ISO 15189:2022
Is ISO 15189 Right for Your Laboratory?
Here’s When it Makes Strategic Sense:
ISO 15189 is the internationally recognized standard for quality and competence in medical laboratories. COLA helps laboratories navigate the accreditation process with knowledgeable assessors and a focus on continuous improvement.
Why Does ISO 15189 Matter?
Medical laboratories play a critical role in patient care. Accurate, reliable laboratory results depend on more than technical testing—they require a comprehensive quality management system that supports competence, consistency and continual improvement.
ISO 15189 provides an internationally recognized framework for evaluating the quality and competence of medical laboratories. Accreditation demonstrates that your laboratory has established processes to support reliable results and quality throughout the laboratory’s operations.
Why Choose COLA for ISO 15189 Accreditation?
01
Support Throughout the Process
From preparation to corrective action, COLA will help your laboratory navigate accreditation with confidence.
02
A Practical Approach to Accreditation
ISO 15189 can be complex. COLA focuses on practical application, not simply checking boxes.
03
Expertise You Can Rely On
Work with experienced assessors who understand laboratory operations and the challenges laboratories face every day.
04
Focus on Continuous Improvement
ISO 15189 goes beyond passing an assessment. Build sustainable quality practices that strengthen your laboratory over time.
Is Your Laboratory Ready for ISO 15189?
Preparing for ISO 15189 accreditation can feel overwhelming. Laboratories may struggle with:
- Understanding the requirements of the standard
- Determining what documentation is needed
- Integrating quality requirements into daily operations
- Identifying gaps before an assessment
- Preparing staff for the accreditation process
- Maintaining compliance over time
- Turning quality requirements into sustainable processes
COLA can help!
Our approach is designed to help laboratories understand what ISO 15189 requires so laboratories can apply those requirements effectively within their existing operations.
Your Path to ISO 15189
Step 1 — Purchase the Standard
Obtain the ISO 15189:2022 standard
Step 2 — Define Your Scope
Determine which processes will be included in your ISO 15189 accreditation
Step 2 — Apply
Submit your application for ISO 15189:2022 accreditation with COLA
Step 3 — Prepare
Implement the standard and prepare your laboratory for assessment
Step 4 — Assessor Assignment
COLA assigns qualified assessors with the expertise needed for your laboratory
Step 5 — Laboratory Assessment
COLA assessors evaluate your laboratory against ISO 15189:2022 requirements
Step 6 — Review Findings
Review any nonconformities identified during the assessment
Step 7 — Corrective Action
Address findings and submit your corrective action response when applicable
Step 8 — Accreditation Decision
The ISO Accreditation Board reviews the assessment and makes the accreditation decision
Step 9 — Accreditation
Receive ISO 15189:2022 accreditation with COLA and demonstrate your commitment to quality and competence
Ready to Get Started? → Talk to COLA
Talk directly with a COLA representative. We’re here to help you determine which program is right for your laboratory.
