Documenting Quality Management Systems
(An Introduction to the ISO 9001 Standard)      

Introduction to Documenting Quality Management Systems

This module presents the titles and subject matter of each of the four modules of the course and provides details on how to navigate through the course material.

Module 1 -- Quality Management as a Strategic Business Process

Progressive organizations have recognized that merely having a product or service that meets a need and is competitively priced provides no guarantee of continued corporate success. Several factors come into play, not the least of which is continuous improvement. In this module, the eight quality management principles are outlined and their benefits and effect on businesses that adopt them are detailed. Secondly, the process approach to quality management is explained. Lastly, the importance of creating documentation to support an ISO 9001-compliant quality management system are considered.

Module 2 -- Quality Management Systems, Management Responsibility, and Resource Management.

The commitment to quality and continuous improvement has a ripple effect throughout the organization: all policies and procedures are interrelated, and the processes of one area will impact those of another. Within successful organizations, the commitment to quality and to continuous improvement flows through all policies and procedures, at all levels of management as well as production and customer service. This module outlines the ISO 9001:2000 requirements for general management processes, top management processes, and resource management processes. For each of these areas, details of auditor’s expectations and checklists for both Level I and Level II documentation are presented. At the end of the module, you can check your understanding of the requirements by completing a brief quiz.

Module 3 -- Product Realization

Within an effective quality management system, the company's products are consistent, reliable and satisfactory to customers. This module focuses on the requirements that promote quality and continuous improvement in the production of goods and services. The ISO 9001:2000 standard covers all aspects of product development, design and evaluation. The auditor's expectations and Level I and II documentation requirements relating to planning, customer-related processes, design and development, purchasing, production, and control of measuring and monitoring devices are topics within this module.

Module 4 -- Measurement, Analysis, and Improvement

Businesses build on their successes and learn from mistakes by incorporating policies that allow them to monitor, measure and analyze the results of their activities. In this module, the ISO 9001 clause that focuses on improvement is examined. First, the general topics of measurement, analysis and improvement are applied to business processes. Secondly, ISO 9001 requirements for monitoring and measurement activities including internal audits are outlined. Finally, the requirements regarding nonconforming products and analysis of data and improvement are considered.