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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

Features/Benefits:

  • 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.

Contents:

  • 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)

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