ISO 15197

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.

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What is ISO 15197?

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:

  1. Blood glucose meters
  2. Test strips
  3. Glucose monitoring kits

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.

Why is ISO 15197 important?

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:

  1. Enables market access and regulatory acceptance.
  2. Reduces product liability risks.
  3. Builds brand credibility and enhances user trust.
  4. Ensures long-term sustainability and competitiveness.

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.

What are the benefits of ISO 15197?

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.

What kind of businesses can benefit from ISO 15197?

Implementing ISO 15197:2013 certification offers tangible and strategic business advantages:

  1. Market Entry and Expansion: Fulfill regulatory requirements to access European CE marking and other global approvals.
  2. Improved Risk Management: Reduce defects and failures in devices, lowering returns, complaints, and liabilities.
  3. Brand Reputation: Establish a high-quality, trustworthy image in a competitive market.
  4. Customer Satisfaction: Reliable product performance leads to better user experience and brand loyalty.
  5. Operational Efficiency: Certification encourages process improvement and product lifecycle optimization.
  6. Regulatory Preparedness: Be audit-ready and compliant with requirements from notified bodies, FDA, and other regulatory authorities.
  7. Increased Sales Potential: Gain preference in tenders and B2B agreements where certified products are prioritized.


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

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.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    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.

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