Risks and opportunities

Answer:

Identifying risks and opportunities can be done by using several different methodologies and it depends on the size of the company and complexity of its processes. However, the standard does not requires organization to document the methodology. For initial stage and introduction of risk-based thinking in an organization it is better to apply some more simple tools such as SWOT analysis or you can simply gather all relevant people in your organization and arrange brainstorming session regarding risks and opportunities in your organization, and the minutes from that meeting can be the evidence that the risks and opportunities are identified.

Risks and opportunities to be identified are the ones emerging from the context of the organization and you need to consider all internal and external issues related to your quality management system.

Plans for addressing risks and opportunities can also come in different forms, it can be q uality objective, some new or updated procedure or work instruction or introduction of some new processes and technologies.

For more information, see:

- How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/05/26/how-to-identify-the-context-of-the-organization-in-iso-90012015/

- Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits https://advisera.com/9001academy/blog/2015/09/08/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/

- Methodology for ISO 9001 Risk Analysis  https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/

- The Role of Risk Assessment in the QMS https://advisera.com/9001academy/blog/2014/01/07/role-risk-assessment-qms/