Risks and opportunities and context of the prganization

Answer:

Context of the organization and the risks and opportunities are closely related. Without proper definition of context of the organization there can be proper identification of risks and opportunities. The best way to start is to determine context of the organization and all its elements. 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 determine methodology for identification and evaluation of risks and opportunities. At this moment, there is lot of discussion regarding the methodology and the most frequently mentioned methodology is FMEA. However, I thing that FMEA can not cover the entire scope of the clause 6.1 since the requirement is to address risks and opportunities emerging form the context and FMEA and other methodologies are focusing mostly on processes. So, I suggest to use more simple methodologies such as SWOT analysis and involve as many relevant people in the company as possible. In this way you will ensure that all elements of the context are considered during identification and evaluation of risks and opportunities. For more information, see Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/

Than you need to make plans to address risks and opportunities and this includes dedicating resources, assigning responsibilities and defining deadlines for the plans realization. The final step is to evaluate effectiveness of the actions taken and this is usually done during the management review.