Professional engineering expert witnesses may opine on ISO 9000. Here is a summary of ISO9000 from the ISO9000 Council.
Section 4: Product Realization
The ISO 9001:2008 standard defines Product Realization as “that sequence of processes and sub processes required to achieve the product.” This is how your product is designed, produced, tested, handled, shipped, etc. This section also applies to service providers. Emphasis is placed on how the company understands, communicates and actually meets customer requirements. This section also contains various requirements for the design of products and for the planning of processes, projects and services.
► Tip: Most companies write work instructions and flowcharts to define and standardize their work processes. You will save yourself much time if you follow the ISO 9001 requirements for document control from the outset when writing these documents.