Clause 9: Performance Evaluation

9.1. Monitoring, Measurement, Analysis and Evaluation

9.1.1. General

Monitoring, measurement, analysis and

evaluation to determine if the expected
results are being achieved
  What needs to be monitored and measured

 Methods for monitoring, measurement, analysis and evaluation, as

applicable, to ensure valid results

 When the monitoring and measuring shall be performed

 When the results from monitoring and measurement shall be analyzed

and evaluated

 Retain appropriate documented information

 Evaluate the quality performance and the effectiveness of the QMS

What if the organization have just started and have no evidence yet?

For example, commissioning paperwork, test results, and technical audits.

Auditing
 Review of documented information (results of monitoring,
measurement, analysis and evaluation)

 What the organization considers needed to monitor and measure

 What methods are used (key performance indicators, conformity of

the products and services, accomplishment of quality objectives,
customer satisfaction, warranty claims, complaints, etc.)