Monitoring and measurement of a QMS based on ISO 9001
Domain 5 is clause 9 plus the measurement controls elsewhere in the standard. The exam tests whether you can separate monitoring from measurement, audit from inspection, and management review from a status meeting.
Monitoring, measurement, analysis (9.1)
9.1.1 requires determining what must be monitored and measured, the methods, when, and who analyses the results. 9.1.2 requires monitoring customer perception, using methods agreed with the customer where appropriate - complaints, surveys, repeat orders, win/loss data. 9.1.3 requires analysis of conformity, satisfaction, process and product performance, supplier performance, audit results and improvement needs, and evaluation of risks and opportunities.
Internal audit (9.2)
The audit programme is planned considering the importance of processes, changes affecting the organization and previous results. Each audit needs criteria and scope; auditors must be objective and impartial, so nobody audits their own work. Results are reported to relevant management, and the programme is itself a QMS process with records.
Management review (9.3)
Inputs are prescribed: status of actions, changes in issues and interested party needs, performance trends, resource adequacy, risks and opportunities, improvement opportunities. Outputs are decisions and actions on improvement opportunities, QMS changes and resource needs.
Worked example
A logistics firm schedules audits by process risk: order handling annually, warehouse every six months. The warehouse auditor comes from sales, not the warehouse. A finding on stock rotation is reported to the operations manager and enters management review as a performance trend, producing a decision to change the shelf-life rule and add a scanning control.
Traps
- Running internal audits as checklist walk-throughs with no criteria, scope or record.
- Management review minutes containing no decisions or resource commitments.
- Equating customer satisfaction with the complaint count alone.