So, have you looked through the draft yet? What are your thoughts?

I haven't spent a great deal of time analyzing the changes but I did notice one big change that should have (imho) always been there. Corrective and preventive actions now have the requirement to review the effectiveness of the corrective or preventive action taken.

So, what is your take on the revisions? Anything earth shattering? Something near and dear to your heart taking place? Something you think is a total waste?

So, have you looked through the draft yet? What are your thoughts?

I haven't spent a great deal of time analyzing the changes but I did notice one big change that should have (imho) always been there. Corrective and preventive actions now have the requirement to review the effectiveness of the corrective or preventive action taken.

So, what is your take on the revisions? Anything earth shattering? Something near and dear to your heart taking place? Something you think is a total waste?Just like you, I have not spent a lot of time digesting the MINUSCULE changes, yet. By design, the revision (amendment) is supposed to bring MINOR clarifications to the ISO 9001 document. Concerning specifically the "effectiveness" of CAPA's, that should be tagged in the back to the future category, because the 2nd Edition of ISO 9001, a.k.a., ISO 9001:1994 had that very requirement already.

The ISO TC 176 and TAG's around the World would have a tough time to justify all the meetings and trips vis a vis the (lack of) changes to ISO 9001:2009.

You are so right, Sidney. I always kind of wondered about taking that step backwards. We never did drop that requirement for reviewing effectiveness from out QMS.

If all goes as documented, I cannot really find anything that will cause any revisions to the way we operate.

I've been looking at it and the 9004 document as well. Some new words, minor changes and stuff like that. I found the recommended changes below a bit interesting.

5.5.2 Management representative
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes.

6.4 Work Environment
NOTE: The term work environment relates to conditions necessary to achieve conformity to product requirements such as clean rooms, anti-static precautions and hygiene controls.

7.5.4 Customer property
NOTE: Customer property can include intellectual property and personal data

I've been looking at it and the 9004 document as well. Some new words, minor changes and stuff like that. I found the recommended changes below a bit interesting.

5.5.2 Management representative
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes.



I guess I just skimmed over that one, cuz I am a member of the org's management....so what does it mean for people who hire a consultant/contractor to act as an MR?

I guess I just skimmed over that one, cuz I am a member of the org's management....so what does it mean for people who hire a consultant/contractor to act as an MR?

Dunno really. I guess that some "real" connection will have to be proven. Actually I've never asked a MR if they are a fulltime, part-time or cntractor. I knda figured there were more important things to be concerned with.

Dunno really. I guess that some "real" connection will have to be proven. Actually I've never asked a MR if they are a fulltime, part-time or cntractor. I knda figured there were more important things to be concerned with.

I am not an auditor (except within my own org) but I never really felt that the contractor scenario was necessarily wrong. I've known some folks from other companies that used a contractor. I don't think you could do that at my plant, but if 1) you have the culture, 2) the contractor/employee relationship is good, and 3) the contractor is dedicated to doing the right things by the org, then I'm with you, there are lots of more important things to worry about.

so what does it mean for people who hire a consultant/contractor to act as an MR?Good question. One of the sources for input in to the 2009 amended 9001 is the bank of interpretations maintained by the TC 176. As discussed several times here, one of the interpretations contained therein is the one that allows for the MR function to be performed by someone that is NOT a full time employee of the organization. If the TC 176 wants to clarify this issue, they better do a better job of reconciling that interpretation with the draft.

1) I am wondering what the addition of 'statutory' in the phrases 'statutory and regulatory requirements' means. What does it change?

2) There a quite a lot notes added to the standard. Why is that? What is the status of a note? For example 7.2.1 'Post delivery activities may include...' Does it mean that you may decide at your own to apply it or not?

Rob.

I have never heard of an organization using an outside contractor as a management rep, which obviously shows that I don't get out much. Call it just a gut feeling, but shouldn't a MR be a full time employee, someone who has more of a stake in the success of the QMS than just a consulting fee?
If I am being naiive you can tell me so. I won't cry. :nopity:

John, back in my home state, out in the boonies, I knew of several small family run businesses that were ISO 9001/2 (at that time) registered. Many of them had a part time contracted employee that implemented and managed the overall QMS, some of them even shared one employee or contractor to be the MR. In small shops, where there are not enough resources, or maybe even enough expertise, it worked out really well for this group of companies. Several of these companies had government contracts (usually state) and/or requirements within contracts to maintain a formal quality system/ISO 9001 registration because they were a regional supplier/servicer to a national company.

There's that pesky naiivete I was talking about. I've never been around a small org that was 9001 certified. My current employer is what I consider medium sized (about 65M US$/yr) and my previous one was a 5B US$/yr automotive Tier II. We found a way to cough up the person-power.

These places were maybe 8-25 persons. but there are some larger companies that do the same.

1) I am wondering what the addition of 'statutory' in the phrases 'statutory and regulatory requirements' means. What does it change? Another good question. Once again, a back to the future change. One can hope that the TC 176 adds a note explaining the difference between statutory and regulatory.

From http://akss.dau.mil/askaprof-akss/qdetail2.aspx?cgiQuestionID=10725&cgiSubjectAreaID=4

Merriam-Webster's Collegiate Dictionary (10th edition) reports that "statutory" refers to something that is based on the passage of a statute (law) by the legislative branch, while "regulatory" is a rule or order issued by an executive authority or regulatory agency of a government and having the force of law. In brief: Statutory -- from Titled Law; Regulatory -- to implement statute or establish policy where law does not exist. Statutory takes precedence over regulatory. A useful reference is below: http://merriamwebster.com/

I'm glad this was a free download, I would hate to think I'd just wasted my money on this trivia. Presumably, though, when the revised version comes out, it will sell by the bucketfull.

Am I alone in seeing this proposal as just a cynical, money making device for the standards bodies? If this is the best they can do, the committee members have totally failed to justify their expense claims.

OK, it's late and I've had a bad day.

I'll sign off now and go and lay down in a darkened bar.:mad:

Tyker, I am with you. That is why I asked the question. It seemed to me that the only real change was in reviewing CA/PA and possibly the MR requirements. All the rest is semantics. Who cares if it is a regulation or a statute except for the lawyers? if someone says do it, we must do it. You are right, there will be millions of copies sold, because we will have to have the current version, and then we will have to have an upgrade audit performed and so on and so on. Let the good times roll!

Think world wide. The question should be, "what is the meaning of 'statuatory' in all the languages of the users of ISO 9001.

It is not just an English language issue.

Please - for everyone that does not like the output of the world wide technical advisory group to ISO process, please please become a member and improve the process.

The changes are intended to clarify the intent of the requirements. If a "sematics" change affects an organization's understanding of the intent of a requirement, then any one of the proposed changes to ISO 9001 could be perceived to be more than just semantics.

I am very glad to see that people that are not directly involved already now the reason for the changes. It is important to reach conclusion based on assumptions.

Regards,

Dirk

Think world wide. The question should be, "what is the meaning of 'statuatory' in all the languages of the users of ISO 9001.

It is not just an English language issue.

Please - for everyone that does not like the output of the world wide technical advisory group to ISO process, please please become a member and improve the process.

The changes are intended to clarify the intent of the requirements. If a "sematics" change affects an organization's understanding of the intent of a requirement, then any one of the proposed changes to ISO 9001 could be perceived to be more than just semantics.

I am very glad to see that people that are not directly involved already now the reason for the changes. It is important to reach conclusion based on assumptions.

Regards,

DirkDirk, instead of being defensive, why don't you as an insider to the US TAG, answer the questions posed here? It would be much more productive. Explain, to us, please, the ISO take on statutory vs. regulatory, the outsourced MR function, why some of the 1994 edition comments are back, such as effectiveness of CA/PA.

Why not just use "legal" instead of statuatory?:confused: Legal is legal regardless of location isn't it?

"Do what is reguired to be done by applicable legal requirements"

Now of course if the location is in a place where there are no legal requirements (laws) then meeting some goofy standard may be among the least of their problems.

Randy-

Yup - I seriously doubt if anyone is implementing ISO 14001 in Mogadishu.

-John

I've only had time to look through 4 and 5 but a couple of things jump out at me.

SteelMaiden - Please recall a brief discussion we had earlier in this thread regarding the use of consultants / contractors as managgement reps. 5.5.2 in the draft refers to the person to be appointed the MR as being "a member of the organization's (my italics and bold face) management. If that stays in, wouldn't that more clearly preclude having a person outside the org serve as the MR? What do you think?

Everyone - there is a debate in another thread about whether correctives and preventives should be covered by one procedure or two. The draft 4.2.1g seemes to give more wiggle room there by stating the one doc can cover one or more procedures and one procedure can be addressed by more than one doc. Least that's how I read it.

Let me go flog the servants and grab a smoke and I'll try to get back later with any blather I might have about 6 & 7. 8 will be for another day.

Regards -John

SteelMaiden - Please recall a brief discussion we had earlier in this thread regarding the use of consultants / contractors as managgement reps. 5.5.2 in the draft refers to the person to be appointed the MR as being "a member of the organization's (my italics and bold face) management. If that stays in, wouldn't that more clearly preclude having a person outside the org serve as the MR? What do you think?

As has been noted before, "member of management" has never been adequately defined, and adding "the organization's" to it doesn't help much. Who gets to define the terms? I can pull someone off the street at random and declare her to be a member of the organization's management.

Everyone - there is a debate in another thread about whether correctives and preventives should be covered by one procedure or two. The draft 4.2.1g seemes to give more wiggle room there by stating the one doc can cover one or more procedures and one procedure can be addressed by more than one doc. Least that's how I read it.

Discussions on the subject, especially in the thread you're referring to, center around preferences for one procedure or two; ISO 9001-2000 is mute on the subject, saying only that there must be documented procedures for each. Other than the familiar counting of the "shalls," users have always been free to combine or separate documents.

Hello Sidney:

What or who am I defending? Read my posting again.

I am trying to expand the Cove's thinking by identifying that humans are great at making decisions based on the data already in our brains; by making decisoins on our own assumptions.

I am concerned about reaching conlcusions based on assumptions. We see patterns in output, process or behavior and conclude cause and effect. How would anyone know the cause of something if they are not part of the process or have no exposure to the thoughts and dynamics of those involved?

It costs the US TAG at least $50,000 a year to have ANSI sponsor the group. The US TAG is required to have a government sponsor for oversight. ANSI charges over $50,000. Where does that money come from? It mostly comes from the profits of ASQ's sales of the QMS standards.

How could any one of us on the Cove know why the 50+ member countries of the TAG act the way they do? I go to the TAG meetings at the US level. I have no idea what happens at the international level even though I participate at the US level.

I am asking for people to get involved to improve the process. I think the TAG processes are not effective. It gets old reading condeming postings of the process when we (including me) really don't know all of the interactions at the international level of ISO.

Also, I wanted to expose readers to the idea that ISO 9001 is world wide. Arguing a point based on what a word means in English is not a complete argument. Legal is legal is legal does not hold true in all translations.

I also wanted to point out that the changes may have zero impact for one organization whereas they may have a big impact on another organziation. This is dependent on the interpretation of the intent of the requirements from 2000 to 2009 versions.

In my opinion, productivity would be greatly enhnaced if the US TAG or any other country's TAG was staffed with volunteers that wanted to be there, that cared about the process and the product, that cared to get involved instead of being an arm chair standards writer.

To address statuatory vs. regulatory. It is a translation thing. The word "regulatory" by itself apparently was not adequate in some countries. That is my understanding.

I have no idea about the outsourced MR function. I am not aware of any intent to bring back 1994 language. If there is 1994 language brought back, my understanding is it is because the 1994 language communicated the intent better than the 2000 language.

Reviewing a corrective action may not include reviewing the effectivenss of the corrective action. The importance of 8.5.2 f) is to require the organization to specifically review the effectivenss of the corrective action. This was vague in the 2000 version. That is my understanding.

I never said I know the answers. Nor did I ever say the process works. I am saying that I don't see US Cove members get involved in the TAG process.

Regards,

Dirk

I was just reminded of another constraint or goal for the 9001 amendment. One of the goals is to improve compatibility of 9001 with 14001. So some of the answers to our questions may be found by reviewing the text of similar requirements in 14001.

Regards,

Dirk

Hello Sidney:
Legal is legal is legal does not hold true in all translations.

I am saying that I don't see US Cove members get involved in the TAG process.

Regards,

Dirk


Violate the law in any country with laws and you'll find the consequences to be the same. The only real difference is the severity of those consequences. Legal is legal is legal.

Get involved? Yeah, you can volunteer, but you have to pay for the privilage to donate your time.

The following article was originally published in the March 2007 issue of Quality Digest. I got permission from the Editor of Quality Digest to reprint this artilce. Credit for the article should be given to the author, Jack West who was the previous leader of the US Technical Advisory Group to ISO.

The article may help us understand the dynamics of the changes to ISO 9001.

http://www.qualitydigest.com/currentmag/columnists/jwest.shtml


How Do You Change a Good Thing? Slowly!
ISO 9001 and ISO 9004 users will see changes by 2009.


Subcommittee 2 of ISO Technical Committee 176 has been working for some time on the next changes to a well-known pair of quality management system (QMS) standards: ISO 9001:2000, “Quality management systems—Requirements,” and ISO 9004:2000. The intent of the work is to produce a minor change (being called an “amendment”) to ISO 9001 for clarification, and a full revision to ISO 9004.

In 2005, the International Organization for Standardization conducted what’s termed a “systematic review” of ISO 9001:2000. This is actually a ballot that requires ISO member bodies to assess the use of the standard being reviewed in their countries and vote on whether it should be reaffirmed as is, revised or cancelled. In the case if ISO 9001:2000, the review concluded that a minor amendment of ISO 9001 should be developed to improve the standard’s clarity. On the other hand, the review concluded that ISO 9004 needed a major revision to make it more useful.

Since the review was completed, specifications have been prepared for the amendment of ISO 9001 and the revision of ISO 9004. The drafts are well underway, and two working drafts have circulated within Working Group 18 of ISO/TC 176, Subcommittee 2. By the time you read this, the first committee draft (CD) should be available to the ISO/TC 176 member bodies for comments. The target for issuing the amended ISO 9001 and revised ISO 9004 is sometime in 2009.

Although there may be quite a few changes to ISO 9001, I think it’s reasonable to expect them all to be minor. This is because the changes are intended to improve the clarity of the text; improve its usefulness as guidance to ISO 14001, “Environmental management systems—Requirements”; and to address issues raised in the ISO 9001 international interpretations process. In other words, at this point the objective appears to be clarification of the intended meaning, not changes in requirements. A few words of caution:

• There’s been a significant amount of pressure from a few countries to expand the permitted changes so that requirements could be added. Their rationale is that the amended ISO 9001 won’t be issued until 2009, and that document’s next systematic review wouldn’t be due until at least 2012. If it were determined that a revision was needed then, it would take several years to develop. This means that the requirements of ISO 9001 would essentially remain stable for perhaps 15 years or more which, it’s argued, is a long time.

• Minor clarifications have a tendency to turn into major changes for some users. If they’ve interpreted part of the standard differently from its originally intended meaning, and that meaning is clarified so it’s evident that the users’ interpretation isn’t acceptable, they’ll need to change their systems.

Even though it’s likely that the 2009 changes will have little effect on current users, it’s a good idea to keep up with the revision process.

ISO 9004:2000’s revision is quite a different matter. Working Group 18 has essentially started over with this one. Early working drafts were very different from ISO 9004:2000, and I expect the committee draft for comment will be different in both format and content than the current standard.

The idea of this revision is to help organizations with an ISO 9001 QMS build a quality system to support long-term organizational sustainability. There’s a balancing act involved here. On the one hand, there’s a desire to maintain the consistency that the current ISO 9004 has with ISO 9001 to make it easy to use the two together. On the other hand, it’s desirable to add newer concepts in ISO 9004 that may not clearly fit within the existing structure of ISO 9001. This has proven to be a difficult challenge but the working group is confident that the objective can be achieved.

The ISO revision process provides that at least two committee drafts and a draft international standard will circulate before the project is completed, so there will be plenty of opportunity for comments. At some point during the revision process, the American Society for Quality will make copies of drafts available for purchase (most likely as PDF downloads). At that point, public comments and recommendations will be welcomed.

Because ISO 9000 was updated in 2005, it’s not yet a candidate for systematic review. On the other hand, it’s recognized that changes to that standard might become necessary to support the 2009 versions of ISO 9001 and ISO 9004. The ISO subcommittee responsible for ISO 9000 has started to get ready for such changes as the drafts of ISO 9001 and ISO 9004 mature.

About the author
John E. (Jack) West is a consultant, business advisor and author with more than 30 years of experience in a wide variety of industries. From 1997 through 2005 he was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in ISO/TC 176 and is chair of the ASQ Standards Group.

This is my take on the revisions.

If the new ISO 9001 standard gave due consideration to the provisions of ISO 14001:2004 to enhance compatibility, then I don’t see the importance of keeping the requirements for documenting the procedures for the control of documents, records, nonconforming product, internal audit, corrective and preventive actions.

I didn’t see a single provision on the 14001 standard that mandates an organization to document (a) procedure(s) unless (of course) their absence could lead to deviation from the environmental policy, objectives and targets. Even the words “environmental manual” is not literally written. So, I don’t see also the importance of mandating an organization to document a ‘quality manual’.

I believe that having or not having a documented quality manual will not impact an organization’s QMS and several discussions on the cove indicate that as long as you have the minimum content of the manual and if it works for the organization then there should be no problem. Most organizations will function and still satisfy their customers even without them. What will a company gain if they document the description of the interaction of their QMS processes, the QMS scope and exclusions, and the reference procedures on a single manual? Satisfied auditors, most probably. Satisfied customers, I don’t think so.

My point is, if ISO 14001:2004 realized that papers would not prevent pollution, then why ISO 9001:2009 is requiring them.

Regards,

tony s

I just did the following and found it to be interesting. Certainly the following is not definitive but it is interesting.

Go to Google translator or any other free, online translation tool. Translate legal, statutory and regulatory into another language. Then translate it back to your starting language.

For example, on Google, legal translated into legale in Italian. Legale translated back into English is lawyer.

Legal translated into German was zugelassen. This translated back to Certified in English.

The concern by the member bodies of ISO is the actual translation of words. At least that is what I think I learned by donating my time.

Regards,

Dirk

Thank you, Dirk, for your input. I feel that you do not give the members of this forum enough credit for being able to realize that this is an international standard. If there are problems with translation, maybe it would be better to put out clarifications until such a time that the standard does actually change? But, thanks for the reminder to not get tunnel vision.

I have to wonder about an organization that does not communicate its intentions back to the people who have worked for it (volutarily) to revise the standard. Why do you not get included into that loop? Isn't that kind of against what ISO 9001 says about communication? Shame on them. To take advantage of free workers, who obviously are passionate about what they do, and then make the draft changes without any further communication back to the very same people who could provide insight to the people trying to use the standards. For shame! sounds like so much political manuevering to me. I'll stand be my comments that it will cost me a bundle of money to get a piece of paper that says we meet a revised standard without actually changing a thing.

I just did the following and found it to be interesting. Certainly the following is not definitive but it is interesting.

Go to Google translator or any other free, online translation tool. Translate legal, statutory and regulatory into another language. Then translate it back to your starting language.

For example, on Google, legal translated into legale in Italian. Legale translated back into English is lawyer.

Legal translated into German was zugelassen. This translated back to Certified in English.

The concern by the member bodies of ISO is the actual translation of words. At least that is what I think I learned by donating my time.

Regards,

Dirk

Thanks for enlightening us that sometimes direct translation into another language may not be 100%. Personally I would have never guessed that one my being from backwoods Arkansas and all.

Of course the English word "legal" may be different so maybe instead of haggling over symantics somebody would be smart enough to use the correct non-english word or phrase that coveys the same meaning into the translated documents? Hopefully the French, Germans, Japanese, Indonesians, Koreans, Indians or anyone else has something in their respective languages that means the same as our English word legal (or at least reasonably close).

sounds like so much political manuevering to me. :agree1: I believe most users of the Standards have no idea of how political the standard development process is. For example, why was the ISO 9001 revision delayed to 2009? Especially if the "clarifications" are so minor in nature? The answer was blowing in the Irish wind.... (http://elsmar.com/Forums/showpost.php?p=160065&postcount=23)

I did want to say "thank you" to Dirk. I truly appreciate the time you spent in your responses, and sticking with a possible "unpopular" viewpoint.

I too, have been enlightened in being involved in volunteer organizations. However, I have also recognized in these situations when I was being rail-roaded, and had become a flower on the wall. I'm not suggesting that is the case here, as I am not involved.

I am not knowledgable/expert enough in these procedures to comment one way or another. However, I do speak as a layman.

Unless the changes are slam-dunk obvious, I would shy away from ISO 9001 changes. Yes, there are some grey areas, but I would rather let the process provide interpretation for the different areas/industry/etc., then struggle with understanding and applicability. This then necessitates another revision. Pretty soon, the document will have a life of it's own, and require a fleet of experts to interpret.

I agree with most of the comments about the standard writing process. I agree with SteelMaiden that the methods used go against the 9001 standard.

SteelMaiden - I made the comments I did about members becaue there are thousands of Cove members, in lots of countries, but I see many responses to be centric around single nations/countries/languages.

These comments are exactly why I ask people to get involved. The eintrie process is not effective and certianly not efficient. We could have many people volunteer for the US TAG and may not affect the entire world wide process. Zimbabwe's vote is equal to the US vote is equal to the German vote is eqaul to the French vote is...... All votes from member bodies are equal.

Also, it is easy for someone to identify themsleves as TAG members and then be pelted with questions were the person asking wants certainty. The TAG member is then put in a position to possibly explain, justify, or defend ISO, the standard, or the methods of producing a standard. This is one reason why TAG members will not identify themsleves. It puts a big target on them.

This is also one of the inherent problems with the interpretation process. Users want certianty with application and interpretation questions. Questions involving application are not accepted by the interpretation process. Only questions related to the intent of the requirements are accepted. An interpretation can easlily cause more confusion and require and interpretation on the interpretation.

It is a slippery slope for me to want to participate in the TAG, help others, and take a chance at having to defend a national or internationtal position. Sidney is the only other TAG member on the Cove (that I know of.) Isn't that interesting? The largest and best online discussion about 9001 only has 2 TAG members actively participating and identifying themsleves as TAG members.

Questions related to the US TAG also assume that the US voted in favor of a specific change, program, or document. How do Cove members know how individual TAG members voted? How do Cove members know how their country voted?

The process at the international level is incredibly political. I do not attend the international meetings. I think it is easy to understand why one may not know what goes on at the international level. Do we know what goes on in our organizations at the Board level? Do we know what goes on at the CEO and VP level? I am not saying this justifies the lack of communciaiton but it may give us some insight as to why member at the national level may not know what is happening at the international level.

The following comments are sarcasm in response to only one of the previous postings: The reason section 7 is called Product Realization is becasue other words did not translate well into other languages. It is too bad that time is spent on the meaning of words and their translation when it is such a simple issue. Multi-cultural issues across the entire world, for all industries, businesses and organizations are usually simple.

Regards,

Dirk

well, more power to the TAG members. I know that it is hard to find volunteers. (more than you could ever know) Unfortunately, I am unwilling to take on this kind of commitment. My volunteer activities take up all the time I can afford to take away from my family as it is. So, I am not going to be disrespectful of the volunteers involved with ISO revs, but I am really disappointed that the ISO organization does not follow its own standards of operation.:(

Sidney is the only other TAG member on the Cove (that I know of.) Dirk, thanks for your candid comments, but, just as a clarification, I am not a TAG member. I am sure that, based on my experience with similar groups, there are a number of people trying to do the right thing but the process, like you said, is inefficient and dysfunctional. The price to reach consensus and hear all interested parties is steep. Especially if you don't have the patience of a buddhist monk.

PS Another Cover that is also a member of the TAG (SC3, if I am not mistaken) is Paul Palmes.

Hello Stell Maiden: Me too. Sometimes it takes the wind right out of my sails.

By the way, since I have posted at least 2 pages of ramblings, I might as well go for another page....

The Cove should know that I represent my employer at the TAG meetings. But I also represent the Cove. I think the Cove provides the best insight into issues that ISO 9001 users have. Where else can the writers of 9001 get such a broad perspective on the trials and tribulations that 9001 users have? I say no where.

One of the common respones to TAG work is that it is done for profit or that the output has no significance. So at alomst every US TAG meeting, I stand up and caution the TAG from producing a product that has no perceived improvement or value to our customers. The members of the Cove are our customers. I try to influence the US TAG's thought on publishing a 2009 version of ISO 9001 that only add the word "statuatory." The common response by general users is, "What good is that?"

I agree. I try to share the thoughts and issues discussed at the Cove. I try.

One could review the subjects of dicussion at the Cove with the changes to 9001. Do they match? I do not think they match.

Regards,

Dirk

Try to hit 'em with some common sense Dirk.

Hello Sidney:

I thought you were a member of the TAG 207 or a different TAG group. My bad. Your depth of knowledge certainly would lead us to think you are a member at the international level.

Paul Palmes is on of the leaders of the US TAG to ISO/TC 176, SC2. For readers, that is the United States Technical Advisory Group to ISO / Technical Committee 176, Subcomittee 2. This TC is responsible for the United State's position on Quality Systems.

http://www.tc176.org/About176.asp

Thank you all for allowing me to ramble on for multiple pages about the upcoming ISO 9001:2009.

I will try to help where I can.

Regards,

Dirk

I looked at the 207 thing, but my work load and having to pay to volunteer turned me off.

The introduction to ISO 14001:2004 states:
"The second edition of this International Standard .......... has taken due consideration of the provisions of ISO 9001 to enhance the compatibility of the two standards ......."

The preamble for the proposed revision of ISO 9001 states that the changes are:
" for clarification and compatibility with ISO 14001."

How many attempts does it take to make the standards compatible?

It feels like forever since I have posted in the cove - but I am trying now to find a bit more time to contribute -.

Anyway I wanted to add my take on the change in the MR terminology - I think the idea there was to ensure that there was some one that had the Authority to make the changes/etc. Responsibility is one thing, Authority is another.

In my point of view having an external person to adminster the system is OK (not ideal but OK) but you would then need to ensure that there was someone that had the authority to take action/make changes/buy resources etc. I think that this was not happening in a lot of cases where there was an external MR.

Ooo - I need to change my profile photo - let's see waht I have on this computer - One with me and 1st born son I think

OK it's good to be back and reading post from the old crew again.

PS My thoughts on the minimal changes are as follows - It was always said that this review of 9001 was going to be mostly about clarification and intergration with 14001 so I didn't really expect much more. As for the 'upgrade' costs, we are yet to see the policy for recertification. We could well see a three year transition period which would catch every one with at least one recertification audit and in effect be no extra cost.

My thoughts on the minimal changes are as follows - It was always said that this review of 9001 was going to be mostly about clarification and intergration with 14001 so I didn't really expect much more.

No, me neither. Interesting to see where & what kinds of minor tweaks have been made in the latest CD.

But 9004... Now, there's a radical and very positive IMO transformation.