Combo Medical Device ISO 13485 and ISO 9001 Management Review Toolkit

The management review is one of the most important requirements in ISO 13485. It brings together all of the key requirements and the data required to be presented. It demonstrates to top management what the quality management systems are all about and is the tool to determine its effectiveness. An effective management review process and its records are the best outputs to show the company’s seriousness in implementing and maintaining the quality and environmental management system and if done well registrar auditors will have greater respect and confidence in how well the organization approached other requirements. We are making this simple preparation checklist available to support your efforts in developing and/or improving your company's management review process to a higher caliber.