Referenzen
Rapid implementation of a comprehensive QMS in accordance with ISO 9001 and ISO 13485 to ensure the ability to produce and supply surgical masks at short notice during the coronavirus pandemic
Kategorie
ISO 13485
Branche
Medical device manufacturers
Unternehmen
A manufacturer of medical surgical masks and FFP2 masks with around 32 employees at its Hamburg site
Ansprechpartner
Ausgangssituation
At the start of the coronavirus pandemic, a manufacturer of medical surgical masks was under considerable time pressure, as demand was rising rapidly and immediate certification was required. A standards-compliant quality management system, as well as evidence of compliance with ISO 9001 and ISO 13485, were absolutely essential for production and delivery to healthcare facilities. However, a formal QMS was only in its infancy; processes were not documented and responsibilities were not clearly defined.
Herausforderung
The greatest challenge lay in the extremely short implementation timeframe, the need for process stability at the same time, and the strict regulatory requirements for medical devices. The organisation had to ramp up production, meet regulatory requirements, prepare documentation and train staff all at the same time. Furthermore, there were no established QMS structures in place, meaning that a complete system had to be set up whilst operations continued as normal.
Lösungsansatz
Carrying out an accelerated gap analysis and defining the necessary core processes
Development of a comprehensive documentation system comprising SOPs, procedural guidelines and forms
Establishing clear roles, responsibilities and effective quality control
Introduction of structured risk and traceability processes
Close collaboration with production, quality assurance and management right through to successful certification
Ergebnis
Within a very short space of time, a fully functional, standards-compliant QMS was established, enabling the company to become immediately eligible for certification to ISO 9001 and ISO 13485. The company was able to ramp up production of surgical masks at a steady rate and reliably supply medical facilities. Audit readiness, process reliability and regulatory compliance were established on a sustainable basis.
