ISO 22870

ISO 22870:2016 is an international standard that specifically addresses Point-of-Care Testing (POCT) — laboratory testing performed near or at the site of a patient. This standard is applicable to medical laboratories and other healthcare settings performing POCT, ensuring quality, competence, and compliance in non-centralized testing environments.

At Quality Asia Certification, we offer ISO 22870:2016 certification services to healthcare organizations looking to enhance the reliability, accuracy, and quality of their POCT services. Our certification process is conducted by experienced auditors under recognized accreditations, helping you meet international regulatory and patient safety standards.

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What is ISO 22870?

ISO 22870:2016 is a companion standard to ISO 15189 and focuses on Point-of-Care Testing (POCT) processes performed outside the traditional laboratory. It applies to situations where testing is carried out near the patient by healthcare professionals or even patients themselves, such as in ICUs, emergency departments, or home healthcare settings.

The certification ensures that the organization:

  1. Maintains quality assurance in POCT processes
  2. Ensures traceability and accuracy in test results
  3. Operates within a robust risk management and documentation framework
  4. Complies with global best practices for patient-centric diagnostic services


Why is ISO 22870 important?

With the rise of decentralized healthcare models and rapid diagnostic technologies, Point-of-Care Testing (POCT) has become essential for timely medical decision-making. However, poor POCT implementation can compromise test accuracy and patient outcomes. ISO 22870:2016 bridges this gap by enforcing internationally accepted quality and competency measures.

You need this certification if your facility:

  1. Conducts rapid diagnostics near patients (e.g., glucose, ABG, troponin tests)
  2. Operates under time-critical environments like ICUs and ambulances
  3. Seeks to align with ISO 15189 while extending quality assurance to POCT
  4. Aims to build patient trust through global compliance standards


What are the benefits of ISO 22870?

By obtaining ISO 22870:2016 certification, healthcare organizations gain:

  1. Validation of Quality: Demonstrates a commitment to international quality standards in POCT services
  2. Risk Reduction: Enhances risk management through structured protocols and documentation
  3. Increased Accuracy: Assures correct test results with minimized human and technical errors
  4. Compliance Alignment: Meets national and international regulatory expectations for diagnostics
  5. Improved Training & Competency: Establishes robust competency frameworks for staff conducting POCT
  6. Integration with ISO 15189: Seamlessly aligns with broader laboratory accreditation frameworks
  7. Patient Safety & Trust: Promotes reliability in diagnostic decisions that directly impact patient care


What kind of businesses can benefit from ISO 22870?

Here’s how ISO 22870:2016 certification from Quality Asia Certification can strengthen your organization:

1.Enhance Diagnostic Credibility

Build trust among stakeholders by showcasing internationally certified POCT quality systems.

2.Regulatory Readiness

Prepare for audits, inspections, and accreditation requirements in compliance with healthcare norms.

3.Brand Reputation in Healthcare

Position your institution as a quality-driven provider of patient-centric diagnostic services.

4.Operational Efficiency

Streamline POCT operations through defined responsibilities, standard procedures, and minimized redundancies.

5.Competitive Advantage

Differentiate your healthcare facility in tenders, partnerships, and international collaborations.

6.Better Patient Outcomes

Enable faster, more accurate decisions by improving the reliability of bedside diagnostic data.

7.Seamless ISO 15189 Integration

Use ISO 22870 as an extension to ISO 15189 for full-spectrum laboratory and POCT quality assurance.


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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