ISO 13485:2016 Certification

Medical devices quality Management Systems

ISO 13485:2016

Welcome to Qzeal ISO Certifications, your trusted partner in ISO certifications and related services. We are pleased to offer ISO 13485:2016 certification services in Chennai to help organizations meet the quality management requirements for medical devices.  

At Qzeal ISO Certifications, we provide comprehensive ISO 13485:2016 certification services to help your organization achieve compliance and improve its QMS. Our services include:  

Gap Analysis 

During the gap analysis process, our experienced auditors will review your organization’s current QMS, including your policies, processes, procedures, and documentation. We will compare your current QMS against the requirements of the ISO 13485:2016 standard to identify any gaps or areas that require improvement.   

Our gap analysis process is designed to clearly understand where your organization stands regarding compliance with the ISO 13485:2016 standard. We will provide you with a detailed report outlining areas where your QMS meets the standard and the areas that require improvement.  


Our documentation services include creating customized templates and guidelines aligning with your organization’s needs and processes. We work closely with your team to ensure the documentation is clear, concise, accurate and meets the ISO 13485:2016 standard requirements.   

We also ensure that the documentation is regularly reviewed and updated to reflect any changes in the QMS or the ISO 13485:2016 standard. Our team can guide how to maintain and control the documentation, including version control, approvals, and distribution.  


Our training programs cover the requirements of the ISO 13485:2016 standard and the best practices for implementing and maintaining an effective QMS. Our experienced trainers use a combination of interactive sessions, case studies, and practical exercises to ensure that your employees understand the concepts and can apply them in their daily work.  

During the training sessions, your employees will learn how to identify and address the risks and opportunities in your organization’s QMS, develop and implement policies and procedures, conduct internal audits, and continually improve the QMS to meet customer and regulatory requirements.

Internal audit 

Our experienced auditors will work with your organization to plan and conduct internal audits at regular intervals, ensuring that all relevant areas of your QMS are thoroughly assessed. During the audit process, we will review your organization’s policies, procedures, records, and other documentation to assess compliance with the ISO 13485:2016 standard.  

We will also interview relevant personnel to understand better how the QMS is being implemented and identify any areas for improvement. Once the audit is complete, we will provide a detailed report outlining any non-conformities and areas for improvement.  

Certification Audit  

We start by assisting in the preparation phase, where we help you identify the necessary documentation and procedures required for the audit. Our experienced consultants work closely with your team to ensure that all documentation is in place and meets the ISO 13485:2016 standard requirements.  

We also help you prepare for the audit by conducting mock audits and providing guidance on how to improve your QMS. During the certification audit, we provide support to ensure that the audit process runs smoothly.  

By choosing Qzeal ISO Certifications for your ISO 13485:2016 certification needs, you can rest assured that you receive professional and reliable services from an experienced team. We are committed to helping your organization achieve compliance, improve its QMS, and enhance customer satisfaction.  

Don’t hesitate to contact us for more information on our ISO 13485:2016 certification services or to request a quote. Let us help you take the first step towards achieving ISO 13485:2016 certification and ensuring the quality and safety of your medical devices. 

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