I have seen the Markups to ISO 9001/2008. What will we be required to do?

Change our Manual for clarity, consistency, emphsis?

or can we just leave it as is and maybe change were it references 9001 2000 to ISO 9001 2008?

Not sure what direction to take?

I just had my surveillance audit (no findings :)). Basically, no changes outside of rewording my exemption from 7.5.2.

The auditor basically said there is effectively NO CHANGE in auditable criteria.

To the general public, I imagine the only thing that will change is that the new cert will say 2008. It will look "new and improved" instead of that "old outdated" 2000 cert.

Agreed. No need to change QMS (other than referencing new edition of 9001) unless it isn't working as well as we'd like. Changes to standard are wordsmithing for clarity only.

I just had my surveillance audit (no findings :)). Basically, no changes outside of rewording my exemption from 7.5.2.

The auditor basically said there is effectively NO CHANGE in auditable criteria.

Surveillance audit including 2008 edition?:confused:

Here (http://www.iso.org/iso/pressrelease.htm?refid=Ref1152) is a communique from ISO saying no auditing to 2008 edition until after it is published (logically).

I hate to put a spanner in the works but perhaps there is an opportunity for everyone to review their systems again and make the changes that should have been made in 2000 and adopt the process approach properly. :notme:

Also see my post in the "when will the new standard be released" thread:
http://elsmar.com/Forums/showthread.php?p=267904#post267904

ANAB has sent this communication to their certified registrars concerning the rules of recertification. But, basically, there are no real new requirements, only some basic clarifications.

There are no requirements changes in ISO 9001:2008 so if you were compliant before, you will be compliant still. Jim "Q" Public has nothing to do except review the changes in the standard and understand them.

:biglaugh: Wow! now that is good news.

Oh yes and thanks for all the help

Paul,

No surveillance audit was to 2000, but he was updating me on the information since the next audit will be after the 2008 is released. :)

I hate to put a spanner in the works but perhaps there is an opportunity for everyone to review their systems again and make the changes that should have been made in 2000 and adopt the process approach properly.

A "spanner"? The first time I heard that was when a Scottish friend of mine asked if I had a "ring-necked spanner" [I think that was the term]. I just kinda looked at him and blinked. Boy did he laugh!!!!!

But your point is well taken. In fact, I would argue that it at needs to be looked at to be in compliance with 5.4.2 b) [maintaining the integrity when things change].

Now is a good time to give your QMS a "tune up", so to speak.

I hate to put a spanner in the works but perhaps there is an opportunity for everyone to review their systems again and make the changes that should have been made in 2000 and adopt the process approach properly. :notme:

Span away!, in all actuality, we should be doing that each and every day (continual improvement)...finding better ways to document our system and make sure that our processes are defined, etc.:whip:

A "spanner"? The first time I heard that was when a Scottish friend of mine asked if I had a "ring-necked spanner" [I think that was the term]. I just kinda looked at him and blinked. Boy did he laugh!!!!!

But your point is well taken. In fact, I would argue that it at needs to be looked at to be in compliance with 5.4.2 b) [maintaining the integrity when things change].

Now is a good time to give your QMS a "tune up", so to speak.

Dang! I should have remembered a spanner is a wrench! :bonk:

Dang! I should have remembered I spanner is a wrench! :bonk:

When are you going to learn English? :tg:

When are you going to learn English? :tg:

Absolutely! Fancy using a personal pronoun. :lmao: The sooner we all speak American the better!

I split off the threads that were asking about ISO 13485 and moved them to the ISO 13485 Forum here:

http://elsmar.com/Forums/showthread.php?t=29472

Good news except for the cost, of course.

According to BSI the price of the standard has not yet been set but is likely to be similar to ISO 9001:2000 at £70.
Yahoo money converts that to US$125.

I know someone has to pay for the technical committee members' holidays but I've got better things to do with my employer's cash.:mad:

Tyker:

How do you know where the profits go, from sales of ISO 9001, in England?

In the US, all technical comittee members pay for all of their own expenses. All!!!! No free lunch in the USA. And profits from the sales of ISO 9001 via the American Society for Quality go to ANSI (American National Standards Institute) for being the official U.S. representative to the International Organization for Standardization (ISO) .

Please describe how it works int he UK and where the profits go.

Thank you,

Dirk

1 million certs currently around the world. Bump to the new standard at $125.00 a pop... Holy Cow thats 125 mill. Not bad for 20 pages
J.K. Rowlings would blush:o:o

Tyker:

How do you know where the profits go, from sales of ISO 9001, in England?

In the US, all technical comittee members pay for all of their own expenses. All!!!! No free lunch in the USA. And profits from the sales of ISO 9001 via the American Society for Quality go to ANSI (American National Standards Institute) for being the official U.S. representative to the International Organization for Standardization (ISO) .

Please describe how it works int he UK and where the profits go.

Thank you,

Dirk


The revenue from standards sales in the UK remains with BSI.

In the dim and distant past when I was on a couple of national technical committees, my employer paid my expenses but the most exotic place I got to was central London.

I suppose there is a chance that the members of the international technical committees pay their own air fares, hotel and restaurant bills on their jaunts around the world, but this old cynic doubts it.

The fact remains that, whoever picks up the tab, creating a new or revised international standard like ISO 9001:2008 is expensive and I don't believe the changes in this standard justify any cost whatsoever.

Hello Tyker:

I agree that the cost of the clarification to ISO 9001 may not be worth the benefit.

However, posting a critical comment about where the profits go based on cynicism, and not fact, may not be too beneficial for the Cove.

In the US, national and international TC176 members pay their own way to meetings. There is a proposal on the table to charge annual dues to pay for some of the international travel.

I too agree about the financial cost not being worth the changes but I suspect that the environmental cost of the changes is even higher.

What about all of those air and road miles travelled by the committee members and think of how many pages of paper are going to be re-printed when people change ISO 9001:2000 into ISO 9001:2008 in their quality manuals and procedures plus all the training course notes and slides that will be changed too.

Hello Tyker:

I agree that the cost of the clarification to ISO 9001 may not be worth the benefit.

However, posting a critical comment about where the profits go based on cynicism, and not fact, may not be too beneficial for the Cove.

In the US, national and international TC176 members pay their own way to meetings. There is a proposal on the table to charge annual dues to pay for some of the international travel.

I'm afraid I don't fully understand your second sentence. If you feel my comments were in some way detrimental to the Cove, feel free to refer them to the moderators.

I just don't care who pays for TC 176 meetings. The money spent to come up with the 2008 revision has, in my opinion, been wasted. My complaint is that their efforts will result in many organizations, including my own, shelling out a lot of cash to buy a standard, the amendments to which are worthless.

My complaint is that their efforts will result in many organizations, including my own, shelling out a lot of cash to buy a standard, the amendments to which are worthless.


I asked our auditor yesterday if we needed to purchase the new standard and keep a copy in house and he said no. I won't be buying a new standard!

I asked our auditor yesterday if we needed to purchase the new standard and keep a copy in house and he said no. I won't be buying a new standard!

I will be having an external auditor from our national certfying body end of the year, so do I need to change our manual and quality policy again, coz we just revised and published our policy or we are allowed to keep the wording and documentation and change over a given period (24 months)?

I thought that there was usually a certain timelag from when the Standard is issued to when it is expected to be fully implemented (the new changes, if abny, that is).

Don't quote me on that but that is just what I have overheard at various places. Maybe the Cove Elites can confirm

Hello Tyker:

Below are are excerpts from two of your postings. Does each posting mean the same thing?

"I know someone has to pay for the technical committee members' holidays but I've got better things to do with my employer's cash."

"I just don't care who pays for TC 176 meetings. The money spent to come up with the 2008 revision has, in my opinion, been wasted. My complaint is that their efforts will result in many organizations, including my own, shelling out a lot of cash to buy a standard, the amendments to which are worthless."

If you wanted to share your concerns with how the revision waste users' money, then say that. But to accuse TC 176 members of profiting from standards sales is a different message. You made a critical comment on TC176 based on assumptions of how profit from standard sales are used.

I work as a consultant and ISO is only one of my many hats. One client I work for is taking this opportunity to completely revise their documentation. It was to 9001:1994 and patched to 2000, but has been a source of problems as it was still structured around the 1994 standard. Their last external audit had several non-conformances that were because of their documentation - the auditors helped in explaining how they were their worst enemies because of it.
Their recertification audit is coming up early next year and will be to the 9001:2008, so they have an impetus to get it done (possible more work for me).

As per the schedule announced for the release of ISO 9001"2008, the standard is expected to be issued by end 2008. It is also stated that certifications issued to ISO 9001:2000 shall not be valid 24 after the release of the new document, which implies that certificate issued say in Dec 2008 just before the release will become invalid by end of 2010 instead of 2011 as it would otherwise.

Now if the new version does not have any change in the requirements as such - has only clarifications - what is the big idea of making the certifications invalid after 24 months instead of 36 months as the normal course?

Could someone please throw some light on this?

During the 24 month period all existing certifications must transition to 2008. The new 2008 certificate would have the appropriate ending date 3 years after the certification/recertification date.

Could someone please throw some light on this?A pundit, prone to conspiracy theories (not me) could infer that by demanding all ISO 9001:2000 certificates become obsolete in 24 months, or less, will ensure that all money transfers and transactions associated with this issue, via purchase of standards, courses, certificates issuance, etc.... will be sped up.

Thanks Howste and Sydney.

I have a client right now ready for re-certification to ISO 9001:2000. Will it be OK if transition to 2008 version is carried out as part of Surveillance audit? I have not yet contacted any of the likely certification bodies though.

Thanks Howste and Sydney.

I have a client right now ready for re-certification to ISO 9001:2000. Will it be OK if transition to 2008 version is carried out as part of Surveillance audit? I have not yet contacted any of the likely certification bodies though.

The 2008 version does not contain any new requirements.
I am not sure why you would want to do this.
Can you clarify?

Stijloor.

I have a client right now ready for re-certification to ISO 9001:2000. Will it be OK if transition to 2008 version is carried out as part of Surveillance audit?Yes, but as indicated in the IAF/ISO communique', no certificate to the 4th Edition of ISO 9001 can be issued until the standard is released and an audit takes place. I have not yet contacted any of the likely certification bodies though.Looks like your client practices the "ancient art" of "shopping around" for a new certification body, when of the re-certification cycle. Another symptom of a commoditization mind-set in the certification sector. Certificates being perceived as a commodity, with price as the only deciding factor, when selecting a registrar.....

There is yet another question bothering me. Since the 2008 version does not have any new requirements, (and I suppose does not omit any of the existing requirements either) would it not be more appropriate to maintain the existing standard and re-issue it as

"ISO 9001:2000 - Reaffirmed in 2008".

In case certain points need to be clarified in "2008 version", these could be added by issuing an amendment to ISO 9004 -Guidelines thus avoiding unnecessary work by various agencies particularly those currently holding certification to ISO 9001:2000. In fact such an action would generate more respect for ISO 9001:2000 besides immense credit to ISO TC 176 who approved and issued 2000 version.

On the other hand issue of new version with no additional requirement and with a "threat" of making earlier certificates invalid after 24 months, may give wrong signals to the industry and businesses. Well is there yet an iota of hope of avoiding the release of this "new" version at this stage? Can anyone help?

"ISO 9001:2000 - Reaffirmed in 2008". Don't be naive. If they did that, how could they (ISO) sell millions of copies of a new revision of the Standard? Well is there yet an iota of hope of avoiding the release of this "new" version at this stage?Short of an unforeseen major disaster, nope. Can anyone help? Help with what?

Question about Management Represenative ISO 9001:2000, Part 5.5.2...when it states in the new 2008 version "must be a member of the organization’s own management. Outsiders may no longer perform this important function," does that mean that the Management Rep must be on the companies payroll, as in W2? Can this person be a full time manager (32+ hrs. wk.), but a self employed contractor who receives a 1099 instead?

We are already ISO 001:2000 certified and gearing up for the new 9001:2008, so I'm beginning to read data on the new changes and/or requirements. I have found this forum helpful in interpertating the requirements, since so much can be subjective.

The interpertation of this still is a little ambigious if it doesn't specify the above requirements. Being a contractor doesn't make you any less commited, and being full time leaves little time for any other employment.

Any comments? :bigwave:

does that mean that the Management Rep must be on the companies payroll, as in W2?No. Can this person be a full time manager (32+ hrs. wk.), but a self employed contractor who receives a 1099 instead?Yes.Any comments?Look at this thread (http://elsmar.com/Forums/showthread.php?p=270472) posts # 285 through # 288. Also, check this official interpretation (http://www.tc176.org/pdf/rfi027_final.pdf).

Right folks, I had a bit of spare time so I thought I would take a detailed look at the FDIS. I have summarised the changes based on Appendix B for those that do not have access to the standard but I have also added my thoughts as to what the proposed changes mean to most certificated organisations and offered some suggested actions.

Feel free to comment on my judgement - it is difficult to try and anticipate all the different applications of the standard so apologies if I have got it wrong for you and yours. :rolleyes:

I have had a bit of feedback regarding the attachment so I have modified it slightly - hope it is useful for you.

No.Yes.Look at this thread (http://elsmar.com/Forums/showthread.php?p=270472) posts # 285 through # 288. Also, check this official interpretation (http://www.tc176.org/pdf/rfi027_final.pdf).

Sidney,

Pardon my ignorance, but would a TC176 interpretation for ISO 9001:2000 be applicable to ISO 9001:2008?

Sidney,

Pardon my ignorance, but would a TC176 interpretation for ISO 9001:2000 be applicable to ISO 9001:2008?The "official" interpretations were used as one of the sources for the "clarifications" allegedly contained in ISO 9001:2008. Since ISO themselves are on the record stating that ISO 9001:2008 brings NO new requirements and is only meant to clarify the previous edition, I don't see why previously issued interpretations would cease to be "valid".

The "official" interpretations were used as one of the sources for the "clarifications" allegedly contained in ISO 9001:2008. Since ISO themselves are on the record stating that ISO 9001:2008 brings NO new requirements and is only meant to clarify the previous edition, I don't see why previously issued interpretations would cease to be "valid".

Wouldn't you think that the 2009 revision incorporated them, making them irrelevant? I wonder if TC176 will address this?

If they were relevant before, why would they be irrelevant now? It's doubtful that the 2008 version will completely eliminate all confusion.

Wouldn't you think that the 2009 revision incorporated them, making them irrelevant? I wonder if TC176 will address this?I am used to think for myself. Read the requirements associated with "management representative" in the FDIS of ISO 9001:2008, then compare it to the current requirement. Do YOU think it is any clearer than before?