The latest version of ISO 13485 was published in 2016, which means medical device companies need to transition from the previous version of the standard and comply with the new requirements. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents and records are needed for an effective Quality Management System (QMS) based on ISO 13485. This white paper is designed to help top management and employees involved in ISO 13485 implementation or transition, and to clear up any misunderstandings regarding the documents required by the standard.

In this document, you will find an explanation of which documents are mandatory according to the ISO 13485:2016 standard, and which non-mandatory documents are commonly used in the QMS implementation, in the same order and numbered clauses as in ISO 13485.