Management of Change
Question: 1. Which ISO 9001:2015 clause refers to the change management in the Process ? Answer: Speaking about ISO 9001:2015 clauses that refer to the Change in process, first of all we should point out the clause 6.3 Planning of changes . This clause even has a reference to clause 4.4 on the process approach implementation. The requirements of cl.6.3 apply to all QMS processes . In addition to that, ISO 9001:2015 contains requirements to manage changes in particular processes: 8.2.4 Changes to requirements for products and services – relevant to ‘Contract analysis’ process. 8.3.6 Design and development changes – relevant to ‘ Design and development of products and services ’ process. 8.5.6 Control of changes – relevant to ‘ Production and service provision ’ process. Question: 2. What are the minimum requirements to notify a customer regarding the change? Change include: change in process change in machine deviation from approved ...