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ISO 9001: Design And Development (Part 3)

The right inputs ensure the outputs will be correct ...

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In this series of blog posts, I will be taking a look at the main sections of ISO 9001, what they are, why they are essential and a few tips on how to implement the standard ...

With ISO 9001 the right inputs ensure the outputs will be correct!

With ISO 9001 the right inputs ensure the outputs will be correct!

copyright: dolgachov / 123rf

This 101 is looking further into Section 8.3.2 Design and Development Inputs. Why is this important to my business? Well, design and development need to be planned to ensure all activities and tasks that are necessary are implemented.

"When you plan anything, this has an impact on money, people
and other resources!"

Design and development also requires good inputs, to ensure the output will be correct. If you are in manufacturing, this could be specifying a new machine. In the service industry, this could be a use case for new software development.

What do I include?

ISO 9001 gives you the following ideas of what must be considered as inputs when designing and developing your next product or service:

  • What requirements does the customer have? This can be functional or performance requirements.

  • Have you carried out any previous work that is similar in the past? Are there any lessons learned that need to be applied this time?

  • What statutory and regulatory requirements do you need to address? E.g. H&S laws, electrical requirements, food safety, etc.

  • Have you signed up to any codes of practice you need to adhere too?

  • Are there any potential areas for failure? E.g. machine going wrong, people not being trained correctly , etc.

Documented evidence of this process must be kept and ideally referred to in the project planning stage where appropriate to do so.

How do I manage this? This will vary depending on your business. You may have a simple form that outlines all the above inputs that you go through as part of a meeting, or it may be part of a more complex project management process your company uses.

There are a variety of ways you can implement this. Personally I use Teamworks to help me plan any project, including design and development ones. You can create a notebook in each project which goes through each of the suggested inputs to record them.

All documentation is version controlled so you can alternatively upload any word docs or link to any google docs you might have that are relevant. All this can be included in a project template that can be replicated for each project.

Many of the companies I have worked with have found it useful to have an independent person to work with them to help understand the requirements and how to implement them.

"Would you like to know more?"

If you'd like to find out more about ISO 9001 then do give me a call on 01858 414226 or click here to ping me an email and let's see how I can help you.

Until next time ...

Book a meeting with me at a time that suits you by clicking this link

More about Ellen Willoughby ...

I'm Ellen, Director of All About Quality and All About Productivity. I have over 20 years experience as professional in the quality world and 17 years as a practising Buddhist. As a result of this, I have a passion for improvement. in both business and personal life.


01164 422546