How to Get ISO 15189 Certification?

Feb 93 min read

ISO 15189 is an internationally recognized standard developed specifically for medical laboratories to ensure quality, competence and reliability in diagnostic services. Obtaining ISO 15189 certification demonstrates a laboratory’s commitment to maintaining high standards in operations, personnel and management systems. If you are a medical laboratory looking to achieve ISO 15189 certification, this guide will walk you through the essential steps.

Understanding ISO 15189

ISO 15189 is a quality management system standard tailored for medical laboratories. It integrates requirements for both quality management and technical competence. The key aspects of this certification include:

Competence of personnel: Ensuring staff is well-trained and qualified.
Laboratory equipment and reagents: Proper maintenance and validation of equipment.
Quality control and assurance: Implementation of processes for consistent and accurate results.
Customer satisfaction: Focusing on patient safety and care.
Risk management: Identifying and mitigating potential risks in operations.

Now, let’s explore the steps required to achieve ISO 15189 certification.

Step 1: Conduct a Gap Analysis

The first step toward ISO 15189 certification is performing a gap analysis to compare your current laboratory operations with the standard's requirements. This involves:

Assessing existing policies and procedures.
Identifying areas that do not meet ISO 15189 requirements.
Creating a roadmap for necessary changes.

Step 2: Develop and Implement a Quality Management System (QMS)

A well-defined Quality Management System (QMS) is the backbone of ISO 15189 compliance. Your QMS should cover:

Documentation control: Establish clear policies and procedures.
Standard operating procedures (SOPs): Ensure all laboratory tests are performed systematically.
Internal audits: Regularly assess compliance and identify areas for improvement.
Quality assurance programs: Implement measures for error detection and correction.

Step 3: Train Laboratory Staff

Employee competency is a crucial requirement for ISO 15189 certification. Training should focus on:

ISO 15189 standard requirements.
Quality management principles.
Proper use and maintenance of laboratory equipment.
Risk assessment and mitigation strategies.

Regular training and competency assessments ensure all staff members align with ISO 15189 expectations.

Step 4: Conduct Internal Audits

Before applying for certification, conduct internal audits to identify non-conformities and corrective actions. Internal audits help to:

Evaluate the effectiveness of the QMS.
Detect process deviations and inefficiencies.
Ensure continuous improvement.

Step 5: Implement Corrective Actions

After internal audits, laboratories must address non-conformities by implementing corrective actions. This may involve:

Revising policies and procedures.
Re-training staff.
Improving equipment maintenance.
Enhancing documentation practices.

Step 6: Select an Accreditation Body

ISO 15189 certification is granted by accreditation bodies recognized in your country. Some well-known accreditation bodies include:

NABL (India)
IQAS (India)
UKAS (United Kingdom)
CAP (USA)
DAkkS (Germany)
JAS-ANZ (Australia/New Zealand)

Choose an accreditation body that aligns with international recognition and regulatory compliance.

Step 7: Undergo External Assessment

Once your laboratory is ready, the accreditation body will conduct an external assessment. This includes:

Stage 1 Audit (Documentation Review): The auditors review your documentation and QMS to check for compliance.
Stage 2 Audit (On-Site Assessment): The auditors visit your laboratory to assess operational practices, staff competence and overall compliance with ISO 15189.

If non-conformities are found, the laboratory will need to implement corrective actions before certification is granted.

Step 8: Obtain Certification and Maintain Compliance

Once your laboratory meets all ISO 15189 requirements, the accreditation body will issue the certification. However, certification is not a one-time achievement; ongoing compliance is necessary. Laboratories should:

Conduct periodic internal audits.
Stay updated with regulatory changes.
Participate in proficiency testing programs.
Continuously train staff.

Benefits of ISO 15189 Certification

Achieving ISO 15189 certification offers numerous advantages, including:

Enhanced credibility: Builds trust with patients and healthcare providers.
Regulatory compliance: Aligns with national and international health regulations.
Improved accuracy: Reduces errors in laboratory results.
Operational efficiency: Streamlines workflows and reduces inefficiencies.
Better patient care: Ensures reliability and consistency in diagnostics.

Conclusion

Obtaining ISO 15189 certification is a structured process that requires commitment to quality and compliance. By following these steps—conducting a gap analysis, implementing a robust QMS, training staff, performing audits and working with an accredited certification body—your laboratory can achieve ISO 15189 certification successfully. The result is a high-performing medical laboratory that meets international standards and delivers excellence in patient diagnostics.