ISO 9001:2008 to 2015 transition - How much work to change?

[TPMB4]

I've finally got top management to start looking at transition. That means I've been told to do it, well that's how it feels. We're a small company that's been certified to 9001 for over ten years without any NC. Well a handful of little ones that got cleared before the auditor was able to write his report / NC finding.

We have mature operations / product realization side. We deal with a few big customers and a few small ones. Suppliers are relatively few and mostly reliable / managed. We're a bit weak on audit (nobody who is formally trained will do it so a few ppl bungling their way through). Basically we have a system that is acceptable for 2008 version.

So how much work is the change to 2015 version really? Is it complete new QMS or just a few more bits to add?

Are we cutting it a bit fine looking at it now?

It looks to me that 4.1, 4.2, 6.1, 7.1.6, 8.3.1 & 10.1 are the clauses that don't have something equivalent in 2005 version. If it's going to be difficult to completely re-do a new QMS top down to the new standard in the time left then it doesn't look like there's that much to add to the existing QMS to get through transition. Shortcut to keep the certificate (and customers) with a new, improved QMS phased in for the next re-cert.

One more thing, next year would be the last surveillance audit before a re-cert. Does transition equate to a re-cert? What I mean is once we are certified to 2015 version next year, would the 3 year cycle be reset? I'm hoping not because it would allow time (one year) to improve the QMS before the re-cert after transition considering we've left it late to make the changes
really needed.

 

[Marc]

Have you done a gap analysis between the two standards, and between your current system and ISO 9001:2015?

 

[BoardGuy]

Yes, there are some changes that will bit you. First major one will be that all certification body audits starting in March of 2018 will be to the requirements of ISO 9001:2015. You will need to establish the context of the organization, risk management and tweak procedures as needed to address new clause requirements.

Keep your current quality manual and add a cross reference from its 2008 clause structure to 2015. Use it to address requirements were a procedure would not be appropriate.

 

[Golfman25]

A couple of things. ISO 2008 expires in Sept. So less than a year left. I would try to transition on your next surveillance audit, depending on timing.

It's not all that big to transition. The newest stuff is really high level "leadership" and management stuff -- context, risk, etc. So if your head guys/gals are on board, it would be easier.

It next depends on how much you want to align your old system with the new system. We took the opportunity to strip the old system, which had remnants from the QS days, clean. We reviewed all procedures and re-categorized and re-number them. It was more work than necessary, but allows us to start with a cleaner slate. Good luck.

 

[century_rain]

Golfman has some good points (I wish I'd had the time to go for the 'clean slate' approach!). You are cutting it a bit fine - if you don't transition by the deadline mentioned, you lose your certification.

Depending on who your certification body is, they will almost certainly have resources to help you make the change - you're not the only ones after all. Ask them to help you with gap analysis etc. Lots of focus on the new areas (context of the organisation etc.) and a bit of polish on existing aspects that have lost their shine will see you through.

 

[TPMB4]

I'd really like to clean slate it. A few issues against that. Top brass will want an easy, cheap and fuss-free transition. I would be the one to do it all (and I'm not confident I know enough to do it right, first time and in time).

Also the big factor is time. If I start with a clean slate start to it then there's no going back. I would have to be certain I don't run out of time. It is a safer option not to do this.

Another question I have. Our certification company that audits us has sent an email informing us that we need to get the transition audit started by 16th March to remain certified. It was worded as if it had been a decree passed down from their CB (or whatever the correct term is). If I think.

Actually just checked, it's not quite like that. They recommend transition audit by then but it is only that all audits after that date will only be to the latest standard. I can't imagine any organisation wanting to audit to 2008 version in the year or becomes obsolete.

 

[AndyN]

Wrong time to be "clean slate" with your QMS! Make that part of an improvement plan - maybe from doing a SWOT analysis as part of addressing the Context requirements. Golfman is accurate with his comments. Apart from addressing sections 4, 5 and 6 the rest of the QMS is very similar.

Your next visit from your CB will be a combined surveillance/recert/transition audit. There will be time added. No choice.

 

[Randy]

You're 2 years behind the power curve! Depending on what you have in place you may not have to replace squat and do no more than create a correspondance table that lines up your present system with the 2015 elements (clauses).

Whatever you do you'll need a completed internal audit & management review to 9K15 before the CB audit and you may need everything done by 1 July like all of my audit clients (1 July date allows time for corrective actions if there's a problem before the September 2018 deadline and everyone turning into a pumpkin)

 

[TPMB4]

Yes! Definitely 2 years late but not down to me. I started to work on stuff October to December 2015 when I had time free from other jobs. It's not like I could get much done until the top brass got the importance through. I gave up.

I wish I'd kept it as my side project though. I'd have had a clean slate QMS to present for approval. Unfortunately we're not fully immersed in the quality ethos. It's a cost here not a benefit. I'm a lone voice that's been silenced a few times.

Still we can't afford not to have 9001 so they're going to have to work on this to keep certification. That and finally pay out £114 for a copy of the standard. That'll pee them off!

 

[SamMiller]

I'm a recent subscriber to the portal. Just saw this post.
To start with,
a. IAF direction to CBs on timeline for transition available in their site.
b. Most CBs have fixed March deadline to carryout audits as per 2008 version.
c. Lot of free resources available in Internet. Hope you have evaluated and addressed the requirements by now.
d. If not, start with linkage matrix between 2008 and 2015 version.
e. Evaluate the gaps in new requirements.
f. All standard requirement to be addressed. The framework to be prepared and made available.
g. Small gaps in implementation any specific requirements can be issued as NC by the CB. Ensuring Improvement.

Go Ahead complete the transition. All the best.

I've finally got top management to start looking at transition. That means I've been told to do it, well that's how it feels. We're a small company that's been certified to 9001 for over ten years without any NC. Well a handful of little ones that got cleared before the auditor was able to write his report / NC finding.

We have mature operations / product realization side. We deal with a few big customers and a few small ones. Suppliers are relatively few and mostly reliable / mmanaged. We're a bit weak on audit (nobody who is formally trained will do it so a few ppl bungling their way through). Basically we have a system that is acceptable for 2008 version.

So how much work is the change to 2015 version really? Is it complete new QMS or just a few more bits to add?

Are we cutting it a bit fine looking at it now?

It looks to me that 4.1, 4.2, 6.1, 7.1.6, 8.3.1 & 10.1 are the clauses that don't have something equivalent in 2005 version. If it's going to be difficult to completely re-do a new QMS top down to the new standard in the time left then it doesn't look like there's that much to add to the existing QMS to get through transition. Shortcut to keep the certificate (and customers) with a new, improved QMS phased in for the next re-cert.

One more thing, next year would be the last surveillance audit before a re-cert. Does transition equate to a re-cert? What I mean is once we are certified to 2015 version next year, would the 3 year cycle be reset? I'm hoping not because it would allow time (one year) to improve the QMS before the re-cert after transition considering we've left it late to make the changes
really needed.