Topic outline

  • Medical Devices (ISO 13485) Quality Management Systems for Regulatory Compliance Training Courses

    ISO 13485 Quality Management System - Maintain regulatory compliance by being ISO 13485 certified

    The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

    The latest ISO 13485:2016 was issued on March 1, 2016. The International Accreditation Forum has agreed to a three years transition period. This means that accredited certificates issued to the 2003 version of the standard will be invalid on March 1, 2019.

    Interestingly, this standard does not follow the Annex SL format that is evident in ISO 9001:2015 and other recently revised standards. In addition, whereas ISO 9001 is no longer requiring formal documented procedures or a quality manual, ISO 13485:2016 still has many requirements for documented procedures and a quality manual. The 2015 version of ISO 9001 no longer has a requirement for preventive action, but this requirement still exists in ISO 13485:2016.


    What is an ISO 13485 Quality Management System?

    ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

    ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.


    What are the benefits of being certified to ISO 13485?

    Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

    • Increase access to more markets worldwide with certification
    • Outline how to review and improve processes across your organization
    • Increase efficiency, cut costs and monitor supply chain performance
    • Demonstrate that you produce safer and more effective medical devices
    • Meet regulatory requirements and customer expectations


    ISO 13485, CMDR, FDA and CE marking services from a notified body

    ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance with the laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the Health Canada Canadian Medical Device Regulations CMDCAS programme.

    Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the European Commission. 


    Documented information

    The documented information for Medical Devices Quality Management Systems includes but not limited to:

    1. Roles undertake by organization under applicable regulatory requirements (4.1.1)
    2. Procedures for validation of the application of software used in QMS (4.1.6)
    3. Statement of quality policy (4.2.1.a and 5.3.)
    4. Statement of quality objectives (4.2.1.a and 5.4.1)
    5. Quality manual (4.2.1.b) See 4.2.2
    6. Procedures required by the standard (4.2.1.c)
    7. Documents necessary for effective planning, operation, and control of processes (4.2.1.d)
    8. Documents specified by applicable regulatory documents (4.2.1.e)
    9. 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 non-conforming 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)