To ensure that changes associated with the equipment, operation, procedures, materials or design that may affect the safety of personnel, equipment or the environment are evaluated and managed to ensure that risks remain at an acceptable level.
A system must be in place, which describes how a change is identified, analyzed, approved and implemented. This must include
Changes to regulatory requirements, codes or industry practices must be tracked and a review to determine if any of the business processes, such as procedures, equipment, training need to be modified.
Adherence with this element will be verified by determining that: