Exclusion of Product Realization clauses 7.2, 7.4 and 7.5

atitheya

Quite Involved in Discussions
Re: Need some advice on exclusion of 7.2, 7.4 and 7.5

Hi Paul,

:yes: Agreeing with what you have said in your post, just an observation and my opinion,

... and if you find there is an element (of whatever clause) that hasn't been met (because you don't do it) then you have an exclusion and you can write that up.

Probably you meant 'because it does not apply', because if 'you don't do it', maybe you need to do it. Remember the words 'shall' and 'as / where applicable'

Just because a company has not been implementing a certain clause/s does not mean it be excluded. There has to be proper justification to the exclusion.

:2cents:
 
A

Alan Au

Re: Need some advice on exclusion of 7.2, 7.4 and 7.5

Thanks Paul, Stijloor and Parag,

I've got your point. Thanks Paul that I got a better point of view. We will decide the exclusion clause at the last step.

By the way, I am thinking that what if our company has two lines of product, say general consumer product and toy. What if we do design only for toy but do design and manufacturing for general consumer product. Is it necessary for us to put them into two separate manuals and two separate certificates as the exclusion requirement for them are difference.

I start to feel that as that are more I know, the more insufficient of knowledge I have.

Best Regards,

Alan AU
 

Paul Simpson

Trusted Information Resource
Re: Need some advice on exclusion of 7.2, 7.4 and 7.5

Thanks to Stijloor for pointing out that exclusions can only be claimed for clause 7 (the doing bit).
Probably you meant 'because it does not apply', because if 'you don't do it', maybe you need to do it. Remember the words 'shall' and 'as / where applicable'

Just because a company has not been implementing a certain clause/s does not mean it be excluded. There has to be proper justification to the exclusion.

:2cents:
No, my point was made (fairly) carefully. The only time an element does not apply is because you do not do it.

So if you go through all your system and find (for example) that you don't do anything covered by design control then you have a justifiable exclusion against 7.3.

There are too many people that start off designing their systems by looking for exclusions (or looking at the standard clauses) rather than looking at what it is they do.

Companies do not implement the standard. They develop a management system that meet their needs and then describe it in a set of documentation (in accordance with the requirements of 9001).
 

atitheya

Quite Involved in Discussions
Re: Need some advice on exclusion of 7.2, 7.4 and 7.5

No, my point was made (fairly) carefully. The only time an element does not apply is because you do not do it.

So if you go through all your system and find (for example) that you don't do anything covered by design control then you have a justifiable exclusion against 7.3.

There are too many people that start off designing their systems by looking for exclusions (or looking at the standard clauses) rather than looking at what it is they do

Companies do not implement the standard. They develop a management system that meet their needs and then describe it in a set of documentation (in accordance with the requirements of 9001).

Completely agree with you Paul. I meant the same (wether what you do is covered by a particular clause, or, wether a clause applies to your process), just said it in a different manner.

..... Is it necessary for us to put them into two separate manuals and two separate certificates as the exclusion requirement for them are difference. .....

It is possible to put them in same manual and certification. You may go for seperate manuals if it works better for your company and similarily for certification.
 

Paul Simpson

Trusted Information Resource
Re: Need some advice on exclusion of 7.2, 7.4 and 7.5

It is possible to put them in same manual and certification. You may go for seperate manuals if it works better for your company and similarily for certification.
Why would any company want a separate manual? When you consider what should be in the manual:
ISO 9001 said:
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
So if you choose to just refer out to the procedures then you have to have:
  • a scope statement covering "...two lines of product, say general consumer product and toy. What if we do design only for toy but do design and manufacturing for general consumer product."
  • Interaction of the processes in the management system (assuming there is no problems with the two activities running side by side (and if there is then how does the company operate? :confused: )

If the company chooses to go for assessment and certification then a common system will be much cheaper to audit.
 

atitheya

Quite Involved in Discussions
Re: Need some advice on exclusion of 7.2, 7.4 and 7.5

Why would any company want a separate manual? When you consider what should be in the manual:

Good question Paul.

It is definitely more economical to go for a common system.

I have also seen examples of both kinds. There have been organisations with units spread across the nation where one organisation choses to develop one QMS for the entire and thus, one certificate covering all the units. Then there has been another organisation with corporate office certified seperately and its units certified independently each having their own QMS and thus the manual, ofcourse all being quite similar to each other (at the unit level). Then there has been an organisation which has had its training division with a seperate QMS and certification. All are doing well and effectively. There are quite a number of examples and everyone had their own reasons, be it effectiveness, top management's decision, centralisation, decentralisation, control over processes, consultant's advice, certification body's advice etc.

One of my own clients was considering developing seperate manuals, and certifications for individual units while we kept advising them for combined certification. Finally they went for a combined certification. Not only this, subsequently they grew into a group of four companies and got themselves recertified as a group under one QMS and certification.

Also to quote from ISO/TR 10013, 'Guidelines for quality management system documentation', 4.4 Quality Manual, 4.4.1 Contents, - 'A small organisation may find it appopriate to include the description of its entire quality management system within a single manual, including all the documented procedures required by ISO 9001. Large, multinational organisation may beed several manuals at the global, national or regional level, and a more complex heirarchy of documentation.'

Sometimes an organisation also decides to develop different levels of manuals (or as they may call them), one Quality Manual for the whole organisation and then departmental manuals including matters relevant to the department (Quality objectives, departmental organisational chart etc) and may also include the departmental procedures.

As you said earlier, look at what they do.
 
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Paul Simpson

Trusted Information Resource
Re: Need some advice on exclusion of 7.2, 7.4 and 7.5

Sometimes an organisation also decides to develop different levels of manuals (or as they may call them), one Quality Manual for the whole organisation and then departmental manuals including matters relevant to the department (Quality objectives, departmental organisational chart etc) and may also include the departmental procedures.

As you said earlier, look at what they do.

I am aware of what the guidance says. I simply asked why the same organization would want to have two quality manuals for two processes.

They can have as many procedures, local manuals, call them what you will that describe the management system at the local level but again:

- Why would they have two quality manuals just because they have two core (customer facing) processes? :confused:
 
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