"We wanted to implement ISO 9001:2015 in our organization so based on that I would like to ask few queries stated below: Could you give me a brief about clause 6.1.1 that which are the necessary area we need address. Is it a mandatory documented process? Or we can skip this clause by only documenting Risk management/ assessment on our company objective?"
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Carlos Pereira da Cruz
Feb 20, 2018
Answer:
It is not a mandatory documented process.
You can’t skip this clause by only documenting risk management/ assessment on your company objective.
Look clause 4.4.1 f) your organization should handle risks and opportunities about your processes
Look clause 5.1.2 b) your organization should handle risks and opportunities about the conformity of products and services.
The following material will provide you information about the risk-based approach:
- ISO 9001 – How to address risks and opportunities in ISO 9001 - https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
- Risk-based thinking replacing preventive action in ISO 90 01:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
- ISO 9001:2015 Risk Management Toolkit - https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
- 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/
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Feb 20, 2018
Feb 20, 2018
Feb 20, 2018