ISO 9001:2000 transition to ISO 9001:2008 - Do I have to rewrite the QMS?

[AndyN]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

To further explain my question. The structure of the Table of Contents of the system we have is right out of the 1994 standard, it has the twenty "elements". The 2008 is very differently structured. Take Training for instance, the 2008 puts it under Human Resources. Do I change the requirements where it is applicable or change Training to Human Resources?

That is correct. However, you've now got everyone's attention about why you're only now asking about this...
Bearing in mind it's been 10 years since ISO 9001:2000 was issued, there are many, many questions which arise, not least of which is to do with the structure of the QMS.

Are you certified by a 3rd party?

 

[hogheavenfarm]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

Scott is right-on here,
I had to revise our our version (1994) to 2008, and I rewrote all the procedures to make them more generic, anticpating future revisions (2014) as well. I removed explicit references in our procedures to the standard, and basically rewrote the procedures as well, then keyed the procedures numbers to the requirements, as well as form references. We had originally written procedures individually by department, so we ended up with 77 procedures, many of which overlapped departments. I scrapped the whole thing and wrote new procedures based on the process, overlapping the departments, and reduced the procedures to 9, again anticpating some future revisions. This made it much more manageable and easier to reference for audits.

 

[AndyN]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

Structure is not that meaningful as far as compliance. If your existing structure has all of the elements to meet the requirements of the current standard then you have to change nothing. A registrar should not care if your training procedure is not part of your human resources documents as long as the procedure is effective.

I'm going to guess your procedures reference the standard and that is causing the question... if this is the case then you will either have to change the references in the procedures to match the current standard or get rid of the references to the standard in the procedures. I would choose the latter. There is no requirement to put an ISO section on a procedure.

Are you ISO 9001 registered?

Scott - it's highly unlikely that a system built on the 94 version meets the 2000/2008 requirements isn't it? Training is a (minor) piece now - as we constantly beat the drum here, it's about COMPETENCE, so I can't agree with your assertion. Let's not overlook the fact that TC 176 - not the CBs - recommended 3 YEARS to transition to the new requirements!

 

[Paul Simpson]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

<snip>Let's not overlook the fact that TC 176 - not the CBs - recommended 3 YEARS to transition to the new requirements!</snip>

TC 176 has no real interest in the certification process :mg: but does get drawn in and ends up 'endorsing' recommendations generally pushed by IAF and ISO's CASCO committee - by and large made up of CBs and ABs. I argued strongly against this but it snuck in when I wasn't looking!

A standard is a standard and exists until it is superseded. As soon as (for example) the 2008 edition is out companies should be making the move towards updating their systems (if needed). Certification bodies could give their own 'last chance to transfer' dates (and used to in the past) but that is now the role of the IAF in order to keep a level playing field. ISO support of the transition date is just to give it extra credibility.

 

[ScottK]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

Scott - it's highly unlikely that a system built on the 94 version meets the 2000/2008 requirements isn't it? Training is a (minor) piece now - as we constantly beat the drum here, it's about COMPETENCE, so I can't agree with your assertion. Let's not overlook the fact that TC 176 - not the CBs - recommended 3 YEARS to transition to the new requirements!

Andy - I think you misunderstood what I wrote and are going off on a tanget.
The question is not about training. The way I read the OP's questions it's that he's worried that he has to re-write the entire QMS becuase 9001 no longer has the elements layed out like in 1994.

My assertion is that it doesn't matter how it's laid our as long as the requirements of the current standard are met.

As to the training tangent - I don't know about your part of the world, but in US it's still really, really common to have a training procedure to meet the needs of 6.2.2. And 6.2.2. is still colloquially referred to as "training" even though it goes deeper.

 

[AndyN]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

Structure is not that meaningful as far as compliance.

Surely, this is at the very heart of an effective management system? And, the old version really didn't have much, and as a result, people documented their silos, in procedure form...

I'm simply concerned that anyone who's asking such questions will go away with the idea that to upgrade their system, it's simply a case of renumbering their existing documentation, when clearly the task to develop a fully compliant and effective system (see Hogheaven's post) is a major undertaking...and we really can't debate what's common, can we?

That's not what I got from your post, Scott!

 

[ScottK]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

Surely, this is at the very heart of an effective management system? And, the old version really didn't have much, and as a result, people documented their silos, in procedure form...

I'm simply concerned that anyone who's asking such questions will go away with the idea that to upgrade their system, it's simply a case of renumbering their existing documentation, when clearly the task to develop a fully compliant and effective system (see Hogheaven's post) is a major undertaking...and we really can't debate what's common, can we?

That's not what I got from your post, Scott!

Andy - I answered the way I did because I feel the OP is having a document control issue and is worried that he has to renumber everything to match the current ISO layout.
Re-read the questions. He's talking about the table of contents and under what section to place what procedure.

You are going way deeper than that.

 

[AndyN]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

You are going way deeper than that.

Indeed, Scott - much deeper, because nearly every day we see somewhat similar questions which are often based on a fundamental misunderstanding of the differences between versions of the standards, misquoted requirements and so on and I'd rather not make assumptions. I've always found that getting back to basics is the most effective if not always expedient way of dealing with such situations. I'm also very cautious about readers who 'pick up' the silver bullet they've been looking for, without the knowledge or nuances of experienced implementers - such as yourself - posting them.

All will come clear once Emil has answered our clarifications as to whether they are certified etc.

 

[Big Jim]

I can't help but jump in here.

Although it is true that the structure of the quality manual and the procedures does not have to follow a specific structure, and that an organization can choose to keep the structure from the 1994 version if they wish, it would certainly lead to confusion.

Just because they can doesn't mean it is the most effective way. I certainly could not recommend it.

 

[Big Jim]

Re: ISO 9001: 2008 - Do I have to rewrite the QMS?

Hi, Emil. Despite the confusion over the standard numbering I hope the consensus is shining through - the changes to the 2008 edition are minor and don't require anything more than a review of existing systems. No rewrite required!

Don't forget that it has to be compatible with the 2008 version. I hope that is what you meant when you say it has to be reviewed. It would be more correct to say it needs to be reviewed and modified as needed to be compatible with the 2008 version. It is likely that the modifications would be light, but it depends on what is found during the review.