ISO 9001:2015 Structure - Top Level Clauses

[Randy]

On the 2015 standard, I assume. So - What say you?

Yep, 1st of 4 sessions, this one was on the high level structure of 9001:2015, so nothing about specific requirements yet because they can still change

LUV-d-4UM -- Your CB will set the rules based on AB requirements

 

[Big Jim]

Re: Remote locations

No they are not in the ISO cert. The scope of our certification is just the manufacturing and distribution of products. If the ISO9001:2015 does not allow for activities conducted at remote location to be excluded from the certificate, how often will the CB visit our remote location support processes if we have 8 manufacturing facilities that is to be registered to ISO9001:2015 with an annual surveillance audit (8 times a year?)?

It is still too soon to tell. I would not expect to see much if any change on that topic though.

I have not seen much yet about what will be in 9002 (recycled old title, now the standard for the 2008 to 2015 transition).

When you really get down to brass tacks, the new standard isn't really that much different. It is mostly re-arranged and a nice ribbon added to the package.

When you look through the correlation matrix of 2015 compared to 2008, most of what you may think of as being new does have some bases from the old standard, even if it is from section one.

Risk isn't new. It is Preventive Action repackaged. At least if you believe Nigel Croft, the chairman of TC-176. Corrective Action and Preventive Action were not combined as some webinars have indicated. The wording with both recurrence and occurrence included, I believe deals with determining the extent of the issue.

 

[Colin]

Firstly, I agree with Big Jim in that much of what is in the DIS is not new but has been re-packaged. However it is my opinion that the hope is that organisations will take a different look at items such as the process model approach.

As for the exclusions, it is in clause 4.3 Determining the scope of the QMS, part of which says:

Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied by the organization.

If any requirement(s) of this International Standard cannot be applied, this shall not affect the organization?s ability or responsibility to ensure conformity of products and services.

The scope shall be available and be maintained as documented information stating the - products and services covered by the quality management system;

- justification for any instance where a requirement of this International Standard cannot be applied

My view on this is that it is more flexible than currently is the case as exclusions are limited to section 7 whereas with the DIS it could theoretically be from anywhere.

 

[Colin]

Marc

Can I exclude Design if it is being outsourced to another branch of our company?

Also will the support activities conducted at remote location be included in the annual surviellance audit by the CB? In our ISO9001:2008, the auditor does not visit these remote locations. But in our TS16949, the auditor visits our remote location (Customer Service, logistics, Supply Network Planning ) once every 3 year cycle.

Thanks.


Thank you.

I don't see any change in either requirement. You are responsible for the design - the fact that you have outsourced it does not relieve you of the responsibility for it.

As for the remote locations, if they are within your scope, they should be audited. Otherwise they are treated as in clause 8.4 of the DIS - Control of externally provided products and services - pretty much like clause 7.4.1 of the current standard.

 

[LUV-d-4UM]

Yep, 1st of 4 sessions, this one was on the high level structure of 9001:2015, so nothing about specific requirements yet because they can still change

LUV-d-4UM -- Your CB will set the rules based on AB requirements

What is the meaning of AB requirements. Where can I get a copy of that requirement? Thank you Randy.

 

[LUV-d-4UM]

Thank you Marc, Randy, John, Colin, Andy, Big Jim (did I miss anyone?) for your answers. I have been enlightened.

Also, thanks for everyone else who have provided inputs to this thread.

All your feedbacks are very valuable.

Regards,

 

[tqmexpert]

If the CB auditor needs to verify new ISO 9001:2015 related clause implications like e.g. "risk based thinking", it may well be now, that the CB auditor WILL need to verify deeper location facts finding, taking your example, IF the verification in person is the ONLY way to do so, as maybe the documentation evidence has not been provided to full extend of verification satisfaction by the headquarter. But the Stage 1 CB audit would maybe bring clarity for that question. Plus in these days, Skype meeting with location manager and team with CB auditor at headquarter Stage 2 CB audit which might be in foreign country might be possible as well now, who knows...
I recommend every organization to document explicitly the transition process to ISO 9001:2015, as CB need to verify all of the ISO 9001:2015 transition processes, so think about preparing FROM START fo rEACH of your processes something like PEAP's (Process Evaluation Assessment Reports) and such.

Hope that helps and good luck,

Robert Jasper

 

[Big Jim]

I understand that 17021 already requires that and under the 2008 standard I have audited those functions many times.

I also understand that the CBs often don't really do it. That may or may not change with 2015.

 

[SpinDr99]

We had our first surveillance audit (ever) for 2008 last month. Our Auditor advised us that under 2015 we can identify any clause which doesn't pertain to us as "Not Applicable". Yes, much more latitude now.