ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

8.1 Measurement, Analysis and Improvement - General  

ISO 9001 Training - Key Explanation Points and Tips:

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 in clause 5.4.1 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 (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 (special cause, common cause).

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. Monitoring can be done manually or by automation (computers or electronic sensors, etc). 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.

Where any of the monitoring, measurement and analysis processes are done off-site (e.g. in large organizations, customer satisfaction feedback may be done at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements. Evidence of the off-site facility’s compliance may include - a copy of their ISO 9001 certification; results of their internal audits to ISO 9001; auditing the outsourced facility; etc. The expectation is to flow down to the off-site facility, the relevant ISO 9001requirements that you would have to implement, had you carried out the process at your own facility.

Clause 8.1 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents, controls and resources are needed (see clause 4.2.1d. and 7.1b.). 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 (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 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.