ISO9001 and Changing Your Quality Management System
Your Quality Management System must be a living and evolving system which means that over time you will make changes to the system either because of a business change, a new system, new staff or as a result of a management review of a process, it doesn't matter how you come to the decision, but you will want to change things as you go along. After all isn't that the whole point of continuous improvement?
Section 6.3 – Planning of Changes is a new section for the ISO 9001:2015 standard, it has now added the requirement for organisations to plan the changes to the Quality Management System and look at the impacts of those changes in the organisation rather than just implement things ad hoc. It actually uses the words "the changes shall be carried out in a planned manner. Shall being ISO speak for you must do this, it's a requirement.
There are 4 elements that the ISO 9001:2015 standard says you SHALL consider when planning your changes
1. The Purpose Of The Change & The Potential Consequences
You don't need to boil the ocean and spend days agonising over every change, but you do have to give it a bit of thought. Why are you making the change to the Quality Management System in the first place, is it an improvement? Will it impact our clients (in a positive or negative way)? What about our
2. The Integrity Of The Quality Management System
What they mean here is are the changes that your making still going to conform to the ISO 9001:2015 standard, for example, if you were changing your Quality Management System to remove the need to measure your quality objectives this would not be in line with the standard and so would impact the integrity of the Quality Management System.
3. The Availability of Resources
It's easy to not fully think through a change and how you will resource it. Adding or removing process or deciding to document every level of everything will have an impact on the resources of your organisation. Will it overload someone and therefore not be done fully or correctly, or will you stress the person out or will you be able to maintain the new requirements over time at a cost your business can sustain. Remember resources are more than just people, consider IT infrastructure, machines, networks to name but a few.
4. The Allocation Or Reallocation Of Responsibilities & Authorities
So you are making a change, you have all agreed that it is a good change and will improve your ISO 9001:2015 Quality Management System, great. The new standard helpfully reminds you that you need to consider who will be responsible for ensuring these changes happen and continue to operate as intended. Who has the authority to make decisions or take actions because of these changes? Have you communicated all these things
The Standard doesn't explicitly state that you have to actually record the changes or the decision process behind it but lets face it, if you don't document these things how do you remember what the decisions were, when they were made and what you decided to do?
Even if you only do this in a set of meeting minutes then do that but if you have a change process within your business why not utilise that?
The addition of the Planning of Changes clause is a requirement, it has the all-powerful "SHALL" attached to it so if you want to gain ISO9001:2015 you need to follow through on this one. When you think about it, however, this one small clause, Clause 6.3 of ISO 9001:2015 creates a fundamental tool for your business to use when making changes in the organisation. If you answer all 4 questions for any decision: Why are you doing the change and what are the consequences, does it impact your Quality Management System, do you have the resources to do this change and do you need to change any responsibilities or authorities as a result of this change, then surely you have a great process for carrying out any change in a well-controlled well thought out manner? Who would have thought ISO9001:2015 could improve your business operations!
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