6.3 Planning of Changes - ISO 9001/AS9100
Planning Significant Changes
Change management is a fully realized concept in ISO 9001/AS9100/AS9120. This clause specifically addresses planned changes. Some of these events could include purchasing of new equipment, hiring of new employees, adoption of new methods, significant change in supplier management, or the application of new regulations. While the standards do not require retained documentation of the changes, it would only be beneficial to keep record of them to show that the changes occurred.
Every change made should be deliberate and planned, however the standards focus on significant changes. The standard requires organizations to consider the significant changes,ones that could be problematic if they are not managed properly. It is up to the designated leadership team to decide what changes must go through a change management process. The standard defines “change management” as addressing four different elements: the purpose of change and its effects, integrity of Quality Management Systems, availability of resources, and allocation of responsibilities and authorities.
Requirements
- Consider changes and their possible consequences.
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- Understand the changes and why they are being made. The third element required by this standard is assessing possible ramifications. This is the speculation of what may happen; thus, these ramifications can be positive or negative.
- Consider how the QMS will be maintained during the change. The point of this step is to ensure that QMS facilitates the change rather than being implemented later.
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- What parts of the system will be affected by the change? Some typical QMS considerations include: maintained documentation, retained documentation, training, infrastructure, and monitoring and measurement.
- Consider resources that will be needed for the change.
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- Plan out which resources are necessary, with clear description of specifications.
- Plan how the resources will be obtained.
- Consider responsibilities and authorities related to change.
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- The organization must define who has responsibility for each change and who has authority. Clear accountability will help ensure that the change is implemented as intended.
A successful and continuously improving company is always making changes, and it is important to plan for those changes. However, In order to make it effective and viable, these plans need to consider the above four aspects of change management.