ISO 9001:2000 Implementation

The Impact of ISO 9001:2000 on your Quality Management System

The release of ISO 9001:2000 in December 2000 brought a significant impact to your organization's quality management system. Understanding the changes and registration implications early will be the key in successfully implementing the new requirements.

What are some of the key issues your organization needs to consider in order to get a jump-start on your ISO 9001:2000 implementation or transition process?

The structure, emphasis, and terminology of ISO 9001:2000 reflect a significant change from the 1994 version. ISO 9001:2000 is based on a "Process Model" with a strong emphasis on customer satisfaction and continual improvement - addressed only passively by the 1994 version. In addition, the Standard has been changed from twenty main requirement clauses to five. Note that you are not required to re-write the entirety of your documentation to "match" the new Standard. However, in addition to addressing the additional requirements imposed by ISO 9001:2000, you should restructure your Quality Manual to reflect the structure of the new Standard, describing at the policy level how the elements of your Quality Management System interact within the construct of the Process Model and describing the sequence and interaction of the processes included in the Quality Management System.
ISO 9001:2000 places an increased emphasis on the role of top management, including consideration of regulatory and statutory requirements within your quality management system and the establishment of measurable quality objectives throughout the organization. In many organizations this will mean that management will need to take a more active role in promoting and supporting the quality management system and will need to give more attention to establishing, tracking, and updating quality objectives.
ISO 9001:2000 places an increased emphasis on Resource Management, including human resources, infrastructure, and the work environment. Your organization's training system may need to be enhanced to address the new requirement to determine training effectiveness. In addition, infrastructure and work environment planning and maintenance must be included in the scope of your quality management system.
ISO 9001:2000 places an increased emphasis on measurement and data analysis related to the effectiveness of your quality management system, organizational processes, and resulting products. Measurements and resulting data analysis must assure conformity and drive continuous improvement efforts. Some organizations may need to develop the systems to obtain and analyze applicable data; others may be able to simply document what they are doing today. In either case, there is a need to demonstrate how your organization's quality policy, quality objectives, audit results, data analysis, corrective and preventive actions, and management reviews work together to facilitate continual improvement.
ISO 9002 and ISO 9003 are being eliminated. Organizations currently registered to ISO 9002 or ISO 9003 will become registered to ISO 9001 by limiting the scope of application or by tailoring the requirements. If your organization performs product design to meet customer or regulatory requirements, you no longer have the option to arbitrarily exclude the design control requirements; they must be addressed by your quality management system.
Certificates issued to the 1994 version of the Standard will have a maximum validity of three years from the date of ISO 9001:2000 publication. This means that since the Standard was released in December 2000, you must have completed the transition process bu December 2003. Although it is expected that ISO 9001:2000 compliance will be evaluated through your regular surveillance audits and that a full reassessment will occur only when your current certificate expires, your registrar will undoubtedly have their own policies regarding the transition process and should be consulted early in your transition process.

What are the most important considerations when selecting a Quality Tool?

An organization (or quality professional) must choose the right tool (or set of tools) for the particular job at hand. Too many organizations find a tool that is hyped as delivering results and then try to force that particular quality tool/method to be used in their situation. Thus an organization must assess their situation thoroughly (culture, goals, barriers, etc.) and then carefully plan out the strategy and tactics they will use to meet their goals. At this point the quality tools should be chosen in a synthesized method, which will support the goals, strategies and tactics. The value of the quality professional is in having a wide understanding of the many tools available, and then pulling together a mixture of tools to solve a particular problem (or meet a particular objective).

When addressing quality management system implementation, a common synthesis of tools includes devising an overall implementation/improvement strategy following the PDCA (Plan, Do, Check, Act) methodology. Education and planning tools are needed to gain management understanding and establish common and aligned goals. Documentation tools such as our Sample Quality Manual and Quality System Procedures are needed to help understand the organization's current process and aid in the brainstorming of how to structure and organize the quality system documentation.

Additionally, training tools such as our pocket guide "What Every Employee Needs to Know About ISO 9001:2000," combined with our self-narrated training presentation (on CD) helps to educate the entire organization as to the purpose, value, and each employees role in the quality system which is critical to successful implementation.

Obviously when shopping around for specific educational and sample documentation materials, one must look at the reputation and track record of the company. The qualifications of the individuals providing the educational materials, past customer satisfaction levels, and how well the materials match with the organizations approach, systems, and philosophy. Steudel & Schultz, LLC's products are continually being developed by highly experienced professionals with over 20 years in the quality field. Our training materials and samples have been refined based on feedback from applications in thousands of organizations with whom we have done business. We have practical, easy to understand materials that are results-focused and based on solid quality principles.