ISO 13485:2016
Medical Devices - Quality Management System

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ISO 13485:2016 | Medical Devices - Quality Management System

capibizO is one among the Top ISO 13485:2016 Medical Devices – Quality Management System Consultant.

ISO 13485 : 2016 is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485:2016 applies to design, development, production, installation and servicing of medical devices. 

It is the most common path to meet the Quality Management System (QMS) medical device requirements in Asia, Europe, Canada, and Australia, and serves as the basis for QMS compliance in other countries like Japan, Korea, and Brazil.

Certification can also expand your market access and improve your company’s profitability. Here are some of the long-term benefits of ISO 13485.

capibizO ISO 13485
Benefits of ISO 13485:2016
  • Increased access to more markets worldwide with certification
  • Outline how to review and improve processes across your organisation
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations

We understand the unique needs and manufacturing scenarios of the industry. With local offices around the world, our team of experienced QA consultants has helped hundreds of medical device and IVD manufacturers achieve ISO 13485 certification.

capibizO - ISO 13485:2016 Certification Process

As geographic barriers between countries deteriorate, with the continued evolution of the internet, ISO 13485:2016 Medical Devices – Quality Management System may be one of the largest differentiators between you and your competitors.

capibizO follows 8 stage roadmap for a successful ISO certification. 

  • Ouestionnaire (to understand business & process)
  • Gap Analysis (identify the area of current state to ideal state)
  • Documentation (Manuals, Policy, Objectives, Process & Records)
  • Training (to train ISO standard & to implement organisation process & policies)
  • Implementation (to amend and implement the process & policies)
  • Internal Audit (to determine compliance to a set of requirements)
  • Management Review (to check the effectiveness of system by top management)
  • Final Audit, resulting Certification (to conduct audit by the certification body and recommend for certification)

A common framework for all Management System Standards has been introduced to provide greater consistency across all the ISO Management Standards. 

With our internationally located consultants, capibizO offer onsite and online consultation solutions for ISO 13485:2016 Medical Devices – Quality Management System certification across the globe.

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