ISO 13485:2016

5 insights from Spark’s ISO journey

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Remi Veenman

One year ago, Spark's quality system has been recognized with ISO 13485:2016 certification, the standard for Quality Management for medical devices. Recently, we passed our intermediate inspection with flying colors, confirming that we are on the right track. Here are five key insights from our journey:

1. Choose a workable QMS


Implementing a Quality Management System (QMS) for medical devices can seem daunting, but with the right approach, it’s more accessible than you might think. This accessibility allows us to extend our QMS practices to non-medical projects with positive results.


2. Be actually committed to quality

A QMS alone doesn’t ensure high-quality, safe, and compliant products. Success depends on a team's dedication to quality and effective risk management.


3. Match your own QMS to your clients

Stricter operating procedures can deepen client relationships. Regular check-ins to understand their perception of the product quality and development process and status.

4. Create practical procedures

Effective forms and procedures are crucial for a QMS. Designing your QMS to genuinely enhance the quality of work, rather than being a mere formality, is essential.


5. Integrate risk management

Risk management is central to a QMS. Integrating risk-based and opportunity-based development on a daily basis is crucial. For medical devices, ISO 14971 provides valuable guidelines on risk management.

These insights help Spark deliver superior, compliant, and reliable medical devices, fostering client satisfaction and trust.


Building on a strong foundation of 30 years of experience in product development, we continue to improve our quality and procedures. We have additional enhancements planned for our QMS and design processes in the coming period, ensuring we help our clients develop the highest quality and most innovative solutions.

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