Documentation requirements ISO 13485:2016

The following definitions from ISO 9000 apply:
 
Procedure: 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