ISO 13485:2016 Medical Devices QMS- Transition training course for Compliance & Quality
At IEHSAS, we are experts in supporting your system implementation of ISO 13485:2016 Medical Devices QMS, delivering global compliance with more secure medical devices, more efficient processes and heightened application of risk management. This standard lays the groundwork for harmonization of the regulation of the medical devices sector, and is essential for manufacturers, suppliers, and service providers throughout the life cycle of the device.
What Is ISO 13485?
Suppose your mind mostly went blank, as it did for me a few years ago. In that case, you might be asking, ‘What is ISO 13485 and why is it so important?‘ Here’s a brief explanation: ISO 13485:2016 is the international standard that specifies the requirements for a quality management system (QMS) for the design and manufacture of medical devices. It addresses risk management, design and development controls, process validation, traceability, and regulatory requirements.
Adopting this standard demonstrates that your organisation prioritises quality, safety, and customer satisfaction, all of which are essential for making a meaningful impact in the highly regulated world of medical products.
ISO 13485:2016 Medical Devices – A Practical Guide
Our authorities rely on ISO 13485:2016 Medical Devices – A Practical Guide, to aid customers in applying current best practices. We educate you on when to use each clause, how to read documentation requirements, and develop systems that work, not just pass muster.
That guidance specifically addressed internal audits, management reviews, CAPA (Corrective and Preventive Actions), and continuous improvement for a medical device company.
ISO 13485 for Medical Devices: How It Works
This framework, ISO 13485 for Medical Devices, applies to any organisation involved in the medical device supply chain. It covers:
- Design and development
- Production and storage
- Installation and servicing
- Technical documentation
- Post-market surveillance and complaints handling
Whether you are a manufacturer or distributor, we clearly and seamlessly walk you through all your needs.
Customized Quality Manual Support
We support you in implementing a comprehensive and customised ISO 13485:2016 quality manual for medical devices, tailored to your operational and regulatory needs. This manual is intended as a guide for conducting audits and inspections, providing procedures, responsibilities, and documentation requirements that are primary resources for performing audits and inspections.
Our documentation process also helps you prepare for ISO 13485:2016 for Medical Devices QMS certification audits with confidence and accuracy.
Benefits of the ISO 13485 Quality Management System for Medical Devices
- Compliance around the world with regulators
- Improved process control and risk management
- Better documentation and tracking
- Enhanced Product Safety and Customer Satisfaction
- Easier entry to the market and brand building
This is what makes the ISO 13485 Quality Management System for Medical Devices a must for companies that want to grow and maintain a consistent quality approach throughout all their processes.
Start Your ISO 13485 Journey with IEHSAS
We Simplify Certification at IEHSAS. Our expert staff will assist you with everything from gap analysis and training to internal audits and documentation, ensuring that you’re compliant and equipped to provide safe, effective medical devices. Starting fresh or enhancing the performance of your QMS, rely on our practical guidance.
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Eligibility Criteria
Education: High school diploma or equivalent.
Experience: Relevant industry experience may be required.
Age: Minimum 18 years old.
Prerequisites: Basic courses may be required for advanced certifications.
