MDR, IS AN EXTENSION THE RIGHT DECISION
December 19, 2022NEED a tried & tested effective QMS
February 22, 2024A quality management system (QMS) can be defined as a collection of business processes that focus on meeting customer and regulatory requirements on a consistent basis. Its purpose is to ensure that, every time a process is performed, the same information, methods, skills and controls are used and applied in a consistent manner. A procedure is a documented method for completing something with steps and instructions for each aspect of the task to ensure the activities of the organisation consistently realise high quality products and services, which in turn brings many benefits, including satisfied customers, regulators, management, and employees.
A clear articulated a process written into a procedure following the KISS principle “KEEP IT STREAMLINED SIMPLE” covering What to do, When to do it, Where to do it, hoW to do it and Who is responsible and prevents the procedures being cluttered with information overload, which maybe useful as part of explanation and / or training, or having many pages with lots of information that clutters the KISS instructions. The KISS objective is to say what you so and do what you say where the procedure becomes the best practice that the organisation has established; The easier something is to understand and use – the more likely it is to be adopted and engaged with .
A Quality Management System, or QMS, is essential for improving your business’s operations and enabling it to meet the requirements of customers. A QMS is a framework documenting all the business processes for people to follow. Whether you manage all your processes in-house or outsource, a QMS allows your organization to remain compliant with the latest standards and regulations.
The two main objectives of QMS is Control and Measure which are largely accomplished through routine, systematic audits of the quality management system. The specifics vary greatly from organization to organization depending on size, potential risk, and environmental impact.