by Larry Whittington
When you're planning a trip, you must know your
starting point and ultimate destination to determine the best route. Similarly, before plotting your transition path to ISO 9001:2000, you need to understand the new and changed requirements. You can begin this process
by ordering the ISO 9000:2000 family of standards (ISO 9001:2000, ISO 9000:2000 and ISO 9004:2000). Copies can be purchased at www.quality press.asq.org. Then take a look at the following 10 tips, which will help you
navigate from the old standard to the new without getting lost along the way.
1. Understand the new and changed requirements
Before opening the ISO 9001:2000 standard, review the quality concepts found in ISO 9000:2000 Quality management systems—Fundamentals and vocabulary. If you're unsure of any of the terms, look up their
definitions in section 3 of ISO 9000:2000. When you examine ISO 9001:2000, pay particular attention to the process approach described in its introduction. This model illustrates the clause links based on the
Refer to Annex B in ISO 9001:2000 to see the clause correspondence between ISO 9001:2000 and ISO 9001:1994. Now you're ready to begin reading through the requirements to
understand the differences.
ISO 9004:2000 provides guidance on performance improvements beyond the basic requirements of ISO 9001:2000. For ease of reference, these requirements are shown in ISO
9004:2000 as boxed text. Because ISO 9004:2000 uses the same clause structure as ISO 9001:2000, it can be used to gain a better understanding of the requirements by seeing possible practices. Remember, however, that
your system will be evaluated against ISO 9001:2000, not ISO 9004:2000.
Another resource is ISO's Web site, which offers helpful transition planning guidance highlighting the key differences in
requirements. The address is www.iso.org/iso/en/iso9000-14000/iso9000/2000rev4.html .
2. Determine QMS scope and permissible exclusions
ISO 9001:2000 is intended to be generic (i.e., applicable to all organizations, regardless of type,
size and product category). However, not all requirements in the new standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may exclude some specific requirements.
ISO 9001:2000's clause 1.2, Application, states that requirements can be excluded only if they're limited to clause 7, Product realization. Exclusions are acceptable only if they don't affect an
organization's ability, or responsibility, to provide products that meet customer and applicable regulatory requirements.
If you find that your organization can't apply a product realization
requirement, you must define and justify this exclusion in your quality manual. In addition, any publicly available documents, such as registration certificates and marketing materials, should be phrased carefully to
avoid confusing or misleading customers and users regarding the scope of your quality management system.
Defining your system's scope involves deciding on which products and sites to include for
registration purposes. A clear description of the scope becomes increasingly important as the December 2003 deadline for transitioning to ISO 9001:2000 draws near. After that, certificates won't be allowed to be issued
for ISO 9002 or ISO 9003.
Remember, too, that any outsourced processes must be identified and controlled. Outsourcing a product realization process to an external organization doesn't justify
excluding the process from your quality management system.
Refer to clause 4.1, General requirements, in ISO 9001:2000 for the specific outsourcing requirement. Guidance on clause 1.2, Application,
is available at www.iso.org/iso/en/iso9000-14000/iso9000/2000rev6.html .
3. Adopt the process approach
A process is a system of activities that uses resources to transform inputs into outputs. The process approach promoted
by ISO 9001:2000 systematically identifies and manages these processes and their interaction within a quality management system.
As mentioned earlier, the process model illustrates the links between
ISO 9001:2000's clauses 4 through 8 based on the plan-do-check-act approach. This PDCA methodology can be applied to all processes.
During the planning phase, you establish objectives and processes
necessary to deliver results in accordance with customer requirements and your organization's policies. These processes are implemented during the do phase. Then you monitor and measure the processes during the check
phase and report the results. During the act phase, the organization implements any changes required to continually improve process performance.
One advantage of the process approach is the ongoing
control it provides over the links between individual processes and their interaction. According to clause 4.2.2 in ISO 9001:2000, your organization's quality manual must describe these interacting processes within your
quality management system.
4. Revise the quality manual and procedures
Documentation for a conforming system
must include the quality policy, quality objectives, quality manual, required procedures and any other documents deemed necessary for the system's effective planning, operation and control. These requirements are
covered in clause 4.2.1 of ISO 9001:2000.
You may already have the necessary documentation in place for the new standard. However, check your current documents to ensure they adequately address the
new and changed ISO 9001:2000 requirements.
Organizations registered to ISO 9001:1994 and an industry-specific scheme—such as QS-9000 for automotive, TL 9000 for telecommunications or AS9100 for
aerospace—may find that many of the new ISO 9001:2000 requirements are already practiced within their current systems.
What the standard doesn't tell you is how all this information should be
documented. As a general rule, you'll want to avoid creating overly complex or burdensome documentation. Use the transition period as an opportunity to examine your current documents for the right level of detail,
usable formats and business value.
You might even decide to merely define some of the simpler processes, rather than to document them. Rely instead on the skills, training and experience of the
people doing the work. This approach may cause auditors to adjust their auditing techniques and focus more on interviewing individuals and observing operations. However, you need to do what's best for your business, and
this may include reducing the amount of documentation compared to your current system.
Although it's not required, most organizations will choose to revise their quality manuals to reflect ISO
9001:2000's new clause structure. A quality manual must address the scope of an organization's system and provide details of any excluded requirements. In addition, it must describe the interaction between processes and
include or reference the procedures.
Only six procedures are specifically required by the new standard: Control of documents (4.2.3), Control of records (4.2.4), Internal audit (8.2.2), Control of
nonconforming product (8.3), Corrective action (8.5.2) and Preventive action (8.5.3). Although these procedures are part of ISO 9000:1994-compliant systems, they may need to be revised to incorporate ISO 9001:2000's new
and changed requirements.
Other procedures required by ISO 9001:1994 (e.g., contract review, design control, purchasing and training) are no longer required in ISO 9001:2000. However, defined
processes for these areas are still necessary and must comply with the requirements.
Many organizations will see the business value in retaining and revising their existing procedures. And it's
unlikely that lower-level work instructions will be affected by the new requirements.
As you examine your current documentation, consider using electronic media for easier access and better document
control. Process mapping will also help you identify your product realization processes and more clearly determine the critical documentation for your quality management system.
The extent of the
documentation and the use of electronic media will vary according to an organization's size, activity type, process complexity and personnel competence. Documents can be in any form or media, but they must be maintained
For more documentation guidance, see www.iso.org/iso/en/iso9000-14000/iso9000/2000rev7.html .
5. Focus on top management's expanded role
ISO 9000:2000 defines top management as the person (or group of people) who
directs and controls an organization at the highest level. Top management leadership, commitment and active involvement are essential when implementing an effective quality management system.
subclause in clause 5, Management responsibility, begins with the phrase, "Top management shall." Top management must provide evidence of its commitment to developing and implementing the quality management system, as
well as continually improving its effectiveness.
Management must focus on meeting customer requirements and establishing the quality policy and objectives. Responsibilities must be defined and
communicated within the organization. The system must be planned, and the results reviewed at planned intervals.
Review these duties with top management and explain the expected benefits for the
organization. Top managers must be willing and active participants in the transition effort.
6. Establish measurable quality objectives
When you drive down the road, you can glance at indicators on the dashboard to see how your car is performing. In a similar fashion, your organization needs to identify key quality measures for
evaluating the performance of its quality management system.
First, use the quality policy statement as a framework for establishing your process and product goals. Then set specific, measurable
targets on the path to attaining these goals.
Product objectives will largely be determined by your product specifications. Focus your attention on the process objectives and the methods you'll use to
measure process performance. These objectives must be established at the relevant functions and levels within your organization. See clause 5.4.1 on quality objectives for the specific requirements.
Provide the necessary resources to collect the product and process data. Analyze the data, as called for by clause 8.4, and use the facts for more effective decision making. If your desired results aren't being
achieved, identify the actions necessary to get the results you want.
ISO 9001:2000 requires an effective system, one that carries out activities according to planned arrangements and achieves planned
results. An efficient system is certainly desirable, but it's not required by the standard. Efficiency relates to the resources used to achieve desired results. Keep this in mind as you set objectives.
7. Prepare the transition plan
To determine your starting point, you should assess your current system against the requirements of the
new standard—i.e., your destination. This gap analysis will identify any missing documentation and practices.
Knowing the needed deliverables, you can determine the appropriate activities and
assignments to enhance your current system for conformity with ISO 9001:2000. Develop this transition schedule in consultation with your registrar.
Depending on your system status and business needs,
you may decide to make the transition quickly by having your entire system assessed during your next scheduled surveillance visit. Alternatively, you can stage the transition over several surveillance visits to minimize
its impact and possibly reduce registrar costs.
Your registrar will develop an assessment plan with you to meet the desired timing for your registration to the ISO 9001:2000 standard. You must
maintain conformity with the ISO 9001:1994 standard during the transition period to keep your current certificate in place. It's important to maintain the currently required procedures during the transition; you can't
drop these procedures, even if ISO 9001:2000 doesn't require them.
Clause 5.4.2 of ISO 9001:2000 requires planning any system changes and maintaining the integrity of the system while implementing
them. Switching to the ISO 9001:2000 standard represents a significant change for your system, and its planning may be the subject of an audit. Have your planning evidence ready.
Registrars want to
see several months of system operation before conducting an audit. You'll need to collect records as evidence that your system is complying with planned arrangements, meeting requirements and effectively achieving the
For advice on making the move to ISO 9001:2000, read the transition planning guidance offered at www.iso.org/iso/en/iso9000-14000/iso9000/2000rev4.html .
8. Inform the organization of changes and plans
It's important to keep everyone within the scope of your
quality management system informed of your plans and progress. Clause 5.5.3 of ISO 9001:2000 requires the establishment of internal communication channels to share information about the system's effectiveness.
Top management will rely on internal communications to convey the importance of meeting customer requirements. The organization must also make employees aware of their activities' relevance and
importance and how they contribute to achieving quality objectives.
Providing this information will involve all employees in helping to improve performance and meet established objectives for their
areas. Management should actively encourage feedback and communication from people within the organization.
9. Update the internal audit program
Clause 8.2.2, Internal audit, requires an organization to consider process status and importance when planning an audit program. Because the quality
management system will be revised to comply with ISO 9001:2000, your internal audit schedule should focus on areas with new and changed practices. In addition, the internal audit procedure must be updated to comply with
the requirements of clause 8.2.2.
Don't overlook training your internal auditors for ISO 9001:2000. They need to understand how the new clause structure and requirements will affect their audit plans.
Instead of auditing by clause, your organization may decide to audit by functional area.
Auditors should consider the new audit trails and expected evidence for conformity with ISO 9001:2000. For
example, auditing to the requirements for quality objectives requires consideration of clause 5.4.1, Quality objectives, as well as related clauses that refer to quality objectives. These include 4.2.1a, 5.1c, 5.3c,
5.4.2a, 5.6.1, 6.2.2d, 7.1a and 8.5.1. Using an electronic version of the standard will help auditors identify important cross-references.
The Registrar Accreditation Board has approved ISO 9001:2000
transition training courses for certified auditors. You should consider this training for your internal auditors. You can see a full list of RAB-approved training courses at www.rabnet.com/content/ISO9k2k/ApprovedCourses.htm .
Internal audits should be conducted against your modified system to determine
its degree of conformity and to identify actions for your transition plan. Ensure that the system is ready, and objective evidence is available, before the registrar arrives for an assessment.
10. Identify areas for continual improvement
According to clause 8.5.1, an organization must continually improve the effectiveness of
its quality management system through its quality policy, quality objectives, audit results, data analysis, corrective and preventive actions, and management review.
Management should continually seek
to improve process effectiveness rather than wait for problems to reveal opportunities for improvement. When a problem does occur, the cause must be determined and a corrective action taken to prevent its recurrence.
The new standard emphasizes planning for the system, its resources, its processes and the measurements necessary to evaluate performance. Part of the planning requires anticipating what might go wrong
and preventing these potential problems from occurring.
Processes can always be more efficient and effective, even when they're producing conforming products. The aim of a continual improvement
program is to increase the odds of satisfying customers by identifying areas needing improvement. After setting improvement objectives, an organization searches for possible solutions, selects and implements the
appropriate one and evaluates results to confirm that objectives are met.
The documented quality policy statement must include a commitment to continual improvement. To ensure this focus, a management
representative must report to top management on the need for any improvements. In fact, improvement recommendations must be one of the management review inputs, and any actions or decisions regarding improvements must
Tips and guidance
These tips, as well as the guidance provided through the ISO Web site, should
prove useful in your transition planning. Although your registrar can't consult on possible practices, it should be involved in setting up the transition audit schedule and interpreting requirements.
Effective application of these new and changed requirements, along with continual improvement, will lead to increased customer satisfaction and business success. Best wishes for a safe and enjoyable journey.
About the author
Larry Whittington is president of Whittington & Associates, a quality system training
and consulting firm in Atlanta. He and his associates are certified lead auditors for ISO 9000, QS-9000, TL 9000 and AS9100. They are experienced in manufacturing, software and services. Whittington & Associates can
be reached at (800) 404-7585 or on the Web at www.whittingtonassociates.com . E-mail Whittington at firstname.lastname@example.org .
Letters to the editor regarding this article can be sent to email@example.com .