9001 Quality Management system Documentation Structure

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

Quality Manual

The QMS system 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.

Quality Procedures

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

Work Instruction

A Work Instruction describes how to undertake a specific part of a function, or activity. It is similar to a procedure but is characterized by increased focus and further detail on a particular task. A work instruction is mandatory, and must be subordinate to a procedure.

Records

Records are a way of documenting that the policies, procedures, and work instructions have been followed. Records may be forms that are filled out, a stamp of approval on a product, or a signature and date on some type of document, such as routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products. They provide data for corrective actions and a way of recalling products, if necessary.

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