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Applying the Principle of Process Approach in ISO 9001

ISO 9001 8 Principle - System Approach To Management

A desired result is achieved more efficiently when activities and related resources are managed as a process. (ISO 9004:2009)


An adequately defined process will have the following elements specified and documented:



These elements are specifically defined as requirements in the ISO 9001 Standards, from determining the requirements of QMS to establishing the processes and their requirements, and documenting them. ISO 9001 Clause 4.1 “General Requirements” requires an organization:




These processes will be documented as standard procedures, work instructions and supporting documents for:




Apart from the core processes, appropriate procedures must be established for the implementation and control of the supporting processes, such as the facilities and infrastructure maintenance processes, human resource management processes, and other management activities.


The ISO 9001:2008 also identifies 6 mandatory procedures in establishing the Quality Management System. These processes are:


1. Control of Documents Procedure

Any necessary document used in QMS, including documents of external origin. These documents can be in any medium


2. Control of Records Procedure

Records are generated to provide evidence of implementation, monitoring and control of QMS processes.


3. Internal Audit Procedure

Internal audits carried out at planned intervals to ensure the maintenance, improvement and integrity of QMS and its processes.


4. Control of Non-conforming Product Procedure

This ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.


5. Corrective Action Procedure

This is action taken to eliminate the causes of nonconformities in order to prevent recurrence, and


6. Preventive action Procedure

This is action taken to eliminate the causes of potential nonconformities in order to prevent their occurrence.


System Approach To Management

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