Mandate Documentation ISO 13485:2016

Roles of organization under applicable regulatory requirements
Procedure and records for the validation computer software use
Quality Manual
Medical device Technical file
Procedure for document control
Procedure for record control
Quality policy
Quality objectives
Responsibilities and authorities
Procedure and records for management review
Procedure for training
Requirements for infrastructure and maintenance activities
Requirements for work environment
Arrangements for control of contaminated / potentially contaminated product
Process for risk management in product realization
Outputs of product planning
Procedure for design and development
Procedure for transfer of design and development outputs
Procedure and records for control of design and development changes
Design and development file
Procedure for purchasing
Procedure and records for servicing of the medical device
Sterilization process
Procedure and records of production and service provision process validation
Procedure and records for validation of process for sterilization and sterile barriers systems
Procedure for product identification
Procedure for traceability
Records of traceability and name and address of the shipping package consignee
Procedure for preserving the conformity of product
Procedure for monitoring and measuring
Record of calibration
Procedure and records for validation of the application of computer software used
Procedure for customer feedback
Procedure for complaint handling
Procedure for internal audit
Identity of the person authorizing release of product
Procedure of control of nonconforming product
Procedure for corrective action
Procedure for preventive action