ISO 9001:2000, the third edition of the international quality management standard originally issued in 1987, will
replace the 1994 versions of ISO 9001, 9002 and 9003. Renamed "Quality Management Systems," the standard has a new orientation built around a process approach, customer satisfaction and
continual improvement. As the Year 2000 approaches, there are many reasons for companies to seek ISO 9000 registration or compliance, including industry requirements, customer mandates,
competitive pressure, public relations value and even the simple realization that compliance can improve the way an organization does business.
The new standard requires
review every five years. As of this writing, the standard has reached its second Committee Draft (CD2) and is on its way to becoming a Draft International Standard (DIS), a Final DIS, and
eventually, the ratified standard, ISO 9000:2000. As you read this, the transformation from CD2 to DIS should have already taken place.
The member bodies of TC 176, viewing
customer needs as the force behind the revision, identified four main thrusts for changes:
1. The desire for a common structure based on a process model similar to the Malcolm
Baldrige National Quality Award criteria
2. The need to demonstrate continuous improvement and prevention of nonconformity -- a clear push toward per-formance measurement
3. The necessity for ease of use and clarity of terminology (an attempt to harmonize the requirements of service-based and manufacturing industries)
4. The desire for compatibility
with ISO 14000, the environmental management standard
The most obvious difference in the standard is the numbering scheme. ISO 9000:1994's 20 elements have
been replaced with four major sections: Management Responsibility; Resource Management; Product and/or Service Realization; and Measurement, Analysis and Improvement. What might not be apparent
is that all 20 of the old elements are alive and well in the new sections.
A second difference is the "process model" -- a schematic view of an organization that
employs customer input to guide internal processes and uses customer satisfaction, confidence and feedback to recharge the business processes in a continuous improvement loop -- the
plan-do-check-act of total quality management.
A third difference is the language. The strong orientation toward manufacturing in the previous versions is replaced by a new
sensitivity toward service industries. Some of the new language is clumsy; for example, the phrase "product and/or service" appears more than 60 times.
How will the
new standard affect your operations? First, the new version emphasizes strengthening the supply chain through organization-to-customer communication, written and unwritten specifications,
contract and design/development review, process management, and supplier and customer feedback. Second, the responsibility lies with the organization to determine measurement opportunities in all
aspects of the business -- order specification, training, process management, monitoring, nonconformity, customer satisfaction -- not only to measure but also to analyze the data for fact-based
decision making and as a basis for continuous improvement. Third, the need to meet customer requirements is represented in every part of the business transaction. Organizations must go beyond
"meeting specs" by being aware of and responding proactively to "fitness for purpose," unspecified requirements, process efficiencies, mid-stream changes, postproduction
activities and customer satisfaction, which the standard refers to as achieving "customer confidence."
Some people have suggested that the new standard will force
them to rewrite most of their documentation, staff new functions (statisticians, for example) and add activities to their already-full agendas -- all as required changes to an already ISO
9000-registered quality management system. However, that would be their decision based on their analysis of the standard, and may be as much a function of size and business complexity as of new
requirements. It's true that more activities will be needed to support the new requirements, and some businesses will want to hire process engineers, customer advocates and data managers.
Regarding documentation, it's estimated that an ISO 9000:1994-registered organization is at least 80 percent of the way to ISO 9000:2000 compliance. The main difference is the new quality manual
and several new procedures.
These are problems that industry must face. In the final analysis, ISO 9001:2000 is attempting to take a major step away from traditional quality
control and quality assurance to become a model for a modern, information-based, customer-driven quality management system that will add value to an organization's processes. A standard written
by a committee of more than 90 member bodies, it contains compromises and contradictions. If these are overcome, ISO 9001:2000 has the potential to become a worldwide model for the next
generation of quality improvement.
About the author
Stanley A. Marash, Ph.D., is chairman and CEO of STAT-A-MATRIX/The SAM Group. He can be reached by mail at One Quality Place, Edison, NJ 08820, by telephone at (732) 548-0600 or by e-mail at email@example.com .