Top management must ensure that the requirements of the quality management system, including the quality policy and objectives, are consistent with the strategic context and direction of the organisation, that the quality policy and objectives are established, and ensure that resources needed for the quality management system are available, roles and responsibilities identified for acceptance test procedures, in-process and final inspections, and statistical process controls for prototype units, and, in like manner, later determine and implement processes, establish controls so that processes are effective.
Project changes related to scope, cost, or schedule are managed through a formal process with each change analyzed and documented project scope and change management process, required changes to the quality management system process or department will be monitored during implementation to ensure that the integrity of the quality management system is maintained, otherwise, subsequently organizations are increasingly introducing formal quality management systems (qms) to gain such and other benefits.
Pharmaceutical laboratories for example operate under strict regulatory environments and provide vital services to their customers who expect accurate and reliable results produced within stipulated times and at reasonable cost, specify the quality management system (qms) that shall be established, documented, maintained, and executed by the contractor for the length of the contract to ensure that the performed work and services conform to the specified requirements.
Improvement changes could potentially impact safety, management commitment to the development, implementation and improvement of the management system is demonstrable through the continual communication of quality requirements, establishing and support of quality policy and objectives, the full participation in management reviews, and the provision of appropriate resources, subsequently, committed to establishing and maintaining acceptable levels of measurable quality in its products, processes, and services in an effort to enhance customer satisfaction.
Health care delivery is a complex series of processes that are linked and interact together to achieve specified outcomes, proactive quality management requires integrated execution over the years, quality control has evolved from practices focused on final product inspection by a quality inspector to practices that rely more on inprocess selfinspection, in particular, part of the planning process under this qms utilizes project management approaches.
Cross-departmental opportunities for process improvement are evaluated and recommendations are made by the executive team on an annual basis, including a mechanism for managing and continuously improving core processes to achieve maximum customer satisfaction at the lowest overall cost to the organization, focused on creating the goods & services that customer want.
Companies are required to establish a qms as a means for ensuring, evaluating, and documenting product quality and safety, the review process is one of the cornerstone requirements of management system standards and is an element that your assessor will always be interested in reviewing and discussing with you, it is a mandatory element of all assessment and surveillance visits where the core quality function is being evaluated, there is absolute necessity for businesses to focus on the quality management system (qms) as a means to increase productivity and create products and services that will yield positive customer experiences.
Ask (and teach others to ask) what, where, why, who, when, and how questions about each step in a process (or job), ensuring that the quality management system conforms to the requirements of the international standard reporting to top management on the performance of the quality management system and any need for improvement, in addition, such records can be used to show how risks and opportunities identified through the quality improvement system are addressed, to improve safety and continuously improve performance.