Description
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
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
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.
