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ISO 15189 checklist

ISO 15189 checklist

The ISO 15189 checklist is designed to assist medical laboratories in meeting the requirements for quality and competence. It helps you evaluate processes, identify gaps, and ensure compliance with international standards. Use this tool to enhance laboratory performance and improve patient safety.

Use this template
or download pdf
ISO 15189 checklist

The ISO 15189 checklist is designed to assist medical laboratories in meeting the requirements for quality and competence. It helps you evaluate processes, identify gaps, and ensure compliance with international standards. Use this tool to enhance laboratory performance and improve patient safety.

Use this template
or download pdf

About the ISO 15189 checklist

The ISO 15189 checklist is designed to help you ensure compliance with quality and competence standards in medical laboratories. It’s structured into clear sections and each section guides you through critical compliance steps, ensuring no detail is missing. 

Using this checklist helps you standardize workflows and maintain consistency across your laboratory operations. You can easily identify gaps in compliance, assign corrective actions, and track progress to improve overall efficiency. 

The template’s structured format not only simplifies audits but also ensures that your laboratory meets international standards, boosting trust with clients and regulatory bodies. Tailor it to your lab’s specific needs by adding fields for unique processes or local regulations. A well-organized checklist like this saves time, reduces errors, and enhances your lab’s credibility. 

5 essential elements of an ISO 15189 checklist template

An ISO 15189 checklist template ensures your medical laboratory maintains quality and competence standards. Here are the five essential elements to include: 

  1. Personnel qualifications and training: Include sections to document staff credentials, certifications, and ongoing training. This ensures your team is qualified and compliant with ISO standards, improving trust and credibility. 
  2. Equipment and maintenance records: Add fields to track equipment calibration, maintenance schedules, and performance checks. Properly maintained equipment minimizes errors and ensures reliable test results. 
  3. Document control: Include sections for managing standard operating procedures (SOPs), policies, and records. A robust document control system ensures consistency and compliance during audits and inspections. 
  4. Quality assurance processes: Incorporate fields to monitor internal audits, corrective actions, and continuous improvement initiatives. This allows you to identify and resolve operational gaps effectively. 
  5. Risk management: Add sections to assess and document potential risks, including mitigation strategies. Proactively managing risks ensures smooth operations and reinforces compliance with ISO standards. 

A template like this serves you by streamlining processes, reducing errors, and ensuring your lab operates at the highest level of quality and compliance.

When to use an ISO 15189 checklist template

If you’re running or managing a medical lab, staying aligned with ISO 15189 standards isn’t just a box to tick, it’s about ensuring quality and competence across everything you do. That’s where a checklist template comes in handy.

You’ll find it especially useful during internal audits. It helps you spot gaps early, stay organized, and feel confident when external inspections come around. It’s also a great tool for onboarding new team members or rolling out updated procedures giving everyone a consistent, clear reference point to follow.

Use it to keep tabs on equipment maintenance, manage your quality assurance processes, or document risk assessments without missing a beat. In a busy laboratory setting, having a structured checklist takes the pressure off, streamlining your workflows and helping you stay on top of what matters most.

Start improving your lab workflows today 

Take the first step toward better compliance and efficiency with an ISO 15189 checklist template. Start using it directly in Lumiform or download the PDF to streamline audits, manage quality assurance, and ensure your lab meets international standards.

Related categories

  • Health and safety management templates
  • Health care templates
  • ISO templates
Preview of the template
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Personnel and Training
Are all personnel in the laboratory adequately qualified and competent to perform their tasks?
Are there documented procedures for personnel training and competency assessment?
Are all personnel aware of their responsibilities and have access to current job descriptions?
Equipment and Instrumentation
Is all equipment and instrumentation properly calibrated, validated, and maintained?
Are there documented procedures for equipment operation, maintenance, and troubleshooting?
Are records of equipment maintenance, repair, and performance verification maintained?
Preanalytical Processes
Are there documented procedures for patient preparation, sample collection, handling, transportation, and storage?
Are there measures in place to ensure the integrity and traceability of patient samples?
Are there mechanisms to monitor and evaluate the quality of the preanalytical processes?
Analytical Processes
Are analytical methods validated and verified for their intended use?
Are there procedures for monitoring the quality of the analytical processes?
Are there mechanisms to identify and correct any problems that may arise during analysis?
Postanalytical Processes
Are there documented procedures for the review, authorization, and reporting of results?
Are there mechanisms to ensure the confidentiality and security of patient information?
Are there processes in place for the retention and storage of laboratory records and materials?
Quality Management System
Is there a comprehensive quality management system implemented in the laboratory?
Are there processes for continual improvement, including the management of nonconformities and complaints?
Are there regular internal audits and management reviews to evaluate the effectiveness of the quality system?

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

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Frequently asked questions

What is an ISO 15189 checklist template used for?

An ISO 15189 checklist template is used to ensure medical laboratories comply with international standards for quality and competence. It helps streamline audits, track equipment maintenance, manage quality assurance, and document risk assessments, ensuring labs operate efficiently while maintaining compliance with regulatory requirements.

Why is ISO 15189 compliance important for medical laboratories?

ISO 15189 compliance ensures your lab meets global standards for quality and accuracy in testing. It builds trust with patients and regulatory bodies while reducing the risk of errors, delays, or penalties. Compliance also improves overall efficiency, helping your lab deliver reliable results and maintain a competitive edge.

Who should use an ISO 15189 checklist template?

Lab managers, quality assurance teams, and compliance officers in medical laboratories benefit most from using an ISO 15189 checklist template. It’s especially useful for labs preparing for accreditation, undergoing audits, or seeking to improve workflow consistency and documentation processes.

How can a lab stay compliant with ISO 15189 standards?

To stay compliant, labs should establish clear processes for quality assurance, equipment maintenance, and risk management. Regular training, internal audits, and using tools like an ISO 15189 checklist template help standardize workflows and ensure all requirements are met efficiently. Continuous improvement is key to maintaining compliance over time.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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