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Design and development in ISO 9001:2015

How do we deal with clause 8.3: Design and Development?

Not many companies are involved in design and development activities. If this is the case, we simply exclude the requirements of clause 8.3 of ISO 9001:2015 - Design and Development. But how do we handle it if the organization is involved in design and development activities? 

If the organization is involved in serious systems development activities, such as aircraft, the armaments industry, ships, software systems, etc, it would normally have a design process in place based on best practices for that industry sector. Companies involved in the defense industry will use something like the Defense Acquisition Handbook which is based on DoD Directive 5000.1 and DoD Instruction 5000.2. This handbook, however, consists of over 500 pages, and will certainly not apply as is to all other types of organizations! 


In most cases, we have a customer who wants something, tells us what he wants, we develop a solution, build it and sell it to the customer. Otherwise, we think that we know what the customer might want, design and develop it, and put it on the market (after testing it with the market, in most cases!).

But there are certain generic activities that we all tend to go through when we design and develop products. ISO 9001:2015 has a few requirements under clause 8.3:

8.3.1 - General
8.3.2 - Design and development planning
8.3.3 - Design and development inputs
8.3.4 - Design and development controls
8.3.5 - Design and development outputs
8.3.6 - Design and development changes

What the standard is looking for is a design and development process, which includes planning, clear input requirements, a controlled design and development process, product specifications that can be used to manufacture and deliver the product, and a process to control changes to the design (specifications, modifications, etc).

Various models are available, but, for the sake of a simplistic approach that would work for most purposes, let's look at a simple process for designing and developing new products. 

A typical design and development process or program consists of several phases. In many cases organizations are applying these phases, but not always in a formal, structured manner. But the basics are normally applied. Typically it can be shown as follows, coupled to the objectives of each phase and the controls that may be applied. As will be seen, the process goes beyond just developing a new product. The product must also be produced and sold to potential customers. Much can be learnt from the feedback of actual customers, which may lead to modifications to make the product more market related:

        Phase

Phase Objective

 Reviews (Controls)

Pre-concept

Commit development funds to the project

System requirements review

Concept

Product strategy development

 

Design

Demonstrate that design intent meets design goals 

System design review

Development

Release design for manufacturing

Preliminary design reviews

Qualification of the product, including validation

Critical design review

Production readiness review

 

Production

First release to the customer

Production inspection and test

Market assessment

Evaluate customer satisfaction

Achievement of business objectives

Customer feedback

Customer satisfaction measurement

The above information is only a guideline to help organizations to comply with the requirements of the standard. Obviously this has to be tailored to suit the organization's requirements. But it does give an indication of what a design and development process could address. 

Bear in mind that disposition of products after it has served its useful life is also the responsibility of the manufacturer. We can no longer turn a blind eye and expect the end-user to dispose of products responsibly. If necessary, we should instruct them on safe disposal, and, if this is not possible for the end-user to do, take responsibility for collection and safe disposal (from an environmental point of view).

In hope that this information is useful. Let me know about your thoughts in the comments below, or e-mail me at koosgouws10@gmail.com.

Koos
    


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