ISO 15189:2012 Certification

Medical Laboratories – Requirements for Quality and Competence

ISO 15189:2012 Certification

ISO 15189:2012 is an internationally recognized standard that specifies the requirements for quality and competence in medical laboratories. It is specifically developed for clinical and diagnostic laboratories to ensure accurate, reliable, and timely medical testing services. This standard integrates quality management system requirements with technical competence requirements, ensuring laboratories consistently deliver valid and clinically relevant results that support patient care and medical decision-making.

What is ISO 15189:2012?

ISO 15189:2012 applies to medical laboratories performing examinations on human samples for the purpose of diagnosis, prevention, and treatment of diseases.

The standard covers:

Quality management system implementation
Laboratory personnel competence and training
Equipment calibration and maintenance
Pre-examination, examination, and post-examination processes
Reporting and interpretation of results
Risk management and continual improvement
Confidentiality and patient information protection

ISO 15189 ensures laboratories operate with a high level of technical accuracy and professional integrity.

Benefits of ISO 15189:2012 Certification

Enhanced Accuracy and Reliability
Ensures consistent, technically valid laboratory results.
Increased Patient Confidence
Demonstrates commitment to quality healthcare services.
International Recognition
Improves global acceptance of laboratory reports.
Regulatory Compliance
Supports alignment with healthcare regulations and accreditation requirements.
Continuous Improvement
Encourages systematic monitoring, evaluation, and performance improvement.

Benefits of ISO 15189:2012 Certification

Who Should Obtain ISO 15189 Certification?
Clinical laboratories
Pathology laboratories
Hospital laboratory departments
Specialized medical testing facilities

ISO 15189 Certification Process

Gap Analysis
Documentation Development
System Implementation
Internal Audit
Management Review
Certification Audit
Issuance of Certificate

Frequently Asked Questions

Now that I have selected Euro Assessments, who will be my contact?

In the short term, you may continue to work with the Client Relations Manager who has been assisting you through the selection process. However, for audit-related information, your primary contact, and the person best equipped to help you will be your assigned lead auditor.

What issues will my auditor be able to help me with?

All of my audit scheduling. | reviewing my documents prior to the Certification Audit. | Coordinating and conducting my Certification Audit. | Interpretations on my quality management system standard.

What will my assigned lead auditor want to know when he/she makes initial contact with me?

Your assigned lead auditor will want to discuss your expected timing for the required certification activities such as document review and the initial assessment. He/she will need to know if you have elected to have a pre-assessment.

If I am not sure when I want to schedule an auditing activity such as the document review or initial assessment how much notice does my assigned auditor need?

Your assigned lead auditor could be “booked” as far ahead as 3 to6 months or more. It is a good idea to “reserve” time on their schedule that is realistic and achievable. Should you cancel a scheduled time without ample notice, your assigned lead auditor may or may not be able to accommodate your needs. In that case, another lead auditor may be assigned to your account.

What steps are there in the certification process?

There are 3 basic steps to a certification process and they are: ✓ Document review. ✓ Initial Assessment. ✓ Certification Panel Review of recommendation.

When will I receive a certificate?

Once the recommendation is accepted by the Certification Panel team you could expect your formal certificates in about 7 to 12 working days, which is approximately 2 weeks from the initial audit.