Content of QM documentation

The documentation of a quality management system typically consists of the three following levels:

• Level 1: Describes the scope of the QM system, how processes work and interact and gives reasons for any deviation from requirements set out in standards
• Level 2: Describes activities and processes needed to be able to implement requirements
• Level 3: Provides precise work instructions for each workplace

QM manual
The QM manual documents a company's areas of activity as well as its organisational structure and workflows. It also describes the company's quality policy and defines responsibilities and powers with regard to the QM system. Rules on how to monitor the system with the help of internal audits are also included.

Process descriptions
Quality management primarily involves specifying workflows and can therefore not be described as simply defining a company's structure. Certainly, organisational charts with names and boxes are just as necessary as descriptions of tasks and responsibilities but they need to be supplemented by detailed specifications, rules and details of employees' authority to issue instructions. Since quality management is a task that covers all areas of a company, it can only be organised in an interdisciplinary manner on the basis of adequately specified instructions.

This means that process descriptions are required for each interface. They specify company-wide workflows and tasks and responsibilities. Process descriptions should be drawn up in a uniform manner on the basis of a specified plan, be agreed between the parties involved and put into force by a higher level. The form the descriptions take can be defined on a company-specific basis. Flowcharts are often used.

Work instructions
In many cases, there are also work instructions or similar instructions relating to the workflow (e.g. design, production or testing) for a specific product.