ISO 13485:2016 Records

The recently revised medical device standard, ISO 13485:2016, requires a quality management system that includes these records.

Required Records (Clause)

01. Records to demonstrate conformance to standard and compliance to regulations (4.1.3.e)

02. Records of validations and revalidations of application of software used in QMS (4.1.6)

03. Records required by the standard (4.2.1.c)

04. Records necessary to ensure effective process planning, operation, and control (4.2.1.d)

05. A least one copy of obsolete documents retained for defined period (4.2.4)

06. Records as evidence of conformity to requirements and effective QMS operation (4.2.5)

07. Records for at least lifetime of medical device; not less than 2 years from release (4.2.5)

08. Records of management reviews (5.6.1.3)

09. Records of education, training, skills, and experience (6.2.e)

10. Records of equipment maintenance (6.3)

11. Records of risk management activities (7.1)

12. Records that realization processes and resulting product meet requirements (7.1.d)

13. Records of results of review of product requirements and actions from review (7.2.2)

14. Records of design and development inputs relating to product requirements (7.3.3)

15. Records of design and development outputs (7.3.4)

16. Records of results of design and development reviews and any necessary actions 7.3.5)

17. Records of results and conclusions of verification and necessary actions (7.3.6)

18. Records of rationale for the choice of product used for validation (7.3.7)

19. Records of results and conclusions of validation and necessary actions (7.3.7)

20. Records of results and conclusions of the design and development transfer (7.3.8)

21. Records of design and development changes, reviews, and any necessary actions (7.3.9)

22. Records demonstrating conformity ,and for changes, maintained in device file (7.3.10)

23. Records of results of supplier evaluations and any necessary actions (7.4.1)

24. Records of relevant purchasing information (7.4.2)

25. Records of verification of purchased product (7.4.3)

26. Records for each medical device or batch of medical devices (7.5.1)

27. Records of medical device installation and verification by organization or supplier (7.5.3)

28. Records of servicing activities carried out by organization or supplier (7.5.4)

29. Records of sterilization process parameters used for each sterilization batch (7.5.5)

30. Records of results and conclusions of process validation and necessary actions (7.5.6)

31. Records of process validation for sterilization and sterile barrier systems (7.5.7)

32. Records of traceability in accordance with applicable regulatory requirements (7.5.9.1)

33. Records of traceability for components, materials, work environment conditions (7.5.9.2)

34. Records from suppliers of distribution of medical devices are available (7.5.9.2)

35. Records of the name and address of the shipping package consignee (7.5.9.2)

36. Records of lost, damaged, or otherwise unsuitable customer property (7.5.10)

37. Records of any special conditions required for product preservation (7.5.11)

38. Records of basis for calibration when no national measurement standards exist (7.6.a)

39. Records of adjustments or re-adjustments to measuring equipment (7.6.b)

40. Records of validity of prior results when equipment is found nonconforming (7.6)

41. Results of calibration and verification (7.6)

42. Records of results and conclusions of software validation and necessary actions (7.6)

43. Records of complaints handling (8.2.2)

44. Records of any correction or corrective action resulting from compliant handling (8.2.2)

45. Records of reporting to regulatory authorities (8.2.3)

46. Records of audit criteria, scope, interval, and methods (8.2.4)

47.Records of internal audits and their results (8.2.4)

48. Evidence (record) of conformity to the acceptance criteria (8.2.6)

49. Records of persons authorizing release of product (8.2.6)

50.Records of test equipment used to perform measurement activities (8.2.6)

51. Records of personnel performing any inspection or testing of implantable devices (8.2.6)

52. Records of nature of nonconformities and any subsequent actions (8.3.1)

53.Records of actions to include evaluation, any investigation, decision rationale (8.3.1)

54. Records of acceptance by concession and the person authorizing the concession (8.3.2)

55. Records of actions taken on the effects or potential effects of nonconformity (8.3.3)

56. Records of actions relating to issuance of advisory notices (8.3.3)

57. Records of rework (8.3.4)

58. Records of the results of data analysis (8.4)

59. Records of the results of any investigation and corrective action taken (8.5.2)

60. Records of the results of any investigations and preventive action taken (8.5.3)

We have a new 1.5 day “ISO 13485:2016 Requirements” course that is available to be taught onsite. The course interprets the ISO 13485:2016 requirements and explains the changed requirements for transitioning organizations. The fee is $3000, plus $50 per student, plus instructor travel expenses.

You can view the course description at this web page at our web site. If you are interested in scheduling an on-site class, please call us at 770-862-1766770-862-1766 or send an email to Larry@WhittingtonAssociates.com.