ISO 15189:2022 – Medical Laboratories

At Quality Austria Central Asia, we provide comprehensive support services to medical laboratories seeking compliance with ISO 15189:2022. We help laboratories build robust systems to ensure the quality, accuracy, and reliability of test results, thereby enhancing patient safety and meeting both national and international requirements. Our expert team delivers end-to-end services — from system development, training, internal audits and accreditation support — designed to strengthen your laboratory’s quality management system, technical competence and recognition from Accreditation bodies who are MRA signatories to International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APAC).

What is ISO 15189:2022?
ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. It is applicable to all medical laboratories, regardless of the number of personnel, number of collection centers or the extent of the scope of testing activities. The standard focuses on improving the quality management system and technical competence to ensure reliable, accurate, and timely test results.

Why is ISO 15189:2022 Important?
Accreditation to ISO 15189:2022 is critical for medical laboratories because it:

• Enhances the credibility and reliability of laboratory services
• Improves patient care and diagnostic confidence
• Builds trust with healthcare providers, regulators, and patients
• Supports regulatory compliance at national and international levels
• Facilitates global recognition and acceptance of laboratory results

Whether you are an independent laboratory or a hospital based laboratory with services like clinical pathology, microbiology, biochemistry, hematology, or specialized diagnostic services, ISO 15189 accreditation signifies a commitment to excellence and patient safety.

Scope of Our Services
At Quality Austria Central Asia, we offer comprehensive services to support laboratories in achieving ISO 15189:2022 accreditation, including:

• Gap Analysis:
  Evaluating current laboratory practices against ISO 15189:2022 requirements to identify areas for improvement.
• Documentation Development:
  Assistance in preparing quality manuals, standard operating procedures (SOPs), work instructions and forms in alignment with the standard.
• Implementation Support:
  Guidance in the establishment of an effective quality management system covering both managerial and technical requirements of ISO 15189 standard.
• Training Programs:
  Conduct customized training sessions for laboratory personnel, technical managers, and quality managers.
• Internal Audit:
  Planning and performing internal audits to assess system performance and ensure accreditation readiness.
• Proficiency Testing/ External Quality Assessment Scheme Guidance:
  Guidance to laboratories in selecting appropriate proficiency testing/ EQAS programs and evaluating performance outcomes.
• Application for ISO 15189 accreditation:
  Support laboratories throughout the application and accreditation process for ISO 15189 accreditation.
• Corrective Action Support:
  Advise on root cause analysis and corrective actions for addressing nonconformities found during audits or assessments.

Why Choose Quality Austria Central Asia?

• National and International Recognition:
  Benefit from our extensive expertise and our integration with globally accepted Conformity assessment practices.
• Widespread Local Presence:
  Our presence across major regions allows us to offer timely support, sample assessments and documentation reviews efficiently.
• End-to-End Services:
  We provide complete support from documentation and training to internal audits and final accreditation assistance.
• Faster Turnaround Time:
  Our expert team ensures timely completion of every stage of your accreditation preparation to help you meet project deadlines and regulatory requirements.
• Commitment to Quality and Excellence:
  Our services are designed to strengthen your laboratory’s commitment to high-quality patient care and continuous improvement.

Build Confidence in Your Medical Laboratory Services
Empower your laboratory with ISO 15189:2022 accreditation and strengthen your commitment to patient safety, quality, and competence. Quality Austria Central Asia stands ready to guide you through every step of your accreditation journey. Our team brings unparalleled knowledge and hands-on experience to help your laboratory successfully implement ISO 15189 requirements and achieve international recognition.

For any queries or further information related to our services, please feel free to contact us at info@qacamail.com or call us at +919599619392. We are here to assist you!