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1. A design and development file for each medical device type or medical device family shall be maintained

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2. A documented procedure for planning of realization processes shall be maintained

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3. A documented procedure for the control of outsourced processes shall be maintained

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4. A member of management shall have the responsibility and authority to ensure that processes needed for the QMS are documented

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5. A procedure to describe the responsibilities and requirements for planning and conducting audits and recording and reporting audit results shall be documented

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6. A quality manual shall be documented and include the scope of the QMS

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7. A quality manual shall be included in the QMS documentation

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8. A risk based approach to the control of the appropriate processes needed for the QMS shall be applied

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9. A risk management process shall be established

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10. Action to eliminate the cause of nonconformities in order to prevent recurrence shall be taken

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11. Action to eliminate the causes of potential nonconformities in order to prevent their occurrence shall be determined

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12. Any outsourced process that affects product conformity shall be monitored and controlled

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13. Any processes for production and service provision where the resulting output cannot be verified shall be validated

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14. Any requirement, procedure, activity or arrangement required to be documented shall be established, implemented and maintained

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15. Appropriate communication processes shall be established

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16. Arrangements for communicating with customers shall be planned and documented

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17. Arrangements for the control of contaminated or potentially contaminated product shall be planned and documented

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18. Changes to documents shall be reviewed and approved

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19. Clinical evaluations or performance evaluations of the medical device shall be performed

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20. Criteria and methods needed to ensure that both the operation and control of these processes are effective shall be determined

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21. Criteria for the evaluation and selection of suppliers shall be established

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22. Customer and applicable regulatory requirements shall be determined and met

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23. Customer property provided for use or incorporation into the product shall be identified, verified, protected and safeguarded

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24. Design and development reviews shall be performed at suitable stages

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25. Design and development validation plans shall be

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26. Design and development verification plans shall be documented

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27. Documents of external origin shall be approved

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28. Documents required by the QMS shall be controlled

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29. For each medical device type or medical device family one or more files shall be established and maintained

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30. For sterile medical devices, requirements for control of contamination shall be documented

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31. Information relating to customer satisfaction shall be gathered and monitored

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32. Infrastructure needed to achieve product conformity shall be monitored

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33. Internal audits shall be conducted at planned intervals

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34. Methods for protecting confidential health information shall be defined and implemented

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35. Nonconforming product shall be accepted by concession only if the justification is provided, approval is obtained and applicable regulatory requirements are met

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36. One or more processes for risk management in product realization shall be documented

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37. Procedures for design and development shall be documented

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38. Procedures for issuing advisory notices shall be documented

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39. Procedures for management review shall be documented

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40. Procedures for preserving the conformity of product during processing, storage, handling and distribution shall be documented

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41. Procedures for product identification throughout product realization shall be documented

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42. Procedures for providing notification to the appropriate regulatory authorities shall be documented

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43. Procedures for the feedback process shall be documented

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44. Procedures for the transfer of design and development outputs to manufacturing shall be documented

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45. Procedures for the validation of processes for sterilization and sterile barrier systems shall be documented

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46. Procedures for the validation of the application of computer software used in the QMS shall be documented

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47. Procedures for the validation of the application of computer software used in production and service provision shall be documented

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48. Procedures for the validation of the application of computer software used for the monitoring and measurement shall be documented

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49. Procedures for timely complaint handling shall be documented

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50. Procedures for traceability shall be documented

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51. Procedures for validation of processes shall be documented

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52. Procedures to control design and development changes shall be documented

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53. Procedures to determine, collect and analyze appropriate data to demonstrate the suitability, adequacy and effectiveness of the QMS shall be documented

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54. Procedures to ensure that medical devices returned are identified and distinguished from conforming product shall be documented

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55. Procedures to ensure that purchased product conforms to specified purchasing information shall be documented

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56. Process mapping shall be established and documented

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57. Product acceptance criteria shall be contained in the design and development outputs

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58. Product which does not conform to product requirements shall be identified and controlled

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59. Production and service provision shall be planned, carried out, monitored and controlled

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60. Purchasing information shall describe the product to be purchased and include product specifications

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61. Purchasing information shall describe the product to be purchased and include requirements for product acceptance

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62. Quality objectives shall be established at relevant functions and levels

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63. Records of design and development inputs shall be retained

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64. Records of the sterilization process parameters used for each sterilization batch shall be retained

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65. Records shall be retained

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66. Requirements for cleanliness of product or contamination control of product shall be documented

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67. Requirements for medical device installation shall be documented

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68. Requirements not stated by the customer but necessary for specified or intended use shall be determined

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69. Requirements specified by the customer shall be determined

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70. Responsibilities and authorities shall be defined, documented and communicated

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71. Rework shall be performed in accordance with documented procedures

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72. Servicing procedures, reference materials and reference measurements shall be documented

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73. Suitable methods for monitoring and, where appropriate, measurement of the QMS processes shall be used

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74. Suppliers of distribution services or distributors shall retain records required for traceability

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75. The availability of resources and information necessary to support the operation and monitoring of these processes shall be ensured

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76. The characteristics of the product shall be monitored and measured

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77. The design and development of product shall be planned and controlled

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78. The design and development planning stages shall be documented

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79. The identity of personnel performing any inspection or testing of implantable medical devices shall be recorded

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80. The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements shall be established and implemented

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81. The monitoring and measurement activities and equipment shall be determined

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82. The planning of the QMS shall be carried out in order to meet ISO 13485 and applicable regulatory requirements

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83. The process for establishing competence, providing needed training and ensuring awareness of personnel shall be documented

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84. The processes needed for product realization shall be planned and developed

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85. The processes needed for the QMS and the application of these processes shall be determined

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86. The QMS processes shall be managed in accordance with the requirements of ISO 13485 and applicable regulatory requirements

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87. The QMS shall be documented and its effectiveness maintained

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88. The quality manual shall be approved by top management

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89. The quality policy shall be applicable to the purpose of the organization

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90. The quality policy shall provide a framework for establishing and reviewing quality objectives

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91. The requirements for the infrastructure needed to achieve conformity shall be documented

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92. The requirements for the maintenance activities shall be documented

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93. The requirements for the work environment needed to achieve conformity shall be documented

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94. The requirements related to product shall be reviewed

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95. The resources needed to implement the QMS shall be determined and provided

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96. The review of requirements related to product shall be conducted prior committing to supply product to the customer

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97. The roles undertaken by the organization under the applicable regulatory requirements shall be documented

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98. Top management shall provide evidence of its commitment to the development and implementation of the QMS

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