ISO 9001:2015 Cl. 6.3 Planning Changes

[Jim Green]

I really don't have a solid understanding regarding were "Planning Changes" fits.
in 9001 2008 it was 5.4.2 Quality Management System Planning.
in 9001 2015 it is 6.3 Change Management.

I am not sure what is what. In the past I thought this was "Quality Planning"

IE a new "large volume" customer or new machine is introduced. We do a "Formal Quality Plan" prior to introduction of the customer or machine.

Management gets together - Looks at our currently Quality System we go through critical things that may change or need attention. For Example.
We will install a new Stretch Wrapper for large steel coils!
We look at training - will anything Change? documents, etc.
Customer notification - Contract Review Communication Will this be ok with them
Maintenance - Infrastructure - What preventative maintenance needs done etc.

Am I on the right track??? Doing formal Quality Plans equates or meets the requirement of 6.3 Change Managment

 

[John C. Abnet]

Good day @jim green. You are not wrong, but...
I would agree, that this structure (6.3) is indeed a revision to the previous 5.4.2. Having said that, don't overthink it. It sounds as if your organization was registered to the previous 2008 and in regards to this particular clause, the change is not that significant. Purpose, resources, and consequences (risk) are the most significant verbiage changes. The intent, however, has not changed. In both the 2008 version and 2015 version, it is referencing change to the management system and its processes. This is indeed a broad statement that includes the activity you mentioned (i.e. I assume the "new machine" conducts/contributes to one of the processes identified in your management system). A project management activity associated with your example [e.g. new customer set up in ERP, assigned responsibilities, infrastructure and support planning, etc..etc...) is indeed appropriate. The actual process development, however, (i.e. APQP for automotive organizations) would fit the standard better in section 8 of the standard (for automotive example, 8.1 and 8.5 can address APQP activity).
Be well.

 

[Golfman25]

I really don't have a solid understanding regarding were "Planning Changes" fits.
in 9001 2008 it was 5.4.2 Quality Management System Planning.
in 9001 2015 it is 6.3 Change Management.

I am not sure what is what. In the past I thought this was "Quality Planning"

IE a new "large volume" customer or new machine is introduced. We do a "Formal Quality Plan" prior to introduction of the customer or machine.

Management gets together - Looks at our currently Quality System we go through critical things that may change or need attention. For Example.
We will install a new Stretch Wrapper for large steel coils!
We look at training - will anything Change? documents, etc.
Customer notification - Contract Review Communication Will this be ok with them
Maintenance - Infrastructure - What preventative maintenance needs done etc.

Am I on the right track??? Doing formal Quality Plans equates or meets the requirement of 6.3 Change Managment

In our company change management is applied to already existing processes. So if we want to change a tool, we go thru a change management process to make sure nothing gets messed up. It's a little more streamlined the a full quality plan. However, in many cases it may trigger a PPAP and customer notification.

 

[tony s]

Am I on the right track??? Doing formal Quality Plans equates or meets the requirement of 6.3 Change Managment

"Quality Plan" as specified in Clause 7.1 Note 1 of the 2008 version is a tool more aptly use during Operational Planning which is covered under Clause 8.1 of the 2015 version. The processes to be "planned" here are part of the core processes which produce the products of the organization. Changes during the planning of the core processes are to be controlled by Clause 8.1 (2nd to the last paragraph).

Clause 6.3 covers a wider range, since it is about changes that will affect the established QMS (e.g. organizational changes, acquisition of new offices/plants, mergers, changes in the organizational goals, etc.)

 

[Jim Green]

So would upgrading to a new Quality system, say ISO 9001 2015 meet the criteria?

 

[ScottK]

So would upgrading to a new Quality system, say ISO 9001 2015 meet the criteria?

Not automatically - you still need to have the procedures/processes in place to meet the requirements.
Logically, though, if you are able to be registered to the 2015 rev then you should have the process in place or you won't pass registration.

 

[ScottK]

That being said I think the steps you have in your initial post are solid - you might just need to formalize them some how.

And - as always with 2015 rev - make sure you consider risk.

How I typically do this is I have a change procedure where a change request is submitted with an overview of the change - this could be as small as a change in color of a component to as large as site move.
Then a small team (usually QA, OPs, Engineering) considers the scope of the change and if it is then routed into a full blown project (which will be assigned a project manager, etc) or can simply be tracked in the CAPA system.