Permissible Exclusions - ISO 9001

[KWalls - 2008]

Hello everyone,

I work for a small CNC machining company and am responsible for our implementation of ISO 9001: 2000. We do not "design" any of the products we produce. The items that we produce come from blueprints that are provided by our customers. At no point in the job (item that we manufacture) are we allowed to stray from the blueprint. Therefore, I feel that we should write a "Permissible Exclusion" for the design and development section of the standard.

My question is: Knowing that, would that be allowed? AND, how do you go about writing an exclusion for that?

I appreciate any response! And apologize in advance for seeming clueless. :truce:

 

[Sidney Vianna]

Re: Need an opinion on Permissible Exclusions.

Hello everyone,

I work for a small CNC machining company and am responsible for our implementation of ISO 9001: 2000. We do not "design" any of the products we produce. The items that we produce come from blueprints that are provided by our customers. At no point in the job (item that we manufacture) are we allowed to stray from the blueprint. Therefore, I feel that we should write a "Permissible Exclusion" for the design and development section of the standard.

My question is: Knowing that, would that be allowed?

Yes.

AND, how do you go about writing an exclusion for that?

In your Quality Manual, you would include a blurb such as: "...CAL Precision does not engage in designing, developing or changing the design of the products we manufacture. Thus, our QMS does not encompass product design and development processes and, therefore, paragraph 7.3 of ISO 9001 is not applicable to our business..."

 

[Cari Spears]

Re: Need an opinion on Permissible Exclusions.

Hi, KWalls - welcome to the cove.

I posted our exclusions in this thread:

Can you show me some examples for rejecting item from 7.1 to 7.2?

 

[KWalls - 2008]

Re: Need an opinion on Permissible Exclusions.

I am grateful for your quick reply to this subject. As a nubie, it is overwhelming and forums like this are a Godsend. Thank you Sidney, very much! (BTW, I think that is a fitting title that you have there at the bottom of your posts... lol!) I also appreciate your response Cari! That gives me an idea to work from. Many, many thanks!

KWalls

 

[RoxaneB]

Re: Need an opinion on Permissible Exclusions.

In addition to Sidney's verbage, I would also add something to the effect that the exclusion does not adversely impact your organization's ability to meet your customer's requirements.

 

[KWalls - 2008]

Re: Need an opinion on Permissible Exclusions.

In addition to Sidney's verbage, I would also add something to the effect that the exclusion does not adversely impact your organization's ability to meet your customer's requirements.

That definitly is something that we will need to include. Thank you for your input!!!

 

[KWalls - 2008]

Re: Need an opinion on Permissible Exclusions.

Okay, so now this begs the question... (and forgive my stupidity, please)
Do I exclude certain sections of the QMS like Planning of Product Realization and all the forms/procedures that go along with it? What is okay to exclude after you write a permissible exclusion?

I do not have a copy of the standard. I am going by a template that I purchased from a company that supplies them for a do-it-yourself implementation. Would it be adventageous to purchase a copy of the standard?

 

[SteelMaiden]

Re: Need an opinion on Permissible Exclusions.

Okay, so now this begs the question... (and forgive my stupidity, please)
Do I exclude certain sections of the QMS like Planning of Product Realization and all the forms/procedures that go along with it? What is okay to exclude after you write a permissible exclusion?

I do not have a copy of the standard. I am going by a template that I purchased from a company that supplies them for a do-it-yourself implementation. Would it be adventageous to purchase a copy of the standard?

I'll start with your last question, yes by all means, buy a copy of the standard. You might also want to think about an implementation class. They can truly be helpful.

Planning of product realization is not the same as design. Planning starts hmmm, well, from the beginning. What is the product, and what are the steps to producing it. Determining requirements, scheduling, production, inspection, storage, protection, shipping (and many other steps) Maybe even how you lay out new process equipment. You need to show that you have taken some sort of orderly planning process to ensure that you meet the customer's requirements.

 

[KWalls - 2008]

Re: Need an opinion on Permissible Exclusions.

I am going to look into that right now!

 

[RoxaneB]

Re: Need an opinion on Permissible Exclusions.

Adding on to Steel's advice, the approach that comes in helpful in determining whether or not to exclude is if it necessary to meet your customer's requirements.

My organization, for example, does not have a sales department on-site. When we transitioned to ISO 9001:2000, we were excited (or should that be hopeful) that we were allowed to exclude customer-related processes. Unfortunately, after some serious thought and a discussion with our Registrar, we ascertained that Sales was indeed part of our process and unable to be eligble for exclusion. Why? Because they are the point-of-contact with the customer and develop our production schedule. If Sales is excluded, how ever would we be able to explain how we know what to make and when to make it (customer requirements, delivery, etc.)?

When it came to production and service, we took the stance that service applied to installation and warranties and stuff like that. We don't install our final product, so we excluded that portion of the clause.

And so on...exclusions require two lines of thinking. (1) Really look at your processes, the inputs and the outputs. (2) Think outside the box.