The ISO 9000 family addresses various aspects of quality management, and is important because of its widespread adaptation. It is supported by national standards bodies from more than 150 countries.

The ISO 9000 family includes standards related to quality management systems (QMS).

ISO 9001:2008 sets out the requirements of a quality management system. These requirements can be measured and certifications may be obtained if necessary by the governing organization.“Quality management systems – Requirements is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations.

ISO 9004:2000 focuses on how to make a quality management system more efficient and effective. It provides guidelines for performance improvements.3

ISO 9001

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Steps to establishing a ISO 9000 series based QMS

After deciding that you need to establish the program, do an initial assessment with either gap analysis or a quality management system development plan.

Gap analysis will give information on what is missing from becoming ISO 9000 compliant. To perform a gap analysis, compare the ISO 9000 standard to your current processes. This is a good incremental approach for an organization that already takes measures in quality management.

The second approach is the QMS development plan, which can be broken down into 12 processes:

  1. Quality Management Process
  2. Resource Management Process
  3. Training and Awareness Process
  4. Product Purchasing Process
  5. Design and Development Process
  6. Production Management Process
  7. Service Provision Process
  8. Product Management Process
  9. Customer relationship Management Process
  10. Internal Quality Management Audit Process
  11. Monitoring and Measuring Process
  12. Management Review Process


Each of the 12 processes can be completed by considering the following 9 steps:

  1. Develop your process
  2. Document your process
  3. Implement your process
  4. Maintain your process
  5. Monitor your process
  6. Measure your process
  7. Analyze your process
  8. Control your process
  9. Improve your process