Incorporating risk-based thinking into QMS procedures

Answer:

Risk-based thinking was already a part of ISO 9001 even before the latest version has been published. Basically, the need for documenting procedures arise from the risk of emerging nonconformities within the processes.

When identifying risks and opportunities, the company needs to take actions to address them but that doesn't mean that all these actions must be documented or incorporated into procedures. Only if you detect the risk of occurring nonconformities within some of your processes and decide that additional work instructions or documented procedures will prevent them, then you should incorporate the action taken for this particular risk into your procedures.

For more information, see: Risk-based thinking replacing preventive action in ISO 9001:2015 – Th e benefits https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/