Find out all about ISO 9001:2015 Clause 6.3 Planning of Changes

In this video, I’m going to cover clause 6.3 Planning of changes, which is the last subclause in clause 6 Planning. It’s not a huge clause, however, I’ll still break it down and turn it into something you can all understand. You’ll then be able to apply this to your own organization's system and understand what the requirements will look like for you. No more guessing! 

Ok, let’s get started! It makes sense that the final subclause is referring to change. Now that we’ve done all of this work, what happens when something changes?  

This clause starts off with stating that

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4)

You can see that it refers to clause 4.4. I believe it must refer to clause 4.4 as this is the overarching quality management system and its processes. And if the change is to be carried out in a planned manner, then the best place to start is in your own quality management system. I did cover the requirements of clause 4.4 in a previous news article, check it out here

Now, to extend on this planned manner more, I like to say that this planned manner can be to use the tools that you’ve already used to get to this point to start with. So, if there has been a change identified go back to clause 4.1 and clause 4.2 and use the tools you used to identify the internal and external issues (maybe that was a SWOT analysis?) and then revisit the needs and expectations you identified for clause 4.2 to see whether these may have changed also.

Then, does this mean that the scope of your system will change? Does this influence the boundaries and applicability of your system as you determined in clause 4.3?

Then it moves on to your policy in clause 5.2 – does your overall intent and commitment change now also? Don’t forget roles, responsibilities, and authorities in clause 5.3 and then another big one is ... Does this change, impact the quality objectives that you set in clause 6.2?

Can you see that all of the processes you have already gone through may be impacted by this change, so just use exactly what you did to identify these in the first place, to revisit and determine what, if anything needs to change? This is a planned manner. Use the tools you already have in your system.

This clause then goes on to state that

The organization shall consider:

a) the purpose of the changes and their potential consequences and;

b) the integrity of the quality management system.

I already mentioned some potential consequences previously with reference to changes in the work you’ve already done to identify changes in external and internal issues, needs and expectations of interested parties, the system's scope and policy as well as the quality objectives. What does this change influence in the business and in the quality management system?

Then the organization also has to consider point

c) the availability of resources and

d) the allocation or reallocation of responsibilities and authorities.

When there is a change to your product or service or any of the other influences another question to ask yourself is ... do we have the available resources? Or do we need to hire someone with a specific skill set – or can this be outsourced?

Resources might also be equipment – do you have the equipment to facilitate the change – particularly if it’s a new product or if it’s a service it could be software that is required to manage the change. Then once you’ve sorted out your resources does this mean there is a change in responsibilities and authorities? Remember this from clause 5.3 – if you need a refresher check out the video on ATOL.tv?

You can see that there isn’t a requirement for a completely separate change management procedure or team to handle this. Always look at the tools you already have and have already used to develop and maintain your quality management system.

Change is a good thing and it is probably the only constant thing that you will see in your system.

If you have an agile and robust system it will manage change itself with the tools and processes that you have built.

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