message   Reply w/Quote
Dan,

Excellent stuff!

I noticed that they comment that they have 42 "qualified" lead assessors, but do not state they are IRCA registered. Only that they have taken a 2 day course for the 2000 revision. I took some heat in another thread about using the term "certified" because I am not IRCA registered so I found this interesting.


It would seem they are probably a bit less expensive because they dispense with the red tape and only require a yearly audit. Most companies now pay a registrar 2 x per year for surveillance.

I also get the impression they have no conflict in consulting the companies they are registering. Something most registrars shy away from.

I still say I can do it less expensive.

Send me the evidence and I send you the cert. for the current rev of the standard good for the life of the company. No annual audits.

On the surface, many people disagree with this, but think about it: If I certify you to the 2000 revision right now and give you a cert, and ISO does their job, we will have a new revision before 2005 right? So really we are only talking about keeping things robust for about 4 years. After initial registration, most companies will stop paying much attention to the system after 18 to 24 months, at which time it will start to fall off, and by the time 3 years rolls around, they will need to start to bring it back up to speed for the next revision. For anyone who thinks this is too long, why do you think it is OK for the standard itself not to be audited every 6 months?

Pactice what you preach my friends.

Good find Dan.

Thanks!

Carl-

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Al Dyer
Forum Wizard

Posts: 622
From:Lapeer, MI USA
Registered: Oct 2000

posted 29 April 2001 03:51 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by Carl:
Marc,

Actually I think Al makes my point pretty well.

First he is quoting QS9000 not Q9001.........

Second He freely admits he cannot get an answer to the question of defining "Intent" from the RAB...........


(1st) Yes, that's why I referenced QS-9000 in the first line of my post.

(2nd) I think I said my responses were "wavering", not "cannot get an answer.

As to the remainder of your post, I agree!

ASD...

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EricC
unregistered
posted 12 May 2001 09:08 AM           Edit/Delete Message   Reply w/Quote
Dear Greenraisin,
I m interested in your PP presentation .... Would u pls send me via email to psdwz_eric@sina.com.
Thanks
EC

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Randy
Forum Wizard

Posts: 228
From:Barstow, CA, USA
Registered: Jun 1999

posted 11 June 2001 12:53 AM     Click Here to See the Profile for Randy   Click Here to Email Randy     Edit/Delete Message   Reply w/Quote
Hey if any of you hear about someone wanting to self declare to 14K and they want a 3rd party verification letter give me a holler. I need to show time on my log and a couple of bucks would'nt be bad either. I'm lots cheaper than a Registrar and I promise to wear clean drawers.

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