Design Control and Release Manual plus a Quality Manual

B

Brian Hunt

#1
I'm currently implementing the quality management system in an organisation which does a lot of design work for clients. As the design control and release processes are the directly value adding activities, I've decided that the creating a stand-alone Design Control and Release Manual which covers Clause 7 (Product Realisation) and clause 8 (measurement analysis and improvement) would, when translated into clear English rather than ISO 9000 speak (who uses the term product realisation in real life?) would help this manual to be used and developed as part of day-to-day operation - it should become a home for documented best practice from around the organisation.

This manual is referenced from the quality manual and these two manuals together describe the documented quality management system and cross-reference the supporting procedures and records.

Has anyone else taken this approach? How successful has it been? If anyone has translated the requirements of Clause 7 and 8 into 'normal' language then please share it with me
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 

somashekar

Staff member
Super Moderator
#5
I'm currently implementing the quality management system in an organisation which does a lot of design work for clients. As the design control and release processes are the directly value adding activities, I've decided that the creating a stand-alone Design Control and Release Manual which covers Clause 7 (Product Realisation) and clause 8 (measurement analysis and improvement) would, when translated into clear English rather than ISO 9000 speak (who uses the term product realisation in real life?) would help this manual to be used and developed as part of day-to-day operation - it should become a home for documented best practice from around the organisation.

This manual is referenced from the quality manual and these two manuals together describe the documented quality management system and cross-reference the supporting procedures and records.

Has anyone else taken this approach? How successful has it been? If anyone has translated the requirements of Clause 7 and 8 into 'normal' language then please share it with me
Hi Brian Hunt...
I see that you are forcing yourself to draft procedures more out of some perceived need than the requirement.
If you are talking ISO9001 QMS then all your "How you do" the design work for clients can be within your procedure for design and development and you can include design delivery just like the design delivery that happens within an organization. As you will have clients who begin to own the design after you deliver, most of the phases of final design approvals indeed happens with the client involvements, and at several places within the design and development procedure, you must map this.
I would say that this procedure you make will not be one, but several that meets each of the clients needs and is accordingly drafted.
For the rest, ISO does not demand a procedure, and where it demands you could have then addressed and controlled separately.
It is good to have documentation that works for you rather than make a volume, looking into all bits and details. Continue to refine them as you begin implementing the documented procedures. The Quality manual can again be as simple and as innovative as you can think of that just meets the ISO9001 4.2.2 requirements.
Just my thoughts ~~~
 
B

Brian Hunt

#6
Thanks for your comments ssomashekar

My intention is not just to do the minimum to get ISO9001:2008 certification but to achieve a better way of managing the design process. ISO9001 provides a good framework for the development of Design Operations Manual - what gets in the way, is the strange language that the standard uses. The use use of 'shall' for one example, is not the language used in business to describe how processes and procedures are managed. Terms like 'product realisation' also create a barrier to understanding.

The Design Operations Manual will be compliant to ISO9001:2008 requirements but will be written in ever day English so that it can be used as aid rather than an hinderance.
 

Marcelo

Inactive Registered Visitor
#7
There's more to clause 7 and 8 to any processes, even contracted ones. For exampl,e how is training of the people performing the process handled? How are the resources used in the process handled? I think I understand what your are tryying to to, but keep in mind that you might need to apply almost the whole of the standard.
 

somashekar

Staff member
Super Moderator
#8
My intention is not ISO9001 certification at all. A good way to manage the design and development process is to identify the stages and the interaction between the stages and the parties involved in finally getting the design and development outputs that is usable.
You will be able to see a mini ISO9001 process within the design and development activity.
As design and development deals with higher levels of personnel, I would not suggest a good rundown procedure steps aka work instructions in the design and development documented procedure.
If you are aligning to the ISO9001 system, then read the standard, understand the intent and concept and draft the procedure in your own type and style. Get correctly the "what to do" and write procedure in a way everyone within the organization understands the "How you do it" part.
 
B

Brian Hunt

#9
Yes - training, infrastructure and the other things have to be in place for an ISO9001 compliant organisation are all relevant. These will be covered in the Quality Manual - the Design and Release Manual will be for the customer value chain i.e. all the activities that add value for the customer from the actions of the design engineer.

That assumes that all staff are trained to do the job and that all the other support functions are in place - the design team don't need to know that.
 
B

Brian Hunt

#10
I went ahead and did it anyway...

Now attached - still in draft and the process of translating ISO9001 speak into something that people recognise as English is still in progress.

I would really value you comment, good and bad on this.

Cheers

Brian
 

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