Ensure the highest standards of quality and safety in medical devices with ISO 13485:2016 certification. True Quality Certification is your trusted partner for achieving compliance with this globally recognized standard.
With True Quality Certification, we provide expert guidance to help your organization navigate the certification process smoothly, ensuring you meet all requirements effectively.
ISO 13485:2016 is an internationally recognized standard for quality management systems (QMS) specific to the medical device industry. It ensures that organizations meet regulatory requirements for the design, development, production, installation, and servicing of medical devices. The standard emphasizes risk management, process control, and documentation, promoting product safety and efficacy. ISO 13485:2016 is applicable to manufacturers, suppliers, and distributors, fostering trust in the supply chain and enabling access to global markets by demonstrating compliance with stringent medical device regulations.
We begin by understanding your organization's needs and requirements. This helps us recommend the right certification process for you.
We review your existing processes, policies, and documents to ensure they meet the standards for ISO certification.
We provide guidance and support to implement the necessary changes and improvements to meet the ISO standards.
We perform an internal audit to assess your organization's compliance with the ISO standard and ensure everything is in place.
A third-party certification body conducts the final audit to ensure your organization meets all the requirements for ISO certification.
Once you pass the audit, the certification body issues the ISO certificate, confirming your organization’s compliance with the ISO standards.
Essential documents for ISO Certification
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