ISO 18113

ISO 18113:2022 Certification is a globally recognized standard that sets specific requirements for the labeling, instructions for use (IFU), and symbols provided by manufacturers of in vitro diagnostic (IVD) medical devices. It ensures that all safety-related and performance information about diagnostic kits, reagents, instruments, and systems is clearly and consistently communicated across markets.

At Quality Asia Certification, we support IVD device manufacturers in achieving ISO 18113 certification by offering comprehensive audits and certification services to demonstrate global regulatory compliance, safety, and product clarity.

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What is ISO 18113?

ISO 18113:2022 is a multi-part international standard published by ISO that provides guidelines for the information provided by the manufacturer of IVD medical devices. It includes the following parts:

  1. ISO 18113-1:2022 – General requirements
  2. ISO 18113-2:2022 – Requirements for labels
  3. ISO 18113-3:2022 – Requirements for IFUs for professional use
  4. ISO 18113-4:2022 – Requirements for IFUs for self-testing
  5. ISO 18113-5:2022 – Requirements for symbols

This standard applies to all IVD manufacturers who distribute products that are used in laboratories or for self-testing by consumers (such as blood glucose monitors, pregnancy kits, or infectious disease tests).

Why is ISO 18113 important?

Manufacturers of IVD devices face complex global regulatory demands. Mislabeling or vague instructions can lead to user errors, safety risks, or non-compliance with regulations like the EU IVDR or US FDA requirements. ISO 18113:2022 offers a harmonized framework for:

  1. Enhancing product usability and understanding
  2. Aligning with EU IVDR (Regulation EU 2017/746) and ISO 13485
  3. Gaining market approval and reducing time-to-market delays
  4. Avoiding recalls due to non-compliance in labeling or instructions

By certifying to ISO 18113, your business demonstrates a commitment to safe, accurate, and internationally acceptable communication of product information.

What are the benefits of ISO 18113?

Getting ISO 18113:2022 certified through Quality Asia Certification offers multiple advantages:

✅ Ensures compliance with global regulatory frameworks for IVD medical devices

✅ Reduces misinterpretation or misuse of IVD products

✅ Improves product safety, quality, and trust among users and regulatory bodies

✅ Facilitates market entry in the EU, USA, Canada, and Asia-Pacific

✅ Aligns with ISO 13485 for Quality Management in medical devices

✅ Establishes uniform labeling and instruction standards for professional and lay users

✅ Enhances brand credibility with a trusted third-party certification


What kind of businesses can benefit from ISO 18113?

Achieving ISO 18113:2022 certification benefits your business in the following ways:

  1. Regulatory Compliance Assurance: Supports your product's compliance with MDR, IVDR, and other country-specific regulations.
  2. Market Expansion: Helps your IVD devices gain faster approval in international markets.
  3. Reduced Product Liability: Clear labeling minimizes the risk of misuse and potential legal issues.
  4. Customer Confidence: Builds trust with healthcare professionals and end-users through accurate and standardized documentation.
  5. Operational Efficiency: Standardized IFUs and labels reduce duplication, rework, and documentation errors.
  6. Competitive Edge: Certification differentiates your products from uncertified competitors, boosting tender and contract opportunities.
  7. Audit Preparedness: Keeps you better prepared for audits by regulatory authorities and notified bodies.


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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