iso 13485 4 2 3 control of documents
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ISO 13485 ( § 4.2.3 Control of documents )

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ISO 13485 ( § 4.2.3 Control of documents ). A documented procedure shall be established to define the controls needed To review and approve documents for adequacy prior to issue, To review and update as necessary and re-approve documents,

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iso 13485 4 2 3 control of documents
ISO 13485 (§ 4.2.3 Control of documents)
  • A documented procedure shall be established to define the controls needed
    • To review and approve documents for adequacy prior to issue,
    • To review and update as necessary and re-approve documents,
    • To ensure that changes and the current revision status of documents are identified,
    • To ensure that relevant versions of applicable documents are available at points of use,
    • To ensure that documents remain legible and readily identifiable,
    • To ensure that documents of external origin are identified and their distribution controlled, and
    • To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
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