ISO 13485 Policies and Procedures


Manufacturers of medical devices that don’t want any more documents than necessary to achieve certification of their quality program can use the bare minimum kit that includes mandatory ISO 13485 policies and procedures.

SKU: 2039 Category:


ISO 13485 Policies and Procedures Bare Minimum Kit $197

Browse the PDF Demo Bare Minimum ISO 13485:2016 Kit

MS Office version ISO 13485 policies and procedures for QMS certification includes:

  • QMS-00 Quality Manual
  • QMS-01 Control of Documented Information
  • QMS-02 Configuration Management
  • QMS-03 Counterfeit Parts Prevention
  • QMS-04 Management Process
  • QMS-05 Responsibilities Authorities
  • QMS-06 Training Program
  • QMS-07 Proposal Development and Contract Review
  • QMS-08 Purchasing
  • QMS-08-1 Purchase Order Review
  • QMS-09 Receiving
  • QMS-10 Production
  • QMS-11 Shipping
  • QMS-12 Internal Auditing
  • QMS-13 Corrective Action
  • QMS-14 Control of Nonconformities
  • QMS-15 Calibration
  • QMS-16 Definitions and Abbreviations
  • QMS-17 Design and Development
  • QMS-18 Risk Mitigation and Planning


  • Approved Supplier List
  • Bulletin
  • Calculated Risk Release
  • Calibration Reference Only Tag
  • Calibration Seal
  • Calibration System
  • Contract Review
  • Corrective Action Request
  • Customer Perception/Satisfaction Survey
  • Daily Receiving
  • Design Review
  • Design Review Work Instruction
  • Dimensional Analysis
  • Engineering Order
  • First Piece
  • Information Request
  • Inspection Instruction
  • Inspection Record, Report, Summary
  • Inspector Log
  • Internal Audit Form
  • Internal Audit Progress Report
  • Internal Audit Schedule
  • Management Meeting
  • Nonconformance, RFS
  • Packing Slip and CofC
  • Procedure Templates
  • Production QC
  • Property Certification from Supplier
  • Property Control Tag
  • Property Management Log
  • Property
  • Purchase Order
  • Purchase Requisition
  • QC Tags
  • Quality System Assessment Checklist (first half completed)
  • Receiving Hold Tag
  • Receiving Instructions
  • Receiving
  • Receiving Log
  • Risk Analysis
  • Risk Analysis Instruction
  • Risk Identification Checklist
  • Risk Status
  • Routing Tickets
  • Schedule to QMS Registration
  • Shelf Life Expiration
  • Shipping
  • Supplier Evaluation
  • Supplier Mail-In Survey
  • Supplier Performance Rating (cover letter and spreadsheet)
  • Supplier Quality Requirements
  • Supplier Survey
  • Training Certificates
  • Training
  • Training Matrix for QMS procedures
  • Training Orientation Request
  • Training Program Progress
  • Traveler
  • Trend Chart, Customer Satisfaction
  • Validation-Verification
  • Work Instructions
  • Work Order

ISO 13485 Policies and Procedures for Certification $197

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Select policies, procedures and forms for QMS certification are available in paperless Efficient QMS™.

One day soon, would your Company like to get the ball rolling to transition from paper-based management to paperless management? Consider the $297 Combination Kit for ISO 13485, which includes this MS Office kit and Complete Efficient QMS™.

If your Company is ready to advance to paperless management, consider standalone $197 Complete eQMS for paperless ISO 13485.