Oud-Beijerland, South Holland, Netherlands
I believe the biggest misconception about standards (such as ISO, IEC, NEN) is that they impose annoying rules on already successful companies, just so they can get the certification they need for whatever reason. In reality, these standards are a collection of best practices of which the effectiveness has already been demonstrated by several companies in the world. The trick is to translate these best practices to your specific vision, products, processes and companies. This enables you to add value tomorrow AND get certified, instead of just getting certified based on a paper tiger. A certification process should be nothing more than an acknowledgment of a company that is in control of its day-to-day business.
I inspire people to create real value through legislation and standards, by supporting—not directing—them in building a quality system that truly serves the organization’s vision. I act as a connector between law, strategy and day-to-day operations, helping prevent paper tigers and enabling continuous improvement from within. Focus area's: # Advisory role to top management on compliance, risks & improvements (incl. GDPR, AI Act, Dutch labor legislation: DBA and WTTA) # Risk analysis, audit coordination (ISO 9001, NEN 7510), policy updates # Continuous improvement of quality & information security processes
I help people add value to and continuously improve their products, services, organization and positive impact on the world, by translating standards and legislation into an understandable, user-friendly and compliant way of working. Focus area's: # Medical Device Regulation (specifically Medical Device Software) # Artificial Intelligence Act (relating to medical devices) # General Data Protection Regulation # International standards • ISO13485 • ISO14971 • IEC62304 • IEC62366 • ISO20417 • ISO15223-1 • ISO27001 • NEN7510-1 • NEN7512 • NEN7513 # Continious improvement Quality Management System # Continious improvement Information Security Management System # Internal Audits (ISO27001, NEN7510-1, ISO13485) # Miscellaneous: GCP, CAPA, Vigilance, Management Reviews, ...
Focus area's: # Medical Device Regulation (and the former Medical Device Directive) • ISO 13485 • ISO 14971 • IEC 62304 • IEC 62366 # Continious improvement Quality Management System • ISO 9001 • ISO 27001 • NEN 7510/12/13 • ISO 31000 # Miscellaneous • Audits • CAPA • Vigilance
Kernactiviteiten: - Analyseren, vaststellen en oplossen van applicatieproblemen. - Inrichten en aanpassen van (klant)systemen. - Converteren bestandsgegevens c.q. databewerking. - Koppelingen realiseren met andere systemen. Nevenactiviteiten: Werkgroep APS (ActiePlan Sjabloon): interne processen vastleggen in BPMN en voorstellen maken tot verbetering hiervan.
Kernactiviteiten: Analyseren, vaststellen en oplossen van applicatieproblemen. Nevenactiviteiten: - (Optimalisatie) releasetraject van nieuwe software - Lid van Commissie Applicatiebeheer Pharmacom - Werkgroepen: centralisering doseringstabel, implementatie Pharmacom Nieuw, implementatie electronisch patiëntdossier
Kernactiviteiten: - Beheer assortiment van verschillende websites. - Bepalen strategie en doorvertaling naar assortiment, prijzen en marketing. Nevenactiviteiten: Inkoopwerkzaamheden verricht (kleinschalig).
Kernactiviteiten: Analyseren, vaststellen en oplossen van klantproblemen.