ISO/CD 9001 2007-02-8 - What are your thoughts?

[John Nabors - 2009]

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

 

[Jim Wynne]

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.

 

[vanputten]

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

 

[vanputten]

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

 

[Randy]

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.

 

[vanputten]

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.

 

[tony s]

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

 

[vanputten]

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

 

[SteelMaiden]

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.

 

[Randy]

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).