Mandatory documented information to enable your Company’s compliance with the medical devices manufacturing standard ISO 13485:2016. The Bare Minimum kit contains only the absolutely necessary policies and procedures for ISO 13485 certification. This is very advantageous to avoid overachieving compliance to the standard.

ISO 13485 Bare Minimum Quality Program Templates $197

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Browse the PDF Demo Bare Minimum ISO 13485:2016 Kit

Policies and Procedures for ISO 13485 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

FORMS AND WORK INSTRUCTIONS

  • 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

Policies and Procedures for ISO 13485 Certification $197

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Support by phone and email is no charge and has no expiration! Visit with us anytime during your Office hours for help to facilitate ISO 13485 in your business.

Your plan to apply policies and procedures for ISO 13485 certification don't always follow a straight line!

Learn how to become your Company’s subject matter expert to achieve compliance and certification for ISO 13485:2016.

Of course, paperless policies and procedures for ISO 13485 certification are available in Efficient QMS™.