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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 ...

How to address ISO 9001:2015 clause 6.3 (Planning of changes)? Could you provide risks and opportunities examples or references for small companies? Planning of changes (cl.6.3 in ISO 9001:2015) is carried out as part of the Management review by the Coordinating Council or an equivalent.  The First leader, area managers including Quality manager are part of the Council.  Decisions on changes are recorded in the Minutes as the Coordinating Council decisions (for minor changes), or implemented based on individual projects. It is expedient to describe the planning of changes in sec. 6.1 of Quality Manual . Wherein it is necessary to pay attention to the following: Sec. 6.1.a. Objective and Rationale of changes are worded by the Initiator, usually a Quality manager. The potential consequences of changes are reviewed in the form of risks and opportunities assessment for examples in accordance with MM 6.1-01-01 Actions to address risks and opportunities in QMS processes...