Can this be a case for Design and Development Exclusion

A

Andre Venter

Good day all

I work for a manufacturing concern, and our products are inter alia flameproof alternators and lighting for the mining industry. We are currently upgrading into I/S intrinsically safe products. So we are being audited by Sira and IECex for exporting.

Products are designed,drawings done by my bosses, owners of business,design and drawings are send to ATL (test lab)and after approval we start production.

Question : Can I exclude Clause 7.3 Design and Development ?
I am not sure who does the development, prototype etc.
 

somashekar

Leader
Admin
Re: Can this be a case for design and development exclusion ?

I have moved this above post to a new thread from the long running thread "should every management system include design". Hope this gets the fresh look and appropriate responses...
Welcome to Andre Venter to the cove ...
 

Big Jim

Admin
Good day all

I work for a manufacturing concern, and our products are inter alia flameproof alternators and lighting for the mining industry. We are currently upgrading into I/S intrinsically safe products. So we are being audited by Sira and IECex for exporting.

Products are designed,drawings done by my bosses, owners of business,design and drawings are send to ATL (test lab)and after approval we start production.

Question : Can I exclude Clause 7.3 Design and Development ?
I am not sure who does the development, prototype etc.

No. You are clearly a design company. The use of a test lab for validation does not permit you to claim exclusion.
 

atitheya

Quite Involved in Discussions
.....

Products are designed,drawings done by my bosses, owners of business,design and drawings are send to ATL (test lab)and after approval we start production.

Question : Can I exclude Clause 7.3 Design and Development ?
I am not sure who does the development, prototype etc.

NO

The organization is designing products, so you can not exclude clause7.3 Design and development. By sending the drawings to ATL you are getting the design validated (see clause 7.3.6 Design and Development Validation). You will need to find out within your organization about the design process and who & how carries it out including the development, prototype etc.
 
A

Andre Venter

Thank you Parag, however I have done some more research and found the easy answer on the official ISO 9001:2008 website.This is what they say " ISO 9001:2008 is intended to be generic and applicable to all organizations, regardless of type, size and product category.It is recognized, however, that not all the requirements of this standard will necessarily be relevant to all organizations, under certain circumstances an organization may consider the exclusion..........
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7..........to provide a product that meets customer and applicable statutory and regulatory requirements.
The products we manufacture must be flameproof and must conform to those statutory regulations only we have no customer requirements stipulating design.
The design does not alter the stat/reg requirements.
It further states " The regulatory authority has not yet revised its requirements to take ISO 9001:2008 into account, but has confirmed that it will continue not to require manufacturer's QMS's to include design.

In conclusion, we dictate the requirements and not our customers (mines). All they need to see and know from us is wether the product is flameproof or intrinsically safe, and applied in the correct zoning areas.
So the product and the customers are the deciding factor here.

We can therefore exclude clause 7.3 from our scope in the manual.
 
A

Andre Venter

Dear Readers
I am including this taken from iso.org,hoping it will help clear up and to make 7.3 easier.

Justification for exclusion

If an organization identifies requirements of clause 7 of ISO 9001:2008 that cannot be applied to its activities, the organization can consider exclusion of these requirements, provided there is valid justification.
The exclusion of requirements of clause 7 of ISO 9001:2008 is only acceptable if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.” The appropriateness of the exclusion depends on considerations of items such as:
  • Who is the customer ?
  • What is the product ?
  • What are the requirements (stated and not stated) related to the product ?
In some cases the exclusion may not be justified depending on who is the customer, and what is the product.
It should be noted that ISO 9001:2008 sub-clause 1.2 Application can be applied to individual requirements or sub-clauses of clause 7 Product realization. For example, an organization may exclude part of (f) of sub-clause 7.5.1 Control of production and service provision, if the organization has no accountability for post-delivery activities.
Sub-clause 4.2.2 Quality manual of ISO 9001:2008 states:
“The organization shall establish and maintain a quality manual that includes
(a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),..…”
All exclusions need to be expressed in the quality manual (with valid justifications) and have to be consistent with the scope of the organization’s QMS. Any publicly available documents, promoting conformance to ISO 9001:2008, should clearly state the scope of the QMS in a way that will not mislead customers and end users. This should ensure that the necessary information is available for the user to determine which categories of product and product realization processes are included. In addition, the scope of the QMS should be explicit in stating the responsibility for product design and development and other principal realization processes such as manufacturing, sales and services.
When an organization is evaluating whether it can exclude requirements from its QMS, it should carefully evaluate the impact of such exclusions from the viewpoint of its customer. If there is an impact on the customer, the exclusion would not be justified, since ensuring the conformity of delivered products to customer requirements is a key element of ISO 9001:2008.
Also, organizations considering exclusions should recognize that customers often have no knowledge of the internal operations of the organization from whom they purchase products (and really do not care how or where organizations design, manufacture or support products). The customer looks at the organization as an entity and expects all elements of the organization (e.g. design, manufacturing, purchasing, repair) to work together to ensure the conformity of its products.
 

atitheya

Quite Involved in Discussions
Dear Andre,

Thank you for your comments. You have answered your question yourself.

You know the organization, its requirements and its processes better and hence can take the best decision on the effects of such implementation to suit your organization.

My response to your original post was based on the information provided there-in and assumptions such as:

a) That the design effects your product and its quality. Generally, the design does have an effect on the quality of the product; yours may be an exception I am not aware of. Though I wonder why a company would do such activity that does not affect the final product.
b) You are implementing and wanting to demonstrate compliance to, ISO9001:2008. This now does not seem the case, as you have stated:


.......It further states " The regulatory authority has not yet revised its requirements to take ISO 9001:2008 into account, but has confirmed that it will continue not to require manufacturer's QMS's to include design.
......


The design clause is generally excluded where the design for the product is provided by the customer. It is a similar situation when a customer specifies the vendors to the manufacturing facility and hence, the facility may not be required to carry out vendor evaluation and re-evaluation.

Another example can be from construction. Case A when the organization designs the building will include design clause where-as in Case B when the building designs are provided to the company by the customer, the design clause will not be applicable.

Or if the company is not involved in design at all.

Just my :2cents:
 
D

DrM2u

... We are currently upgrading into I/S intrinsically safe products. So we are being audited by Sira and IECex for exporting.
...
Question : Can I exclude Clause 7.3 Design and Development ?
I have no idea what is the audit criteria of Sira and IECex, so I suggest that you review their criteria to evaluate your level of compliance. You are questioning the applicability of one of the clauses found in ISO 9001:2008 and other standards derived/based on ISO 9001 without clearly indicating what standard you are refering to. A little more information about your organization will enable us to give you a more accurate answer related to the applicability of ISO 9001 clause 7.3. Here are two questions of interest to me:
- Does Sira and/or IECex require compliance or registration to any international standards?
- Is your organization registered as compliant with the ISO 9001 or other similar standards?
 
D

DrM2u

...
In conclusion, we dictate the requirements and not our customers (mines). All they need to see and know from us is wether the product is flameproof or intrinsically safe, and applied in the correct zoning areas.
Oh, but I have to disagree with you on this point of view. When an organization is designing and producing a product for a market segment and not a specific customer then the 'customer' is the market itself. The target market and its customers are going to dictate the requiremetns for the product. Ignore these requirements and you risk producing something than no one or very few will purchase. When you properly identify the product requirements then they become the input in your product design, clause 7.3.2 in ISO 9001. The rest will follow from there ...
 
R

Richard Pike

"Products are designed,drawings done by my bosses, owners of business,design and drawings are send to ATL (test lab)and after approval"

This infers that ATL must approve the product design. They therefore have Design Approval - not you. I would use this (as well as the very well documented replies for esteemed Covers) to justify exclusion.
 
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