ISO 13485:2016 Documents

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

Required Documents and Procedures (Clause)

01. Roles undertaken by organization under applicable regulatory requirements (4.1.1)

02. Procedures for validation of the application of software used in QMS (4.1.6)

03. Statement of quality policy (4.2.1.a) See 5.3.

04. Statement of quality objectives (4.2.1.a) See 5.4.1.

05. Quality manual (4.2.1.b) See 4.2.2.

06. Procedures required by the standard (4.2.1.c)

07. Documents necessary for effective planning, operation, and control of processes (4.2.1.d)

08. Documents specified by applicable regulatory documents (4.2.1.e)

09. Quality manual: scope, exclusions, procedure references, process interactions (4.2.2.a-c)

10. Outline in quality manual of documentation structure used in QMS (4.2.2)

11. Medical device file with documents demonstrating conformity and compliance (4.2.3)

12. Procedure for control of documents (4.2.4)

13. Procedure for control of records (4.2.5)

14. Documents of external origin necessary for planning and operation of the QMS (4.2.4.f)

15. Responsibilities and authorities (5.5.1)

16. Interrelation of personnel who manage, perform, or verify work affecting quality (5.5.1)

17. Procedures for management review, including documented planned intervals (5.6.1)

18. Processes for establishing competence, giving training, and ensuring awareness (6.2)

19. Requirements for infrastructure: conformity, avoiding mix-ups, orderly handling (6.3)

20. Requirements for maintenance activities, including maintenance intervals (6.3)

21. Requirements for work environment needed to achieve product conformity (6.4.1)

22. Procedures to monitor and control the work environment (6.4.1)

23. Requirements for health, cleanliness, and clothing of personnel (6.4.1.a)

24. Arrangements to prevent contamination: work environment, personnel, product (6.4.2)

25. Requirements for control of contamination for sterile medical devices (6.4.2)

26. Processes for risk management in product realization (7.1)

27. Output of planning for product realization (7.1)

28. Product requirements (7.2.2.a)

29. Arrangements for communicating with customers (7.2.3)

30. Procedures for design and development (7.3.1)

31. Design and development planning (7.3.2) See 7.3.2 a through 7.3.2.f.

32. Arrangements for design and development reviews (7.3.5)

33. Arrangements for design and development verification(7.3.6)

34. Verification plans for design and development: methods, criteria, techniques (7.3.6)

35. Arrangements for design and development validation (7.3.7)

36. Validation plans for design and development: methods, criteria, techniques (7.3.7)

37. Procedures for transfer of design and development outputs to manufacturing (7.3.8)

38. Procedures to control design and development changes (7.3.9)

39. Procedures for purchasing process (7.4.1)

40. Purchasing information for traceability (7.4.2)

41. Procedures and methods for control of production (7.5.1.a)

42. Requirements for cleanliness of product or contamination control of product (7.5.2)

43. Requirements for medical device installation and acceptance criteria (7.5.3)

44. Procedures for servicing, including reference materials and measurements (7.5.4)

45. Procedures for validation of processes for production and service provision (7.5.6)

46. Procedures for validation of application of SW used in production and servicing (7.5.6)

47. Procedures for validation of processes for sterilization and sterile barrier systems (7.5.7)

48. Procedures for product identification (7.5.8)

49. System to assign unique device identification to the medical device (7.5.8)

50. Procedures to identify returned medical device and distinguish from conforming (7.5.8)

51. Procedures for traceability (7.5.9.1)

52. Procedures for preserving conformity of product and its constituent parts (7.5.11)

53. Requirements for special conditions needed if packaging alone cannot preserve (7.5.11.b)

54. Procedures for control of monitoring and measuring equipment (7.6)

55. Procedures for validation of software used for monitoring and measurement (7.6)

56. Methods for obtaining and using customer feedback on meeting requirements (8.2.1)

57. Procedures for feedback process, including production and post-production (8.2.1)

58. Procedures for complaint handling in accordance with applicable regulations (8.2.2)

59. Justification for any compliant not investigated (8.2.2)

60. Any correction or corrective action resulting from complaint handling process (8.2.2)

61. Procedures for notifying the appropriate regulatory authorities of complaints (8.2.3)

62. Procedure for internal audit: planning, conducting, recording, and reporting (8.2.4)

63. Arrangements for product verification (8.2.6)

64. Procedures for product verification (8.2.6)

65. Procedure for control of nonconforming product (8.3.1)

66. Procedures for issuing advisory notices in accordance with applicable regulations (8.3.3)

67. Procedures for performing rework (8.3.4)

68. Procedures for determining, collecting, and analyzing data (8.4)

69. Procedure for corrective action (8.5.2)

70. Procedure for preventive action (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.