ISO/DIS 9001:2015, 6.1

Clause 6 of ISO/DIS 9001:2015 has three sub-clauses:

6. Planning for the Quality Management System
6.1 Actions to Address Risks and Opportunities
6.2 Quality Objectives and Planning to Achieve Them
6.3 Planning of Changes

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 6.1 and highlights the changes from ISO 9001:2008. Other articles in this newsletter describe clauses 6.2 and 6.3.

6.1 Actions to Address Risks and Opportunities
6.1.1

When planning for the quality management system, consider issues referenced in clause 4.1, and the requirements referenced in 4.2.

Determine the risks and opportunities that need to be addressed to:

  • give assurance that the quality management system can achieve its intended results;
  • prevent, or reduce, undesired effects;
  • achieve continual improvement.

6.1.2

Plan:

  • actions to address these risks and opportunities
  • how to:
    • integrate and implement the actions into its quality management system processes (see 4.4);
    • evaluate the effectiveness of these actions.

Take actions to address risks and opportunities that are proportionate to the potential impact on the conformity of products and services.

Note: Options to address risks and opportunities 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.

Changes:

  • This is a new clause on risks and opportunities
  • Replaces old clause 8.5.3 on preventive action
  • Need methodology to identify and address risks
  • Could decide to accept risk and take no action

Note that ISO 9001:2008 in its requirement clauses 4 through 8 does not mention risk or risks. ISO/DIS 9001:2015 in its requirement clauses 4 through 10, mentions risk or risks 14 times.