About this document
ISO 13485 Documentation Overview by munier is a document available to read on EtoBox.
The document lists 46 mandatory documents and records that must be maintained by an organization according to ISO 13485:2016. These include documents like quality manuals, procedures, reports, and records related to design, purchasing, production, installation, servicing, auditing, and corrective and preventive actions. Maintaining these documented information is essential to comply with ISO 13485 requirements.
- Author
- munier
- Language
- EN