Description
Paperless ISO 13485 is based on the old ISO 9001:2008 standard, which requires a dedicated product download. A separate download is necessary because newer Complete eQMS is based upon ISO 9001:2015 and AS9100:2016.
Click/tap here to browse paperless Efficient QMS™ – link opens in new tab/page on our eQMS website – onlinequalitysystem.com
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
