ISO 9001 - Understanding ISO 9001 Requirements

0.2 Process Approach

ÞTherefore, in general, in order to plan and implement your QMS using the ‘Process Approach’, you must:

ÞIdentify the processes needed for the QMS (see listing above)

ÞDetermine their sequence and interaction (show the sequence and interaction of your COP’s). There are many ways to document this, e.g., a high level flowchart or a process map.

ÞDetermine the application of QMS processes throughout the organization (show how MOP’s; SOP’s and QMP’s are applied to each COP and to each other). There are many ways of documenting this. A popular way is through graphical representation, e.g. process maps.

ÞDetermine (plan) the criteria, methods, information, controls and resources needed for each QMS process. These include:

ÞIdentify the internal/external customer-required output.

ÞDescribe the process activity that produces the output.

ÞIdentify the resources needed for the process activity.

ÞIdentify the inputs for the process - information, materials, supplies, etc.

ÞDefine the process methods, procedures, forms etc., that may be needed to produce the output.

ÞDefine the controls to prevent or eliminate risk of errors, omissions, or nonconformities in the process activity. These controls may come from the TS 16949 standard; customer; regulatory and your own organizational requirements (more details provided in clause 4.1).

ÞInteraction - with sources that provide the inputs (internal process or external supplier); uses the output (internal process or external customer); or provide the resources (internal support process) to perform the process activity.

ÞImplement your QMS according to your plan.

ÞMonitor, measure and improve each QMS process and its interaction with other processes. Performance indicators to monitor and measure process performance may come from the TS 16949 standard; customer; regulatory and your own organizational requirements. Performance indicators may relate to the process output as well as the process activity.

ÞPerformance indicators for process output must focus on meeting customer and regulatory requirements. Performance indicators for process activity should focus on measuring process effectiveness and efficiency. See clause 5.4.2 for quality objectives.

ÞIt is useful to point out that while we do need to identify all QMS processes and describe their interaction, not all identified QMS processes need to be documented or documented in the detail described above. Review notes on clause 4.1 General Requirements in conjunction with the above notes on the process approach, for more insight on process documentation.

ÞFor those interested in gaining a deeper insight into understanding and implementing the process approach, study the ISO guidance document on the concept and use of the process approach for management systems - Document: ISO/TC 176/SC 2/N544R2(r), issued 13 May 2004 on the ISO website.

ÞKeep in mind that the above notes and reference are for guidance and the manner and detail of application and documentation of the ‘process approach’ will vary from organization to organization, due to a variety of factors such as size and complexity of the organization; products, processes; customers; etc. See clause 4.1 for more details on applying the process approach.



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