2019

Quality Management Principles

Foundation of the ISO 9000:2000 family

by Jack West, with Charles A. Cianfrani and Joseph J. Tsiakals

Last month we discussed the first four of eight fundamental quality principles identified by ISO Technical Committee (TC) 176 as the basis for the ISO 9000:2000 revisions. This month we continue with principles five through eight. (All eight are presented in the sidebar).

While these eight principles do not contain auditable requirements, it is important to understand their relationship to the requirements of the 2000 revisions to both ISO 9001 and ISO 9004. The application of the principles can lead to quality excellence for an organization.

Past editions of the ISO 9000 family were primarily based on practices, ideas and concepts. These were consolidated into a collection of pragmatic elements by TC 176, and the ISO 9000:2000 revision continues to contain much of this pragmatism.

Principle 5--System Approach to Management

Identifying, understanding and managing a system of interrelated processes for a given objective improve the organization's effectiveness and efficiency.

Relationship to ISO 9001:2000

* With the development of a basic quality management system, the organization moves to integrate the processes for creating the product or service with those processes that verify that the product or service meets customer needs.

* At this level, the emphasis is on developing a quality management system that is suitable for the organization's situation and effective in assuring that customer requirements are met.

* The challenge at this level is to create an effective system with fully integrated processes while avoiding unneeded paperwork and bureaucracy.

* At this level, the purpose of the quality management system is to achieve customer satisfaction. Fully effective systems at this level use measures of customer satisfaction along with other data to perform day-to-day management and decision making. The management review process has matured and uses these data along with audit results to assess system effectiveness.

Relationship to ISO 9004:2000

* In relation to ISO 9004:2000, the organization fully understands and manages the interactions among the various processes in the business. Processes are aligned with each other and with the goals of the organization.

* At this level, the organization is focused on achieving results by continually improving the management system. While achieving customer satisfaction remains a key driver of business success, the organization now can use data on its processes along with customer feedback for strategic decision making and overall business planning.

Principle 6--Continual Improvement

Continual improvement should be a permanent objective of the organization.

Relationship to ISO 9001:2000

* At this level, there are mature and robust corrective action processes, and a preventive action process is in place.

* The organization is focused on improving the effectiveness of the quality management system based on facts (see principle 7) obtained from pervasive measurement processes (in other words, use of statistical methods).

Relationship to ISO 9004:2000

* At this level, leaders are establishing targets and goals based on key measures of customer satisfaction and internal performance. There is a drive to reach challenging improvement goals. Leaders themselves are involved in the improvement process and provide resources to ensure targets are met.

* The organization is focused on efficiently meeting future customer needs and on achieving business results through the quality management system.

Principle 7--Factual Approach to Decision Making

Effective decisions are based on the analysis of data and information.

Relationship to ISO 9001:2000

* Facts and data are used in the quality management system to make decisions related to the system's operations. The information is gained from analysis of audit results, corrective actions, process performance, customer complaints and other sources.

* Analysis tends to be focused on data that can be used to improve customer satisfaction and the efficiency and effectiveness of the quality management system.

Relationship to ISO 9004:2000

* Decisions and actions are based on the analyses of a broad range of data. Customer data are derived by using all available listening posts to understand what is important and make decisions that will improve the organization's market position. Techniques such as focus groups, surveys and tracking studies are routinely used to obtain facts that will assure understanding of customer needs and requirements.

* Information is derived from analysis of data and from the innovative ideas of all members of the organization. The focus is on improving productivity while eliminating waste and rework and enhancing market value.

Principle 8--Mutually Beneficial Supplier Relationships

An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

Relationship to ISO 9001:2000

* With the development of a quality management system, an organization will have defined processes and document requirements suppliers must meet. There will also be processes in place to review and evaluate suppliers' abilities to meet those requirements and assess the congruence of organization and supplier objectives.

Relationship to ISO 9004:2000

* The focus tends to change as organizations establish strategic alliances or partnerships with suppliers. In many cases, organizations involve suppliers very early in defining requirements for joint development and in broad-based concurrent engineering.

* Organizations work with suppliers to develop mutual trust, respect and commitment to customer satisfaction. Mutual efforts focusing on continual improvement become the norm of operation for both parties.

* Integration of the supplier quality process with other efforts related to supplier systems becomes common.

Relationship of principles and process

In an earlier article in this series, a process model was introduced. It should be clear, however, that there is a significant relationship between an organization's processes and principles. Indeed, two of the principles point out that all work is best managed as a value adding process and that the quality management system is really a collection of processes.

The relationship of processes to the principle of customer focus should also be clear: Each process has customers with requirements that must be understood and met as well as suppliers who provide inputs to those processes and are critical to successful operations.

The people in an organization should be using data and innovation to continually improve performance. From beginning to end, an organization's success is driven by the leadership of its managers and employees as it implements its work and adds value through many interconnected serial and parallel processes.

Integration is the key

Perhaps the most important concept the principles espouse is the notion of integration. The overall management system--its leaders, processes, data, people and suppliers--works best when fully integrated.

The eight quality management principles, when consistently applied across an organization, should en-gender optimal overall performance, which will lead to performance excellence far more effectively than a series of individually optimized activities.


JACK WEST is chairman of the U.S. Technical Advisory Group for ISO/TC [technical committee] 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 family of quality management standards. He was with Tenneco for 30 years, is a quality excellence business consultant based in The Woodlands, TX, and is a member of the board of directors of the Registrar Accreditation Board. He can be e-mailed at jwest92144@aol.com

CHARLES A. CIANFRANI is the U.S. expert representative to ISO TC [technical committee] 176/SC [subcommittee] 2/WG [working group] 18, the group writing ISO 9001/4:2000. He is managing director, customer focused quality, at ARBOR Inc., Media, PA. He is a Fellow of ASQ; an ASQ certified quality engineer, certified reliability engineer and certified quality auditor; and a Registrar Accreditation Board certified auditor. He can be e-mailed at cianfranic@aol.com

JOSEPH J. TSIAKALS represents the medical device product sector on the ISO/TC [technical committee] 176 writing team for ISO 9000:2000 and previously was the lead U.S. delegate for the development of ISO 9001:1994. He is one of the founding members of the ISO Medical Device Quality Committee and has more than 25 years of experience in quality management and engineering. He is a member of the Board of Directors of the Registrar Accreditation Board and can be e-mailed at jtsiakals@aol.com

If you would like to comment on this article, please post your remarks on the Quality Progress Discussion Board, or e-mail them to editor@asq.org.


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