ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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8 Measurement, Analysis and Improvement 8.2.3 Monitoring and Measurement of Processes The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate. NOTE: When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate. NOTE: When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. |
ISO 9001 Training - Key Explanation Points and Tips:
You must establish methods and
indicators to monitor and measure your QMS processes (see clause 4.1e and 5.4.1) to demonstrate process capability
to achieve planned results and identify opportunities to improve the process. Use your organizations
cross-functional knowledge of customer requirements; product; technology; manufacturing processes; etc, to
determine process monitoring and measuring indicators and controls. Monitoring and measurement may be done manually
or by automated means.
Another way to identify useful methods and
indicators is to review what problems could occur or have occurred within a particular process. Monitor and measure
these occurrences and develop process controls to reduce or eliminate them. Problems (risks) can occur with any of
the variables in a process - e.g. - materials; equipment; facility; methods; technology; personnel; computer
hardware or software; etc. By using fishbone analysis or similar tools, you can develop very useful monitoring and
measuring methods and process performance indicators.
Correction refers to action taken
to eliminate a detected nonconformity, i.e. the symptom. (see clause 8.3). Correction involves the
containment, evaluation of the nonconformity and action that may result in rework; regrade; scrap; return of
nonconforming material/work to supplier or outsourcer; or acceptance through a customer concession or deviation
permit.
Correction differs from
corrective action (clause
8.5.2). Corrective action is action taken to eliminate the
cause of a detected nonconformity to prevent
recurrence; whereas correction does
not address cause. Managers or personnel responsible for corrective action must be promptly informed of
product and process nonconformities.
You must monitor your manufacturing QMS processes:
First to determine and establish capability of new processes to conform to
requirements
And secondly, to monitor these
processes over time to verify ongoing
stability and capability to meet
requirements
And thirdly to determine and achieve
levels of continual
improvement
To achieve planned results, control methods used for monitoring and
measurement should focus on achieving the performance indicators we have identified for each QMS process. The
monitoring and measurement techniques, sampling plans, acceptance criteria may be documented or referenced in your quality plan; or
you could use a combination of specific practices, procedures, documents and methods. Look at the risks and
benefits in determining the extent of documented controls you need to have (also see clause 4.2.1
notes).
Performance indicators are not needed
for this clause as it provides direction for the application of monitoring and measurement performance
indicators for all QMS processes. However the output of monitoring and measurement methods used within each
QMS process provides useful performance indicators for determining the effective implementation and
maintenance of QMS processes. Review the performance indicators within each process covered this
far.