Considering the impact that Covid-19 has had on businesses worldwide I am wondering if ISO 9001 deserves to be the most popular/implemented ISO standard after all.

In my mind risk management has always been an integral part of the quality assurance. You may be able to build a state of the art products, but what if you cannot deliver? All effort goes for nothing.

The principle of the QMS as per ISO 9001 is sound, but it lacks a comprehensive approach (or guidance at least) to risk management. Some may argue that the clause “6.1 Actions to address risks and opportunities” is the answer. I beg to differ.

At the end of this post, you will find a BONUS that will help you with the implementation of ISO 9001:2015

I remember that a few years ago, some of the business started including Brexit in their risk analysis. That was clever. Implications of the UK leaving the EU were (are) considerable and forward-thinking leaders made sure these were not underestimated.

Unfortunately, with every example of a proactive approach to risk management come many more of lesser or non-value at all.

ISO 9001 leaves risk management open to interpretation. Many companies choose the path of least resistance to tick the box. Due to the ambiguity of standard requirements, auditors have virtually no chance to enforce effective implementation. What is an effective implementation in the first place?

My question is this – should ISO 9001 be updated with a comprehensive risk management section or different standard should be promoted?

What are your thoughts on this? I would welcome your comments and suggestions.

Now I invite you to download your BONUS!

Below you will find a complete ISO 9001 Quality Manual (.PDF) that will help you improve your Quality Management System (QMS)

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