ISO 13485
ISO 13485: 2016 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. ISO 13485 international standard for medical devices quality management systems (QMS). Medical devices can be simple or complex, but all of these can benefit from being designed and manufactured under ISO 13485 which is the most widely used medical device QMS standard. It is required in Europe, Canada and many other countries for most devices. In the US the FDA Quality System Regulation (QS Reg.), also known as the cGMP, is required. Although the QS Reg. is structured very differently than ISO 13485, they have no conflicting requirements.ISO 13485 follows the process approach introduced in ISO 9001:2015. The process approach treats the QMS as a set of interrelated processes covering not only the manufacture of a product or provision of a service, but also management processes and support processes. A "process" is something that transforms a collection of inputs into outputs.
Integration with other standards:
ISO 13485 can be implemented as it has been based on ISO 9001. It is international recognition, and is an auditable standard which can be accredited by certification body. When a business already has ISO9001 in place, achieving ISO 13485 becomes much simpler. Quality Associates is an expert in system integration. We can embrace the ISO 13485 into other management systems such as ISO 14001, ISO 45001, ISO 9001 and others that related to your business as your needs. Please contact our customer service for inquiry. CONTACT US!
Quality Management Principals 