ISO 13485 Clause 4

General requirements for documenting and maintaining the quality management system: its processes, outsourced processes, software validation, and the documentation it needs, including the quality manual and records.

What each part covers

4.1

Document the quality management system, maintain its effectiveness, and control its processes, including outsourced processes and validation of software used in the system.

4.2

Keep the documentation the system needs, including a quality manual and the records that show requirements were met. Records are kept for at least the lifetime of the device as the organization defines it, or the period regulatory requirements set.

Where it is written

ISO 13485:2016, clause 4

Also called

clause 4, ISO 13485:2016 clause 4

Related terms