Q1: What are considered Significant Changes?
A: Significant Changes are items included in a quality management system that may affect the capability of the management system to continue to fulfill the requirements of the standard used for approval. These include, for example, changes relating to:
a. The legal, commercial, organizational status or ownership,
b. Organization and management (e.g. key managerial, decision-making, or technical staff),
c. Contact address and sites,
d. Scope of operations under the approved management system, and
e. Major changes to the management system and processes.