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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,

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ISO 13485 ( § 4.2.3 Control of documents )

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  1. 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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