Discussion in 'ISO 9001:2015 - Quality Management Systems' started by alipasa, Nov 19, 2016.
What do I have to do for ISO 9001:20015 clause 6.1
According to 6.1, risks and opportunities are to be determined during QMS planning. There are at least two types of planning i.e. strategic and operational. (See 4th bullet on page 4 of ISO/TC 176 RBT presentation as attached here).
For strategic planning, to define the strategic directions of an organization where your organization's quality policy and objectives must support - you can use an analysis tool like the SWOT analysis. See below:
For operational planning, actions to address risks/opportunities can be determined by tools like FMEA or a simple matrix like the one below (Example: Analysis of risks/opportunities at a fastfood Order Handling process):
The "actions" should be incorporated into your QMS process. Then your internal auditors should evaluate the effectiveness of these actions in achieving the "planned results". The results of the evaluation should be part of the input on your management reviews.
I forgot to attach the RBT guide of ISO/TC 176. Here it is.
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