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Line Clearance Procedure

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The ISO 13485:2016 Line Clearance Procedure defines the methods of controlling medical device manufacturing operations to prevent the accidental mixing of components and production line errors.

  • MS Word Format

  • Includes Related Forms

  • Digital Content - Instant Download

Line Clearance Procedure

The Line Clearance Procedure defines the method of controlling manufacturing operations to prevent the accidental mixing of components and production line errors.

Line Clearance Procedure - Overview

The Line Clearance Procedure assigns tasks and responsibilities for required line clearance activity for production lines. The Line Clearance Procedure includes unique requirements for each production area and includes line clearance forms that are made part of the Device History Records (DHR).

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