Introduction to ISO 9000 ISO 9000 2000

Introduction The information in this presentation is based on the 2000 international standard (FDIS), ISO/FDIS 9001/2000. In the following slides, the standard is paraphrased for instructional purposes. Refer to the standard for the actual text. The draft standard will now be submitted for a final vote, however no more changes will be made. Members will vote yes or no for the FDIS to be changed to an international standard, but will not be able to submit comments.

Questions we will cover today: What is ISO 9000? What does a company need to do to Register to ISO 9000? Why was the standard revised? What are our next steps?

ISO 9000 The ISO 9000 standard was designed by representatives from many different countries The standard outlines the basic elements of a good quality management system These elements are good business practice Each member country has representatives that make up a Technical Advisory Group (TAG). These groups draft the standard, then members comment and vote on the standard. The document then becomes and ISO standard. These standards are not regulations. They are a method of getting a standard set of criteria for quality management systems. An outside agency, the registrar, will then audit to see if you have all the required elements in place. If you do, you will get ISO 9000 registration. This registration tells others all over the world that you have this quality system in place. As we go through the training, and cover the requirements you will see that these requirements are basically just good business practice.

Registration To become registered a company must first implement the requirements of ISO 9000 Evaluate your current quality system Add systems and processes to meet the requirements Document your processes as a Quality Manual, Procedures and Work Instructions Evaluate your current quality system: Many of the requirements of the standard are already addressed by practices in place already. These practices may or may not be documented. Other requirements of the standard may not be addressed at all. These need to be implemented and documented. The standard is designed to bring control and consistency to the companies processes. Documenting the processes is part of this control. It helps ensure that people are doing the same thing, to get consistent results. The document Pyramid: Quality Manual: a top level document that describes briefly what you have in place to meet the standard. Procedures: describe what is done, for example the overall procedure for purchasing or training. What is included in the process? Work Instructions: detailed documents that describe how to perform a process, for example how to fill out a purchase order.

Benefits of Registration Improved operations Improved operating margin External recognition Market expansion Improved Operations: Remember, the requirements of ISO 9000 are good business practice. Experts from around the world got together and identified the basic elements a business should put in place to have a good quality management system. By using the ISO 9000 standard to design your quality management system you are drawing on this expertise. You will be designing an effective quality management system that will lead to improved operations. Improved Operating Margin: This improvement in operations also leads to an improvement at the bottom line, an improvement in operating margin. A survey of 700 companies showed and average improvement of 5% that managers attributed to having an ISO 9000 quality system. External Recognition: ISO 9000 is recognized worldwide. When you are ISO 9000 registered other companies know that you have a quality management system in place. They know you have a corrective action system, a system to handle client complaints and nonconformances. They know that you are continually addressing problems and improving your operations and performance. Market Expansion: Some marketplaces require ISO 9000 registration. You will be able to sell services or products to these markets. Some marketplaces do not openly require registration, but prefer to work with ISO 9000 registered suppliers. An unregistered company faces a definite disadvantage in these markets.

The New Revision The standard has recently been revised. The last revision was published in 1994, and is still in use. The new standard is ISO 9000 2000 Companies may register to either standard while they coexist for 3 years. By the end of 2003, all companies will need to comply with the 2000 revision Companies that are already registered to ISO 9000 1994 will have 3 years to change to the new standard. Companies that have not yet registered are strongly encouraged to register to the ISO 9000 2000 revision.

Why was the standard revised? Continuous improvement is built in to the standard, just like the systems it governs. An important focus has been to make the language more applicable to a wider range of organizations. The standard has been changed to follow a “Process Model”. The wording in the 1994 version is very familiar to manufacturing organizations, but the standard is applicable to all types of organizations. The new revision makes the standard language more applicable to service and other industries. Even school districts are obtaining ISO 9000 registration.

The Process Model An organization is a system of interlinked processes The new standard is geared at managing and improving those processes Key processes – those that lead to products and services- must be identified Methods to measure and control these processes must now be included The Process Model Approach We just said the new standard is based on a process model approach. But what is a process model? See slide bullets The standard is moving from documenting processes to managing processes. lets look at the process model….

The Process Model Process Model C U S T O M E R C U S T O M E R Quality Management System (QMS) Continual Improvement Management Responsibility Measurement Analysis and Improvement Resource Management Refer to page 5 of the student manual. The new standard looks very different from its 1994 predecessor. Much of the change is in the organization of the standard. Many of the old requirements remain a part of the Quality Management System section of the new standard. the changes, however, in the new standard are not insignificant. The changes have been planned to take us from a “Life Cycle Approach” based on 20 separate business areas, to a “Process Model” approach. This is a significant change in philosophy, and addresses many of the criticisms of the previous revision of the standard. This example of the process model is included in the standard. The five clauses are all found on the process model. Management Responsibility, Measurement Analysis and Improvement, Product Realization and Resource Management make a cycle. The most important input to this cycle is customer requirements. The output of the cycle is customer satisfaction and continual improvement of the quality system. The standard has been organized around this model. Product Realization