Now that the much-anticipated ISO 9000:2000 series of standards has been officially released, the
pressure is on for companies registered to ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 to make the transition. With less than three years to complete the changeover, organizations can't afford
to take a haphazard approach to upgrading their quality management systems. Fortunately, those who take the time to develop a solid, systematic plan for the transition won't find the process too
The core documents of the ISO 9000 family include:
ISO 9000:2000 Quality management systems--Fundamentals and vocabulary
ISO 9001:2000 Quality management systems--Requirements
ISO 9004:2000 Quality management systems--Guidelines for performance improvements
ISO 19011--Guidelines on quality and/or environmental management systems auditing (pending revisions)
ISO 10012--Measurement control system
The ISO 9000:2000 series represents the most thorough overhaul of these standards since they were first published in 1987. "The new versions take account of
developments in the field of quality and the considerable experience that now exists of implementing ISO 9000," states an official ISO press release. "Among the changes
made are the following: reduced number of standards; explicit requirements for achieving customer satisfaction and continual improvement; more logical structure; an
approach based on managing organizational processes; easier to use by service-sector organizations and by small businesses; built on eight universal quality management
principles; possibility of going beyond certification to achieving satisfaction not just of customers, but of all interested parties, such as employees, shareholders and society as
a whole." To read the entire release, visit www.iso.ch/presse/iso9000_2000.htm.
Changes from the FDIS
The final release of ISO 9001:2000 contained only minor changes from the Final Draft International Standard (FDIS). Typically, only typographical and grammar changes are
made between an FDIS and the final published standard. One of these grammar changes included removing the word "quality" from the phrase "quality records"
throughout the standard. In many areas, the word "fulfilled" has been replaced by "met or meeting." Other minor changes included adding "in accordance with planned
arrangements" to the text of 7.3.4 Design and development review and 7.3.5 Design and development verification.
Transition planning basics
The Registrar Accreditation Board (RAB) has stated that the 1994 versions of the ISO
9000 series will officially expire three years from the release of the 2000 series. Therefore, those companies holding an ISO 9001, ISO 9002 or ISO 9003 (1994)
registration have until Dec. 15, 2003, to become compliant to ISO 9001:2000. Most registrars are allowing this three-year window; however, some are either suggesting or
requiring that their clients become compliant to the new standard before the deadline. Each organization should contact its registrar directly and inquire about timing
requirements. Typically, registrars will verify compliance to the new requirements during their routine surveillance audits. As the deadline approaches, though, registrars
may need to add audit days to their schedule to accomplish the surveillance and the upgrade audits at the same time.
Everyone knows how quickly three years can pass, so organizations should develop transition-planning activities as soon as possible. The following transition strategies are
considered "high-level" and do not include all of the details.
1. Discuss changes with top managers to ensure their commitment.
2. Determine and plan resource allocation.
3. Appoint an ISO 9001:2000 transition team and project leader.
4. Ensure that the transition team is adequately trained and understands ISO 9001:2000.
5. Contact the registrar to confirm transition policies and timing.
6. Ensure that internal auditors are trained in ISO 9001:2000.
7. Develop a high-level project timeline with assigned tasks, personnel and due dates.
8. Ensure frequent timeline review so the project stays on track.
9. Determine and provide training on the changes for appropriate personnel.
10. Involve top management throughout the transition process.
The transition time for each organization will vary depending on several factors:
is the most important factor in a successful transition. Management must allocate adequate resources and time to implement the
new requirements. Management must also be committed to upgrading the system.
Maturity of the quality management system--If an organization already has effective
systems in place for the new requirements, the transition time will be shorter. Conversely, if it only has a basic system in place, it will take longer to develop and
implement systems to meet the new requirements.
Adequate resources--Without enough resources assigned to the transition plan, the activities won't get implemented in time.
Solid action plan--The plan should include a timeline, a list of specific activities,
personnel involved and due dates. A frequent timeline review is necessary to ensure that the plan stays on track and that any roadblocks can be dealt with right away.
Transition planning tips
When developing the transition plan, organizations should focus on the following key
topics: documentation, training, auditing and management. These four areas will require modifications due to ISO 9001:2000's new requirements. Following are a few
tips for each category that will help get the ball rolling.
Identify and document quality management system processes within the quality manual.
- Develop a cross-reference matrix that shows how the ISO 9001:2000 requirements are aligned within the existing documentation structure.
- Determine if any gaps exist in documentation, and develop actions to close the gaps.
- Utilize the existing quality manual as a springboard for new documentation.
- Consider whether this is a good opportunity to streamline existing documentation.
- Identify training needs, and ensure that training supports the achievement of the quality objectives.
- Define personnel competency needs.
- Determine how identified competencies will be communicated (e.g., job descriptions and training plans).
- Train personnel to handle any new changes that affect them, and record the training.
- Determine and document established criteria to verify training effectiveness.
- Provide ISO 9001:2000 training for internal auditors.
- Reduce the scope of audits by breaking them into smaller chunks until auditors become comfortable with the changes.
- Review the audit plan, and ensure that audits are grouped logically (i.e., 5.1, 5.3, 5.4.1, 5.4.2).
- Ensure that enough objective evidence is available to confirm the effectiveness of the quality management system. (This may require three months of records.)
- Modify audit checklists to align with ISO 9001:2000's requirements.
- Ensure that the resources for implementing the upgrades are allocated.
- Review the quality policy, and ensure that it aligns with the quality objectives.
- Ensure that quality objectives are measurable.
- Ensure that quality objectives are established at relevant functions within the organization.
- Confirm that people are aware of how they contribute to the achievement of the quality objectives.
- Evaluate how well current measurements and data are used as a basis for quality management system improvement. Ensure that the measures support quality objectives.
- Review how customer information is currently monitored. Ensure that necessary changes are made to include customer perceptions as one of the
measures of performance of the quality management system and that methods and the use of such information is included.
- Ensure that the continual improvement of the quality management system is effectively planned and implemented.
- Ensure that supplier relationships are included in improvement activities.
One organization's transition planning
MTS Sensors, located in Cary, North Carolina, began its transition planning activities last fall by requesting an assessment to ISO 9001:2000 (FDIS). In fact, MTS was one
of the first Det Norske Veritas (DNV) clients to be audited to the new 2000 requirements in October 2000. Stacey Gross, quality assurance engineer for MTS, was present during the assessment and
stated that issues within Section 4 Quality management system and Section 8 Measurement, analysis and improvement were noted during the audit. The auditor
noted the following noncompliances:
4.1 General requirements: Processes needed for the quality management system and their application throughout the organization were not identified.
4.2.2 Quality manual: No description existed of the interaction between the
processes of the quality management system.
8.2.2 Internal audits: No evidence existed that previous audit results are considered during audit planning; reporting on verification results was not included in follow-up activities.
8.2.3 Monitoring and measurement of processes: Methods were not applied for monitoring processes within the quality management system.
8.5.3 Preventive action: There was no documented procedure for preventive action requirements.
When asked what major challenges MTS faces in making the transition to ISO 9001:2000, Gross cites the organization of the company's current activities in
accordance with the new requirements. "This includes using a matrix to link the 'new' numbering system to the 'old' 1994 numbering system and ensuring that relevant
documentation addresses the new requirements," explains Gross. "Another challenge is ensuring our effort of showing that the interaction between the processes of our
quality management system is correct and has management's approval. We further need to clarify current objectives and goals, set up to monitor them effectively and
make them visible. Our final hurdle is training all employees about the changes and getting the internal auditors trained and ready."
For MTS, the transition has been easier than expected because the ISO 9001:2000 standard contains requirements for systems that the organization already has in place,
such as measuring customer satisfaction. (For six years, MTS has been conducting customer satisfaction surveys that have been used as a management tool to help
identify how well it's satisfying its customers.)
For organizations developing their transition plans, Gross offers this advice: "Train
each department's personnel separately by focusing on the changes in requirements for their specific area. Because the standard is more 'business friendly,' show management
how some of the systems--such as customer satisfaction surveys, product teams reducing defects, and stated goals and objectives--are already in place. Set your plan
first. Review the changes in the standard against what you do in your company. Consider a pre-assessment by a third party. Perform a gap analysis of any observations
or findings from the pre-assessment in order to determine who needs to do what to meet the requirements. Obtain target dates from those employees that will be
responsible. Follow up on the assigned items until they are closed. Finally, perform an in-house audit to the new requirements to determine the readiness of your facility."
Transition planning pitfalls
With less than 36 months left to comply with ISO 9001:2000, organizations must
avoid pitfalls in the transition planning process that will cost them unnecessary delays and wasted time. The following list offers some of the common pitfalls, but there are
more, and organizations need to consider what additional problems may occur.
Total commitment from management and/or transition team members isn't secured before the transition.
Management isn't trained in the new requirements.
Personnel undocument the organization's current documentation.
Appropriate personnel aren't provided training on new documentation.
Adequate resources aren't allocated to implement the transition plan activities.
Internal auditors aren't adequately trained in ISO 9001:2000.
Pertinent information about the transition isn't effectively communicated within the organization.
The organization waits until the last minute.
No formal plan is developed.
Information about ISO 9001:2000 can be found in a variety of places, including
magazines, Web sites and training catalogs. But even though the information is plentiful, it's not all necessarily accurate. A recent Web search returned several
advertisements for information and training based on previous iterations of the standard, not on the officially released ISO 9001:2000 standard. Because there have
been changes throughout this standard from each version to the next, it's imperative that organizations confirm that training, tools and information are based on the correct
version. Also, if outside resources are used, ensure that those selected are up-to-date and knowledgeable about the changes. Not doing so could waste a great deal of time and money.
Many organizations will be challenged as they begin their own transition process. They will require a committed transition team empowered by top management. Once
key personnel have reviewed the ISO 9001:2000 standard, organizations should begin the first steps in assembling a team and putting a plan together. Once this plan is given
the green light by top management, organizations should remain focused and make it happen.
About the authors
Jeanne Ketola and Kathy Roberts conduct transition training, internal audit training
and executive overviews for the revised standard. Their transition course is approved by the RAB. Ketola and Roberts are authors of the international bestseller ISO
9000:2000 In a Nutshell: A Concise Guide to the Revisions, published by Paton Press. Their second book, ISO 9001:2000 Management Responsibility In a Nutshell, is to be
published in March 2001. For more information about their book, visit www.patonpress.com
or call (530) 342-5480. The authors also have a joint Web site, www.inanutshellproductions.com ,
which contains ISO 9000 products, services and information. If you have questions or comments about this article, e-mail the authors at firstname.lastname@example.org or email@example.com .