The Art of Creating a Standard
It's easier to be a critic than a playwright
by Charles A. Cianfrani, with Jeffrey H. Hooper, Joseph J. Tsiakals and Jack West
This is part three of a series of articles explaining the latest version (Committee Draft 2) of ISO 9000:2000.
The preferred way to develop an international standard is to achieve widespread consensus among the delegates who must vote in its acceptability. These delegates represent many diverse national interests. Understanding this process of consensus building may help Quality Progress readers better understand the content of the updated ISO 9001:2000 and ISO 9004:2000 quality management system standards.
The basic process whereby a standard is updated and rereleased is generally controlled by procedures from the International Organization for Standardization (ISO).
The ISO Technical Committee (TC) called ISO/TC 176/Sub-Committee (SC) 2 is responsible for ISO 9001 and ISO 9004 standards and has some discretion regarding how the basic standard development process is implemented. A simplified over-view of the process implemented for the update of ISO 9001:1994 and ISO 9004:1994 is shown in Figure 1.
Working groups (WGs) are assigned to deal with a specific standardization project covering more than one standard. WG 18 was established under SC2 to develop the 2000 revisions to ISO 9001 and ISO 9004. Each member body of TC 176/SC 2 was permitted to nominate four experts to this WG.
The United States has eight individuals involved directly or indirectly in the creation of ISO 9001 and ISO 9004. These include expert representatives, liaison representatives and the overall project leader, Jeffrey H. Hooper of Lucent Technologies.
The revision of these standards began with a detailed project plan that documented the planning and operations of the working group. The objectives of the revisions were carefully formulated. These included:
* Providing compatibility with existing standards to enable users to build easily on existing quality management systems.
* Providing structures for management, with emphasis on customer orientation.
* Accommodating all sizes of organizations from all industry sectors.
* Connecting business processes with an organization's quality system.
* Facilitating compatibility with other management systems.
* Providing simple and clearly understood standards.
WG 18 made impressive enhancements to the process for revising a standard and for effectively reviewing and incorporating, as appropriate, the many suggestions and comments received from around the world during each stage of the revision.
It is fair to say that there is more interest and involvement in the revision process of these standards by individuals and organizations worldwide than there has ever been. The process used to accomplish this work has combined high tech and contemporary project managementmethodology with a focus on small teams and a blending of the experts' talents, backgrounds and viewpoints.
E-mail and the Internet have had a profound impact on the efficiency and effectiveness of the development process. Essentially all communication between WG meetings takes place by e-mail and via the WG 18 Web site, which makes an enormous amount of information pertinent to the project readily available to all WG members.
During WG meetings, there were several computers with state-of-the-art support in every meeting room so that work proceeded effectively. The Verification Task Group, for example, used multiple computer driven projectors to review, sort, cut and paste thousands of comments on the first committee draft (CD 1). During a week just prior to the full WG meeting this group devoted 1,000 intense man-hours to assure effective adjudication of comments.
WG 18, with the approval of SC 2 member bodies, instituted an important advance over past procedures when it decided to use project management methodology for the entire development process--from developing the management and project plans to customer needs analysis and communications to verification and validation, product introduction and product support.
This entire spectrum of activity was broken down for work by 27 task groups. Each group had a carefully defined task and a task monitor to help remove roadblocks. Likewise, each group was carefully staffed with a balanced set of experts. The Planning and Operations Task Group managed the interrelationships among the task groups. See Figure 2 for the the organizational structure used by WG 18 and Figure 3 for the work structure breakdown.
A decision by WG 18 to manage the development of ISO 9001:2000 and ISO 9004:2000 just like the development of any new product--in other words to follow the requirements defined in ISO 9001, Clause 4.4--had a profound effect on the update. Early on, WG 18 administered an extensive, worldwide survey of customer needs. More than 1,100 people from 40 countries responded. Early in the development process participants agreed that to achieve as clean a release of this new standard as possible, the process must incorporate, among many other things, robust and formal verification and validation.
Verification is an internal WG 18 process that independently checks the drafts of the standards with the design specifications and project objectives. This provides quick feedback to the drafting groups on how well they are achieving their objectives and adhering to the design specifications.
Validation is an external process that directly checks how well the new draft standards are meeting customer needs. WG 18 structured a validation process to get direct user feedback, expecting that changes would become necessary as a result.
On a worldwide basis, 31 countries and 338 organizations (42 from the United States) participated in the CD 2 validation process. As shown over and over again in the industrial sector, the validation process yields important feedback. This feedback was used to revise CD 2 and resulted in a more robust draft international standard (DIS). There is another validation process scheduled in the project plan for the DIS stage of revision. The process for this next step was appropriately revised to incorporate lessons learned from the CD stage.
Another important advance resulting from addressing the development of the 2000 updates as product development projects was the incorporation of both product introduction and product support in the scope of the development process.
Regarding the structure and content of the standard, evolving changes reflect a growing understanding of the needs of customers in all major product and service sectors. Balance was sought in addressing the quality management system requirements of hardware, service, processed material, and software customers and producers. Many of the new improvements are a reflection of this migration from the original standard with its hardware focus to one that applies equally well to the service and software sectors.
The U.S. participation in the actual writing of the language of the standard focused on meeting the needs of the private sector because more than 95% of the experience base of the U.S. experts and a vast majority of U.S. users are from that sector. The primary concern of the U.S. representatives was to address the requirements and needs of these users, with a goal of creating a standard that can add value, lower costs and achieve customer satisfaction.
Some major changes in the revised standards were based on a desire to improve compatibility between ISO 9001 and ISO 14001, the environmental management standard. Most of the changes to improve the compatibility with ISO 14000 were made in the earlier WGs and in CD 1 and CD 2.
It has been observed that the present draft is somewhat longer than the current standard. As clarity and simplification are pursued, words and paragraphs are added. Also adding to the standards' length is the need to make crystal clear requirements that were always intended but previously were not explicitly stated.
An example is continual improvement. In 1987 and 1994, standards writers believed that improvement was clearly mandated by the linked requirements of management review, corrective and preventive action, and internal audit. However, what were believed to be clear mandates were neither clear nor considered mandates.
Claims of extra costs associated with implementing the current ISO 9001 and even higher extra costs for ISO 9001:2000 have no basis in fact. No organization should do anything just to meet a requirement in a standard. The effort must have a legitimate organizational justification. Compliance with ISO 9001 should not add any extra cost but may expose requirements that should have been already considered but were not adequately addressed.
Perhaps the specific area requiring the greatest amount of discussion has been the question of what constitutes minimum requirements for an effective quality assurance process. The spectrum of opinions on this issue ranges from revisionist (revert to the 1987 requirement and even eliminate some of those) to expansionist (include all ISO 9004 content in a requirements format and more).
These diverse viewpoints have their origins in the varying degrees of maturity of quality management systems, the size and nature of typical user organizations (large, small, hardware, service, sector needs and so on) and the experience of the individual experts.
Resolution of what to include in ISO 9001:2000 has generated the most debate and compromise in the overall effort to produce an updated, balanced standard that is truly generic and appropriate for all types of users. This debate will continue up to the very last moment as the standard progresses to its final released form.
ISO/TC 176 has a track record of successfully producing standards that add value. The last 12 years of experience with ISO 9001 demonstrate that the standard does provide a useful model for most organizations--one that has positively contributed to meeting organizational objectives.
The authors believe that ISO 9001:2000 and ISO 9004:2000 will prove to be even more useful and valuable to organizations than their predecessors.
Parts one and two of this series, covering changes in format, presentation, terminology and requirements, appeared in QP's October and November Standards Outlook columns.
CHARLES A. CIANFRANI is the U.S. expert representative to ISO/TC 176/SC 2/WG 18, the group writing ISO 9001/4:2000. He is managing director, customer focused quality, at ARBOR Inc., Media, PA, and has held a variety of executive positions in design, manufacturing, quality and general management, primarily in high-tech electronics. 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.
JEFFREY H. HOOPER is the project leader of ISO/TC 176/SC 2/WG 18, which is responsible for the year 2000 revisions to ISO 9001 and ISO 9004. He is also director, international services, with Lucent Technologies, where he is responsible for marketing and sales support, improvement of service delivery performance and customer satisfaction for international services. Hooper earned a doctorate in operations research from Cornell University. He can be e-mailed at firstname.lastname@example.org.
JOSEPH J. TSIAKALS has more than 25 years of experience in quality management and quality engineering and currently represents the medical device product sector on the ISO/TC 176 writing team for ISO 9001:2000. He is one of the founding members of the ISO Medical Device Quality Committee (ISO/TC 210), serves as liaison between ISO/TC 176 and ISO/TC 210 and is a member of the Board of Directors of the Registrar Accreditation Board. He can be e-mailed at email@example.com.
JACK WEST is chair 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 is a quality excellence business consultant based in The Woodlands, TX, and a member of the Board of Directors of the Registrar Accreditation Board. West can be e-mailed at Jwest92144@aol.com.