ISO 13485 - Chapter 4
Original text
Expert opinion
Quality Management System
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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
