ISO 9001-Clause 8.1

ISO 9001-Clause 8 Measurement, analysis and improvement

ISO 9001-Clause 8.1   General

ISO 9001 Requirement

The 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.

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

Mandatory Procedure : Not applicable
Mandatory record: Not applicable
Evidence/ Implementation document ( Not mandatory but helps in fulfillment of requirement): 
Statistical methods to verify product characteristics and process parameters include – process capability studies, control charts, Pareto analysis, variation analysis (special cause, common cause).

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