Combo Medical Device ISO 13485 and ISO 9001 Management Review Toolkit

Professional Management Review Process Development

The management review is one of the most important requirements in ISO Standards. It brings together all of the key requirements and the data required to be presented. It demonstrates to top management what the quality and environmental management systems are all about and is the tool to determine their effectiveness. An effective management review process and its records are the best outputs to show the company’s seriousness to implementing and maintaining the 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. Our experience has shown that without a well-accepted starting point that the management review can lead to over 5 findings alone. After assessing your company’s management review status against this checklist, MSI offers our most effective Management Review PowerPoint template and meeting minutes form which has addressed every requirement that must be addressed for the management review process. We at MSI utilize the management review process to cover a variety of the ISO 9001 and 13485 requirements such as data analysis. In the near future, other versions of the ISO Standards Management Review Tool Kits will be available.