Clause 4 vs Clause 9

1. How can we be sure we have identified all the internal and external issues?

Answer:

ISO 9001:2015 does not use the word “identify” but the word “determine” and that makes a difference. “Determine” means that it is the organization that decides what is an issue. The purpose is not to make the longest list of issues but the most relevant list of issues. The purpose is not to keep a list of issues but to look for risks and opportunities.

For example, this week, working with a client they considered:

• negative internal issue - Low negotiation capacity
• negative external issues - (Economic crisis x Increased competition in the sector x Falling public / private investment)

I ask them to see if they could match any risk from mixing those issues. They said what was clear:

– More competition, tighter margins

- Is that relevant for any interest party?

- Yes, it is for the shareholders - they answered.

- What can the company do about it?

And they pick a positive internal issue – Experience of working abroad

Decision – invest much more in commercial contacts in order to win projects abroad

Arriving at sound decisions to grab opportunities or minimize risks is what is important.

2.How can we be sure we are monitoring and measuring them effectively?

Answer:

This is not about monitoring and measuring (clause 9.1) this is still about clause 4 and perhaps clause 9.3. “monitor and review information” this is more about keeping a radar checking for relevant issues and being able to make decisions about them. Organizations are effective when they avoid or minimize risks and when they are able to grab opportunities. That can be done during management review, for example. An evaluation on the ability to:

• determine relevant issues
• evaluate them
• decide upon them (minimize or avoid risks, take advantage of opportunities)

You can find more information in the following links:

• About the radar concept, please check its use here - https://community.advisera.com/topic/examples-in-organizational-knowledge/
• How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
• Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book – Discover ISO 9001:2015 Through Practical Examples –https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/