The Cove Business Standards Discussion Forums
ISO 9001:2015 Cl. 6.3 Planning Changes
UL - Underwriters Laboratories - Health Sciences
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
ISO 9001:2015 Cl. 6.3 Planning Changes
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

ISO 9001:2015 Cl. 6.3 Planning Changes


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
change(s) (general), iso 9001:2015
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 5th April 2018, 09:18 AM
Jim Green

 
 
Total Posts: 45
Please Help! ISO 9001:2015 Cl. 6.3 Planning Changes

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

Sponsored Links
  Post Number #2  
Old 5th April 2018, 09:50 AM
John C. Abnet

 
 
Total Posts: 48
re: ISO 9001:2015 Cl. 6.3 Planning Changes

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.

Last edited by John C. Abnet; 5th April 2018 at 11:30 AM.
Thanks to John C. Abnet for your informative Post and/or Attachment!
  Post Number #3  
Old 5th April 2018, 11:24 AM
Golfman25

 
 
Total Posts: 1,407
re: ISO 9001:2015 Cl. 6.3 Planning Changes

Quote:
In Reply to Parent Post by Jim Green View Post

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.
Thanks to Golfman25 for your informative Post and/or Attachment!
  Post Number #4  
Old 11th April 2018, 03:34 AM
tony s's Avatar
tony s

 
 
Total Posts: 138
Re: ISO 9001:2015 Cl. 6.3 Planning Changes

Quote:
In Reply to Parent Post by Jim Green View Post

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.)
  Post Number #5  
Old 11th April 2018, 10:49 AM
Jim Green

 
 
Total Posts: 45
Re: ISO 9001:2015 Cl. 6.3 Planning Changes

So would upgrading to a new Quality system, say ISO 9001 2015 meet the criteria?
  Post Number #6  
Old 11th April 2018, 11:32 AM
ScottK's Avatar
ScottK

 
 
Total Posts: 2,708
Re: ISO 9001:2015 Cl. 6.3 Planning Changes

Quote:
In Reply to Parent Post by Jim Green View Post

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.
Thanks to ScottK for your informative Post and/or Attachment!
  Post Number #7  
Old 11th April 2018, 11:38 AM
ScottK's Avatar
ScottK

 
 
Total Posts: 2,708
Re: ISO 9001:2015 Cl. 6.3 Planning Changes

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.
Thanks to ScottK for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
ISO 9001:2015 and EMS 14001:2015 combined audit checklist rewalvh General Auditing Discussions 2 5th January 2018 12:45 PM
ISO 9001:2015 - Is Strategic Planning audited? QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13 26th August 2017 04:28 PM
What do I have to do for ISO 9001:2015 Clause 6.2 - Planning sarializade ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2 21st November 2016 03:13 AM
ISO 13485:2015 and ISO 9001:2015 divergence ? retain both under the EU MDD? SteveK CE Marking (Conformité Européene) / CB Scheme 2 20th June 2016 06:36 AM
Planning ahead for 2015 Wes Bucey Meeting and Dining Adventures with fellow 'Elsmar Covers' 0 15th January 2015 02:44 PM



The time now is 01:51 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"