Lecture Summary: 

  • When some changes happen in your QMS, you need to carry them out in a planned manner
  • Changes are intended to be beneficial, but also relevant and achievable
  • The need for a change to your QMS can be determined in many different ways


Why is so important to know how to manage and control changes? By effectively handling the changes, you will gain the ability to respond quickly to changes in various circumstances. Those circumstances can be perhaps:

  • changes originating from customer demands
  • competitors
  • strategies
  • revision of regulatory requirements

What does managing changes essentially mean? It represents an action, a planning certain activity that will help change turn to reality. It also includes controlling the result after its implementation. If you fail to adequately manage changes in your QMS, it’s very likely to increase the level of possible nonconformities.

But that’s why ISO 9001 standard provides you guidelines on how to follow and implement the requirements. It aims to ensure that changes to your QMS be consistent with the strategy of your company. Plus, per the needs and expectations of the interested parties.


What to consider while planning changes:

Ask your team and yourself these few questions before implementing a change:

  • What is the purpose of the change?
  • What could be the potential consequences of the changes?
  • How are you standing with the availability of resources?
  • Are there going to be any allocations or relocations of responsibilities and authorities?

Bear in mind that every change has to have a purpose – about the reason why did you initiate them in the first place. The intensity of a change is depending upon the nature and complexity of the modified element, for example, of a process or its output. The purpose of a change implies the anticipated outcome of the change, and it guides your planned actions. Therefore, understanding the purpose of the change is critical for the planning of the change.

In case you lack the understating of the purpose, it’s more likely it will lead you to implement wrong decisions. That’s why, we recommend you ask yourself if the change necessary, which quality problem will be satisfactorily solved by its implementation, by whom the change needs to be executed, when must be carried out, etc.






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