Clause 6 of ISO 9001:2015 emphasises the need to plan actions to address risks and opportunities, change management, and quality objectives. It's a proactive approach that requires an understanding of the context of the organisation and the needs of interested parties.

This clause necessitates a review, verification, and validation of design changes done by an organization. Design changes, in other words, must go through the complete design process.

ISO 9001 Clauses Develop a process to identify, collect and analyze management system performance data and information from both internal and external sources. Implement an internal audit programme to collect and analyze customer and management system data to ensure valid results and effective performance.

Specific Focus of ISO 9001:2015 Clause 6.3 Clause 6.3 zeroes in on ensuring that changes to the QMS are carried out in a systematic manner. It emphasises that changes should not be made haphazardly but should be planned considering their potential impact on the QMS.