Monitoring, measurement, analysis, and evaluation process. ( ISO 9001:2015 clause 9.1)
The 9-clause beginning with defining requirements for
evaluated the quality performance and effeteness of quality management system.
This is done by monitoring, measurement, analysis, and evaluation.
The propose of implementation the monitoring and measurement
activities is to verify that the criteria for control of processes or outputs
are met. For example, if your organization shaping a metal parts, you will need
to monitor the brushing processes and when the product is finished, wot will
measure its dimension to see if they met the product requirements.
Monitoring refers to reviewing and observing while the
measuring refers to determine the amount or size of something by using concrete
values.
For example, monitoring customer satisfaction refers to
reviewing the results of customer satisfaction over some period and measuring
customer satisfaction means obtaining information of the customers.
Analysis means examining the results of the measuring. For
example, comparing the results of the customer satisfaction from previous
survey to the result of the current survey. If the analysis show the level of
customer’s satisfaction is decreasing, the company can investigate this.
The company shall determine the below to get purpose of monitoring. Measurement, analysis,
and evaluation processes:
1- What needs to be monitoring and measured.
Mainly what are measured parameters of the process. For
example, the number of nonconforming products during the storage or number of
customers complains.
2- The methods for monitoring, measuring, analysis and evaluation.
The methods for
monitoring , measuring, analysis, and evaluation should be defined in order to
get useful results. For example, method for monitoring can be generate report
about customer satisfaction and method for measuring can be generate reports
with numerical information.
3- The frequency and timing for monitoring and measuring.
For example, the monitoring of customer satisfaction is done
every six months and report for detailed measurement for warehousing temperature
can be generated daily.
4- The person responsible for conducting monitoring and the corresponding measurements.
This can be the production manager as a person who is
responsible for production process.
5- When the results will be analyzed and evaluated and who will be responsible.
For example, the detailed analysis of weekly report may be
done weekly by the quality assurance manager and evaluation to be conducted on
monthly meeting.
The standard requires that the results from the monitoring
and measuring are documented as evidence. In other hand, ISO 9001 standard
doesn’t define what needs to be monitored and measured in terms of organization
products, services and processes. However, for the larger companies should have
this process documented as a procedure in order to have effective monitoring
and measuring. And this procedure will define all the above-mentioned elements.
For example, in a small company, it is usually the quality
assurance manager is responsible for monitoring and measuring while in larger
companies the responsibilities can be divided to different people such as
production manager who will monitoring the production process, the HR manager
who will control the HR controls, etc.
The time schedules, frequencies, tools, methods should be
also prescribed within the procedure.