ISO 15189:2012 Certification

Requirements for Quality and Competence in Medical

ISO 15189:2012

Welcome to Qzeal ISO Certifications, your trusted partner for ISO certifications in Chennai. We provide many ISO certification services to help businesses achieve excellence and meet global standards. One such Certification is ISO 15189:2012 Certification, which we offer with complete professionalism and expertise.  

At Qzeal ISO Certifications, we provide comprehensive services related to ISO 15189:2012 Certification. Our team of experienced consultants will guide you through the entire process, from initial assessment to final Certification.   

We offer the following services related to ISO 15189:2012 Certification:

Gap Analysis 

The gap analysis is a valuable tool that helps us to identify the strengths and weaknesses of your laboratory’s existing systems and processes. We will provide you with a detailed report highlighting the areas that need improvement to meet the standard.   

The report will provide clear guidance on the steps needed to address the identified gaps, including recommendations for changes to processes, documentation, and quality management systems. By identifying areas that need improvement, our gap analysis service enables you to make informed decisions about the steps required to achieve ISO 15189:2012 Certification.  


Our team of experienced consultants will work closely with you to develop a comprehensive quality manual that outlines your medical laboratory’s policies, procedures, and processes related to ISO 15189:2012. We will also help you develop the necessary procedures and work instructions to ensure your medical laboratory complies with ISO 15189:2012 requirements.   

We follow a systematic approach to documentation development, starting with a review of your existing documentation (if any) and identifying any gaps that need to be addressed. Then work with you to develop a customized documentation plan that meets the specific requirements of your medical laboratory.  


Our training programs are designed to be interactive and engaging, ensuring that your staff will understand the standard’s requirements and how to apply them in your medical laboratory. We provide customized training programs tailored to your specific needs and requirements.   

Our trainers are experienced professionals who deeply understand ISO 15189:2012 and the healthcare industry. They use real-world examples and case studies to make the training sessions more relevant and impactful. We also offer online training options, which are convenient and flexible for busy professionals.  

Internal Auditing 

During the internal audit process, our consultants will review your laboratory’s processes, procedures, and documentation to ensure that they meet the requirements of ISO 15189:2012. We will also assess the effectiveness of your quality management system and identify any areas of non-conformance that need to be addressed.  

This will enable you to take corrective action and improve your laboratory’s quality management system. Our internal auditing services are designed to provide you with an objective assessment of your medical laboratory’s quality management system.  


Our certification process is designed to ensure that your medical laboratory meets all the requirements of ISO 15189:2012. We begin by conducting a thorough assessment of your laboratory to identify any gaps that need to be addressed. Based on the assessment, we provide you with a detailed report outlining the areas of improvement required for your laboratory to meet the certification requirements. 

Once the necessary improvements have been made, we conduct a final audit to ensure that your laboratory complies with all the requirements of ISO 15189:2012. If your laboratory meets all the requirements, we will issue a certificate of compliance demonstrating your commitment to quality and competence.  

By choosing Qzeal ISO Certifications for your ISO 15189:2012 Certification needs, you can rest assured that you will receive the highest service and expertise. Our team of consultants is dedicated to helping you achieve your goals and meet the requirements of ISO 15189:2012.   

Contact us today to learn how we can help you obtain ISO 15189:2012 Certification and gain a competitive advantage in the healthcare industry. 

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