Types of Changes

ISO/DIS 9001:2015 introduces the terms “planned” change, “unplanned” change, and “unintended” change. What are the differences?

Planned Change

An example of this usage in ISO 9001:2015 is clause 6.3, Planning of Changes:

“Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner.”

A “planned” change is based on a deliberate decision to make a needed change. A planned change is managed to ensure it is properly implemented and achieves its objective.

Unplanned Change

An example of this usage in ISO 9001:2015 is clause 8.5.6, Control of Changes:

“The organization shall review and control unplanned changes essential for production or service provision to the extent necessary to ensure continuing conformity with specified requirements.”

An “unplanned” change is an immediate change that must be made due to an unforeseen situation. The unplanned change must still be controlled to ensure requirements are met.

Unintended Change

An example of this usage in ISO 9001:2015 is clause 8.1, Operational Planning and Control:

“The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.”

An “unintended” change is the unexpected outcome resulting from a change. Action may be needed to lessen the severity of the result.