Quality System Development
A useful Quality System should consist of:
- Processes, defining activities, responsibilities and output work products
- Commented template providing structure and guidance on work products
- Good examples of documents, that can be used as models for the projects
- Guidelines that provide detailed “how-to” in needed areas
The processes and templates may be the formal elements expected by a standard but for the end-user templates, good examples and guidelines are often more useful in the daily work.
A process should contain the following elements:
- Objectives and review criteria for the process outputs
- Input and output work products
- Activities to create the process output
- Guidance as needed
Copying the standard is not useful. A process need to define the company approach, using company terminology and referring to the company document structure. A process typically also requires more detail than what the standard provides.