Dear All,

We are a product design house for consumer products and we design the mechanical and electronic side of our customers. We would deliver the design material only to our customers. We may build a functional prototype for design verification purpose only. We are about to setup the Quality manual for us. We are a bit lost with the following question

1) Can I say that the prototype is for demonstration purpose only and exclude it from the QMS scope
2) If I can take it away from the scope, shall I take away the term "Development" in the "Design and Development" and what should not be claim when we make contract with our customers (ie in their terms)
3) If I cannot take it away from the scope, can I ignore the control of the purchasing (ie. Clause 7.4) of the components for the prototypes as it is not a major part of our deliverable ( our major deliverable should be our design)
4) If the making of the prototype should kept in the scope, should I consider the process to make it as "Production" (ie. Clause 7.5)

Sorry for the long question but I really need more advice on it.

Best Regards,

Alan AU

Dear All,

We are a product design house for consumer products and we design the mechanical and electronic side of our customers. We would deliver the design material only to our customers. We may build a functional prototype for design verification purpose only. We are about to setup the Quality manual for us. We are a bit lost with the following question

1) Can I say that the prototype is for demonstration purpose only and exclude it from the QMS scope
2) If I can take it away from the scope, shall I take away the term "Development" in the "Design and Development" and what should not be claim when we make contract with our customers (ie in their terms)
3) If I cannot take it away from the scope, can I ignore the control of the purchasing (ie. Clause 7.4) of the components for the prototypes as it is not a major part of our deliverable ( our major deliverable should be our design)
4) If the making of the prototype should kept in the scope, should I consider the process to make it as "Production" (ie. Clause 7.5)

Sorry for the long question but I really need more advice on it.

Best Regards,

Alan AU

Alan,

This is a first for me (others on the Cove may have seen cases like this). My first question : Does your organization do any of the Development along with your clients? During the Development of your Design, does the client come back to you with changes or errors or any other feedback? If the answer is YES to any of those, then IMHO, Development is applicable to your QMS hence 7.4 is also applicable...

Alan,

This is a first for me (others on the Cove may have seen cases like this). My first question : Does your organization do any of the Development along with your clients? During the Development of your Design, does the client come back to you with changes or errors or any other feedback? If the answer is YES to any of those, then IMHO, Development is applicable to your QMS hence 7.4 is also applicable...

Right, Ted, It is possible that some customer may demand us to change or do some touch up to the first design. So, as you said, it would become a development. I would like to know if there is any place defining the term "Development". I have a discussion with my boss that how much of "development" we are doing. Can you suggest me some reference about the definition or explaination of the term "Development". I have to gather more information to explain this to my boss. Thank you very much again.

Alan AU

Right, Ted, It is possible that some customer may demand us to change or do some touch up to the first design. So, as you said, it would become a development. I would like to know if there is any place defining the term "Development". I have a discussion with my boss that how much of "development" we are doing. Can you suggest me some reference about the definition or explaination of the term "Development". I have to gather more information to explain this to my boss. Thank you very much again.

Alan AU

I don´t have the 2005 version of ISO 9000, my 2000 version does not clarify DEVELOPMENT at all... I´ll keep looking though...

Right, Ted, It is possible that some customer may demand us to change or do some touch up to the first design. So, as you said, it would become a development. I would like to know if there is any place defining the term "Development". I have a discussion with my boss that how much of "development" we are doing. Can you suggest me some reference about the definition or explaination of the term "Development". I have to gather more information to explain this to my boss. Thank you very much again.

Alan AU

Unfortunately The guidance on ISO9001:2000 and ISO9004:2000 terminology just says "See ISO9000:2000 clause 3.4.4". And I don't have ISO9000:2000.
Maybe someone here can paraphrase that for us.

Either way - it seems that ISO9004:2000 refers to "Design and/or Development". So I'm thinking you'll have to comply with most of 7.3 and include "Developing" the prototype.

And you state that you design for verification anyway - so you're still responsible for 7.3.1-7.3.5. You may be able get out of 7.3.6 by saying "D&D validation is performed by the customer".
The standard says "where possible the validation is performed prior to the delivery or implementation...".
In your case this is not possible because you don't manufacture or implement systems.

just my :2cents:

(PS - I moved the thread to the ISO9000 forums since we're focusing on those requirements)

Unfortunately The guidance on ISO9001:2000 and ISO9004:2000 terminology just says "See ISO9000:2000 clause 3.4.4". And I don't have ISO9000:2000.
Maybe someone here can paraphrase that for us.

ISo 9000:2005 (same as ISO 9000:2000)
3.4.4
design and development
set of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or into the specification (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1)

NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process.

NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development or process design and development).

It still does not clarify anything for me.... :confused:

NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process.

I think this Note says what we need.

It's up to the organization to define what "design" and "development" mean to them.

In this case I might leave out "development" altogether and just call it the "Design Process".

Still - I think the prototype needs to be included in the process.

Businesses need new products to meet market needs and to do that, a set of activities known as new product development is set in place. The input for new product development comes from a combination of activities such as improvements, market feedback, market trends, technological changes and so on. This is not an exclusive ISO term because it was practiced long before the existence of ISO.

Once the concept of the new product is developed, the designs (both aesthetics and engineering) should proceed. Therefore design is an integral part of development and sometimes used interchangeably.

Mock ups or models are usually used to validate the aesthetic part whereas prototypes are normally used to validate engineering design as well as the complete ‘new’ product. Therefore, mock-ups, scale-models, prototypes are just methods of validation during the design stage.

All these fall within the scope of design and development.

We are a product design house for consumer products and we design the mechanical and electronic side of our customers. We would deliver the design material only to our customers. We may build a functional prototype for design verification purpose only.This paragraph describes and defines what YOUR product is and the scope of your QMS. It is ALWAYS critical to keep in mind what YOUR product is and don't get confused what the final and/or customer product is. 1) Can I say that the prototype is for demonstration purpose only and exclude it from the QMS scope From what you describe, you can not exclude the prototype from your QMS because it is part of the product you deliver to your customers. The prototype is tangible, but it is just a part of the whole product package you deliver. Since the prototype also helps the product design be validated and is part of the deliverable, the processes associated with the prototype should be part of your QMS.
2) If I can take it away from the scope, shall I take away the term "Development" in the "Design and Development" and what should not be claim when we make contract with our customers (ie in their terms)You can't, IMO.
3) If I cannot take it away from the scope, can I ignore the control of the purchasing (ie. Clause 7.4) of the components for the prototypes as it is not a major part of our deliverable ( our major deliverable should be our design) As I establish above, since the prototype IS part of your deliverable and as you procure components to make it, you can not exclude purchasing. However, keep in mind that the level of control over purchasing processes (just like any other process) needs to be commensurate with it's criticality. So, if you have simple components being purchased, you don't have to make your purchasing processes more complicated than what they need to be.
4) If the making of the prototype should kept in the scope, should I consider the process to make it as "Production" (ie. Clause 7.5) Since we establish that you have a product, with both tangible and intangible components, you MUST have product realization processes. Your design development and product realization processes get tangled, and thus the confusion.