Paperless ISO 13485

$197.00

Paperless ISO 13485 medical devices management system applies to all functional areas of a Company’s business operation.

SKU: 2136 Category:

Description

Paperless ISO 13485 is based on the old ISO 9001:2008 standard.

Complete Paperless ISO 13485 eQMS contains all documents listed below:

MANUAL AND PROCEDURES:

  • Quality Manual
  • Calibration
  • Configuration Management
  • Control of Documented Information
  • Control of Nonconformities
  • Corrective Action
  • Counterfeit Parts Prevention
  • Definitions and Abbreviations
  • Design and Development
  • Internal Auditing
  • Management
  • Production
  • Proposal Development and Contract Review
  • Purchasing
  • Receiving
  • Responsibilities and Authorities
  • Shipping
  • Training Program

FORMS AND WORK INSTRUCTIONS:

  • Action Item
  • Bulletin
  • Calculated Risk Release
  • Calibration Report
  • Contract Review
  • Daily Receiving Log
  • Design Review
  • Design Review Work Instruction
  • Document Control
  • Engineering Order/Change Order
  • Inherently Stable Measurement Equipment Log
  • Internal Audit
  • Investigation and Corrective Action Request
  • Management Review
  • Nonconformance (Request For Support)
  • Production Inspection Freeform
  • Production Inspection
  • Property
  • Purchase Order
  • Receiving Inspection
  • Request for Change
  • Request for Quote/Information
  • Returned Goods
  • Risk Analysis Summary
  • Risk Status Report
  • Shelf Life Expiration Log
  • Shipping Log
  • Supplier Evaluation – Approved Suppliers
  • Supplier Product Release
  • Training Report
  • Verification and Validation

COMPLEMENTARY MS OFFICE DOCUMENTS:

  • Calibration Reference Only Dot
  • Calibration Seal
  • Calibration System Forms
  • First Piece Inspection Report
  • QMS Procedure Process Maps
  • Quality Handbook
  • Quality System Assessment Checklist

$197 Paperless ISO 13485 is a very low cost solution when your Company needs to break away from paper-based management.

Perhaps your Company is planning to transition to “paperless” while using paper-based management docs? Consider the $297 combination kit for ISO 13485 that combines MS Office docs with Efficient QMS™.

Click/tap here to browse demo links and learn more about paperless quality plan Efficient QMS™ – link opens in new tab/page on our website onlinequalitysystem.com.