ISO 9001: Design and Development (Part 4)

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 important ...

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:

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

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.


If you would like to know more about anything I've mentioned in this blog post, do give me a call on 01858 414226 or leave a comment below and let's see how I can help you.