8. Managing output data

ISO 9001 does not include any requirements for records relating to the methods and tools used, or their results (analysis, assessment).

However, some of the documented information required by ISO 9001:2015 is linked to (or derives from) the risk/opportunity approach:

• quality objectives (§ 6.2.1);

• evidence of results, measurements, monitoring and analysis of the performance and effectiveness of its QMS (§ 9.1.1);

• the output of the management review, which must include a review of internal and external issues and the effectiveness of actions taken to address risks and opportunities (§ 9.3.3).

It is through these elements that the reality of the risk and opportunity approach can be demonstrated. So, at the very least,...