Line Clearance Procedure

SKU: SOP 7-020
$39.00
$39.00
Unavailable
per item
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

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).

Line Clearance Procedure - Compliance

The Line Clearance Procedure is ISO 13485:2016 and 21 CFR Part 820 compliant.
Form more information about our Line Clearance Procedure please contact us at info@aplyon.com 

RELATED LINKS

Medical Device Quality Management System BASE PLUS
​​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
ISO 13485 Line Clearance Procedure
Line Clearance Procedure

Customer's also viewed

Device History Record Procedure

$119.00
The Device History Record Procedure governs the creation of a Device History Record (DHR) of a finished device or critical component for each work order and establishes the process for final release into finished goods.
 
  • ​ISO 13485:2016 Compliant
  • ​FDA QSR Compliant
  • Includes Related Forms
  • MS Word Format
  • ​Digital Content - Instant Download ​
view

Medical Device Quality Management System | BASE PLUS SYSTEM

$1,799.00

The Medical Device Quality Management System | BASE PLUS is configured for companies engaged in the design and manufacture of medical devices who need only the minimum required content to obtain ISO 13485:2016 certification and FDA QSR compliance. Products installed in 43 countries and growing!​

  • Quality Management System Manual
  • 38 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view

Medical Device Quality Management System | MANUFACTURING

$2,899.00

The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 43 countries and growing!​

  • Quality Management System Manual
  • 60 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view

Medical Device Quality Management System | MANUFACTURING PLUS

$3,599.00

The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 43 countries and growing!​

  • Quality Management System Manual
  • 72 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view
Copyright © 2010-2021