ISO Documentation Structure

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ISO 9001:2008, a standard published by the International Organization for Standardization (ISO), has the title "Quality Management Systems - Requirements." The standard specifies four levels of documentation that an organization must observe to document its quality management system (QMS).

Quality Manual

The ISO documentation standard prescribes the minimum requirements for the content of a quality manual. The standard recognizes that the structure and format of the manual will depend on the size, culture and complexity of the organization.

Documented Procedures

The ISO standard requires “documented procedures” for the following six tasks: control of documents, control of records, internal audit, control of nonconforming product, corrective action and preventive action.

Essential Documents

The ISO standard mentions three documents that the organization may be required to create to show that it has effectively implemented its QMS. The standard specifically mentions three documents: quality policy, quality objectives and a quality manual.

Records

The ISO standard specifies records that an organization must create to show that its products, processes and QMS are in conformity. The standard lists the 21 records in Annex B.

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