Change is present in several ISO 9001 clauses

Answer:
Clause 6.3 is about planning how to handle changes without breaking the quality management system. For example, when an organization moves to a new location or introduces a set of new production equipment it is necessary to plan the introduction of these changes in a controlled way. In your case, it could be the introduction of a new production line for sterile or wanting to get approval to export to South America a product developed for the European market. Both would require new procedures and practices.

Clause 8.1 is a general clause. Other clauses of section 8 have more precise references to changes. It can be, changes to planning, changes to the design, changes to raw materials, changes to people, changes to … For example, your production planning could be changed due to an urgent need in the market for a product currently out-of-stock.

Clause 8 .5.6 is about changes in the day-to-day of the organizations by the most varied reasons. For example, due to a delivery delay, your organization will use in production a raw material from a different supplier. Due to an equipment breakdown, production will be done at a different production line.

The following material will provide you more information about planning and controlling changes:

- ISO 9001 – QMS Change Management in 7 steps - https://advisera.com/9001academy/blog/2016/11/29/qms-change-management-in-7-steps/
- Free online training ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/