ISO 15189:2022 Medical Laboratories Accreditation Certification – Ensure Reliability and Global Recognition

Who Can Apply for ISO 15189:2022 Certification?

This certification is designed for medical laboratories, diagnostic centers, hospitals, and healthcare institutions that conduct medical testing. It is applicable to both public and private laboratories aiming to prove their competence, accuracy, and quality in patient testing services.

What is ISO 15189:2022?

ISO 15189:2022 is the international standard that specifies quality management system requirements particular to medical laboratories. It ensures that laboratories meet global standards for competence, impartiality, and consistent operation, with a strong focus on patient safety and reliable test results. This standard integrates elements of ISO/IEC 17025 and ISO 9001 but is specifically tailored for medical laboratories.

When Was the Latest Version Released?

The latest revision of this standard was published in 2022. It introduces updates to align with modern healthcare needs, risk management, digital technologies, and continuous improvement in clinical laboratory practices.

Benefits of ISO 15189:2022 Certification

• Demonstrates laboratory competence on an international scale
• Enhances patient safety and trust in test results
• Ensures compliance with healthcare regulations and requirements
• Improves efficiency, accuracy, and reliability of laboratory processes
• Reduces errors, risks, and potential liabilities
• Strengthens eligibility for international collaborations and recognition

Who Is Eligible for ISO 15189 Certification?

• Clinical laboratories in hospitals and healthcare institutions
• Independent diagnostic and medical testing centers
• Public health laboratories
• Private and government medical research facilities
• Laboratories providing specialized or routine diagnostic services

How the ISO 15189 Certification Process Works

• Click the “Apply Now” button on this page
• Register your laboratory through our secure application portal
• Submit required documentation regarding quality management, testing processes, and regulatory compliance
• Complete the payment process
• Certification will be reviewed, approved, and delivered via email within 7 business days

Remote Review and Digital Audit

The International Accreditation Board conducts a remote review of documentation. On-site audits are not required. Certification is granted once compliance with ISO 15189:2022 is verified, ensuring global validity.

Why You Should Get ISO 15189 Certified

• Strengthens credibility and trust in medical laboratory services
• Provides an internationally recognized benchmark for competence
• Improves laboratory operations and efficiency
• Meets both national and international healthcare compliance standards
• Builds confidence among patients, healthcare providers, and regulators

Key Considerations

• Certification is accredited and globally recognized
• Each certificate includes a QR code and online verification link
• The process is fully online, transparent, and efficient
• Full refund guarantee if the certification is not approved

Business Advantages of ISO 15189 Certification

Accreditation to ISO 15189 enhances a laboratory’s international reputation, ensures patient confidence in results, and enables participation in cross-border healthcare initiatives. It also provides a competitive advantage in tenders and contracts where certified competence is a requirement.

Validity & Renewal of Your ISO 15189 Certificate

Your certificate will be valid for 1 year, in line with global ISO accreditation practices.
Annual renewal is available via our website.

Why Our ISO 15189 Certification Is More Affordable

We use digital evaluations rather than expensive on-site audits, delivering the same internationally accredited certification at a lower cost, without compromising on quality or global recognition.

100% Money-Back Guarantee

If your certification is not approved, we provide a full refund. The process is risk-free, transparent, and internationally valid.

Frequently Asked Questions (FAQ)

How long does the process take?
Certificates are issued within 7 business days of application.

Is ISO 15189 certification mandatory?
In many countries, ISO 15189 accreditation is a requirement for medical laboratories, especially those serving hospitals or government institutions.

Can small laboratories apply?
Yes, both small and large laboratories can apply for ISO 15189 certification.

How can certificates be verified?
Each certificate includes a QR code and verification link, accessible online worldwide.

Certificación de Acreditación de Laboratorios Médicos ISO 15189:2022 para Empresas e Instituciones