🗊Презентация Quality Engineering 3

Overview (Lecture the 2nd) QMS QMS Elements Basic steps of QMS

QMS QMS - is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction ISO 9001:2015 the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems and ISO 9004 – both are parts of ISO 9000 family, priority is to achieve robust success in the organization processes ISO 14000 - environmental management system ISO 13485 - quality management systems for medical devices ISO 19011 - auditing management systems ISO / TS 16949 - quality management systems for automotive-related products

QMS ELEMENTS AND REQUIREMENTS OF A QMS: The organization’s quality policy and quality objectives Quality manual Procedures, instructions, and records Data management Internal processes Customer satisfaction from product quality Improvement opportunities Quality analysis

QMS ESTABLISHING AND IMPLEMENTING A QMS In order to help customer satisfaction before implementing QMS there is structure is based largely on the Plan-Do-Check-Act (PDCA) cycle and allows for continuous improvement to both the product and the QMS. The basic steps to implementing a quality management system are as follows: Design Build Deploy Control Measure Review Improve

QMS Design and Build The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation. Senior management should oversee this portion to ensure the needs of the organization and the needs of its customers are a driving force behind the systems development. Deploy Deployment is best served in a granular fashion by breaking each process down into sub-processes, and educating staff on documentation, education, training tools, and metrics. Company intranets are increasingly being used to assist in the deployment of quality management systems. Control and Measure Control and measurement are two areas of establishing a QMS that 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. Review and Improve Review and improvement detail with how the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit.

QMS The Plan–Do–Check–Act Procedure Plan: Recognize an opportunity and plan a change. Do: Test the change. Carry out a small-scale study. Check: Review the test, analyze the results and identify what you’ve learned. Act: Take action based on what you learned in the study step. If the change did not work, go through the cycle again with a different plan. If you were successful, incorporate what you learned from the test into wider changes. Use what you learned to plan new improvements, beginning the cycle again.