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Applying the Principle of System Approach To Management in ISO 9001

Identifying, understanding and managing interrelated processes as a system contribute to the organization’s effectiveness and efficiency in achieving its objectives. (ISO 9004:2009)


ISO 9001 QMS is displayed as a system map which schematically outlines the whole system, accompanied by outline description of it. Among other things, the system map shows the following:



System Map of Normal Manufacturing QMS

1. Determined Processes

A typical system for a manufacturing QMS shows above. The rectangular boxed items are processes that are determined as needed by QMS and their application through the organization as per ISO 9001 Clause 4.1 (a).


2. Relationship of Processes

The map also illustrates the sequence and interaction of the processes as per ISO 9001 Clause 4.1 (b). The arrows show the relationships between the processes in terms of input-process-output flow.


The inclusion of the clauses provides evidence of conforming to the requirements of the ISO 9001 standard. It shows the integration of the criteria and methods needed for the operation and control the processes.


3. Requirements of ISO 9001

4. System Concept

This schematic illustration provides the visual picture of the system whole, enabling managers to see the impact and interaction of changes within the system. The description of the system map is documented in the quality manual defined in ISO 9001 Clause 4.2.2 “Quality Manual”.


The description of the sequence and interaction in the system map should include descriptions of key requirements of QMS. These include human resource, Information, criteria and methods of implementation and control, infrastructure and etc.


5. Resources and Information

ISO 9001 8 Principle - Involvement of People

Involvement of People

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