10 Characteristics of Effective Quality Management Systems


Trusted Information Resource
Quality management systems can become cumbersome and bureaucratic if 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 couple of decades. These common denominators of quality management, when properly implemented, can improve your organization's ability to satisfy customer 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. A process is in place to ensure the needs and expectations of customers and other interested parties are clearly defined.

2. The quality policy and quality objectives are defined, deployed throughout the organization and understood by employees at all levels.

3. Processes are documented in simple to use procedures that are up to date and controlled while responsibilities of personnel are established and followed up on to achieve objectives.

4. Resources to meet objectives are identified and provided. Resources include people, processes, equipment and infrastructure.

5. Metrics are established and monitored for each process. The old adage, "If it is not worth measuring, it is not worth doing," is certainly true for business processes. When a process is not monitored and measured, how can leaders know if it is producing the desired outcomes? 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 really work.

6. Management is committed to using the metrics for process improvements and for communications within the organization as well as for holding people accountable for their performance. Accountability is dependent upon two factors: 1)the people know what is expected and 2), the leaders follow-up to insure people do what is expected.

7. A process is in place for preventing non-conforming product or services and in the event non-conforming the situation is documented and corrective actions taken. In the case of non-conforming product, the process provides for identification and segregation to prevent it from getting to a customer.

8. Continual improvement is a priority and simple approaches are implemented to involve people throughout the organization in identifying continual improvement opportunities.

9. A framework for verification of processes and products is in place and functioning as planned. This includes internal audits of the processes as well as product quality verification at various stages of production.

10. Management is involved in the system and reviews the entire system at appropriate intervals to insure the system is functioning as planned, is effective for the business and is being maintained.

A quality management system built on these ten foundational principles will give your business a competitive advantage and should not be a bureaucratic nightmare.

Note : While each of the characteristics are supposed to be driving the outcome due to QMS, management commitment/review will drive the evolution of the rest of the key characteristics ..

Davis M. Woodruff, PE, CMC is an internationally recognized consultant, professional speaker and author who is an expert in showing companies how to be the low cost, high quality, environmentally responsible leader in their industry. The benefits he brings to his clients include: developing leaders; optimizing resource utilization; improving processes, quality and customer satisfaction; and saving time and $$$. Since 1984 he has served clients in 35 states and on 3 continents. Davis is the author of a full length book Taking Care of the Basics: 101 Success Factors for Managers, and dozens of published articles. He is a 1972 Engineering graduate of Auburn University, a Certified Management Consultant (CMC) and Professional Engineer (PE). His consulting firm, Management Methods based in Decatur, AL, is now in its third decade. Davis can be reached at [email protected] or for more information visit https://www.daviswoodruff.com.


Wes Bucey

Prophet of Profit
So tell us, v9991, what was your purpose in clipping and posting this article written by Davis M. Woodruff?

It would have been more meaningful if you had added a comment why you thought this was pertinent to post in the Cove. Does the subject matter of the article directly relate to work you, yourself, are performing or are planning on performing?


Trusted Information Resource
My thought...(highlighted in blue color font in the original post)
I believe that continual improvement and effectiveness shall be essentially driven by Management review and participation. (interms of calibrating the targets and the mile stones etc.,)

My Query...
And wanted to hear out the comments specific to Quality systems in Pharma industry...

Wes, Thanks for helping out... most probably my query got deleted due to a duplicate post on same subject...:eek: Nevertheless, it was is an interesting article to share with covers!
Top Bottom