Friday, November 11, 2016

Management of Change

1. Which ISO 9001:2015 clause refers to the change management in the Process ? 

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:
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.

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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