Line Clearance Procedure
SKU: SOP 7-020
The ISO 13485 Line Clearance Procedure defines the methods of controlling medical device manufacturing operations to prevent the accidental mixing of components and production line errors.
- ISO 13485 Compliant
- FDA QSR Compliant
- MS Word Format
- Includes Related Forms
- Digital Content - Instant Download
ISO 13485 Line Clearance Procedure
The purpose of the line clearance procedure is to define the methods of controlling manufacturing operations to prevent the accidental mixing of components and production line errors. The procedure applies to all manufacturing lines, label printing and product packaging areas.
Line Clearance Procedure Overview
The line clearance procedure assigns responsibilities and defines required line clearance activity for production lines, print on demand label printing areas and final product packaging areas. The line clearance procedure includes individual requirements for each area and includes line clearance checklist forms for each area that can be easily made part of the device history record (DHR) documentation.
Line Clearance Procedure Compliance
The line clearance procedure is ISO 13485:2016 and 21 CFR Part 820 compliant.
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