Hi All,
I've just been asked if I could take over the transition process for our QMS 9001-2008 to the 2015 standard, target date is our scheduled audit in Feb. I'm a little lost in the weeds at the moment, anyone able to offer any direction of key elements I need to focus on and what the major differences are?
TIA
Anders
9001 Transition to 2015 Standard
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Re: 9001 Transition to 2015 Standard
Hi Anders,
I have recently gone through the process of transition.
Ok where to start...
Do you have a copy of the 9001:2015 standard?
Have you been involved in the maintenance of the management systems previously?
Have you had any Transition training? If not, I would advise to get on a course asap. The big accreditation bodies are all running them so have a look for availability.
Next, go to the LRQA and BSI website and they have gap analysis tools to help you see what you need to do to transition.
The main areas of change are: More of a focus on top management to drive the Management System, risk based thinking (you'll need to identify risks and opportunities for the business, who are interested parties and what are the companies internal and external issues), Documents and Records are now known as 'documented information'.
Those are just a few sound bites I can think of.
Hope that helps.
Glen
I have recently gone through the process of transition.
Ok where to start...
Do you have a copy of the 9001:2015 standard?
Have you been involved in the maintenance of the management systems previously?
Have you had any Transition training? If not, I would advise to get on a course asap. The big accreditation bodies are all running them so have a look for availability.
Next, go to the LRQA and BSI website and they have gap analysis tools to help you see what you need to do to transition.
The main areas of change are: More of a focus on top management to drive the Management System, risk based thinking (you'll need to identify risks and opportunities for the business, who are interested parties and what are the companies internal and external issues), Documents and Records are now known as 'documented information'.
Those are just a few sound bites I can think of.
Hope that helps.
Glen
'Train people well enough so they can leave, treat them well enough that they don't want to!' - Richard Branson
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Re: 9001 Transition to 2015 Standard
Thanks Glen, I initially led the 9001:2008 implementation but I changed roles shortly afterwards and have been working at a new site on mobilisation projects so although I implemented it I haven't necessarily been maintaining it myself, but I do have some knowledge and experience.
I've done some research and think I have a handle on things, there is one area I'm struggling with and that is whether we have exclusions to the 2015 standard. for the 2008 version our exclusions were; 7.3 Design & Development and 7.5.2 Validation of Processing etc. The wording in 2015 section 8 has changed to Products & Service Development. We don't manufacture an end product but supply facilities services so I'm guessing we no longer have any exclusions, would you consider this correct??
I've done some research and think I have a handle on things, there is one area I'm struggling with and that is whether we have exclusions to the 2015 standard. for the 2008 version our exclusions were; 7.3 Design & Development and 7.5.2 Validation of Processing etc. The wording in 2015 section 8 has changed to Products & Service Development. We don't manufacture an end product but supply facilities services so I'm guessing we no longer have any exclusions, would you consider this correct??
- Blackstone
- Grand Shidoshi
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Re: 9001 Transition to 2015 Standard
Hi Anders,
I would agree that 8.3 may no longer be an exclusion as you provide a 'Service' to your clients, IF, you design and develop this service. You would need to show the planning, inputs, controls and outputs to those services.
edit: on reflection it may not quite be black and white so it may be worth running it past your auditor before the audit.
Glen
I would agree that 8.3 may no longer be an exclusion as you provide a 'Service' to your clients, IF, you design and develop this service. You would need to show the planning, inputs, controls and outputs to those services.
edit: on reflection it may not quite be black and white so it may be worth running it past your auditor before the audit.
Glen
'Train people well enough so they can leave, treat them well enough that they don't want to!' - Richard Branson