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ISO 9001:2008 section 4.1e monitor, measure and analyse these processes.

ISO 9001:2008 clause 4.1e requires you to monitor and measure your QMS processes. It's interesting to note that ISO 9001:2008 clause 8.1 states '...organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed...'. This in regard to the quality management system and processes therein as determined by clauses 4.1 a-d. There is an immeasurable number of ways to monitor and measure QMS processes at various levels throughout the process cycle. These can be as diverse as simple tick sheets to external audits. The important thing to bear-in-mind is that collected data should, where necessary, trigger appropriate actions to promote improvements. Therefore, the analysis of QMS processes may be done through a review of measurement and monitoring of data collected for key performance indicators, performance targets, period reports, product tolerance breaches, process checks and the like. These reviews must identify opportunities to improve the product or service supplied. Such analysis of data may also be used as an input into higher level management reviews. This in order to provide information for improving the performance of the organization by top management.

ISO 9001:2008 section 4.1f implement actions necessary to achieve planned results and continual improvement of these processes.

Key words planned and continual improvement.

Given the general theme that runs through section 8. Measurement, analysis and improvement its not difficult to see the link to ISO 9001:2008 clause 4.1f

8. Measurement, analysis and improvement

8.1 General

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

8.2.2 Internal audit

8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of product

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

Let's face it organizations don't generally plan to fail. However, not everything in life goes to plan. ISO 9001:2008 clause 4.1f is aimed at making the organization think not only about planning to succeed, but also

how to manage things when they are not going quite to plan, etc. This is one of the most significant clauses in the whole standard, it's saying where things are going well plan to improve, where things are not going well correct, prevent and improve.

Basically processes must be continually improved through the setting of incrementally realistic, measurable objectives, whether as process improvements or process fixes the goal should be the same, i.e. continual improvement.

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