Quality management systems can become cumbersome and bureaucratic if they are not properly developed, implemented and maintained. Effective quality management systems have ten common characteristics that I have discovered in my consulting practice over the past two decades. These common denominators of quality management, when implemented correctly, can improve your organization’s ability to satisfy customers and manage your processes and products more effectively. These ten common denominators are relevant and applicable for organizations seeking ISO 9001, AS 9100, ISO 13485 or TS 16949 registration.
1. There is a process to ensure that the needs and expectations of customers and other interested parties are clearly defined.
2. The quality policy and quality objectives are defined, implemented throughout the organization and understood by employees at all levels.
3. Processes are documented in easy-to-use, up-to-date, and controlled procedures, while staff responsibilities for achieving objectives are established and tracked.
4. Resources are identified and provided to meet the objectives. Resources include people, processes, equipment, and infrastructure.
5. Metrics are established and monitored for each process. The old adage, “If it’s not worth measuring, it’s not worth doing,” is certainly true for business processes. When a process is not monitored or measured, how can leaders know if it is producing the desired results? Many organizations fail to establish criteria for monitoring and measuring processes, and as a result, inefficiencies are rampant and it is very difficult to implement corrective actions that actually work.
6. Management commits to using the metrics to improve processes and for communications within the organization, as well as to hold people accountable for their performance. Accountability depends on two factors: 1) people know what is expected and 2) leaders follow through to ensure that people do what is expected.
7. There is a process to prevent non-conforming products or services and, in case of non-conformity, the situation is documented and corrective measures are taken. In the case of a nonconforming product, the process includes identification and segregation to prevent it from reaching a customer.
8. Continuous improvement is a priority and simple approaches are implemented to engage people across the organization in identifying opportunities for continuous improvement.
9. A framework for process and product verification exists and works as intended. This includes internal audits of processes as well as verification of product quality at various stages of production.
10. Management is involved in the system and reviews the entire system at appropriate intervals to ensure that the system works as planned, is effective for the business and is maintained.
A quality management system based on these ten fundamental principles will give your business a competitive advantage and shouldn’t be a bureaucratic nightmare.