Need Exclusions to be shown in ISO 9001 Certificate

[Thomas Dorner]

Hi altogether,

I am a very new member of this board and I first have to say, this is a great source for Quality Management.

We have a discussion in our company about exclusions within ISO 9001.

Our company (injection/composite molding) does not create or design new products. We just create our drawings (little adds) based on customer drawings. We are creating drawings or specifications for molds or fixtures.

Our most recent Quality Manual says we exclude paragraph 7.3 because we don't create products

Now my question:

Must the ISO Certificate show that we exclude "Design and Development" respective Paragraph 7.3

Does't fit tooling engineering into 7.3

We are a little confused.

Thank you in advance for your help.

Thomas

 

[PaulJSmith]

Hi, Thomas!

Just because you are not designing the original product does not mean you can request exclusion from clause 7.3. If you are making any changes to the designs "(little adds)", then you will need to address that under 7.3.7 Control of Design and Development Changes.

...and, no, Tooling is not addressed by 7.3, only Product.

 

[Jim Wynne]

I disagree; the responsibility for 7.3.7 belongs to the owner of the design. Any changes that affect the requirements of the product need to be controlled and approved by the design owner. If that's not the case, that's a different problem.

 

[PaulJSmith]

the responsibility for 7.3.7 belongs to the owner of the design.

Well, that's my point. If you make changes to an existing design, you are now the owner of that "new" design.

Perhaps I misunderstood the OPs meaning of the phrase "(little adds)".

 

[Big Jim]

Your certificate includes your scope statement.

If you are a design company, your scope statement may read something like:

Design, Manufacture, and Sales of Widgets to the Widget Industry

If you are not a design company, your scope statement may read something like:

Manufacture and Sales of Widgets to the Widget Industry

If you also buy finished product to sell with your widgets or even other similar widgets, your scope statement may read something like:

Manufacture, Sales, and Distribution of Widgets and related products to the Widget Industry

If you own the design, and modify the design, then you would be a design company. If you own the design but do not alter it, you are not a design company.

What you do to enable manufacturing (planning for production), including the design of tooling, is not design. It fits under 7.1. It is not design of product.

I hope this helps.

 

[Jim Wynne]

Well, that's my point. If you make changes to an existing design, you are now the owner of that "new" design.

Perhaps I misunderstood the OPs meaning of the phrase "(little adds)".

Maybe some clarification from the OP would be helpful, but I can't conceive of a case where a product is being manufactured in accordance with someone else's design and the contractor has rights to change it unilaterally. You can add all you want, but in the end whomever the thing is being made for has to buy of on whatever you've done and it's their responsibility to abide by 7.3.7 if it's applicable at all.

 

[Thomas Dorner]

Thank you everyone for your statements, I really appreciate.

As a fact, we are not designing our own products. (little adds) We make certainly some requested changes (ECR) to the product, but the client only has the right to approve or to execute these changes. After the client approves, our ECR will turn into an ECO, we placed this process under the chapter 7.3.7 "Control of design and development changes".

But as far as I understand, we don't have to consider the chapters 7.3.1 to 7.3.6. Is there any disagreement?

 

[Mikishots]

Hi altogether,

I am a very new member of this board and I first have to say, this is a great source for Quality Management.

We have a discussion in our company about exclusions within ISO 9001.

Our company (injection/composite molding) does not create or design new products. We just create our drawings (little adds) based on customer drawings. We are creating drawings or specifications for molds or fixtures.

Our most recent Quality Manual says we exclude paragraph 7.3 because we don't create products

Now my question:

Must the ISO Certificate show that we exclude "Design and Development" respective Paragraph 7.3

Does't fit tooling engineering into 7.3

We are a little confused.

Thank you in advance for your help.

Thomas

You are required to identify in your manual the exclusion and justification for that exclusion; this you've done.

As far as the certificate goes, the scope statement defines what you do. If you claim not to design anything, simply do not mention design in the scope.

 

[jelly1921]

Thank you everyone for your statements, I really appreciate.

As a fact, we are not designing our own products. (little adds) We make certainly some requested changes (ECR) to the product, but the client only has the right to approve or to execute these changes. After the client approves, our ECR will turn into an ECO, we placed this process under the chapter 7.3.7 "Control of design and development changes".

But as far as I understand, we don't have to consider the chapters 7.3.1 to 7.3.6. Is there any disagreement?

You are involved in part of product design.
Before you decide to change the original design from the client, what should you do? You review the design and then make a verification, or even validation. Then you submit your ECR to your client. Your client, not you, decide whether the design should be changed or not, that is subject to clause 7.3.7. If your client says yes, then your ECR become a part of final design of product by your client!

So clause 7.3.4, 7.3.5 should be not excluded, ane even 7.3.6 if applicable. Clause 7.3.7 is suitable to you.

Jelly