ISO 9001-Clause 8.1
ISO 9001-Clause 8 Measurement, analysis and improvement
ISO 9001-Clause 8.1 General
ISO 9001 RequirementThe organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity to product requirements,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
Explanation:
You must plan and implement processes
that measure, analyze and improve the health of your QMS. The focus of
these processes must be on product and process conformity and improving
QMS effectiveness. Consider using a variety of methods including
statistical techniques. In planning what to track and measure, let us
review the quality objectives we established and all of the performance
indicators we established for each of our QMS processes and activities.
You must be careful not to overwhelm your organization with objectives
as this may cause more frustration than positive results. Start with
objectives that focus on meeting customer requirements and then slowly
develop meaningful objectives for key processes and risk prone
processes, as initial targets are achieved. Planning of measurement and
data analyses processes must consider the methods and resources such as
time, manpower, computer, software, statistical tool, etc needed to
collect, organize and analyze product and QMS performance data.
Measurement involves physically measuring product characteristics or
process parameters against acceptance criteria at predefined intervals
and sampling sizes, using predefined measurement devices. Measurement
results may not always be fully recorded. Use your organizations
cross-functional knowledge of customer requirements, product,
technology, manufacturing processes, etc., to determine what statistical
methods to use for each process and to what extent to use them. Include
these methods in your quality plan. Statistical methods to verify
product characteristics and process parameters include process
capability studies, control charts, Pareto analysis, variation analysis.
Define and implement appropriate training and competency requirements for all personnel using statistical methods, tools and analysis. Monitoring usually involves conducting ongoing periodic checks to determine whether product characteristics or process parameters are within acceptable limits. The frequency of monitoring may vary on the risk and reliability of product and processes. Monitoring is also useful in determining the scope and frequency of product and process measurement. The results of monitoring may or may not be recorded. You must identify and document all processes addressing this clause as part of your QMS . For these processes, you must also identify what specific documents, controls and resources are needed. You could use a product quality plan, documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have . Performance indicators are not needed for this clause as it provides direction for the application of monitoring and measurement methods and tools for all QMS processes. However the output of monitoring and measurement methods used within each QMS process provides useful performance indicators for determining the degree of conformity of product and QMS to requirements and whether the QMS has been effectively implemented and maintained.
Define and implement appropriate training and competency requirements for all personnel using statistical methods, tools and analysis. Monitoring usually involves conducting ongoing periodic checks to determine whether product characteristics or process parameters are within acceptable limits. The frequency of monitoring may vary on the risk and reliability of product and processes. Monitoring is also useful in determining the scope and frequency of product and process measurement. The results of monitoring may or may not be recorded. You must identify and document all processes addressing this clause as part of your QMS . For these processes, you must also identify what specific documents, controls and resources are needed. You could use a product quality plan, documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have . Performance indicators are not needed for this clause as it provides direction for the application of monitoring and measurement methods and tools for all QMS processes. However the output of monitoring and measurement methods used within each QMS process provides useful performance indicators for determining the degree of conformity of product and QMS to requirements and whether the QMS has been effectively implemented and maintained.
Audit Checklist:
- It can be assessed by auditing the requirement of Clauses 8.2, 8.3, 8.4, 8.5
- Are measurement & monitoring activities planned and implemented to demonstrate conformity of the product
- Are measurement & monitoring activities planned and implemented to ensure the conformity to QMS
- Are measurement & monitoring activities planned and implemented to continually improve the effectiveness of the QMS
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