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 review outputs
6. Resource requirements
6.1 Allocation requirements
6.2 Personnel requirements
6.3 Infrastructure requirements
6.4 Environmental requirements
6.4.1 Control your working conditions
6.4.2 Plan your contamination controls
7. Realisation requirements
7.1 Planning requirements
7.2 Customer requirements
7.2.1 Determine product requirements
7.2.2 Review your product requirements
7.2.3 Communicate product requirements
7.3 Development requirements
7.3.1 Prepare design and development procedures
7.3.2 Organise design and development activities
7.3.3 Determine design and development inputs
7.3.4 Generate design and development outputs
7.3.5 Carry out design and development reviews
7.3.6 Perform design and development verifications
7.3.7 Conduct design and development validations
7.3.8 Manage design and development transfers
7.3.9 Control design and development changes
7.3.10 Maintain design and development files
7.4 Purchasing requirements
7.4.1 Establish purchasing process
7.4.2 Clarify purchasing information
7.4.3 Verify purchased products
7.5 Production requirements
7.5.1 Control medical device production and service provision
7.5.2 Define requirements for cleanliness/contamination controls
7.5.3 Specify product installation and verification requirements
7.5.4 Develop servicing procedures and reference materials
7.5.5 Maintain a record of sterilisation process parameters
7.5.6 Validate processes for production and service provision
7.5.7 Validate processes for sterilisation and sterile barrier systems
7.5.8 Preserve product identity throughout product realisation
7.5.9 Establish suitable traceability procedures and records
7.5.9.1 Establish suitable product traceability procedures
7.5.9.2 Establish suitable records for implantable devices
7.5.10 Protect property supplied for medical devices by customers
7.5.11 Preserve medical device products and components
7.6 Measurement requirements
8. Remedial requirements
8.1 Planning requirements
8.2 Research requirements
8.2.1 Implement suitable feedback methods and procedures
8.2.2 Develop and document complaint handling procedures
8.2.3 Establish and maintain regulatory reporting procedures
8.2.4 Perform internal audits at planned intervals
8.2.5 Find out whether processes achieve planned results
8.2.6 Monitor and measure medical device characteristics
8.3 Product requirements
8.3.1 Prevent unintended delivery/use of nonconforming products
8.3.2 Deal with pre-delivery nonconformities and keep suitable records
8.3.3 Manage nonconforming products detected after delivery
8.3.4 Specify how product rework should be carried out
8.4 Analytical requirements
8.5 Improvement requirements
8.5.1 Take action to change QMS and products
8.5.2 Take action to correct actual nonconformities
8.5.3 Take action to prevent potential nonconformities