Internal Audit Procedure | ISO 13485 | FDA QSR Compliant

SKU: SOP 8-005
$99.00
$99.00
Unavailable
per item
The ISO 13485 Internal Audit Procedure defines the process, methods and cycle for conducting internal audits. ​
  • ISO 13485:2016
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download

Internal Audit Procedure

The Internal Audit Procedure defines the process, methods of documenting and scheduling for conducting internal audits. 

Internal Audit Procedure - Overview

​The Internal Audit Procedure applies to all areas of the company that could affect the quality of medical device products and medical device regulatory compliance.

The Internal Audit Procedure defines the process to systematically review the ISO 13485 Quality Management System to determine if it is effectively implemented and maintained. The Internal Audit Procedure ensure audits are performed throughout the audit cycle to measure conformance to:
  • Product realization practices
  • Applicable standards and regulations.
  • Company’s standard operating procedures.

Internal Audit Procedure - Compliance

The Internal Audit Procedure is FDA QSR and ISO 13485:2016 compliant.
To learn more about our Internal Audit Procedure contact us at info@aplyon.com

RELATED LINKS

​Corrective and Preventive Action Procedure
Management Review Procedure
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
ISO 13485 Internal Audit Procedure
Internal Audit Procedure

Customer's also viewed

Management Review Procedure | ISO 13485 | FDA QSR Compliant

$119.00
The ISO 13485 Management Review Procedure governs the management review process, management responsibilities,  review inputs and outputs, review schedule and includes standardized forms to support all management review activity. 
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • Management Review Forms 
  • MS Word Format
  • Digital Content - Instant Download​​​
view

Corrective and Preventive Action Procedure | ISO 13485 | FDA QSR Compliant

$149.00
The ISO 13485 Corrective and Preventive Action (CAPA) procedure governs the process to initiate, investigate, implement and track corrective and preventive actions.
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • Includes Related Forms
  • MS Word Format
  • 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 46 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 46 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 © 2010-2023