Quality Management Principles:
Foundation of ISO 9000:2000 Family

Practical application came first

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

This is part five of a series of articles on the year 2000 revisions of the ISO 9000 series. The first four articles explained changes in requirements, format, presentation and terminology; the processes and approaches used to develop the revisions; and the driving force for change and corresponding response.

Many successful quality programs started with actions, not a defined philosophy. Often the most successful organizations act first and only later take the time to define the basis for their actions.

The same has been true of the ISO 9000 family of standards. Past editions of the ISO 9000 family were primarily based on practices, ideas and concepts that have worked. These were consolidated into a collection of elements that were deemed necessary for a quality system by the experts from around the world who served on Technical Committee (TC) 176. This pragmatic foundation has served well and the standards have become the most widely used in the International Standards Organization's (ISO) history.

The ISO 9000:2000 revision continues to contain much of this pragmatism. Sufficient time had elapsed to make it feasible to state the principles upon which quality management is really based. Instead of being set out first, with practice following, the concepts and principles of quality management in the revision have evolved from actual practice.

During the mid-1990s ISO TC 176 established a working group with the charter to research basic quality management principles (QMPs) and develop a brochure to explain them. That work resulted in the identification of fundamental principles (see the sidebar "The Eight Quality Management Principles"), which are intended to be the basis of the entire system.

While it is important to understand and apply the principles in the development of quality management systems, it is equally important to understand that the principles do not contain auditable requirements.

The development of the principles was a difficult task. The working group assembled and reviewed a vast array of documents on the subject of quality systems, including quality award criteria from around the world.

Attaining consensus on core QMPs required two international ballots and consumed almost five years of work. The result was a coherent set of principles. ISO is expected to publish a brochure on the principles and their application sometime in 2000.

The principles can lead to quality excellence for an organization that is willing to continuously focus its efforts on following them. This article describes the relationship of the first four quality management principles to the requirements document (ISO 9001:2000) and to the guidelines of ISO 9004:2000. Principles five through eight will be discussed in the March issue.

Principle 1--Customer Focused Organization

Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.

Relationship to ISO 9001:2000

* At the basic quality management level, the organization's focus should address not only the control of defined characteristics but also the understanding of overall customer needs. Even a quality management system (QMS) containing minimum requirements (such as an ISO 9001 compliant QMS) should focus on customer requirements throughout all processes.

Examples include processes for contract review, new product design and corrective action. An intense focus on identifying customer requirements may be the single biggest value in adopting ISO 9001 as a model for the QMS for an organization.

* A QMS typically includes linking customer complaint and returns processes to data analysis. These processes provide the beginnings of a systematic means of understanding customer feedback in order to prevent future problems from developing.

Relationship to ISO 9004:2000

* In relation to ISO 9004:2000, one can envision an organization that has complete knowledge of its customers--their current and future needs and perceptions.

Many organizations claim to have this knowledge--even with no quality system at all. They might point to their sales or research and development departments as having the customer insight needed to understand such things even without interacting with customers (the "field of dreams" syndrome). For some organizations, this is adequate.

But in a total quality management (TQM) environment, such knowledge is not just considered on an individual basis nor is it the purview of only a few departments. Information should instead be collected systematically throughout the organization from many sources and integrated into a process that provides a coherent and balanced view of customer and marketplace needs and wants.

* At the TQM level, sharing customer information and data is also pervasive in the organization. There are processes to define customer perceptions of organizational performance and drive market performance by affecting changes in customer perceptions of how well their expectations are met.

* Ultimately, the organization is able to capture markets and create loyalty because of preferred products and services at attractive prices while addressing the requirements and needs of internal customers as well.

Principle 2--Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

Relationship to ISO 9001:2000

In any organization, there are leaders at all levels. Certainly, top management is responsible for providing the vision and strategic direction for all aspects of the business, including the vision for quality management and the QMS.

* For every dimension of the QMS there should be a leadership presence assuring that all internal and external processes are being structured and operated in a way that maximizes internal productivity and external customer satisfaction.

Relationship to ISO 9004:2000

* In organizations using ISO 9004 to strive for excellence, leadership can become more personal, with managers continually providing examples of behaviors that facilitate creation of high levels of customer satisfaction.

* At this level, the organization's leaders treat quality as a strategic issue. Target setting and management review are ongoing activities, and leaders fully integrate the quality and human resources plans of the organization with strategic business plans.

Principle 3--Involvement of People

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.

Relationship to ISO 9001:2000

* A basic quality management system assures that individuals involved in work are fully qualified and capable of carrying out the processes to which they are assigned. Training and process qualification have been mastered by the organization and are integral elements of the QMS, not an afterthought.

* People are respected for their ability to contribute to improvement. Examples include dynamic participation in the corrective action process and participation on teams to introduce new products or processes, improve safety and conduct other activities.

Relationship to ISO 9004:2000

* Organizations at this level have mastered the art of fully engaging employees in their jobs and actively involving them in the improvement process.

* There is a process for communication between leadership and all employees. The leaders focus on achieving full alignment between the goals of the organization and the personal goals of individual employees.

Organizations at this level tend to share business data and information with all employees. They do this to make certain everyone has the same understanding of goals, targets and objectives.

Principle 4--Process Approach

A desired result is achieved more efficiently when related resources and activities are managed as a process.

Relationship to 9001:2000

A fundamental dimension of 9001:2000 is the adoption of the process approach to all work performed by an organization. The new process model with its implications about how to carry out work under controlled conditions should be much easier to use than the old model was since it represents the way most organizations really operate--as a series of connected inputs and outputs.

* When a basic quality management system is present, the organization will have clearly defined the processes for designing, producing and delivering the product or service. Processes for ensuring that customer requirements are met will have been defined and implemented. Control of product and service quality will have moved upstream from control only of process outputs to control of the process itself.

* The organization should also have the other processes discussed in ISO 9001 for such activities as corrective and preventive action, audits, management reviews and so on.

Relationship to ISO 9004:2000

* In relation to ISO 9004:2000, an organization is focused on the optimization of resources in each process. Its culture says that the processes can always be improved, and activity is present in the organization to make planned improvements.

* The organization will be using process measures extensively, and there is clear understanding of process performance. The measures of process outputs are regularly correlated with measures taken at key points in the process to help identify actions needed to make these improvements.

Quality management principles five through eight will be discussed in the March issue.

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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