ISO 9001 or ISO 13485 for a Medical Device QMS?
Both ISO 9001 and ISO 13485 are the standards for Quality Management System (QMS) that help organizations to oversee and manage different processes that assure delivery of quality products/services. However, there is one sharp exception to the ISO 13485 standard which is its specialization for medical devices QMS. Apparently, it is a specified standard designed to accredit the QMS for medical devices organizations and ensures that they provide the best quality and safest products to the customers. Quality and safety are priority concerns for the medical device sector because the products are used for the purposes of healthcare, treatment, or diagnosis and hence, unreliable, or substandard products can adversely affect the lives of people. However, many medical device manufacturers consider achieving ISO 9001, the general QMS standard which is applicable to all industries. In fact, ISO 13485 is based on the framework of ISO 9001. Therefore, manufacturers think it is comprehensive and wo...