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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.
ISO Checklist
  Campbell Rodriguez


on January 1, 2012

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