ISO 13485 Small Business Package

The ISO 13485 Small Business Package includes everything a small business needs for certification: Manuals & Forms, Checklists and employee training. Includes support!

File Size: 9.16 MB
Format: Word/Excel/PPT
Language: English
Product Type: Package
Provider: 13485 Store

Price: $697.00
Product Details


  • An affordable, streamlined package for smaller businesses looking to implement an ISO 13485 compliant Quality Management System.
  • For organizations with fewer employees, who do not plan to train their own Internal Auditors (for example, may have an outside consultant perform audits).
  • All documents are written in MS Word or Excel format for ease of editing.


  • 40 page customizable ISO 13485 Quality Manual
  • (26) Quality System Procedures
  • (41) related Forms (MS Word and Excel)
  • 40 page ISO 13485 Gap Analysis Checklist
  • 46 page ISO 13485 Internal Audit Checklist
  • Intro to ISO 13485 Presentation Materials
  • (20) sessions of ISO 13485 Employee Training (web based)

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed