With the release of the draft international standard (DIS) edition of ISO 9000:2000, the revision process enters its last stage before the standard's final publication (scheduled for the end of the

For More Information… Copies of the ISO 9000:2000 DIS revision, although not yet intended for quality system design purposes, are available from the American Society for Quality for $40. Visit www.asq.org , or call 800-248-1946. Order Kanholm's ISO 9000:2000, 28 New Requirements and Compliance Guide direct from the Quality Digest E-store.

year). Although still a draft and subject to change, a DIS is usually very similar to the final version of the standard. As such, registrars, consultants and registered companies can use the DIS to upgrade their systems and train personnel without having to wait for the final publication.

 The next important step in the ISO 9000:2000 revision process is the July meeting of TC 176 in Kyoto, Japan. (TC 176 is the ISO technical committee responsible for the development and revision of the ISO 9000 standards.) The committee will review comments about the DIS edition and will ultimately elevate the standard to final draft international standard, which is normally not published for public distribution. Instead, it's submitted for balloting, translations and final reviews by national standardization bodies. After these standardization bodies have approved it, the draft becomes the final international standard. So far, the process is on schedule and the final publication of the ISO 9000:2000 series is still expected to take place in the fourth quarter of 2000.

New series

 The ISO 9000:2000 series includes three standards: ISO 9000, ISO 9001 and ISO 9004. ISO 9000 discusses underlying concepts and approaches and provides definitions for the new vocabulary. ISO 9001 is the actual specification for quality management systems, and its requirements define the criteria for the quality system audit. The role of this standard in the series hasn't changed, but its content and sectional organization have been completely revised. ISO 9004 is intended as a guide for organizations that want to further expand and improve their quality systems after implementing ISO 9001. ISO 9004 is not a specification and may not be used for registration or certification assessment. In fact, it should not even be used to interpret ISO 9001. The fundamental difference between ISO 9004:2000 and ISO 9004-1:1994 is that the new standard deliberately goes beyond ISO 9001, whereas the old revision was a guide for application of ISO 9001.

 When the three new standards are finally published, the ISO 9000 series will shrink considerably, as nearly all standards in the current ISO 9000 series will be withdrawn. And this doesn't apply only to the current ISO 9000, ISO 9001, ISO 9002, ISO 9003 and ISO 9004 that are being directly replaced by the new standards. The current vocabulary (ISO 8402) and all ISO sector-specific guides will also be withdrawn. The new ISO 9001 and ISO 9004 are now supposed to be sufficiently broad and generic that they can be applied to any organization in any industry without the need for additional guides and clarifications. With this new revision, TC 176 wants to reset the sector-specific fragmentation of the standard and start fresh with only one specification for all.

 Previously, organizations could choose between ISO 9001, ISO 9002 or ISO 9003, depending on the nature of their operations and needs. Now there is only one choice, ISO 9001:2000, but organizations may claim exclusions from various requirements that don't apply to their operations. The intent is to have only one specification but retain the flexibility of the previous configuration.

 The rules for claiming exclusions are specified in clause 1.2. Exclusions are limited to those within clause 7, Product realization, and exclusions may not affect the organization's ability to provide product that meets customer and regulatory requirements. There is also a warning that whenever permissible exclusions are exceeded, conformity to the standard should not be claimed.

 The intention is primarily to allow exclusion of design control requirements where there are no design activities. Other typical exclusions, especially in service industries, would include requirements related to product identification and traceability, customer property, preservation of product, and control of measuring de- vices.

New sectional organization

 The most visible change in ISO 9001 is the new sectional organization. The standard has been reorganized based on very different logic. The 20 sections of ISO 9001:1994 represented a linear list of elements, functions and activities comprising the quality system. The new specification is organized into five sections based on the plan-do-check-act loop approach. The first section of the specification, clause 4, Quality management system, includes some general requirements for developing and documenting the quality system. Clause 5, Management responsibility, addresses quality policy, quality objectives and planning, quality system administration, and management reviews. Clause 6, Resource management, concerns human resources, training, facilities and work environment. Clause 7, Product realization, is the largest section, encompassing all requirements pertaining to the control of product development, purchasing, production (realization), verification, delivery and customer-related processes (to include identification and review of customer requirements and customer communication). Clause 8, Meas-urement analysis and improvement, is dedicated to the measurement of product and process characteristics, quality system performance monitoring, and the pursuit of continual improvement.

 Considering this new sectional organization, companies upgrading from ISO 9000:1994 to ISO 9000:2000 will have to decide whether they want to change the structure of their existing documentation to align it with the new standard or keep the old 20 sections. Registrars will accept both, as long as all new requirements are adequately addressed. However, it may be difficult to logically incorporate new requirements and convey the standard's new approach using the old structure. Organizations may therefore want to reorganize and update their quality manuals to be more consistent with the new standard. Also, with time, quality systems documented under the old 20 sections will look neglected and out-of-date as more customers and competitors change to the new structure.

New requirements

 An important category of the new requirements pertains to customer-related processes. In fact, customer satisfaction is now defined as the principal objective of the ISO 9000 quality management system. The first requirement in this category is in clause 5.1, which requires top (executive) management to communicate to the organization the importance of meeting customer requirements. Clause 5.2 requires that customer needs and expectations be determined and converted into specific product requirements. Clause 5.5.3 gives the management representative the new responsibility of promoting awareness of customer requirements throughout the organization. Clause 5.6 requires that management reviews consider customer feedback and improvement opportunities related to customer satisfaction. Clause 7.2.1 directs organizations to determine customer requirements, including those that the customer does not specify but which are necessary for use or compliance with laws and regulations. Clause 7.2.3 requires organizations to implement planned arrangements for communicating with customers regarding product information; enquiries, contracts or order handling; and customer feedback, including customer complaints. Finally, clause 8.2.1 requires implementation of measures for obtaining and using information about customer satisfaction and dissatisfaction.

 Another major category of the new requirements pertains to continual improvement. It starts with clause 5.3, which requires that the quality policy include details about the organization's commitment to continual improvement. Clause 5.4.1 requires that measurable quality objectives be established to support the commitment to continual improvement. Clause 5.6.3 stipulates that management reviews are to be concluded with actions related to improvement of the quality system and products. Clause 8.4 requires collection and analysis of quality performance data to identify areas for potential improvements. Finally, clause 8.5.1 requires organizations to plan for and manage continual improvement of the quality system, including the use of quality policy and objectives as well as quality performance data.

 In ISO 9000:2000, continual improvement is not a discreet process or an element of the quality system but a way of managing the system. The standard requires that opportunities and priorities for quality system improvement be identified by means of a comparison of the actual quality performance to objectives defined in the quality policy and quality objectives. The organization determines the actual quality performance by analyzing customer satisfaction information, product and process conformance data, supplier performance data, internal audit results, and other data and information relevant to quality performance. Management reviews are used in part for assessing this information against the quality policy and objectives and determining where improvements are needed. Corrective and preventive actions and special management programs are the means for implementing improvements. This model contains no new elements or activities; all necessary quality system elements and processes are already required elsewhere in the standard. Continual improvement is just a way to use the system to facilitate improvement.

 In addition to these two important categories, ISO 9000:2000 introduces miscellaneous new requirements pertaining to quality planning, internal communication, management reviews, training and awareness, work environment, purchasing control, and measuring and monitoring devices.

Transition

 Transition from the 1994 version to the 2000 revision is an important issue for registered organizations, accreditation bodies and registrars. TC 176 set up a special joint working group with the International Accreditation Forum to study the issues and publish transition planning guideline documents. The Sept. 26 meeting of the joint working group in Vienna, Austria, issued a communiqué stating the following:

  No certifications may be issued to ISO 9001:2000 prior to the final publication of the international standard. However, registrars may begin assessing conformity to the draft international standard as part of surveillance or reassessment audits.

  Certificates issued to the 1994 edition of ISO 9001, ISO 9002 and ISO 9003 must expire within three years of the date of the final publication of ISO 9001:2000.

 In practice, the first statement means that registered organizations may start their transition as soon as the DIS is released and may be assessed to the new standard when ready, without having to wait until the end of the year. However, the formal certificate for ISO 9001:2000 cannot be issued before the final standard is published.

 Practical consequences of the second statement will depend on how accreditation bodies and registrars define their specific transition rules. Obviously, organizations registered to any of the 1994 standards prior to the publication of ISO 9001:2000 will be able to continue until their certificates expire, not to exceed three years.

 It's not clear what will happen when the certificate expires, for instance, one year after publication of the new standards. In theory, recertification can be done again to the 1994 edition, but the certificate could only be valid for two years. More uncertainty exists about how long after publication of ISO 9001:2000 registrars will be willing to issue new certificates to the 1994 editions. In theory, this should be possible for up to three years, but such certifi- cates will have to have shorter expiration periods.

 Accreditation bodies and registrars are expected to define their specific transitional rules in the second quarter of this year. A likely outcome is that recertifications and new certificates to the 1994 editions will be available for up to one year after ISO 9001:2000's publication. Surveillances will probably be available until the expiration of the current certificate, not to exceed three years.

 Overall, the DIS revision of ISO 9000:2000 is much more mature, balanced and mellow than was the committee draft 2 (CD2). The most striking difference is the dramatic reduction in documentation requirements. Documented procedures are only required in five instances: for document control, control of quality records, internal audits, control of nonconformity, and corrective and preventive action.

 Another significant difference is in the approach to quality planning. Instead of having one general clause dedicated to quality planning, clauses throughout the standard require planning of the quality system, methods to achieve quality objectives, product realization processes, product verification and validation activities, measurement and monitoring activities, and continual improvement.

 The DIS revision also dropped many controversial and ambiguous requirements and straightened out others. For example, the clause requiring identification of legal and regulatory requirements has been deleted completely, unrealistic requirements have been cut from the clause pertaining to work environment, and the esoteric and ambiguous requirements for process control have been replaced by requirements for planning realization processes and verification activities. The DIS is much cleaner and more elegant than CD2, but it also lost a lot of teeth in the revision process. Many clauses are now so general that they may no longer be fully auditable, especially where documentation requirements have also been drastically cut back.

About the author

 Jack Kanholm is the author of several books on ISO 9000, QS-9000 and ISO 14000. This article was inspired by the second edition of his ISO 9000:2000, 28 New Requirements and Compliance Guide, published in January and available through his www.iso9000y2k.com Web site. All of Kanholm's books are available on the Internet at www.aqapress.com. If you have any comments or questions regarding this article, e-mail the author at jkanholm@qualitydigest.com .