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 control plan.

  Answer:
Communicating changes to the customers:

• Has to be implemented in compliance with cl.8.2.4 Changes to requirements for products and services when the products/services requirements defined by the Contract, have been changed. A good practice is to notify the customer in a form of Protocol of Disagreements or Contract Amendment.
• May be conducted when provisioning serviced in accordance with cl.8.5.6 Control of changes, if, by the decision of the Organization, those notifications are ‘… necessary actions arising from the review’.

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