ISO 9000:2000 Shifts Focus of Quality Management System Standards
Look for changes in format, presentation and terminology
by Jack West, with Charles A. Cianfrani and Joseph J. Tsiakals
This is the first of a series of articles explaining the latest version (Committee Draft 2) of ISO 9000:2000.
As we move to the next millennium, the ISO 9000 family of quality management system standards is being updated to reflect a modern understanding of quality.
This article is based on the second committee drafts (CD 2) of the three basic standards in the family. The reader should remember that these documents are subject to change as the standards development process continues. They should not be used as a basis for changing existing management systems.
The three basic standards in the ISO 9000:2000 family are:
ISO 9000:2000, Quality Management Systems--Fundamentals and Vocabulary.
ISO 9001:2000, Quality Management Systems--Requirements.
ISO 9004:2000, Quality Management Systems--Guidelines for Performance Improvement.
Each of these three documents has its own role in the family. ISO 9001 will remain the most used of the three, but the other two are useful companions that should not be ignored.
Context for the update
Over the years, the world's view of how quality is created and assured has been evolving. This natural progression did not directly create the need to revise the ISO 9000 family, but it may be useful to view the proposed revisions in the context of the evolution of quality thinking.
The original ISO 9000 family was based on the understandings of an earlier era in which quality was thought to be primarily a technical discipline--the purview of the quality professional. In the 1980s we discovered that this view was incomplete. We heard the slogan "Quality is a human resources problem, not a technical problem." So programs were developed to get workers involved in quality improvement.
Today most organizations understand that all work is accomplished through processes, which are most effective when they are actively managed. As the 1990s advanced it became clear that quality has both a technical and a human side.
There has also been an increasing interest by organizations other than traditional manufacturing (such as the services sector, education, governmental agencies) in using ISO 9001 as a basis for quality management. This has proven to be somewhat awkward because ISO 9001:1994 uses language that is focused on manufacturing.
It is not surprising to find this maturing of quality thinking and application in the mid-1990s reflected in revisions to quality system standards.
ISO Technical Committee (TC) 176, the group responsible for the ISO 9000 family, long recognized that the standards needed an overhaul. In the early 1990s the committee put plans in place to make the updates. These plans included the development of specifications for the changes to ensure that the needs of users around the world would be met.
The specifications outlined how the ISO 9000:2000 revisions would resolve perceived shortcomings with the current documents. These specifications created the criteria for a significant advancement of the ISO 9000 family and reflect contemporary concepts of quality management. The goals of the specifications are summarized in the sidebar "Goals for the New Revisions."
Two types of changes are apparent with the latest committee drafts. There are:
Changes in presentation, terminology and format.
Changes in the actual requirements.
This article presents an overview of the changes in presentation, terminology and format. Future articles will highlight changes in requirements in ISO 9001.
Quality management principles
As an initial step along the road to the ISO 9000:2000 revisions, TC 176 developed a consensus on a set of quality management principles (QMPs). The principles were developed after research of the quality concepts in use around the world. Many input sources were considered.
Eight principles resulted from this work and they have been used as a foundation for the revisions (see sidebar "The Eight Quality Management Principles"). These principles appear in both ISO 9000 and ISO 9004.
While the principles were a basis for developing ISO 9001, they do not formally appear in that document. Each principle has a place within the ISO 9001 requirements, but the extent of application to ISO 9001 is quite limited compared to its application in the new ISO 9004. ISO 9004 uses each principle fully to help organizations drive for excellence.
Format and presentation
The format of ISO 9001 and ISO 9004 has been changed to link the quality management system with the processes followed by most organizations. The requirements of ISO 9001 are now given as four primary processes.
The interrelationship of these four processes in the quality management system is shown graphically in the quality management process model in Figure 1, which is reproduced with the permission of the International Standards Organization (ISO). The model may change as the standards progress through the draft stages. Each process is described below:
Management responsibility--Management sets direction and objectives of the system.
Resource management--Resources are determined, provided and managed.
Product and/or service realization management (called process management in Committee Draft 1)--Processes are established for creating and delivering the organization's products and services and are verified and managed. Product realization processes take inputs from customers in the form of requirements, needs and/or wants and convert them into the products and services that satisfy customer requirements.
Measurement, analysis and improvement--Products, processes and customer satisfaction or dissatisfaction are measured. Audits are conducted of the quality management system. Data are analyzed and results provided as input to the management review process. The data and analysis are used to improve the system continually.
There has been a major effort to use everyday English terms that are easily understood. This is more difficult than it would seem. For example, the first committee draft attempted to avoid jargon by using common words.
Unfortunately, a careful reading of the draft revealed that many of these common words have several meanings. In many cases, when words were used multiple times in the draft, the various uses had different intended meanings. Much of this has been corrected with the CD 2, but simple language remains a challenge.
A good example of a shift to common language is the word used to describe an organization that implements ISO 9001. In the 1994 edition, the term "supplier" is used. This is derived from the initial focus of ISO 9001 as a tool to be used in a contractual relationship between a customer and a supplier. The ISO 9001:2000 drafts have used the term "organization" to describe the entity that implements the standard, and the term "supplier" has its normal English meaning.
Changes in actual requirements
This article has discussed reasons for a change in focus for the ISO 9000:2000 standards and has introduced the quality management principles. It has also reviewed changes in format, presentation and terminology. Subsequent articles in this series will discuss the QMPs in more detail, particularly the changes in requirements that are included in the second committee draft of ISO 9001:2000.
JACK WEST is chairman of the U.S. Technical Advisory Group for ISO/TC 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 and currently is a quality excellence business consultant based in The Woodlands, TX, and a member of the board of directors of the Registrar Accreditation Board. He can be e-mailed at email@example.com.
CHARLES A. CIANFRANI is the U.S. expert representative to the TC 176 working group that is 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 firstname.lastname@example.org.
JOSEPH J. TSIAKALS represents the medical device product sector on the ISO/TC 176 writing team for ISO 9000:2000 and 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 email@example.com.
Meet stakeholder needs.
Be usable by all sizes of organizations.
Be usable by all sectors.
Be simple and clearly understood.
Connect quality management system to business processes.
Involvement of people.
System approach to management.
Factual approach to decision making.
Mutually beneficial supplier relationship.