Quality assurance in healthcare is a necessity, not a qualification. The work is to meet the need in front of us — and the standard we would still meet if no one were watching.
How we keep it
A quality culture is built into the operation: the Quality Management System, the watch on legislation, the ethics of the desk, and the practices that keep the company solvent and responsible. The QA team monitors the QMS, runs regular controls and audits, and names any process that would keep us from the work.
What we adhere to
- 01Local, national and international legislation
- 02ICH Guidelines and Principles
- 03Ethical, legal and regulatory standards
- 04Standard Operating Procedures
- 05ISO 9001:2015, ISO 27001, ISO 37001, ISO 13485 and YA 4822
Certified since 2004
CORONIS has held EN ISO 9001 since 2004. The present certificate states that the Quality Management System — including all processes — meets ISO 9001:2015 for clinical study design and conduct, pharmacovigilance, data management and statistics, medical writing, regulatory affairs, patient support, training, healthcare consulting, and medical information management.
For client-facing audits, SOPs, and inspection readiness, see Quality & Compliance.