What will the face of ISO 9000 look like when the new ISO 9001 is published in November 2000? In August, committee drafts of both ISO 9001:2000 and ISO 9004:2000 began circulating for comment within ISO Technical Committee 176, which is responsible for drafting and revising ISO 9000 standards.
Both committee drafts have been reorganized to provide for business needs without imposing too many new requirements. (Table 1 lists the contents of ISO/CD 9001 by clause structure.) Companies already ISO 9000-registered or planning to implement a quality management system in 2000 will find the revised editions easier to understand and use.
Since early this year, speculation has increased concerning how quality management systems based on revised ISO 9000 standards will affect businesses. Let's look at what is changing and what the new ISO 9001 will offer users.
The year 2000 family
TC 176 will present only four complete ISO 9000 standards in 2000: ISO 9000 (a terminology standard), ISO 9001, ISO 9004 and ISO 10011 (a revised auditing guideline). However, ISO 10011 might not be included in the year 2000 family if plans for a combined quality and environmental auditing guidance standard halt revisions of ISO 10011.
Most likely, a technical report will provide for automotive-sector quality requirements beyond what ISO 9001:2000 will require. Other technical reports will offer information on metrology, training and quality-related activities.
ISO/CD 9001 involves a business-oriented process approach, easier-to-understand requirements, customer satisfaction and continuous improvement, compatibility with environmental management and other management system elements, and wider applicability for organizations outside traditional manufacturing.
To prepare for the future, organizations will need to consider three issues:
ISO/CD 9001's process approach and "consistent pair" structure.
New and altered QMS requirements.
Preparing for the standard's publication in November 2000.
New approach and structure
If comments submitted by TC 176 member bodies don't result in significant alterations to ISO 9001:2000's first committee draft, two related changes -- the process approach model and the new consistent-pair structure -- will affect how companies view and use the revised standard. Figure 1 illustrates the process model contained in both committee drafts.
The model focuses on two cycles for developing, outputting and using products and/or services. The first cycle comprises an organization's internal processes and is represented in Figure 1 by management responsibility (Clause 5 of ISO/CD 9001) and resource management (Clause 6), which feed into process management (Clause 7).
Process management also is subject to the second cycle, input and output, which involves customer interaction. This cycle provides companies with product or service requirements as well as feedback on how well the actual products or services meet expectations.
Both cycles share measurement, analysis and improvement (Clause 8), which serves as a feedback loop for extracting information from customer responses as well as from all activities relative to an organization's QMS.
Thus, the process approach embodied in ISO/CD 9001 emphasizes actual activities of companies using ISO 9001-based QMSs that result in products or services intended for customers.
Figure 1 also contains a Plan' Do'Check'Act cycle within the internal loop where measurement requirements lead back to management responsibility. A QMS in conformance with ISO 9001:2000 must establish a baseline against which processes can be measured.
Unlike ISO 9001:1994's 20-clause structure, which includes in Section 4, Quality System Requirements, any business activities relating to quality assurance, ISO/CD 9001 contains a nine-clause structure that groups all operational activities into Clause 7, Process Management. All other aspects of an organization's activities loop back to process management.
Although many companies have developed their QMSs to conform with ISO 9001:1994 and have grown comfortable with the old structure, the change in approach should not require an upheaval in existing QMS documentation, although QMS adjustments will be necessary for companies not using a process approach.
Table 2 (Annex A in ISO/CD 9001) indicates where the requirements contained in ISO 9001:1994's 20 clauses appear in ISO/CD 9001's nine clauses. For organizations currently registered to ISO 9000, Annex A may prove the most valuable implementation and maintenance aspect of ISO 9001:2000. It will permit them to preserve their current QMS documentation and make adjustments as needed by new or altered requirements.
Will registrars expect documentation changes due to structural reorganizations when ISO 9001:2000 is published? The entire issue boils down to whether a registrar's audit team, when conducting a surveillance audit of a facility registered to ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, will be able to audit for conformance with ISO 9001:2000 without major revisions to the company's QMS documentation.
Typically, registrars have not expected clients to change their QMS documentation if it conforms to ISO 9000 requirements. Instead, many companies have used matrixes to show where their existing QMSs fit into ISO 9001's 20-clause structure. Similarly, registrars will expect their clients to perform gap analyses of their QMSs to ensure they conform to ISO 9001:2000 requirements and then simply revise their matrixes. The registrars' auditors will use these updated document control charts when conducting surveillance audits for QMS conformance with ISO 9001:2000.
ISO/CD 9001 represents an opportunity for companies to look at their existing QMSs in an easier-to-follow process approach format. It will help them eliminate unnecessary documentation and procedures that hinder process effectiveness and efficiency, and it will encourage product and service improvements.
ISO/CD 9001's new requirements
The significant changes in ISO 9001's structure will at worst create temporary challenges. Most structural change issues will be resolved by developing guidance tools to help auditors, quality managers and top management see where existing documents fit into the new clause structure. However, what will be the permanent, long-term challenges in terms of new requirements?
Five changes that will affect companies' QMSs are worth examining briefly.
Terminology changes -- New wording drafted by Working Group 18 will make ISO/CD 9001 easier for readers to understand and will more clearly define requirements while maintaining their generic natures. For example, "quality system" is replaced by "quality management system," "supplier" by "organization," "subcontractor" by "supplier," "product" by "product and/or service" and "supplier's management with executive responsibility" by "top management."
In simplifying the language, efforts have been made to avoid implying more restricted requirements and to prevent disputes between companies and their registrars due to a requirement's awkward, ambiguous wording. This will ensure that companies can determine effectively what is required for conformance. Even the standard's shrinking title reflects this: "Quality Systems -- Model for Quality Assurance in Design, Development, Production, Installation and Servicing" now simply states, "Quality Management Systems -- Requirements."
The language revisions will make the conformance standard easier to understand and apply to a company's processes. By spelling out what might appear obvious to those familiar with ISO 9001:1994, ISO 9001:2000 will allow new users to apply the requirements without unnecessary implementation expenses.
Scope changes -- It has been known for some time that when ISO 9001:2000 is published, ISO 9002:1994 and ISO 9003:1994 will cease to exist as options for conformance and registration. Instead, companies will register to (or replace their existing registration certificates with) ISO 9001:2000. Any limitations on an organization's QMS -- i.e., activities provided for in ISO 9001:2000 that don't occur within the organization -- will be indicated on the certificate.
Clause 1, Scope, provides requirements and guidelines relative to this scope limitation. If a company doesn't engage in design activities, Subclause 1.2.2, Reduced Scope -- Design and Development Excluded, specifies exactly what part of ISO 9001 doesn't apply to that company. Subclause 1.2.3, Tailoring, allows companies to restrict the applicability of Clause 7, Process Management. Nevertheless, ISO/CD 9001 reminds users that companies remain responsible for the results of their activities, i.e., the products and/or services they provide to their customers.
ISO 9002's and ISO 9003's elimination may prove inconvenient for some companies involved in design activities. Many organizations faced with registering to ISO 9001 or ISO 9002 to satisfy customer requirements have avoided putting their design and development activities through QMS implementation. Until now, this was possible by registering to ISO 9002:1994. However, this option might not be possible in the future. Like it or not, ISO 9001:2000 will be the only choice, and companies will have to specify their lack of design and development activities.
Additional customer satisfaction requirements -- While ISO 9000 always has focused on customer-based product and service specifications, ISO/CD 9001 includes subclauses that actually specify customer satisfaction requirements. The subclauses -- 5.2, Customer Needs and Requirements; 7.2, Customer-Related Processes; and 22.214.171.124, Measurement of Customer Satisfaction -- formalize customer satisfaction in ISO 9000-based QMSs.
Does ISO/CD 9001 require companies to collect new customer information and use it to change products and/or services, or alter QMS elements? No. However, companies will have to evaluate their available resources and consider new information sources for maintaining and improving both their QMSs and customer satisfaction levels.
Some of these new requirements relate to ISO 9001:1994's Clause 4.3, Contract Review, which specifies that a contract between a company and its customer must be evaluated to ensure the company can meet its customer's contractual needs and that contractual changes are handled properly within the QMS.
Examining these subclauses a bit closer shows that 5.2 requires companies to ensure that their processes meet customer requirements, which include encouraging customers to return.
Subclause 7.2 requires organizations to identify customer requirements in their products and/or services, engage in contract reviews and establish effective communication systems with their customers. Obviously, a customer's specified product and/or service requirements are important for sales, compliance with legal and regulatory requirements, delivery and follow-up services, and ensuring that products and/or services are appropriate for use.
Subclause 126.96.36.199 requires companies to determine what types of customer satisfaction data they need and how it should be collected, although they're not required to gather a specific amount or type of data. Companies also must define how customer satisfaction will be measured, what data are important and how they will use the data to assess their QMSs.
Most ISO 9001-based organizations rely on some level of customer satisfaction feedback; ISO/CD 9001 basically requires them to document formally what they do to obtain that feedback. It's up to the organizations to decide whether their processes sufficiently ensure that their customers' needs are met.
Formally requiring continuous improvement -- Through its management responsibility, internal quality audits, and corrective and preventive action clauses, ISO 9001:1994 infers that companies should engage in continuous improvement. So why is Element 8.4.3, Improvement Processes, necessary in ISO/CD 9001?
For one thing, many companies won't pursue continuous improvement unless it's necessary for conformance. Also, because ISO 14001 and QS-9000 already require continuous improvement as an auditable element of a management system, the element's inclusion in ISO/CD 9001 will help organizations achieve greater compatibility with these environmental and automotive objectives. The CD requires companies to use the resources available to them to achieve improvement results.
New focus on management responsibility and resource assurance -- Although ISO/CD 9001's requirements for management accountability and resource allocation haven't increased, new wording in the CD clarifies top management's responsibility toward establishing an effective QMS that leads to continuous improvement and customer satisfaction. While this isn't as important a change as the new and altered requirements, it does emphasize effective process management.
The new structure also will permit consistency between ISO 9001:2000, which provides generic requirements for developing an efficient and effective QMS, and ISO 9004:2000, which provides system elements that companies can use when developing their QMSs. The new standard will help organizations establish total quality management processes similar to the Baldrige Award criteria.
Start thinking about November 2000
Given the above information and the affect ISO 9001:2000 will have on sector-specific requirements such as AS9000 and QS-9000, organizations should start looking at how well their existing QMSs conform to current standards. Changes to QMSs already in conformance with ISO 9000 should not be significant. The fact that organizations can document changes using matrixes and other tools should resolve many concerns in the business community.
By all indications, ISO 9001:2000 will prove easier to understand and apply. Thus, not only will the next edition eliminate the need for a number of guidance standards, it will make ISO 9001 a more widely accepted and employed baseline from which organizations can work.
Use the time before ISO 9001:2000 becomes the standard to ensure that your QMS is in complete conformance with ISO 9000 and that it aims for measurable customer satisfaction and continuous improvement. ISO/CD 9001 contains few new requirements and doesn't eliminate any ISO 9001:1994 requirements. The future is now if your company plans to benefit from the advanced lead time.
Copies of ISO/CD 9001 and ISO/CD 9004, sold as a set for $30, are available from the American Society for Quality, telephone (800) 248-1946, fax (414) 272-1734. Or purchase them online at ASQ's Web site: www.asq.org .
About the author
Jim Mroz is editor-in-chief of The Export Practitioner, published by MK Technology Associates Ltd. in Washington, D.C. Formerly senior editor of The Informed Outlook, Mroz also served as a U.S. member of the TAG to TC 176. He can be reached by fax at (202) 429-9812 or e-mail at firstname.lastname@example.org .