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Documentation and the process approach

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Guest user Created:   Apr 09, 2018 Last commented:   Apr 09, 2018

Documentation and the process approach

"I am new to ISO with little experience. Our company has various departments which all have individual procedures and work instructions. I am not sure under which clause these procedures and Work Instructions must fall? A consultant assisted us and created a Clause 11 (Procedures), clause 12 (Work Instructions) and clause 13 (Flow Charts). According to my understanding ISO 9001 has only 10 Clauses so i'm confused. Please assist.?”
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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 Apr 09, 2018

Answer:

You wrote about departments and ISO 9001 clauses. I recommend you try another approach. According to ISO 9001:2015 you should have used the process approach. So, you should have developed a map, a model of how your organization works as a set of interrelated processes. You can number each process as 01, 02, and so on.

When you look into two procedures you can ask: where are these two procedures most used? In process 2. Then, number the procedures as 2.1 and the other as 2.2. Then look into a work instruction and ask: this work instruction is most related to how to make something related wit h procedure 2.1. Then you can call it work instruction 2.1.1 (the first work instruction related with procedure 2.1)

For example, your organization has a process for buying materials. You can describe the process in one or more procedures like: 3.1-To order material; 3.2-To receive material. 3.1 is mostly about clause 8.4 and 3.2 is about clauses 8.4; 8.5.2; 8.5.3; 8.5.4; 8.6 and 8.7. Everything should be around the process approach.

The following material will provide you information about the process approach and documentation numbering:

- ISO 9001: The importance of the process approach - https://advisera.com/9001academy/blog/2015/12/01/iso-9001-the-importance-of-the-process-approach/
- How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
- 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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