Hi,

Is necessary to revise the whole set of QMS documents (including manual, procedures & forms) to indicate the ISO 9001:2008 transition. Pls clarify.

Thanks.

Rajes.

OK, I'll advise...........If all your documentation was goodlast year, leave it alone.

If you made references to ISO 9001:2000 in any of your documentation just change that.

There are no new requirements or any deleted requirements.

Hi Rajes,
Randy is right with regard to the reference to ISO9001:2000 you can change it or you can write a one page provision that all documents using the ISO9001:2000 will be change or be revised to ISO9001:2008 if there is a major revision due to the following organizational change, document arising from audit findings (internal /external), corrective and preventive action and continual improvement. (But this will depend who is your CB, because some CB may take it as nonconformance using an obsolete standard. Other CB may look at these as a practical way of cost reduction measure)
Hope this helps.
best regards,
raffy :)

Some existing ISO 9001:2008 transition (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=9001+transition) discussion threads.

Note: This is a 'rough' search so it does include some other 'transition' threads, but it may help you a bit.

Hi,

Is necessary to revise the whole set of QMS documents (including manual, procedures & forms) to indicate the ISO 9001:2008 transition. Pls clarify.

Thanks.

Rajes.

As others have said, I would not change it. I am not requiring clients to chnage it. If you revise a document for other reasons, perhaps that would be a good time to change it.

Perhaps it would be wise to just refer to ISO 9001 in your future docuemnts, and leave off the revision year.

A notation in your doc control procedure, or quality manual about the switch (2000 = 2008) might be good, if your CB requires it.

Agree that you would be best served by referencing the ISO 9001 standard and just state in your manual that it complies with the most current published revision.

You also might want to spend some time reviewing the changes, which is very nicely explained in the appendix of the 9001:2008 document. You may find some differences in your interpretations based on the notes or the minor rewording of the requirements - there are 4 requirements where worded has been altered. It's always good to know!

-QG

OK, I'll advise...........If all your documentation was goodlast year, leave it alone.

If you made references to ISO 9001:2000 in any of your documentation just change that.

There are no new requirements or any deleted requirements.

I keep the documents the same way. However, the problem is when (external) auditor does not find any NCs he raises these doc related issues.

What if i'm going to plan for iso9001 now? it should be 2008 version, shouldn't it?

What if i'm going to plan for iso9001 now? it should be 2008 version, shouldn't it?

Yes. Basically they are the same but with some amplification and minor changes here and there in the 2008 version. Read the discussions on ISO 9001: 2008. (http://elsmar.com/Forums/showthread.php?t=30978)

As others have said, I would not change it. I am not requiring clients to chnage it. If you revise a document for other reasons, perhaps that would be a good time to change it.

Perhaps it would be wise to just refer to ISO 9001 in your future docuemnts, and leave off the revision year.

A notation in your doc control procedure, or quality manual about the switch (2000 = 2008) might be good, if your CB requires it.

ISO auditors, is it acceptable to refer to ISO 9001 and leave revision year?

Is it acceptable if I just change the revision year 2000 to 2008 by just using correction pen, without revised the revision status?

Hey Esthyl.....it's acceptable to not even refer to it at all.

I keep the documents the same way. However, the problem is when (external) auditor does not find any NCs he raises these doc related issues.

Hey Esthyl.....it's acceptable to not even refer to it at all.

Randy, do you think so? In my view, we still need to refer some sentences of Quality Manual (QM) & Quality Procedures (QP) to ISO clauses as stated in manual. Else, QM & QP will be lengthy to include all the clauses.

As Amanbhai mentioned, some external auditors might raise the transition related issues if couldn't find any NC. :)

Randy, do you think so? In my view, we still need to refer some sentences of Quality Manual (QM) & Quality Procedures (QP) to ISO clauses as stated in manual. Else, QM & QP will be lengthy to include all the clauses.

As Amanbhai mentioned, some external auditors might raise the transition related issues if couldn't find any NC. :)

Really? I only make a single reference to meeting ISO 9001 - once you've done that, why do you need to reference any clauses? And why would you do this in procedures?? I never do this, it just adds extra work that is neither necessary nor required.

And if your auditor raises doco things if s/he can't find anything else to raise an NC about, sounds like not much of a value-adding auditor. Have you considered a change?

ISO auditors, is it acceptable to refer to ISO 9001 and leave revision year?

Is it acceptable if I just change the revision year 2000 to 2008 by just using correction pen, without revised the revision status?

You could do this if you wish - if so, I'd initial it so it's clear who did it. But seriously - what value does it add if you do? And what's the risk if you don't?

Also - if your Doc Ctrl procedure doesn't permit this and you have a particularly anal persnickety auditor, he may bounce you for not following procedure.

Esthyl, there are very effective QMS's out there that meet all the requirements of 9001 without ever having referenced or used it.

Really? I only make a single reference to meeting ISO 9001 - once you've done that, why do you need to reference any clauses? And why would you do this in procedures?? I never do this, it just adds extra work that is neither necessary nor required.

Jane & Randy, sorry that I have confused you all, I should write clearly :cool:

In previous post, I have doubt to Randy's suggestion it's acceptable to not even refer to it at all. I assume the 'it' is ISO 9001. I didn't include any clause in QM / QP, but there are many ISO 9001:2000 phrases in between lines of QM / QP, eg. QM, which is a documentation ...... in relation to the ISO 9001:2000. So, I have doubt if the documents make sense if take off those ISO 9001 phrase. I hope you get what I meant now. :)

Jane & Randy, sorry that I have confused you all, I should write clearly :cool:

In previous post, I have doubt to Randy's suggestion it's acceptable to not even refer to it at all. I assume the 'it' is ISO 9001. I didn't include any clause in QM / QP, but there are many ISO 9001:2000 phrases in between lines of QM / QP, eg. QM, which is a documentation ...... in relation to the ISO 9001:2000. So, I have doubt if the documents make sense if take off those ISO 9001 phrase. I hope you get what I meant now. :)

I wasn't before, but now I'm confused. Perhaps you could post a short example to illustrate what you mean? (And yes, the 'it' = 9001)

I wasn't before, but now I'm confused. Perhaps you could post a short example to illustrate what you mean? (And yes, the 'it' = 9001)

All right, before I get everyone confused, I will try my best to make this clear. Randy, pls don't mind to rectify me if I get you wrong.

An example in my current QM:
MR shall establish, implement and maintain the quality system in accordance with the requirements of the ISO 9001:2000 standard.

My understanding with Randy's suggestion:
MR shall establish, implement and maintain the quality system in accordance with the requirements.
===========================================================
Another example in my current QM:
The Management Team, together with the ISO Committee, shall review the quality management system to ensure its continuing suitability and effectiveness and that all aspects of the quality requirements in ISO 9001:2000 Standard are fully satisfied.

My understanding with Randy's suggestion:
The Management Team, together with the ISO Committee, shall review the quality management system to ensure its continuing suitability and effectiveness and that all aspects of the quality requirements are fully satisfied.

Esthyl,

OK, thanks - now I see. (A couple of examples are worth it!!) Yes, your suggested rewrite is pretty much as Randy is suggesting, I think.

My own suggestion would be that you do put ISO 9001 in somewhere (after all, you need a commitment to it), eg: XYZ company is committed to a quality system that meets all relevant requirements including those of ISO 9001.

I say 'all relevant ...including' because you may have other internal requirements or there may be relevant legislation/regulations, etc etc. in your field. Don't use the year, you can just say 'ISO 9001' because then it's to the current one.

Then after that, I would simply refer to 'relevant requirements', you don't need to keep repeating 'ISO 9001' because you've already committed to that.

Randy is right in one way BUT not even mentioning 9001 would/might/could get some less enlightened auditors a bit twitchy, so I'd definitely do it once, where you make the commitment (eg, as in your first example below).

MR shall establish, implement and maintain the quality system in accordance with the requirements of the ISO 9001:2000 standard.

My understanding with Randy's suggestion:
MR shall establish, implement and maintain the quality system in accordance with the requirements.


Yes... but I prefer your original one because it's clearer. 'the requirements' is a bit vague.

If it were me, I'd make it even shorter (drop 'establish' because presumably you've already done that). And I don't care for 'shalls' - but that's up to you.

MR implements and maintains a quality system that meets the requirements of ISO 9001.


The Management Team, together with the ISO Committee, shall review the quality management system to ensure its continuing suitability and effectiveness and that all aspects of the quality requirements in ISO 9001:2000 Standard are fully satisfied.

My understanding with Randy's suggestion:
The Management Team, together with the ISO Committee, shall review the quality management system to ensure its continuing suitability and effectiveness and that all aspects of the quality requirements are fully satisfied.

I'd write this something like so:

The Management Team and ISO Committee review the quality management system to ensure its continuing suitability and effectiveness and that all relevant requirements are fully satisfied.

Look at what happens
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems – Fundamentals and vocabulary.

This means that ISO9000:2005 is irrelevant to ISO9001:2000

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references,only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005, Quality management systems - Fundamentals and vocabulary

Again if ISO 9000 is updated it will not be relevant to ISO 9001.

I can't agree that ISO 9000 is 'irrelevant' to 9001, Howard. I hope this doesn't sound overly picky (and perhaps I'm inferring a meaning that you didn't intend).

Au contraire, ISO 9000 is part of the 9000 suite of documents (as indicated by its number) and useful - eg, to check the definitions that are being used of terms in 9001 for example. (Which is much better than people guessing or making up their own.)

And the official line (http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9000_selection_and_use.htm) on this says "It is highly recommended that you use ISO 9000 to become familiar with the basic concepts and the language used before you adopt ISO 9001 to achieve a first level of performance. "

Now, I don't actually agree with that 'highly recommended' either - I think starting out by reading all of ISO 9000 is rather a big ask and a lot to try to digest (I wouldn't and if I should ever feel a slight urge to do so would lie down until it passed; I only use it as a reference when needed).

But I don't and can't accept that it is 'irrelevant'.

Right at the front of ISO 9000:2005

Foreword

This document (ISO 9000:2005) has been prepared by Technical Committee ISO/TC 176 "Quality management and quality assurance", Subcommittee 1, “Concepts and terminology”, in collaboration with the CEN Management Centre (CMC).

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2006, and conflicting national standards shall be withdrawn at the latest by March 2006.

This document supersedes EN ISO 9000:2000.


ISO 9000 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 1, Concepts and terminology.
This third edition cancels and replaces the second edition (ISO 9000:2000). It includes the changes accepted in the Draft Amendment ISO/DAM 9000:2004.

9000:2005 is relevant to 9001:2000 and 9001:2008...no question, no debate

By all means look forward. The standard has been published since 15 Nov 08, and no new certificates will be issued for :2000 after 15 Nov 09, as I have read. Besides, the changes and explanations all are helpful.

Bert