The Big Picture
A context for ISO 9001 and ISO 9004
by Joseph J. Tsiakals with Charles A. Cianfrani and Jack West
This is part four of a series of articles on the year 2000 revision of the ISO 9000 series. The first three articles explained changes in requirements, format, presentation and terminology and in the processes and approaches used for developing the revisions. This article will elaborate on the bigger picture: the major driving force for the change and the corresponding response.
Is the ISO 9000 series of quality management standards one of the greatest con games of all time? What's the value? Are its critics justified? Or are they confused by a lack of understanding of the role of ISO 9001? Should changes be made in order to deal with this confusion?
What reader hasn't heard criticisms about ISO 9001?
* ISO 9000 does not ensure quality. If you specify garbage, you will get garbage.
* ISO 9000 is very expensive to implement, with questionable benefits.
* Instead of drafting useless documents for meeting standards, it is more important to analyze and improve the manufacturing process.
* We do Baldrige (the Malcolm Baldrige National Quality Award). ISO 9000 is the old paradigm of an internal, overlay quality program implying that quality costs money.
* ISO 9000's focus on conformity means that it doesn't address customer-driven quality.
Although there are grains of truth in each of the above misconceptions, these criticisms, some from supposedly informed experts, are all widely off the mark. They originate partially in the frustration that comes from unrealized or unrealistic expectations or from expectations that arise from different approaches.
From these and other criticisms, however, it became clear that a key motivation for the 2000 revision of the ISO 9000 series should be to address the organizational need to ensure quality, provide for meeting customer needs and requirements, create efficient and low cost operations, and achieve marketplace success.
Paradoxically, in light of all the criticism, there are more than 270,000 organizations currently registered to ISO 9001. Each of these organizations has implemented a system and retains external auditors to obtain and maintain its registration. And the upward trend is continuing.
To understand why the ISO 9000 series of quality management standards has been so widely embraced, it's important to see the big picture. Only then does one understand the major driving force for change and the corresponding response of ISO Technical Committee 176 (ISO/TC 176) through development of an aligned pair of standards that are designed to be used together.
Two major approaches
The efforts of governments to lower trade barriers, along with a drive for international markets, tough competition and customer pressures on suppliers have all resulted in great focus on quality. Many agree that quality serves as a major unifying principle of business. The many differing methods for achieving quality have coalesced into two main quality management approaches:
* ISO 9001 quality management systems (including ISO 9002 and ISO 9003), which focus on process management.
* Performance excellence models, which focus on results oriented improvements. The various national or regional quality award programs such as the Baldrige Award, the Deming Prize, and the European Quality Award, along with efforts such as the Six Sigma process, best characterize the performance excellence models. ISO 9004:1994, as a guidance standard for quality management, also has had a focus on performance excellence. It uses ISO 9001 as the basic system and gives guidance on improving all aspects of the quality system, including achieving improved performance of the cost of quality and continual quality improvement.
Each of these two approaches--ISO 9001 and performance excellence--is legitimate. Organizations that embrace one of these approaches typically engage in many elements of the other approach. Both approaches, in fact, need to be embraced.
The real issues involve understanding the goals of each approach, the roles to be played by them in providing value to an organization and the ways in which they might be integrated into one cohesive quality system. Much of the confusion today arises because of the tendency by practitioners to promote one approach by emphasizing the differences and inadequacies of the other. Instead, it is better to embrace both approaches in a unified manner.
Maslow's Hierarchy of Human Needs
A useful way to illustrate the relationships between ISO 9001 and performance excellence is to draw a parallel to a well-established model, namely Abraham Maslow's Hierarchy of Human Needs (see Figure 1).
Maslow first published his theory of human needs and incorporated it into leadership training for the U.S. Air Force during World War II. This theory attracted much interest as a basic structure for at least broadly understanding human motivation. Basically, the theory holds that individuals have a hierarchy of needs:
* Survival or basic needs.
* Security or safety.
* Love or belonging.
* Status or esteem and self-realization or self-actualization.
The theory holds that individuals are motivated by lower order needs until these are relatively satisfied. Higher order needs are then addressed. Even so, the lower levels must be maintained. If not, their importance overshadows the reaching to self-actualization. Lower order needs must be dealt with first. It is difficult to be self-actualized if you are hungry, with no coat, and outdoors in a snowstorm. First things first.
Motivation for the lower needs is to avoid deficiency, while self-actualized people are growth oriented and continually expanding their interests and contributions to society. Fulfillment at the highest levels of the hierarchy tends to be episodic. Maslow later redefined self-actualization as a function of frequency of peak experiences.
The Quality Hierarchy
Consider ISO 9001 and performance excellence as existing in a hierarchy of quality needs parallel to the Maslow model, as shown in Figure 2. ISO 9001 is at the base, and everything above the base represents performance excellence. Goals differ at each level: survival or effectiveness (assure quality through an effective quality system), efficiency (minimize resource utilization), and competitive advantage (maximize shareholder value). Clearly, organizations must first meet the needs at the base. They cannot achieve and sustain higher levels in the hierarchy without the base.
The nature of the actions differs at each level (see Figure 3):
* Effectiveness addresses such areas as conformance to customer requirements, prevention of customer dissatisfaction, recalls and defects, and achievement of safe products.
* Efficiency is concerned with such issues as using resources prudently, reducing material costs, reducing cycle times and increasing productivity.
* Competitive advantage focuses on ensuring delighted customers, increasing market share and increasing profitability.
Organizations should target results at each level that are aligned with their strategic and tactical objectives. At the base, product and service related processes, functions and workers are of primary concern. At the top of the hierarchy, all processes, all functions and all employees need to be involved.
There are other major differences between the base and the top of the hierarchy. The base is defined by a quality system consisting of a minimum set of actions that must be performed. In order to be able to provide customer confidence, the system must be able to be audited. It either complies or it doesn't. Requirements are fulfilled, or organizations are in noncompliance. Product is defective or acceptable. Customers either complain or don't. The base can be considered as a binary territory. Quality, at the base, deals with meeting those aspects of customer satisfaction achieved through conformance to requirements.
In sharp contrast to this is the nature of the world above the base. Above the base the world exists on a continuum. Strengthening competitiveness depends upon pursuit of operational excellence--referred to as excellent or superior or world-class quality.
Organizations must look outside of themselves and benchmark for the best practices and the best results to gain understanding of what they must do. Success depends on deployment throughout the organization and ever improving results. Above the base, organizations need concern themselves not only with present but also with future customer needs.
Whereas an organization must meet all the requirements at the base in order to pass a compliance audit and achieve registration, no organization ever fully arrives at the top of the Quality Hierarchy.
The earlier description of performance excellence (everything above the base) sounds enticing. Why then bother with ISO 9001? Why not just go directly for world class quality and competitive advantage? After all, isn't there criticism that ISO 9001 does not ensure quality? Surprising to some, there is strong evidence that ISO 9001 does ensure quality, while performance excellence may not.
Consider the fact that medical devices are among the most reliable products in the world. For critical functional characteristics, most achieve beyond six sigma levels of performance. These products are among the most critical, as evidenced by the fact that governments consider it necessary to regulate them.
As an example let's look at one type of medical device--a heart valve. Heart valves are implanted through open-heart surgery. If requirements--including those related to sterility and functionality--are not 100% fulfilled 100% of the time, a patient's death may result. In such a critical application, the adequacy of design and manufacture is paramount.
The U.S. Food and Drug Administration as well as corresponding regulatory bodies for other first world countries all regulate the design and manufacture of heart valves using the ISO 9001:1994 quality system standard (or the regulatory equivalent) as the core requirements.
ISO 9001 requires the following:
1. A thorough documentation of quality requirements, quality related processing steps and results.
2. Implementation of controls to maintain the system.
3. Complete compliance to the defined system requirements.
Assurance of fulfillment of these requirements is achieved through internal audit, management review and corrective or preventive action, which, as required in ISO 9001:1994, encourages continuous improvement of the system for meeting customer requirements.
The ISO 9001 quality system or its equivalent is a minimum requirement with which every single medical device manufacturer must fully comply. Compliance is a requirement to even enter the market. It doesn't guarantee marketplace success. Instead, it is used, along with enforcement actions, to ensure product safety and reliability.
Since performance excellence does not require the rigor of a quality management system, to be sustained it is best implemented in the context of ISO 9001. Although some might argue that not all products are as critical as medical devices, isn't it obvious that ISO 9001 should come first? A major part of the 2000 revision was the restructuring and careful crafting of ISO 9001 to be generically appropriate for all organizations and for all types of products, including services and software. The nature and extent of the specific requirements for a given quality system are dependent on the nature of the product, size and type of organization, complexity and interaction of the processes and competence of personnel. For example, ISO 9001 applied to a business of 25 employees is significantly different from its application to a business of 1,000 employees, all other aspects being equal.
While ISO 9001 is necessary for assuring the meeting of quality requirements, it is not sufficient for the organization's continuing success. Through its systems approach, ISO 9001 sets the foundation for efficiency and low cost production, but it does not deal directly with cycle time reduction, low cost material, higher productivity or any of the other means of achieving competitive advantage.
Performance excellence does deal with these needs. Executive management may use performance excellence or an equivalent approach to achieve operational excellence. By their very nature, the tools of performance excellence work best in the project-by-project mode. As projects are completed, focus tends to shift to other projects without adequate institutionalization. And so the gains may be lost.
As in the Maslow model, achievement at the highest level of the Quality Hierarchy tends to be episodic. It is the formal quality management system at the base that serves as the means to standardize and institutionalize the improvements that are gained from the projects.
The consistent pair: ISO 9001:2000 and ISO 9004:2000
ISO/TC 176 has attempted to address the greatest concerns of the users of ISO 9001--the desire to ensure quality and provide for marketplace success--by developing and promoting the use of a consistent pair of standards:
* ISO 9001:2000 covers quality management system requirements.
* ISO 9004:2000 provides guidance for performance improvement.
From the initial publication of the ISO 9000 series in 1987, ISO 9004 served as guidance for achieving improved performance. Quite naturally, with the pressure of audits for conformity to ISO 9001, ISO 9004 has been all but ignored. Few even know of its existence.
One of the changes implemented by the 1994 revision of the ISO 9000 series was alignment between ISO 9004 and ISO 9001 in order to allow integration of the two standards. The alignment will be completed with the upcoming revision, which uses matching clause numbers and titles to achieve a much higher degree of consistency between the two.
Additionally, a set of eight quality principles has been developed by ISO/TC 176 to serve as the necessary linkage between the base (ISO 9001) and higher levels that are above the base (ISO 9004).
Why ISO 9000:2000?
If one were to gather representatives on quality worldwide from all types of organizations and have them describe a system to ensure quality by preventing product and service failures and field recalls, the result would be ISO 9001:2000. It encompasses the requirements at the base of the hierarchy of quality needs.
Likewise, if one were to gather representatives on quality worldwide from all types of organizations and have them describe approaches to provide for marketplace success through efficient operations and competitive advantage, an equivalent or an approximation of ISO 9004:2000 would emerge. It provides guidance for all of those activities of a quality nature that need to be considered above the base.
The first article in this series (October 1999) outlined the technical reasons for the changes specified in the design documents for the 2000 revision. These reasons included the need to achieve a consistent pair of quality management system standards--ISO 9001:2000 and ISO 9004:2000. From a big picture standpoint, the new revision facilitates rapid and smooth progression from baseline quality to performance excellence.
To ensure quality and marketplace success, all organizations need to embrace both the requirements within ISO 9001 and the performance improvement guidance within ISO 9004.
The next article is this series will explain how these principles and their application are allowing fulfillment of a truly unified, consistent pair of standards.
The Quality Hierarchy was developed and trademarked by Joseph J. Tsiakals to describe the relationships among various approaches for quality management.
To avoid awkwardness in the text of this article, the popular usage of the names ISO 9000 and ISO 9001 is used. ISO 9000 in the listing of criticisms refers collectively to the requirement standards ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994. ISO 9001 throughout the text means the quality management system requirements standards and includes ISO 9002 and ISO 9003. The ISO 9000 series refers to ISO 9001 and ISO 9004.
JOSEPH J. TSIAKALS represents the medical device product sector on the ISO/TC [technical committee] 176 writing team for ISO 9001:2000 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 email@example.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 firstname.lastname@example.org.
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 a member of the board of directors of the Registrar Accreditation Board. He can be e-mailed at email@example.com.