6.1 Action to address risks and opportunities (6.1.2)

6. PLANNING

6.1 Action to address risks and opportunities

6.1.2

The organization shall plan

• a) actions to address these risks and opportunities;
• b) how to:
• 1) integrate and implement the actions into its quality management system processes (see 4.4 via  4.4.1 & 4.4.2);
• 2) evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

Go to
Clause 8.1 (Operation planning & control)
Clause 9.3.2 (Management Review)


Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 5.1.2 (Customer focus)
Clause 8.5.5 (Post delivery activities)
Clause 9.1.3 (Performance analysis and evaluation)
Clause 10.1 (Improvement)
Clause 10.2.1 (Nonconformity and corrective action)