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How to Address Risks & Opportunities in  ISO 9001:2015 ?
(by Choong Ewe Lee)


One of the major changes of ISO 9001:2015 is, the concept of Risk Based Thinking. This concept has specified requirements that we have to clearly understand the context of their organization, and determine the risks & opportunities, as the basis of QMS planning. The findings of risks & opportunities analysis will serve as the basis to plan and implement the Quality Management System (QMS) processes, and also to determine the extent of documented information required.

So, what are the related clauses of Risks & Opportunities in ISO 9001:2015 ?


Different consultants will classify them differently. We would recommend to address the 4 key clauses in the Risks & Opportunities Procedures as below :
•    Understanding the organization and its Context (Clause 4.1)
•    Understanding the needs and expectations of interested parties (Clause 4.2)
•    Action to address risks and opportunities (6.1)
•    Planning of changes (6.3)

How to conduct Risks & Opportunities in ISO 9001:2015 ?
•    Design a Risks & Opportunities Format.
•    Identify the Risks & Opportunities based on external context of your company.
•    Identify the Risks & Opportunities based on internal context of your company.
•    Identify the Risks & Opportunities based on the needs & expectations of interested parties.
•    Analyse & prioritize the effects of Risks & Opportunities specified.
•    Address the additional actions to be taken for those with high priority number.
•    Evaluate the effectiveness of actions taken.

The most important point here is, the action to address risks & opportunities shall be able to link to the current QMS & its processes. And, this will be treated as the basis to develop the Process Diagram (Figure 1 of 0.3.1 Process Approach). We will elaborate more in the next issue.

Next Issue:
“Do we need to develop the Turtle/Process Diagram ?” is a new topic in ISO 9001:2015 version.

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