Documentation for ISO 9001
The quality management system documentation includes:
- documented statements of a quality policy and quality objectives,
- a quality manual,
- documented procedures and records required by the ISO 9001:2008 International Standard. ISO 9001:2008 specifically requires the organization to have “documented procedures†for the following six activities, Control of documents, Control of records, Internal audit, Control of nonconforming product, Corrective action, Preventive action
- documents, including records determined by company to be necessary to ensure the effective planning, operation and control of its processes
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (example corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (example internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
