ISO 9000:2000: A Shift in Focus
Changes in requirements
by Jack West,
with Charles A. Cianfrani and Joseph J. Tsiakals
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. In last month's Quality Progress, the authors reviewed the reasons changes are needed and discussed changes that relate to presentation, terminology and format. This article will review the general changes in the actual requirements (refer to the sidebar "Requirement Changes").
The shift in focus discussed in last month's article is also evident in the overall change in focus of some of the requirements. When the authors refer to the requirements, this means the requirements as stated in ISO 9001. The article is not addressing the ISO 9004 guidelines for performance improvement, which will be discussed in a future article.
The changes in ISO 9001 explained in the following are things that all organizations using that standard will have to consider and address--assuming that the changes in the second committee draft (CD 2) actually appear in the final ISO 9001:2000.
For this to happen, ISO/CD 2 9001:2000 will have to survive the worldwide consensus process. This complex process includes several cycles of comments and votes. Assuming the vote on CD 2 is positive, there still will be comments and votes on a draft international standard and final draft international standard. It is anticipated that this consensus building process will result in the revised standard being published in the fourth quarter of 2000 (see Figure 1).
With this caveat, let's consider a sampling of the basic changes contained in the current drafts.
In ISO 9001:1994, the concept of continual improvement was, at best, implied. The 1994 edition of the standard requires corrective and preventive action which, when taken together and linked with the management review requirements and quality audit, strongly imply that continual improvement is required.
But, there is quite a difference between the implied requirement in the 1994 edition and the words in CD 2 of ISO 9001:2000. CD 2 clearly states that the organization establish "a system level procedure ... to facilitate continual improvement."
CD 2 includes the concept that the organization measure process and product/service output, analyze these data and include them (along with audit results and so forth) in the management review. The emphasis has been shifted to require the use of information and data to continually improve performance.
One of the most fundamental reasons for the existence of ISO 9001 is to achieve customer satisfaction with products and services provided by an organization. CD 2 underscores the importance of customer satisfaction by specifically requiring measurement of customer satisfaction and dissatisfaction. In addition, attention to customer satisfaction is included in the requirements of several other elements of CD 2.
Measurement of customer dissatisfaction was added during the analysis of comments on CD 1 of ISO 9001:2000, which had required simple measurement of customer satisfaction. Comments indicated that it was unclear whether measurement of dissatisfaction was sufficient to comply with the requirement to measure satisfaction.
While the basic requirement change appears to be an issue of measurement and feedback, there is more going on here. The focus of ISO 9001 has been shifted to one of explicitly understanding and satisfying customer requirements, needs and wants rather than merely satisfying the customer's stated requirements. The shift may be subtle, but it is an important point to understand regarding the evolution of the standard to address market needs.
Statistical techniques and measurement
ISO 9001 has always required measurement of products to ensure conformity with requirements, and CD 2 is no exception.
Use of statistical techniques is not new to ISO 9001, but in CD 2 the organization must not only consider, but also use the appropriate techniques. And the requirement does not just apply to the product realization activities; CD 2 also requires measurement of processes as well. This is different from the actual requirement in the 1994 edition.
The organization will have the freedom to determine what techniques are used and where in the quality management system to apply these techniques.
While the change in measurement and statistical techniques is significant, it is more significant that with CD 2, data must be analyzed and provided as input for management review. Clearly the intent here is to facilitate the continual improvement of the system through actions based on facts.
With ISO 9000:2000, there will be no ISO 9002 or ISO 9003. For most organizations this will not be an issue.
CD 2 of ISO 9001 contains a clause that permits a reduction in the scope of a quality management system with regard to product or service realization. However, an organization may not exclude any requirement that affects its ability to provide a conforming product or service.
This clause describes what an organization may not exclude. It may prove to be somewhat difficult for organizations that perform product or service design activities but have opted to use ISO 9002 (excluding design controls from their quality management system) in the past. CD 2 makes it clear that organizations cannot exclude for convenience elements of the quality system that impact on the quality of the products or services provided to customers. This will also impose a requirement on auditing agencies to carefully train their auditing personnel.
Summary of the changes
It has been said that the devil is in the details. And so it may be with ISO/CD 2 9001:2000. The authors have not attempted to cover all the changes in this brief article, but rather to highlight a few of the changes that will affect organizations that desire to retain or achieve compliance status.
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 firstname.lastname@example.org.
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 email@example.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 firstname.lastname@example.org.