ISO 13485 - Chapter 2
Original text
Expert opinion
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
Please be informed that ISO 13485 is based on ISO 9001 with the addition of the medical device specifics.
Please be futher informed that the ISO 13485 does not follow the High-Level Structure (HLS) as other quality management systems do.
