ISO 13485:2012 Certification

ISO 13485: 2012 is an international standard that represents the necessities for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory necessities, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485: 2012 applies to the design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet client and legal requirements.

The medical device standard ISO 13485 is a member of the ISO standards family and “specifies necessities for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services”. Medical companies expect this certification from their vendors and Argos is equipped to meet their necessities.

ISO 13485 is the most widely used for medical devices throughout the world. Successful design and manufacture of medical devices and supplies entails Quality Management System based on ISO 13485.

The standard ISO 13485:2012 was created specifically for medical devices and supplies and is based on ISO 9001. The standard has been made into a tool for the manufacturer to use in creating preconditions through which to cater for the regulatory safety and performance requirements as well as client requirements at various stages of product life.

Benefits of ISO 13485 Certificate

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