Iso 13485 Certification

Iso 134852003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Iso 13485 certification. Iso 134852016 is based on the iso 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Requirements of iso 134852016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Implementation of iso 13485 helps an organization to keep the quality and consistency of medical devices moreover it is an assurance to their clients. Asqs iso 13485 training courses can help any organization involved in the design production installation and servicing of medical devices understand and apply quality management standards.

While iso 13485 is based on the iso 9001 process model concepts of plan do check act it is designed for regulatory compliance. Like other iso management system standards certification to iso 13485 is not a requirement of the standard and organizations can reap many benefits from implementing the standard without undergoing the certification process. Iso 134852016 can also be used by suppliers or external parties that provide product including quality management system related services to such organizations. Certification to iso 13485.

Its primary objective is to facilitate harmonized medical device regulatory requirements. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Iso 13485 adapts the iso 9000 process based model for a regulated medical device manufacturing environment. Iso 134852016 is the standard for a quality management system qms for the design and manufacture of medical devices.

We have dynamic course owners around the world allowing delivery of training in many local languages. Iso 13485 is an international standard that specifies requirements for quality management systems for the medical device manufacturing industry. Certification to the standard requires an organizations quality management system to pass a third party medical device single audit program or mdsap audit. Design and develop medical devices to international quality standards ensure smooth submission meet iso 13485 standards satisfy customers and keep ahead of all regulatory developments with our medical devices training courses.