Documentation requirements ISO 13485:2016
The following definitions from ISO 9000 apply:
Procedure: a specified way to carry out an activity or a process
Record: a document stating results achieved or providing evidence of activities performed.
Overview of required documents/procedures
| paragraph | standard element |
| 4.1.1 | Document the role(s) undertaken by the organization |
| 4.1.5 | Written quality agreements with outsourcing partners |
|
4.1.6, / 7.5.6 / 7.6 |
Procedure for the validation of the application of computer software |
| 4.2.1 | Quality Manual |
| 4.2.1 | Quality Policy |
| 4.2.1 | Quality objectives |
| 4.2.4 | Procedure for Document control |
| 4.2.5 | Procedure for Record control |
| 5.5.1 | Responsibilities and authorities |
| 5.6.1 | Procedure for management review |
| 6.2 | Procedure for competence, training and awareness |
| 6.3 | Requirements for the infrastructure |
| 6.3 | Requirements for maintenance activities |
| 6.4.1 | Requirements for work environment |
| 6.4.1 | Procedure to monitor and control the work environment |
| 6.4.1 | Requirements for health, cleanliness and clothing of personnel |
| 6.4.2 | Arrangements for the control of contaminated or potentially contaminated product |
| 6.4.2 | Requirements for control of sterile medical device contamination |
| 7.1 | Process for risk management in product realization |
| 7.2.3 | Arrangements for communicating with customers |
| 7.3.1 | Procedure for design and development |
| 7.4.1 | Procedure for purchasing |
| 7.5.1 | Procedure and methods for the control of production |
| 7.5.2 | Requirements for cleanliness of product |
| 7.5.3 | Requirements for medical device installation and acceptance criteria for verification of installation |
| 7.5.4 | Procedure for servicing activities of medical devices |
| 7.5.6 | Procedure for validation of processes |
| 7.5.7 | Procedure for the validation of processes for sterilization |
| 7.5.8 | Procedure for product Identification |
| 7.5.9.1 | Procedure for traceability |
| 7.5.11 | Procedure for preserving the conformity of product |
| 7.6 | Procedure for monitoring and measuring equipment |
| 8.2.1 | Process for customer feedback gathering |
| 8.2.2 | Procedure for complaint handling |
| 8.2.4 | Procedure for internal audit |
| 8.3.1 | Procedure for control of non-conforming product |
| 8.3.3 | Procedure for issuing advisory notices |
| 8.3.4 | Procedure for rework |
| 8.4 | Procedure for analysis of data |
| 8.5.1 | Advisory notice |
| 8.5.2 | Procedure for corrective actions |
| 8.5.3 | Procedure for preventive actions |
Overview of required registrations
| paragraph | standard element |
| 4.1.6 /7.6 | Records of software validation activities |
| 4.2.3 | Medical device file |
| 5.6.1 | Records of management review |
| 6.2 | Records of education, training, skills and experience |
| 6.3 | Records of maintenance activities |
| 7.1 | Records of risk management activities |
| 7.1 | Output of product realization planning |
| 7.2.2 | Records of the results and actions arising from review of requirements related to product |
| 7.3.2 | Design and development planning documents |
| 7.3.3 | Design and development inputs |
| 7.3.4 | Design and development outputs |
| 7.3.5 | Records of design and development review |
| 7.3.6 | Records of the results and conclusions of design verification |
| 7.3.7 | Design and development validation plans |
| 7.3.7 | Records of the result and conclusion of design and development validation |
| 7.3.8 | Result and conclusion of design and development transfer |
| 7.3.9 | Records of design and development changes |
| 7.3.10 | Design and development file |
| 7.4.1 | Records of the results of evaluation, selection, monitoring and re-evaluation of supplier |
| 7.4.3 | Records of purchased product verification |
| 7.5.1 | Record for each medical device or batch of medical devices |
| 7.5.3 | Records of medical device installation and verification of installation |
| 7.5.4 | Records of servicing activities |
| 7.5.5 | Records of the sterilization process parameters |
| 7.5.6 | Records of the results and conclusion of validation |
| 7.5.7 | Records of the results and conclusion of sterile medical device validation |
| 7.5.9.2 | Records of traceability |
| 7.5.9.2 | Records of the name and address of the shipping package consignee |
| 7.5.10 | Report to the customer on changes to his property |
| 7.6 | Records of the results of calibration and verification of monitoring and measuring equipment |
| 8.2.1 | Customer feedback report |
| 8.2.2 | Complaint handling records |
| 8.2.3 | Records of reporting to regulatory authorities |
| 8.2.4 | Internal audit plan |
| 8.2.4 | Internal audit report |
| 8.2.6 | Evidence of conformity of products with the acceptance criteria |
| 8.2.6 | Identity of the person authorizing release of product |
| 8.2.6 | Identity of personnel performing any inspection or testing of implantable medical devices |
| 8.3.1 | Record of nonconformity |
| 8.3.2 | Records of the product acceptance by concession and the identity of the person authorizing the concession |
| 8.3.3 | Records of actions relating to the issuance of advisory notices |
| 8.3.4 | Records of rework |
| 8.4 | Records of the results of data analysis |
| 8.5.2 | Results of corrective actions |
| 8.5.3 | Results of preventive actions |
|
Health, cleanliness and clothing of personnel as they come into contact with the product |