Professional engineering expert witnesses may opine on ISO 9000. Here is a summary of ISO9000 from the ISO9000 Council.
The ISO 9001 standard contains requirements affecting virtually all aspects of any company. Because ISO 9001 is designed for any company of any size and in any industry, the requirements are rather broad and hard to read. The ISO 9001:2008 requirements fall into the following sections:
Section 1: Quality Management System. This section of the ISO 9001:2008 standard outlines the necessary steps to implement the ISO 9001 quality management system:
1. Identify the process (or activities) needed for the quality management system,
2. Determine the sequence and interaction of these processes,
3. Determine how these processes are effectively operated and controlled,
4. Ensure that all information is available to support the operation and monitoring of these processes,
5. Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement.
The ISO 9001 quality management system requires documentation that includes a quality manual, certain procedures, as well as work instructions. All documentation (including quality records) must be controlled according to a document control procedure. Also in this section, ISO 9001 emphasizes the need for continuous improvement.