What a job! What a beautiful team achievement and what a fantastic result! We have passed the ISO 13485:2016 certification. Thanks to the entire team that has worked incredibly hard over the past few months to make it happen. Special thanks to our QA manager Jessica Ossel, who expertly guided the team through all challenges.
For those not entirely familiar with the quality world: ISO 13485:2016 is an internationally recognized standard specifically developed for quality management systems in the medical devices industry. Achieving an ISO 13485 certificate demonstrates that an organization meets the requirements in quality management for one or more stages of the life-cycle of a medical device, including design, development, production, storage and distribution.
The value of this certificate includes:
- Reliability and trust: It provides assurance to customers and partners that the company delivers high-quality and safe products, which is crucial in the medical sector.
- Market access: Many countries and regions require ISO 13485 certification as part of their market entry requirements. This enables an organization to sell its products globally.
- Risk management: ISO 13485 helps in identifying and minimizing risks in the production process, resulting in fewer errors and recalls.
- Efficiency and consistency: It ensures standardized processes, promoting consistency in production and efficiency within the organization.
- Competitive advantage: Companies with ISO 13485 certification stand out in a competitive market due to their commitment to quality and patient safety.
Achieving ISO 13485:2016 certification demonstrates that SBMC delivers high-quality customer services, maintains top-tier laboratories and equipment, and employs well-trained, experienced personnel.
