If you will be implementing a modified quality management system to comply with the
requirements of ISO 9001:2000, we offer these ten tips to help you get started.
When you are planning a trip, you must know your starting
point and ultimate destination to decide on the most efficient and effective route.
Similarly, you need to understand the new and changed ISO 9001:2000 requirements before
plotting your transition path. Start by ordering the ISO 9001:2000, ISO 9000:2000, and ISO
9004:2000 family of standards. Copies can be purchased at http://qualitypress.asq.org.
http://www.iso.ch/iso/en/iso9000-14000/iso9000/2000rev4.html
that highlights the key requirement differences.
You will need to provide awareness training to top management and other personnel
responsible for facilitating the transition. We offer a two hour ISO 9000:2000 Revisions
Overview either through our public course offerings or we can bring this training on site
– tailored to your needs. See our class schedule at http://www.mttc.org/Calendar.htm, or contact
us at (502) 367-2186.
ISO 9001:2000 is intended to be generic and 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.
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.
The documentation for a compliant quality management system
must include the quality policy, quality objectives, quality manual, required procedures,
and other documents deemed necessary for its effective planning, operation, and control.
These requirements are covered in clause 4.2.1 of ISO 9001:2000.
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 for an effective quality
management system.
When you drive down the road, you can glance at the
indicators on the dashboard to see how your car is performing. In a similar fashion, your
organization needs to identify the key quality measures for evaluating the performance of
your quality management system.
We began these tips by talking about planning a trip. To
know your starting point, you should assess your current system against the requirements
of the new standard (your destination). This gap analysis will identify any missing
documentation and practices.
http://www.iso.ch/iso/en/iso9000-14000/iso9000/2000rev4.html
for advice on making the move to ISO 9001:2000.
You will need to provide transition training to top management and other personnel
responsible for facilitating the transition. We offer a two hour ISO 9000:2000 Revisions
Overview either through our public course offerings or we can bring this training on site
– tailored to your needs. See our class schedule at http://www.mttc.org/Calendar.htm, or contact
us at (502) 367-2186.
It is 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 internal communication channels be established to share information
about the effectiveness of your quality management system.
Clause 8.2.2, Internal Audit, requires an organization to
consider the process status and importance when planning an audit program. Since the
quality management system will be revised to comply with ISO 9001:2000, your internal
audit schedule should focus on the areas of new and changed practices. In addition, the
internal audit procedure must be updated to comply with the requirements of clause 8.2.2.
According to clause 8.5.1, the organization must
continually improve the effectiveness of the quality management system through the use of
the quality policy, quality objectives, audit results, analysis of data, corrective and
preventive actions, and management review.
Tips and Guidance
We hope you find these tips, as well as, the guidance in the referenced documents at
the ISO web site, useful in your transition planning. Although your registrar cannot
consult on possible practices, they should be involved in setting up the transition audit
schedule and interpreting requirements.
Visit our web site regularly for
the latest information regarding the ISO 9000:2000 standards and related transition
guidance, training courses and consultation. Let us help you begin the "Move from
Conformance to Performance" in the year 2001! Contact Aimee Cecil [email protected], or Mike Paten [email protected], RAB Certified Quality Management System
Auditor. |
