ISO 15197:2013 Certification is a globally recognized standard that defines the performance requirements for blood-glucose monitoring systems (BGMS) used for self-testing by individuals managing diabetes mellitus. This certification ensures the accuracy, reliability, and safety of BGMS used outside clinical settings. At Quality Asia Certification, we provide end-to-end certification support to help medical device manufacturers meet the stringent compliance standards of ISO 15197:2013 and position their products for trust, usability, and market acceptance globally.
65% Cost Reduction
60% Sustainability
Customer Attraction
Increase Your Competitive Edge
ISO 15197:2013 specifies requirements for in vitro diagnostic test systems intended for self-monitoring of blood glucose concentrations in human whole blood. The standard outlines technical performance criteria, user interface requirements, system design specifications, and evaluation procedures that manufacturers must meet to ensure their products are suitable for layperson use.
The certification applies primarily to:
It is crucial for manufacturers, suppliers, and exporters of glucose monitoring systems looking to enter regulated markets such as the EU, US, and other major economies where compliance to international standards is mandatory.
With diabetes being one of the most prevalent global health concerns, the demand for safe, accurate, and user-friendly blood glucose monitoring devices has surged. ISO 15197:2013 certification:
Achieving this certification not only strengthens a company’s quality management but also demonstrates a strong commitment to patient safety and regulatory responsibility—critical for success in the medical device industry.
✅ Demonstrates Compliance with international safety and accuracy benchmarks for glucose monitoring.
✅ Improves Product Quality by streamlining development, testing, and post-market surveillance.
✅ Boosts Credibility among consumers, regulators, and healthcare providers.
✅ Minimizes Recalls and Legal Risks due to improved performance reliability.
✅ Increases Export Opportunities by fulfilling international trade and conformity requirements.
✅ Enhances User Confidence in the performance and usability of your devices.
Implementing ISO 15197:2013 certification offers tangible and strategic business advantages:
Top management commitment while practicing and accomplishing the standard is the key to success.
Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.
Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.
Review systems, policies, processes, and procedures for a smooth working of QMS.
Speaking to customers & suppliers while getting feedback & working on improvements.
Training staff carrying out the internal audits with the opportunity for improvement.
Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.
Ensure continuous improvement by regularly reviewing and updating your quality management practices.
Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.
QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.