ISO 17511

ISO 17511:2023 is an internationally recognized standard that establishes a framework for metrological traceability of values assigned to calibrators and control materials used in in vitro diagnostic (IVD) medical devices. The certification ensures that test results are traceable to reference measurement procedures and materials, ensuring accuracy, comparability, and confidence in clinical diagnostics.

Quality Asia Certification provides ISO 17511:2023 certification to manufacturers, testing labs, and healthcare institutions to demonstrate compliance with the latest global metrological standards, supporting both regulatory acceptance and market credibility.

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What is ISO 17511?

ISO 17511:2023 titled "In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples" is the latest version of the standard, replacing the earlier 2003 edition.

This standard provides comprehensive requirements and guidelines for establishing metrological traceability chains for calibrators, trueness control materials, and human samples used in laboratory medicine. It ensures that IVD measurement systems produce accurate and reliable results that are comparable across different platforms and locations.

Why is ISO 17511 important?

The demand for precise diagnostic results in medical testing is non-negotiable. ISO 17511:2023 certification is essential for:

  1. IVD manufacturers developing or marketing medical test systems.
  2. Laboratories ensuring the traceability of control materials and calibrators.
  3. Regulatory compliance under IVDR (EU), US FDA, and global health authorities.
  4. Product registration and market expansion in Europe, USA, and Asia-Pacific regions.
  5. Enhancing quality management systems and maintaining trust in medical results.

With increasing emphasis on global harmonization in healthcare, this certification is a strategic asset for any IVD stakeholder.

What are the benefits of ISO 17511?

  1. Ensures Metrological Traceability: Validates the traceability of calibrators and control materials to recognized reference measurement systems.
  2. Improves Diagnostic Accuracy: Enhances clinical reliability of IVD test results across different laboratories and equipment.
  3. Supports Regulatory Approvals: Meets critical requirements of international regulatory bodies, facilitating faster approvals.
  4. Strengthens Quality Systems: Aligns with ISO 13485 and ISO 15189 for improved QMS integration and harmonized testing.
  5. Reduces Measurement Uncertainty: Helps in standardizing reference values and reduces result variability.
  6. Enhances Global Market Access: Builds credibility for product registration in regulated markets like the EU and US.
  7. Boosts Customer Confidence: Assures end users of test result consistency, improving trust in diagnostic devices.
  8. Drives Competitive Advantage: Sets your brand apart in a highly regulated and quality-sensitive medical device market.

What kind of businesses can benefit from ISO 17511?

Getting certified for ISO 17511:2023 through Quality Asia Certification adds measurable value to your business operations and growth strategy:

📌 Regulatory Readiness: Streamlines compliance with IVDR, FDA, and other international regulatory frameworks.

📌 Market Expansion: Facilitates product approval in new countries by demonstrating traceability and result reliability.

📌 Operational Efficiency: Reduces rework and quality failures due to misaligned or non-traceable calibrators.

📌 Brand Trust: Enhances your brand’s reputation as a quality-centric, globally compliant medical device company.

📌 Strategic Partnerships: Improves stakeholder and investor confidence, aiding in collaborations and licensing deals.

📌 Risk Management: Reduces liability risks related to incorrect or inconsistent diagnostic test results.


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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