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.
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’.
Other ISO 9001:2015 Documents and Templates
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