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ISO 9001: Design and Development (Part 4)

Control the processes ...

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In this series of helpful blog posts, commonly called a 101, I will be taking a look at the main sections of ISO 9001, what they are, why they are important to your business and a few tips on how to implement the standard ...

With ISO 9001 you can keep control of your design and development process!

With ISO 9001 you can keep control of your design and development process!

copyright: nexusplexus / 123rf

This 101 is looking further into Section 8.3.4 Design and Development Controls. Why is this important to my business? Well, design and development, just like any other process needs to be controlled. This helps makes sure the process is effective. If you do not check your processes are working as expected, without issues then there is every chance there will be errors along the way.

How do I do this? In order to control design and development processes (or any process for that matter), you can do the following:

  • Review – activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve objectives or the determination of efficiency.

  • Verification – confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

  • Validation – confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.

These definitions were taken from ISO9000 – Quality management systems – fundamentals and vocabulary. The standard also guides us with the following points:

  • Everyone involved with design and development understands the end user requirements and what the intended output is.

  • You can use people outside the design and development process to help you review such as other departments, sub-contractors and customers.

  • Verification can include comparing old and new designs, carrying out product or service testing and review of the documentation before release.

  • Validation can include marketing trials, testing when in operation or simulations if this cannot be done, customer tests and feedback.

  • Actions to deal with any issues highlighted need to be dealt with and reviewed to ensure effectiveness.

  • It is a good idea to record evidence of all control activities such as meeting minutes, test results and feedback so you know what was agreed or requested to be changed.

How do I manage this? There are a variety of ways you can manage this. Personally I use Teamwork to help me plan any project, including design and development ones.

You can upload results of tests such as certificates to the files area for everyone to see and all documentation is version controlled. Any issues can be raised as tasks and tracked through the system. Hours that need to be recorded for billing or internal finance purposes can be recorded so you understand how long the process has taken. There are a lot of options to suit whatever process you decide on.

Many of the companies I have worked with have found it useful to have an independent person to work with them to help control their design and development processes.

"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 ...


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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.


01858 414226