Organisations are required by ISO 9001:2015 to determine:

1. What needs to be measured and monitored,
2. Methods to be employed for the monitoring, measurement, analysis and evaluation needed to ensure valid results,
3. When the monitoring and measuring must be carried out,
4. When the results obtained from the monitoring and measurements taken shall be both analysed and evaluated. Note: Organisations are also required to evaluate the performance and the effectiveness of the management system and retain appropriate documented information (records) as evidence of the results of monitoring, measurement, analysis and evaluation.

Comment:

Note the detailed requirement in this clause to identify and implement the What, How and When.

Monitoring, measurement, analysis and evaluation of performance is the very heart of the 9001 standard and is the crucial part of the Plan, Do, Check, Act cycle. In the 8.0 series of articles we looked at the “Do” operational aspects of the management system. We are now concerned with monitoring of the performance of the organisations management system and its processes. IE the “Check”.

Whether we are considering the effectiveness of the management system through the results of internal audits or the output of processes via Statistical Process Control (SPC) and customer feedback, the resultant Key Performance Indicators are crucial in determining if results are in line with expectations, and if not, afford the opportunity to make improvements.

What to measure?

The planning aspect is a crucial part of the process and great care should be taken in identifying what is important now in the business for it to monitor and control. EG:

New manufacturing processes might require monitoring via Statistical Capability studies / Control Charts and a high frequency of monitoring and sampling initially as confidence is gained.

Organisations undergoing restructuring may as part of their change control process (see article 8.5.6) wish to introduce temporary monitors and increased systems and / or process audits, to ensure that quality of services provided is not adversely affected during the transition phase.

A risk based approach will help to identify the What, How and When, but it is also important to focus on “the vital few” when planning monitors and measures to implement. Too many organisations suffer from information overload resulting in ineffective analysis and evaluation and as a result, missed opportunities to improve. Lagging (reactive) Indicators are often used as a starting point to determine which processes require attention.

Once processes are embedded and proven to be working effectively, a further review should be carried out and metrics re-structured accordingly. Some ongoing Key Performance Indicators (KPIs) will still need to be maintained to confirm stability however. Leading (predictive) indicators can also be used to monitor further opportunities to improve.

At an operational level these metrics should be documented or referenced in the relevant Control or Quality Plan if you use these forms of documentation. Turtle diagrams and Process Flow Diagrams if used as part of management system processes mapping, can be used to show not only the expected outputs but also the measures to be used to monitor performance of the process.

At a strategic level, as a minimum, Key Performance Indicators should form part of the inputs into the planned management review process. (See article 9.3.)

Audit Check:

Auditors will wish to confirm that the appropriate what, how and when to measure, have been determined and that as a result, processes are in control at all levels in the business. IE trends and improvement opportunities identified.

Be prepared to show documented evidence (records) to demonstrate that evaluation of the results of monitoring and measurement has taken place. IE not just their collection and analysis, but also appropriate actions where required.