ISO 13485 Quality Management System for Medical Devices
ISO 13485 2016 identifies needs for a quality management system where an organization requirements to demonstrate its capability to offer medical devices and related services that constantly meet client and applicable regulatory needs.
Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and improvement or provision of associated activities and (e.g. technical support). ISO 13485 2016 can also be used by dealers or external parties that deliver product, including quality management system-related services to such organizations.
Benefits of ISO 13485:
The benefits of ISO 13485 cannot be overstated. Companies of all sizes have realized significant savings in cost and time, plus other improvements that an efficient Quality Management System naturally bring about. The following is a list of six top reasons to implement ISO 13485 in your company:
- Improve your company’s credibility and image.
- Improve customer satisfaction.
- Improve your processes.
- Improve decision-making.
- Create a culture of continual improvement.
- Better employee engagement.
Why ISO 13485?
As the international standard for Quality Management Systems in the medical device industry, ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements. And, along the way, your company will naturally enjoy better control over its processes, and continual improvement – driving continual ROI.
What do we offer for ISO 13485 Certification for your organization?
With a team of highly qualified consultants and trainers having vast industrial experience, Vanguard Consulting & Inspection Services assists organizations across the world to implement and achieve ISO 13485 certification. Our consultation approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client’s organization.
Contact us at info@vanguardconsultant.com to get your organization ISO 13485 certified
Our roadmap for your business success
Develop vision &
objectives
Understanding existing
process
Identify change
levels
Implement new
process
Evaluate the new
process
