ISO 13485:2016 is the globally recognized standard for implementing a quality management system throughout the lifecycle of a medical device. The initial creation and implementation of a quality management system poses a major challenge for many organizations. The greatest difficulty is to capture the normative and regulatory requirements in documented procedures that can be implemented in practice and in everyday business.
ISO 13485:2016 details the processes for which you must implement documented procedures. As a first step, identify the processes that are important to your business. This list serves as the basis of your quality management manual and your project plan for the complete implementation of your QMS.

In addition to the documented procedures, you must also create forms, checklists and work instructions. According to the QM documentation, appropriate records must be kept proving the effectiveness of the QMS. Employees must know the processes and must be trained. Top management must provide appropriate resources both for the implementation phase and for continued effectiveness.

After the implementation phase, the processes of the QMS must be carried out and maintained. Evidence must be documented and archived. As part of internal audits, you put your system to the test. If your system complies with your internal as well as the regulatory and normative requirements, nothing stands in the way of certification by a notified body. When planning a project, think about getting in contact with a notified body at an early stage, as this is the only way to secure your desired date.

We are one of the authors of this standard as an active member of the standardization group ISO TC210/WG1. Use our expertise to start your own QMS. We will show you which documented procedures (process descriptions) and records you need and how the individual requirements are implemented. Working together, we create processes that are tailored to your company. In addition to the normative requirements, we also consider the regulatory requirements of the countries relevant to you (such as 21 CFR 820 Quality System Regulation, ANVISA RDC 16/2013 and the Medical Device Single Audit Program (MDSAP)).