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Requirements
The organization established, documented, implemented, and maintained a quality management system in accordance with the ISO requirements.
The organization determined the processes needed for the quality management system and their application throughout the organization.
The organization determined the sequence and interaction of these processes.
The organization determined criteria and methods needed to ensure that both the operation and control of these processes are effective.
The organization ensured the availability of resources and information necessary to support the operation and monitoring of these processes.
The organization monitored, measured where applicable, and analyzed these processes.
The organization implemented the actions necessary to achieve the planned results and continual improvement of these processes.
These processes are managed in accordance with the ISO requirements.
The organization ensured control over any outsourced processes that affect product conformity with requirements.
The type and extent of control of these outsourced processes been defined within the quality management system.
Documentation Requirements
System documentation includes documented statements of quality policy and quality objectives.
System documentation includes a quality manual.
System documentation includes documented procedures and records required by ISO.
System documentation includes documents to ensure the effective planning, operation, and control of its processes.
Quality Manual Requirements
Quality manual includes scope of the quality management system, including details of, and justification for, any exclusions.
Quality manual includes documented procedures established for the quality management system, or reference to them.
Quality manual that includes description of the interaction between processes of the quality management system.
Control of Documents
The documents required by the quality management system are controlled.
Records (a special type of document) are controlled according to the requirements.
A documented procedure has been established to control documents.
The documented procedure defines the controls to approve documents for adequacy prior to issue.
The documented procedure defines the controls to review, and update as necessary, and re-approve documents.
The documented procedure defines the controls to ensure that changes and the current revision status of documents are identified.
The documented procedure defines the controls to ensure that relevant versions of applicable documents are available at points of use.
The documented procedure defines the controls to ensure that documents remain legible and readily identifiable.
Documents of external origin necessary for the planning and operation of the quality management system are identified and their distribution controlled.
The documented procedure defines the controls to prevent the unintended use of obsolete documents.
Control of Records
Records are established and controlled to provide evidence of conformity to requirements and of the effective operation of the quality management system.
A documented procedure has been established for controlling records.
The documented procedure defines the controls needed for the Identification of records.
The documented procedure defines the controls needed for the Storage of records.
The documented procedure defines the controls needed for the Protection of records.
The documented procedure defines the controls needed for the Retrieval of records.
The documented procedure defines the controls needed for the Retention time of records.
The documented procedure defines the controls needed for the Disposition of records.
Records are kept legible, readily identifiable, and retrievable.

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