Design and Development is often an element of Management Systems which is either neglected or excluded from the scope of an organisations certification. This post explains whether you need a design and development procedure and how to meet the requirements.
What constitutes Design and Development?
Any new or substantially modified product or service you provide your customers with is considered a likely candidate for design and development. The only exception to this is if your product or service is already established (so has already been designed or developed). So a company selling a product which another company designed and developed would justify a d&d exclusion.
What if I subcontract the design?
The design and development exclusion is justified if you hire a designer, providing you also hire a design manager. It’s the management element that’s critical as we are dealing with management systems. Of course as a responsible company you will be expecting your design manager to operate in accordance with ISO 9001 too. Therefore even with an exclusion you may want to have a procedure available to confirm that your design manager knows what he is doing.
So why exclude it?
Well the truth is that you shouldn’t. It’s almost as much effort to exclude a procedure as it is to write one. Then, if at some point you do have to manage design you will have already done the exclusion and then have to write the procedure.
I’ve decided that I need a procedure now how do I write it?
- Understand what your customer wants. Make sure you adequately define what it is you are designing / developing. Include customer, legal, health, safety, environmental, end-user requirements as well as other requirements such as your company’s requirements. For instance you may want to insist that all output carries your company .
- Monitor the progress of the design.
- Changes to the design or the customer requirements should be documented and involve a review of all preceeding steps. For instance a change to the customer requirements could mean that you are no longer able to undertake the project.
- Define what the output of the design should be (such as drawings, calculations, supporting materials, etc)
- Verify that the design output meets the inputs (verification)
- Validate the output againsts the initial requirement (validation)