Both ISO 9001-2015, and ISO 14001 Standards require a “documented management system” not a “system of documents”.
One of the goals of the QMS, OHSAS and EMS is to bring control and consistency to processes. Documentation is one way to manage and control processes. Written procedures and work instructions ensure consistency of process.
ISO 9000 documentation comprises four tiers. Each tier points to the next.
- The Quality Manual – briefly describes why the Organization meets the requirements of the standards. The manual must refer to procedures.
- Procedures – describe how to perform a task in general, outlining the key steps and their order. For example: a purchasing procedure may describe who is responsible for approving purchases and what records need to be kept. Procedures can be described as looking at what you do (not necessarily how you do it). Procedures should reference related work instructions.
- Work Instructions – provide detailed step-by-step descriptions of a task, not just an outline. They should describe how you perform a task. A purchase order work instruction would tell you how to fill out a purchase order, line by line. Work instructions should reference related records.
- Records – the documents you keep to show that you follow your quality system. For example: your completed purchase order becomes a record. Records constitute a history of what has occurred and as such should not change.