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ISO 13485

Documentation Set - List of Documents

  1. 21 CFR 820 - ISO 13485:2003 Correspondence Matrix, .pdf file free download - not included in the set)

  2. Approved Supplier List

  3. Audit Certificate

  4. Audit Checklist ISO 13485 2003 / 9001 2008

  5. Audit Confidentiality Agreement

  6. Audit Non-conformity Record

  7. Audit Notes

  8. Audit Procedure ISO 13485 2003Audit Report

  9. Audit Schedule

  10. Audit Strategic Plan ISO 13485 2003

  11. Calibration Master List

  12. Communication Log

  13. Communication Procedure ISO 13485 2003

  14. Contract Review Procedure

  15. Controlled Environment Procedure

  16. Corporate Identity Procedure

  17. CMDCAS Specific Requirements

  18. Counsil Directive93/42/EEC Index

  19. Customer Satisfaction Analysis Procedure

  20. Customer Satisfaction Survey

  21. Data Analysis Procedure

  22. DCR Form

  23. DCR Log

  24. Design History File ToC

  25. Design Input Output Matrix

  26. Design Management Procedure

  27. Device History Record ToC

  28. Device Master Record ToC

  29. Document Template Procedure

  30. Documentation Management Procedure

  31. Documentation Master List (Contains sections listed below)

  32. Document Distribution Matrix

  33. External Document Verification Record

  34. Document Reference Matrix

  35. FMEA Table

  36. Form Template landscape

  37. Form Template Portrait

  38. Infrastructure Procedure

  39. Inspection and Testing Procedure

  40. Job Description Template

  41. Maintenance Record

  42. Maintenance Schedule

  43. Management Review Certificate

  44. Management Review Procedure

  45. Management Review Record Template

  46. MDD 93/42/EEC ER Checklist

  47. Measuring Equipment Procedure

  48. NC-CAPA Log

  49. NC-CAPA Procedure ISO 13485

  50. NC-CAPA Record ISO 13485

  51. Organizational Chart

  52. Process Interaction Matrix

  53. Process Map Template

  54. Product Identification Procedure

  55. Product Order Record

  56. Product Realization Procedure

  57. Project Plan

  58. Purchase Requisition Form

  59. Purchasing Procedure

  60. Quality Manual ISO 13485 2003 / ISO 9001 2008

  61. Quality Manual ISO 13485 2003 / ISO 9001 2008 Review Checklist

  62. Quality Manual Reference Matrix

  63. Quality Objectives

  64. Quality Policy ISO 13485 2003

  65. Records Matrix

  66. Records Procedure

  67. Resource Management and Infrastructure Procedure

  68. Risk Analysis Procedure

  69. Service Procedure

  70. Supplier Qualification Record

  71. Technical File ToC

  72. Training Matrix

  73. Training Procedure

  74. Training Record

  75. Validation Procedure

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