ISO 9001:2008 Permissible Exclusions

[arin_23]

Re: ISO 9001:2008 Exclusions

I can imagine that organizations do this. However, that list of activities under 7.5.2 specifically pertains to what we refer to as "special process."

Stijloor.

What is a special process? IMHO special processes are such, output of which can not be immediately ascertained. (Painting. welding etc. are classical examples) To my understanding Blaise had mentioned :

".....This product can be treated or untreated depending on the customer's need....."

If untreated , then OK, but if treated then what??? Treatment process may definitely require validation.

In my opinion 7.5.2 can not be excluded before further elicitation.

Regards,

Arin

 

[Stijloor]

Re: ISO 9001:2008 Exclusions

If untreated , then OK, but if treated then what??? Treatment process may definitely require validation.

If this "treatment" can be inspected/checked/verified before shipment, 7.5.2 does not apply.

Stijloor.

 

[arin_23]

Re: ISO 9001:2008 Exclusions

7.5.2

Your company doesn't do approval of equipment or qualification of personnel? If I were auditing, I would definately question that one. Any input???

Qualqeen,

In my opinion your questions would fit more into requirements of 6.3 and 6.2.2 (Competence part) and to the whole organization.

In 7.5.2 the mention of equipment and competence is for carrying out the special process, but if Blaise has already disowned 7.5.2 (Jokes Apart) you can not frighten him with these issues as far as 7.5.2 is considered.

Regards,

Arin

 

[arin_23]

Re: ISO 9001:2008 Exclusions

If this "treatment" can be inspected/checked/verified before shipment, 7.5.2 does not apply.

Stijloor.

I fully agree with you sir!!!!

But just consider the simple workflow of final inspection & shipment of electroplated products.....The quality inspector okays the product after determining the plating thickness through an elcometer testing (or perhaps using NDT) as per the control plan ...records it .... the dispatcher ships it.

The "treatment" is checked/verified/inspected before shipment. but can we do away with 7.5.2?????

Regards

Arin

 

[Stijloor]

Re: ISO 9001:2008 Exclusions

I fully agree with you sir!!!!

But just consider the simple workflow of final inspection & shipment of electroplated products.....The quality inspector okays the product after determining the plating thickness through an elcometer testing (or perhaps using NDT) as per the control plan ...records it .... the dispatcher ships it.

The "treatment" is checked/verified/inspected before shipment. but can we do away with 7.5.2?????

Regards

Arin

Yes. (except for ISO/TS 16949:2002).

Stijloor.

 

[arin_23]

Re: ISO 9001:2008 Exclusions

Yes. (except for ISO/TS 16949:2002).

Stijloor.

Dear Stijloor,

I beg to differ. Electroplating is a special process and the quality of output of this process can be determined at a much later stage.

Regards,

Arin

 

[trainerbob]

Re: ISO 9001:2008 Exclusions

In regards to 7.3, I guess that I tend to think in terms of continual improvement rather than just meeting the standard. I look at ISO 9004 and see that it has almost as many references to processes as it has products. Jim, I have to agree with you that it may not necessarily apply in a job shop situation, but this particular organization has continual product ralization using the same process and they are depending on that process to work the right way at all times. How does one do that without having a good plan for product realization? They are not operating a drill press or a milling machine or a lathe.

 

[Stijloor]

Re: ISO 9001:2008 Exclusions

Dear Stijloor,

I beg to differ. Electroplating is a special process and the quality of output of this process can be determined at a much later stage.

Regards,

Arin

You said:

But just consider the simple workflow of final inspection & shipment of electroplated products.....The quality inspector okays the product after determining the plating thickness through an elcometer testing (or perhaps using NDT) as per the control plan ...records it .... the dispatcher ships it.

The "treatment" is checked/verified/inspected before shipment.

So based on this, the product including its electroplating treatment are inspected. The product is OK. So why would 7.5.2 apply?

Stijloor.

 

[Jim Wynne]

Re: ISO 9001:2008 Exclusions

In regards to 7.3, I guess that I tend to think in terms of continual improvement rather than just meeting the standard. I look at ISO 9004 and see that it has almost as many references to processes as it has products. Jim, I have to agree with you that it may not necessarily apply in a job shop situation, but this particular organization has continual product ralization using the same process and they are depending on that process to work the right way at all times. How does one do that without having a good plan for product realization? They are not operating a drill press or a milling machine or a lathe.

Having effective processes and having design responsibility are separate categories, which is the point I was trying to make.

 

[Trackterror03]

Re: ISO 9001:2008 Exclusions

Hi All,

I too have a question in relation to "permissable exclusions". We are a machine shop that supports the Petroleum/Natural Gas Industry by building/providing support equipment.

My question is this...Our customers/business does not require the use of "Contracts".
Can Contract Review be a permissable exclusion? They do not require a review of requirements, other than the product works. We do have design authority if that makes a difference.

Any input would be greatly appreciated.

Thank you