Determining the context and risks and opportunities step by step
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First step is determine all internal and external issues relevant to your organization, your products and services and your customer satisfaction. This can be done on the meeting with all relevant roles in your company. You also must decide what you want to document regarding the context and how. My advice is to establish procedure for determining the context because in this way it will be much easier for you to identify all elements of the context that need to be discussed. For more information, see How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
Next step is to decide what methodology to use for identifying and evaluating risks and opportunities, you can go with some simple methodology for small companies and simple processes or you can choose some more comprehensive methodology depending on the size of your compa ny and complexity of your processes. For more information, see Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
Then you need to identify key risks and opportunities and make plans for actions to address them, making plans includes defining deadlines, resources and responsible persons.
THe last step is to evaluate the effectiveness of the actions and this is usually done during management review.
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May 25, 2016