ISO 13485 and FDA Compliant Internal Audit Tools: Checklist, Procedure and Forms

The 13485 FDA Internal Audit Checklist contains all the requirements to audit a Management System to both ISO13485 and FDA requirements, and highlights the additional FDA requirements above 13485. Includes Internal Audit Checklist, Internal Audit Procedure, Planning Forms, and Guide to ISO 13485 Internal Audit Presentation.

File Size: 1.45 MB
Format: Word/PPT
Language: English
Product Type: Checklist
Provider: 13485 Store

Price: $95.00
Product Details


  • This complete Internal Audit Checklist & Tools Package provides the tools needed to establish an ISO 13485 and FDA QSR compliant Internal Audit Process.
  • The Internal Audit Checklist contains the requirements to audit an existing ISO 13485 QMS, and highlights the additional requirements FDA QSR adds to ISO 13485.
    • Provided in both MS Word and MS Excel for flexibility and ease of use.
    • 59 pages covering every section of the standard.
    • Contains links to supporting information on key ISO 13485 topics to help with understanding of the requirements.


  • 59 page customizable ISO 13485 and FDA Compliant Internal Audit Checklist
  • An Internal Audit Procedure
  • (3) Internal Audit Planning Forms
  • Internal Audit Report Form
  • Guide to ISO 13485 Internal Audit Presentation

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