Driving QMS Implementation
Selangor, 21 Jul 2025 – On 15–16 July 2025, Reszon Diagnostics International Sdn Bhd (“Reszon”) successfully conducted a comprehensive in-house training on Software and Process Validation for Medical Devices Industry at our USJ headquarters. The program brought together 20 staff members across various departments, with the goal of strengthening organizational capability in meeting quality management system requirements for ISO13485: 2016 while fostering a culture of risk-based validation planning and implementation.
The training was structured to go beyond theory. While it covered key ISO 13485:2016 clauses—namely Clause 4.1.6 (Software Validation), Clause 7.5.6 (Process Validation), and Clause 7.6 (Monitoring & Measuring Equipment)—the heart of the session was its interactive and application-driven workshops.
Throughout the two days, participants worked in groups to:
- Draft process flow for managing software changes, incorporating risk and impact assessments;
- Brainstorm and develop software validation protocols tailored to Reszon’s operational context;
- Plan and outline types of software testing—including functionality, security, and error-handling—relevant to our internal systems
The hands-on activities were practical, helping participants better understand how to translate theoretical concepts into actionable practices. The encouraging outcomes of these workshops helped broaden team members’ perspectives and built their confidence to independently plan and conduct validation activities moving forward.
To reinforce learning, a written examination and an interactive online Quiz session were conducted at the end of the training. We are proud to celebrate the top scorers of the online Quiz session:
- Shireley Yeo (QA Department)
- Fatin Izzati (QA Department)
Congratulations to the winners for your outstanding performance and enthusiasm in embracing new knowledge!
This training is part of Reszon’s ongoing commitment to building a strong internal Quality Management System (QMS) infrastructure that aligns with international standards and supports our mission of delivering safe, effective, and reliable rapid point-of-care diagnostic solutions.
We thank all participants for their active engagement and look forward to seeing the practical application of the knowledge and insights gained during the session in our daily operations.
