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Change is present in several ISO 9001 clauses

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Guest user Created:   Feb 25, 2019 Last commented:   Feb 25, 2019

Change is present in several ISO 9001 clauses

"I want to know the detailed differences between ISO 9001 2015 clauses No, 6.3, 8.1 and 8.5.6 supported with some examples in pharmaceutical industries (Nonsterile)....”
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Feb 25, 2019

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://training.advisera.com/course/iso-9001-foundations-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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