ISO 23665

ISO 23665:2021 is an international standard that provides guidelines for the clinical performance studies of in vitro diagnostic (IVD) medical devices. Published by ISO, it ensures standardized, ethical, and scientifically sound processes for conducting clinical performance evaluations. With the global rise in diagnostic tools and technologies, particularly in response to health crises like COVID-19, ISO 23665:2021 plays a critical role in harmonizing global clinical performance requirements for IVDs.

At Quality Asia Certification, we offer ISO 23665:2021 certification to help organizations demonstrate compliance with globally accepted standards, improve the credibility of their IVD studies, and support global market access.

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What is ISO 23665?

ISO 23665:2021 is titled “In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice”. It outlines comprehensive guidelines for designing, conducting, recording, and reporting clinical performance studies for IVD medical devices.

This standard emphasizes:

  1. Proper ethical approval,
  2. Use of human specimens,
  3. Ensuring study integrity and traceability,
  4. Reliable data collection and reporting.

It is applicable to all manufacturers and laboratories conducting clinical studies to validate the performance of in vitro diagnostic devices before market placement or regulatory approval.

Why is ISO 23665 important?

With increasing scrutiny from regulatory bodies and the global demand for reliable diagnostic solutions, ISO 23665:2021 certification ensures that your IVD clinical performance studies meet international best practices.

Whether you're developing molecular diagnostics, serological tests, or point-of-care devices, this certification helps:

  1. Build confidence in test reliability,
  2. Improve regulatory acceptance,
  3. Enhance market reputation and competitiveness.

Choosing ISO 23665 also reflects your organization’s commitment to patient safety, ethical compliance, and evidence-based performance validation.

What are the benefits of ISO 23665?

  1. Standardized Study Practices: Encourages global consistency in conducting clinical performance studies.
  2. Improved Data Credibility: Strengthens the reliability of results through transparent and traceable methodologies.
  3. Ethical Assurance: Promotes ethical handling of human specimens and data.
  4. Risk Management: Reduces the risk of study-related errors or regulatory non-compliance.
  5. Global Market Compatibility: Aligns with international regulations, easing global product approvals.
  6. Supports ISO 13485 & IVDR Compliance: Complements other regulatory frameworks, including ISO 13485 and EU IVDR (2017/746).

What kind of businesses can benefit from ISO 23665?

Implementing ISO 23665:2021 and obtaining certification from Quality Asia Certification provides your organization with the following business advantages:

✅ Accelerated Product Approvals: Smoother navigation through regulatory processes, reducing time-to-market.

✅ Market Expansion: Gain access to international markets where regulatory compliance is mandatory.

✅ Brand Credibility: Enhance trust among healthcare providers, laboratories, and patients.

✅ Investor Confidence: Meet due diligence requirements from investors and stakeholders.

✅ Reduced Legal Risks: Lower the possibility of litigation by adhering to globally recognized ethical and procedural standards.

✅ Operational Excellence: Standardized processes result in better coordination between R&D, quality, and regulatory teams.

✅ Regulatory Alignment: Prepares your organization for audits by notified bodies or health authorities.


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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