ISO 13485 - Chapter 4

Original text

Expert opinion

Quality Management System


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

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