A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization (i.e., areas that can impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a Quality Management System. Show
Some people generically refer to the group of documents as a QMS, but specifically, it refers to the entire system – the documents just describe it.
A QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. A process based QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance. A complete ISO 9001 Quality Management System must address all the requirements of ISO 9001, including the ISO 9001 documentation requirements. A great way to understand how ISO 9001 works is to apply it to an example. Here is an easy example of ISO 9001 applied to making cookies.
A Quality Management System in its basic concept is quite simple. It seeks to,
There are many definitions for general quality management systems. Most of them emphasize the use of some type of system that is repeatable, measurable and constantly improving. In an ISO 9001 (or other ISO standards) quality system, this structured way of delivering a better service or product is supported by documented information such as procedures, work instructions, policies and forms. The key is to provide all those who must execute the quality system with documented, understandable and workable instructions which define both expectations, responsibilities and actions to achieve the stated quality goals. Most of the systems include some type of external and internal auditing process which ensures that the system is in compliance with requirements. At its core, a quality management system is an integrative element, uniting diverse aspects of a company into a unified purpose of delivering products/services in their best form. Rather than be seen as a cost burden, an effective quality management system is viewed as a key component of success. Quality management systems focus on:
Implementing a quality management system affects every aspect of an organization's performance. Benefits of a documented quality management system include:
These benefits offer additional advantages, including:
ISO 9001:2015 and other QMS standardsISO 9001:2015 is the most recognized and implemented quality management system standard in the world. ISO 9001:2015 specifies the requirements for a QMS that organizations can use to develop their own programs. Other standards related to quality management systems include the rest of the ISO 9000 series (including ISO 9000 and ISO 9004), the ISO 14000 series (environmental management systems), ISO 13485 (quality management systems for medical devices), ISO 19011 (auditing management systems), and IATF 16949 (quality management systems for automotive-related products). Elements and requirements of a QMSEach element of a quality management system helps achieve the overall goals of meeting the customers’ and organization’s requirements. Quality management systems should address an organization’s unique needs; however, the elements all systems have in common include:
Establishing and implementing a QMSBefore establishing a quality management system, your organization must identify and manage various connected, multi-functional processes to help ensure customer satisfaction. The QMS design should be influenced by the organization’s varying objectives, needs, and products and services provided. This 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 and BuildThe 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. DeployDeployment is best served in a granular fashion by breaking each process down into subprocesses 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 MeasureControl 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 ImproveReview and improve detail 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. industrial influence on quality and standardizationThe history of quality can trace its roots back centuries when craftsmen began organizing into unions called guilds. When the Industrial Revolution came, early quality management systems were used as standards that controlled product and process outcomes. As more people had to work together to produce results and production quantities grew, best practices were needed to ensure quality results. Eventually, best practices for controlling product and process outcomes were established and documented. These documented best practices turned into standard practices for quality management systems. Quality became increasingly important during World War II, for example, when bullets made in one state had to work with rifles made in another. The armed forces initially inspected virtually every unit of product. To simplify the process without sacrificing safety, the military began to use quality techniques of sampling for inspection, aided by the publication of military-specification standards and training courses in Walter Shewhart’s statistical process control techniques. The importance of quality only grew after the war. The Japanese enjoyed a quality revolution, improving their reputation for shoddy exports by fully embracing the input of American thinkers like Joseph M. Juran and W. Edwards Deming and shifting focus from inspection to improving all organization processes through the people who used them. By the 1970s, the U.S. industrial sectors, such as electronics and automobiles, had been broadsided by Japan’s high-quality competition. The Rise of Quality Management SystemsThe American response to the quality revolution in Japan gave birth to the concept of total quality management (TQM), a method for quality management that emphasized not only statistics but approaches that embraced the entire organization. In the late 20th century, independent organizations began producing standards to assist in the creation and implementation of quality management systems. It is around this time that the phrase “Total Quality Management” began to fall out of favor. Because of the multitude of unique systems that can be applied, the term “Quality Management System” or “QMS” is preferred. At the start of the 21st century, QMS had begun to merge with the ideas of sustainability and transparency, as these themes became increasingly important to consumer satisfaction. QMS ResourcesYou can also search articles, case studies, and publications for QMS resources. BooksAchieving Customer Experience Excellence Through A Quality Management System Beyond Compliance Design Of A Quality System How To Audit The Process Based QMS Unlocking The Power Of Your QMS: Keys to Business Performance Improvement ArticlesHealthcare QMS Self-Assessment Based On A Maturity Model (Journal for Quality and Participation) Details on how the self-assessment process should be modified as the organization advances through the six maturity stages. Process maps and worksheets and worksheets are included for each stage. How Well Is Your Healthcare Quality Management System Performing? (Journal for Quality and Participation) This article explains how a quality management system model can provide a solid foundation for healthcare organizations. It also details the importance of ongoing self-assessments of existing gaps and how to address them to ensure improvement. How Organizational Context And Risk-Based Thinking Influence A Quality Management System (Journal for Quality and Participation) Implementation of a QMS should consider the interplay of the various risks an organization faces. Risk-based thinking examines the differential impacts that an individual risk can have on different processes, and how multiple risk factors impact the overall outcome of an organization's stated goals. The Impact Of Human Factors On A Hospital-Based Quality Management System (Journal for Quality and Participation) The phrase "human factors" defines the interaction between humans and their environment; it also outlines the impact of these factors as they relate to implementing the quality management system and its goals of exceptional quality, safety, and patient outcomes. CoursesImplementing and Auditing an ISO 9001: 2015 Quality Management System Integrated Quality Management ISO 9001: 2015 Certified Internal Auditor (Quality Management System) ISO 9001: 2015 Certified Lead Auditor (Quality Management System) Process Auditing Techniques WebcastsAn Introduction To The Hospital-Based QMS Pierce Story and Grace Duffy provide an introduction to the hospital-based healthcare QMS model developed collaboratively by the ASQ Quality Management and Healthcare Division's Healthcare Technical Committee. This model is directed to the CEO and CMO who are seeking to improve patient outcomes, safety, and satisfaction, as well as cost savings, risk management, and regulatory compliance. Improving Quality During A Restart Of The Manufacturing Shop Floor The current global scenario is unique and has a prominent impact on the health care system. Hence, the role of a Medical device manufacturer is critical in terms of the safety and efficacy of products, which necessitates greater diligence at the shop floor apart from having a robust QMS. Quality Management Systems-Background, Evolution, And The Future Of ISO 9001 ISO 9001 expert Mark Ames walks through the evolution of quality management systems, from their beginnings and right into the most utilized standard of all, ISO 9001. |
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