Using your current QMS to plan for ISO 9001 2015

[silentrunning]

But ISO gives us the minimum requirements. Correct? If we are functioning properly with a Management Representative and written procedures, are we not going to be able to continue with them? If Preventive Actions are an integral part of our Quality system and we feel a need to continue with them, will that be against the standard? This seems like it would be similar to telling an ISO company that they can’t have Risk Management documentation because it isn’t in the current standard.

 

[G_arion]

But ISO gives us the minimum requirements. Correct? If we are functioning properly with a Management Representative and written procedures, are we not going to be able to continue with them? If Preventive Actions are an integral part of our Quality system and we feel a need to continue with them, will that be against the standard? This seems like it would be similar to telling an ISO company that they can?t have Risk Management documentation because it isn?t in the current standard.

I can't imagine that if you continued with things such as preventative actions if they were completely removed from the standard you would be penalised for it. It may be that they implement a different process that is effectively supposed to eliminate the need for CA and so you may find that in making the changes the new standard enforces you might change your processes anyway. However if the necessity to have certain things (i.e. a management representative) is removed altogether then I don't see that you would encounter issues because you have decided to continue doing something that you believe (and can give evidence of) provides a benefit to the business from a quality perspective.

 

[Reg Morrison]

Andy, I find the prospect of having to make wholesale changes to a functioning Quality Management System that is achieving good results (judged by the customer) very disturbing.

ISO would like everyone to believe that changes to their most successful product (ISO 9001) is necessary in order to adequate the document to the modern quality management practices, but, make no mistake: The planned obsolescence of ISO standards exist just to generate them more money.

It does not help that consultants, accreditation bodies, certification bodies, trainers, book writers, etc. are also positioned to ca$h in, big time, whenever there is a revision to the standard.

Even the "clarifications" edition in 2008 was followed with a dictate that organizations HAD to purchase the new edition of the standard and "adequate" their quality manual to the "revised" edition, despite the fact that NO CHANGES were in place.

Doug, I am with you, but, I guess we all should "take one for the team". People need to make a living.... or we could start the "Occupy ISO 9000" Movement

 

[AndyN]

Interesting viewpoint, Reg. How will a CB "cash in" if there's been no indication that the IAF's MD5 document will be affected in anyway? Transition can be done at regularly scheduled surveillance. I'm not planning on retiring on the money I make from the upgrade...(and not planning on selling any more books, either)

 

[John Broomfield]

Apparently, Doug, the feedback they got was that there are some bits which are broken. Preventive action being one - so they are proposing removing it! As they are removing the need for documented procedures, a quality manual and...wait for it...a management representative (per today's requirement)

How'd you like THAT?

Andy,

Preventive action was specified in the CD version of ISO 9001:2015. Not, perhaps, as a separate process to invoke when:

• Setting a new objective
• Updating your management system to avoid future nonconformity
• When a trend indicated the need to act proactively

...but PA remains.

Decoupling PA from so-called CAPA may help enormously. Perhaps the definition of CA will be reworded to avoid use of the word prevent. "Removing root causes from the system to stop recurrence of nonconformity" could stop the confusion.

Practically speaking I see the System Manager role continuing if only to assist the CEO in providing a management system that helps people to determine and meet requirements.

System manuals may continue but more to help newcomers to quickly understand their management system and how it works.

John

 

[AndyN]

OK, so we're drifting off topic here. I'd like to get back to discovering HOW an organization, with a 2008 QMS can use various parts of that system to understand, make aware various management, engage them in decisions which will affect them, plan, implement and, finally, validate the changes made.

For example, today, a Quality Manual is required, but it's possibly going away. What mechanisms within a QMS exist to put this option on the table, in front of management for them to evaluate if they should keep it, pitch it or replace it with something else?

I know that, if I were a CB auditor and I didn't see some kind of plan - or the use of the various processes of the QMS - to assist in making the transition, I'd seriously wonder if management understood the purpose of the QMS...

 

[Reg Morrison]

Interesting viewpoint, Reg. How will a CB "cash in" if there's been no indication that the IAF's MD5 document will be affected in anyway? Transition can be done at regularly scheduled surveillance.

A couple of ways that cb can increase their revenues:

1. offer generic training to their clients; there is no prohibition to that.
2. offer "preliminary assessments" to the ISO 9001:2015 standard, as an extension of the surveillance and recertification audits against the ISO 9001:2008 standards.
3. Mandate stage 1 audits as part of the transition process to ISO 9001:2015 certification.

Obviously, there are other ways. There is no shortage of Innovation and creativity in cb's marketing groups.

As for your comment on the IAF MD5, let's remember that the tables contained therein do not SET audit days; they set the starting point of the audit-time determination. The injection of a new standard can (and should) justify the INCREASE of audit days. And, apparently, you are not aware of the ISO/IEC TS 17023:2013 document.

 

[AndyN]

A couple of ways that cb can increase their revenues:

1. offer generic training to their clients; there is no prohibition to that.
2. offer "preliminary assessments" to the ISO 9001:2015 standard, as an extension of the surveillance and recertification audits against the ISO 9001:2008 standards.
3. Mandate stage 1 audits as part of the transition process to ISO 9001:2015 certification.

Obviously, there are other ways. There is no shortage of Innovation and creativity in cb's marketing groups.

As for your comment on the IAF MD5, let's remember that the tables contained therein do not SET audit days; they set the starting point of the audit-time determination. The injection of a new standard can (and should) justify the INCREASE of audit days. And, apparently, you are not aware of the ISO/IEC TS 17023:2013 document.

Thanks for the ideas, Reg...

 

[Reg Morrison]

Don't mention it.

The concern is: cb's (and everybody else) will want to capitalize on this transition as early as possible. Way before the ISO TS 9002 gets released, and way before the TC 176 puts new guidance documents out. In other words, with the void of authoritative documents, opinions on how implement ISO 9001:2015 will abound.

The risk? Each cb, trainer, consultant, auditor, quality person come up with their own take on the new requirements and interpretations, leading to a myriad of confusing and conflicting approaches.

But certainly there is an opportunity...

 

[AndyN]

Well, that's partly due to the pressure from those clients who want to be "first" or whatever... As I'm sure you're well aware, there are people who would want to implement the cd content right now - go figure. We can't change human nature, and the competitiveness it demonstrates, I guess.