Accreditation Services

ISO 15189:2022

Achieve Medical Laboratory Accreditation with ISO 15189:2022 Certification

At Alpine Quality Consultants, we specialize in helping medical laboratories implement and achieve ISO 15189:2022 certification, the internationally recognized standard for quality and competence in medical laboratories. Our expert consultancy services ensure that your laboratory meets the latest ISO 15189:2022 requirements, enhancing accuracy, reliability, and international recognition.

What is ISO 15189:2022?

ISO 15189:2022 is the globally recognized standard for Medical Laboratories – Requirements for Quality and Competence. It establishes a framework for medical laboratories to ensure accuracy, reliability, and consistency in testing and diagnostics. Achieving ISO 15189:2022 certification enhances credibility, regulatory compliance, and patient safety while meeting international standards.

Our Consultancy Services

We provide a structured, end-to-end approach to obtaining ISO 15189:2022 certification, including:

Gap Analysis & Readiness Assessment

  • Comprehensive evaluation of your current laboratory management system
  • Identification of gaps against ISO 15189:2022 requirements
  • Strategic action plan for achieving compliance

Documentation & Process Implementation

  • Development of Quality Manuals, SOPs, and compliance documentation
  • Assistance in method validation, risk management, and continual improvement
  • Integration of ISO 15189:2022 into existing laboratory operations

Employee Training & Competency Development

  • Training sessions on ISO 15189:2022 principles and regulatory requirements
  • Workshops on internal auditing, risk assessment, and quality assurance
  • Coaching for laboratory personnel on best practices and regulatory compliance

Internal Audits & Certification Preparation

  • Conducting internal audits to assess laboratory effectiveness
  • Pre-certification audits to ensure compliance readiness
  • Corrective action planning and risk mitigation strategies

Certification & Post-Certification Support

  • Assistance with accreditation body selection and audit coordination
  • Support during certification audits for a smooth approval process
  • Ongoing maintenance and continuous improvement of the laboratory management system
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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