The ISO 13485 Foundation certification is a professional certification for professionals needing to have an overall understanding of the ISO 13485 standard and its requirements.
The principal competencies and knowledge skills needed by the market are the ability to support an organization in managing a Medical Devices Quality Management System as specified in ISO 13485:2016.
Various professions may apply for this certification:
- Person responsible for the quality management or conformity in an organization
- Member of the quality team
- Staff involved in the implementation of the ISO 13485 standard
- Technical expert wanting to prepare for a quality audit function
The requirements for this certification are:
|Credential||Exam||Professional experience||MS audit/ assessment experience||MDMS project experience||Other requirements|
|ISO 13485 Foundation||PECB Certified ISO 13483 Foundation exam or equivalent||None||None||None||Signing the PECB code of ethics|
Informations and registration:
Alexandra Niculae, Training Director ENVISO