ISO 13485 in Canada
About ISO 13485 in Canada ISO 13485:2016 outlines the parameters for a Quality Management System that demonstrates an organization’s capacity to supply medical devices that meet the device’s regulatory requirements and, if applicable, patient safety goals. ISO 13485:2016 is applicable to all organizations involved in the design and manufacturing of medical devices, including device manufacturers and service providers. What does it mean to be ISO 13485 Certified? The ISO 13485 standard is a stand-alone specification. It is based on the ISO 9001:2015 structure, but it contains medical device-specific standards such as risk analysis, sterile production, rework, and traceability. An organization that has established an ISO 13485 Quality Management System (QMS) and has successfully completed all applicable requirements, as assessed by the certification body, is referred to as an “ISO 13485-certified company.” How to Prepare Your Organization for ISO 13485 Certification ISO...