ISO 23640
Ensure the reliability and safety of your in vitro diagnostic (IVD) products with ISO 23640:2023 certification. At Quality Asia Certification, we help IVD manufacturers, developers, and distributors demonstrate their commitment to international stability evaluation standards. This ISO certification is crucial for global market access, regulatory compliance, and long-term product integrity. Our accredited certification services provide a robust pathway to meet international regulatory requirements and improve customer confidence.
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What is ISO 23640?
ISO 23640:2023 is the latest version of the international standard titled "In vitro diagnostic medical devices — Stability evaluation of in vitro diagnostic reagents." This standard provides comprehensive guidance for evaluating the stability of IVD reagents used in diagnostics. It specifies general principles and detailed procedures for establishing shelf life, transport stability, and in-use stability to ensure consistent performance.
The 2023 revision incorporates updated terminology, enhanced procedures for accelerated and real-time stability studies, and improved alignment with global regulatory expectations, especially from the EU IVDR and FDA.
Why is ISO 23640 important?
With increasing regulatory scrutiny and global competition, medical device companies must ensure that their products remain stable and perform consistently over time. ISO 23640:2023 is a critical compliance tool for:
- Meeting European Union IVDR and FDA stability requirements
- Avoiding regulatory delays and recalls due to expired or unstable reagents
- Enhancing your brand’s trust and credibility in global healthcare markets
- Supporting product registration dossiers with validated stability data
This certification demonstrates your proactive approach to product safety, efficacy, and regulatory adherence, which are critical in the highly sensitive diagnostics sector.
What are the benefits of ISO 23640?
- Establishes a scientific and regulatory framework for stability studies
- Ensures IVD reagents remain reliable under transport, storage, and usage conditions
- Reduces risk of false test results due to degraded reagents
- Facilitates faster regulatory approvals in international markets
- Aligns your company with the latest best practices and compliance protocols
By adopting ISO 23640:2023, you take a strategic step toward total quality management in IVD production.
What kind of businesses can benefit from ISO 23640?
Achieving ISO 23640:2023 certification through Quality Asia Certification brings measurable benefits to your business:
✅ Global Market Access: Demonstrate compliance with EU IVDR, WHO, and FDA guidelines to enable smooth entry into international markets.
✅ Reduced Product Liability: Minimize the risks associated with expired or unstable diagnostic products.
✅ Customer Confidence: Boost trust among healthcare professionals, laboratories, and regulators.
✅ Operational Efficiency: Standardized procedures reduce time and cost associated with repeated stability testing.
✅ Improved Product Lifecycle Management: Make informed decisions on shelf life and storage, leading to better supply chain and inventory control.
✅ Competitive Advantage: Stand out in the market as a reliable and regulatory-ready IVD manufacturer.
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.
