Documentation Requirements
Documented information needed to be retained by the organization to provide evidence of compliance. The type and amount of records required will differ from one organisation to another. Many people assume the standards require records for everything as proof of compliance. The truth is that the standards are not only about evidence; they are about good business practice, however. In only a few places, the standards specify when a record is needed. The following lists some of the common high-level and low-level documents necessary for an ISO management certification standard.
High-level documents:
- The scope of the quality management system (4.3)
- Documented information necessary to support the operation of processes (4.4)
- The quality policy (clause 5)
- The quality objectives (clause 6.2)
- This documented information is subject to the requirements of clause 7.5.
Lower-level documents:
- Organization charts
- Process maps, flow charts, process descriptions
- Procedures
- Work instructions
- Specifications
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality manuals
- Strategic plans
- Forms
