ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place.
It is all about process
Where this approach differs from the previous standard is that it improves upon it by offering an appreciably more generic structure that is readily adaptable, acceptable and applicable across virtually all sectors of the economy and sizes of organizations. Another area where it has made life easier is that it explains the requirements in plain and uncomplicated language that is shorn of Quality waffle and is relatable to people for whom it is meant –organizations’ line managers.
The customer is the focal point
The primary focus of ISO 9001:2000 is on improving the effectiveness of a QMS in order to heighten customer satisfaction by meeting customer requirements. It finds its complement in ISO 9004:2000, whose aim is improvement of the effectiveness and efficiency of a QMS by meeting interested party requirements.
Broadly, these are the steps in this methodology:
- Step 1: Establish the responsibilities for managing the process;
- Step 2: Define the process;
- Step 3: Identify customer requirements;
- Step 4: Establish measures of process performance;
- Step 5: Compare process performance with customer requirements;
- Step 6: Identify process improvement opportunities;
- Step 7: Improve process performance
How is a QMS built?
- A QMS comprises of four categories of interrelated processes, which make up the process approach:
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement