ISO 13485 planning list for medical device manufacturers
4. Systemic requirements 4.1 Organisational requirements 4.1.1 Develop a QMS 4.1.2 Clarify structure 4.1.3 Support processes 4.1.4 Manage changes 4.1.5 Control outsourcing 4.1.6 Validate software 4.2 Documentation requirements 4.2.1 Manage information 4.2.2 Prepare manual 4.2.3 Establish files 4.2.4 Control documents 4.2.5 Maintain records 5. Management requirements 5.1 Commitment requirements 5.2 External requirements 5.3 Policy requirements 5.4 Planning requirements 5.4.1 Establish quality objectives 5.4.2 Carry out quality planning 5.5 Managerial requirements 5.5.1 Clarify responsibility and authority 5.5.2 Appoint management representative 5.5.3 Establish internal communications 5.6 Review requirements 5.6.1 Perform regular management reviews 5.6.2 Study management review inputs 5.6.3 Generate management Continue reading