This chapter defines the requirements for the Quality Management System (QMS) for medical devices and in-vitro diagnostics.
The chapter consists of General Requirements as well as of Documentation Requirements.
General Requirements of the QMS consist of:
- written QMS
- maintained QMS
- written processes
- control of processes
- control of outsourced processes
The Documentation Requirements consist of:
- a Quality Manual
- a Medical Device File (DMF)
- the control of documents
- the control of records