A quality management system (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).[1] It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early qualitymanagement systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011audit regime applies to both and deals with quality and sustainability and their integration.
Other QMS, e.g. Natural Step, focus on sustainability issues and assume that other quality problems will be reduced as result of the systematic thinking, transparency, documentation and diagnostic discipline.
The term "Quality Management System" and the initialism "QMS" were invented in 1991 by Ken Croucher, a British management consultant working on designing and implementing a generic model of a QMS within the IT industry.
The concept of a quality as we think of it now first emerged from the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 19th century pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Birland established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects.
Application of statistical control came later as a result of World War production methods, which were advanced by the work done of W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named. Joseph M. Juran focused more on managing for quality. The first edition of Juran's Quality Control Handbook was published in 1951. He also developed the "Juran's trilogy", an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control, and quality improvement. These functions all play a vital role when evaluating quality.
Quality, as a profession and the managerial process associated with the quality function, was introduced during the second half of the 20th century and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession.
The quality profession grew from simple control to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession[2]
As Lee and Dale (1998) state, there are many organizations that are striving to assess the methods and ways in which their overall productivity, the quality of their products and services and the required operations to achieve them are done.[3]
Medical devices
The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the US FDA 21 CFR 820 regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines.
ISO 13485 are harmonized with the European Union Regulation 2017/745 as well as the IVD and AIMD directives. The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).
Quality System requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983 and were instituted as requirements in a final rule published on October 7, 1996.[4] The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at 21 CFR 820.[5]
According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation.[5] As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.
The FDA has identified in the QS regulation the 7 essential subsystems of a quality system. These subsystems include:
Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.
The International Organization for Standardization's ISO 9001:2015 series describes standards for a QMS addressing the principles and processes surrounding the design, development, and delivery of a general product or service. Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis (FMEA).[6]
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
The Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.
In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organizations that have displayed outstanding performance in the areas of Quality and workplace wellness, and have met the institute's criteria with documented overall achievements and results.
The European Quality in Social Service (EQUASS) is a sector-specific quality system designed for the social services sector and addresses quality principles that are specific to service delivery to vulnerable groups, such as empowerment, rights, and person-centredness.
The Alliance for Performance Excellence is a network of state and local organizations that use the Baldrige Criteria for Performance Excellence at the grassroots level to improve the performance of local organizations and economies. browsers can find Alliance members in their state and get the latest news and events from the Baldrige community.
Process
A QMS process is an element of an organizational QMS. The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products[7],[8][9][10][11][12]
ISO 9001 requires that the performance of these processes be measured, analyzed and continually improved, and the results of this form an input into the management review process.
Software
Quality management software offers the techniques, processes, structure, and resources needed to simplify manufacturing and ERP activities while handling quality concerns efficiently and cost-effectively.
Helps manufacturers to monitor, control, and document quality processes electronically to guarantee that goods are made within tolerance, meet all necessary requirements, and are defect-free. Quality management software is often used in the manufacturing industry to identify potential issues before they occur.[5]
Some benefits of quality management software include:
Quality management software can be integrated with manufacturing execution systems (MES). A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products.[13] When combined with QMS, these systems:
Quality management software focuses on 4 main elements:[2]
Document management: Quality management software enables companies to manage all product and quality records and documents, including product specifications, work instructions, standard operating procedures (SOPs), quality policies, and training records, among other things, to fulfill highly regulated requirements. Quality management software centralizes the storage of these documents.
Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures (CAPA) possible, which result in faster issue resolution and issue prevention.
Feedback loops: Quality management software permits staff to submit feedback or recommendations through centralized software. In turn, this way, managers gather insights from the shop floor creating a feedback loop.
Training and skill management: To maintain product quality, quality management software can provide a fixed system through which employees and staff can be trained. This fixed system provides more clarity in the different tracking processes of the company and simplifies the tracking of different skill levels of employees.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements".
Total quality management (TQM) consists of organization-wide efforts to "install and make permanent climate where employees continuously improve their ability to provide on demand products and services that customers will find of particular value." "Total" emphasizes that departments in addition to production are obligated to improve their operations; "management" emphasizes that executives are obligated to actively manage quality through funding, training, staffing, and goal setting. While there is no widely agreed-upon approach, TQM efforts typically draw heavily on the previously developed tools and techniques of quality control. TQM enjoyed widespread attention during the late 1980s and early 1990s before being overshadowed by ISO 9000, Lean manufacturing, and Six Sigma.
The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success.
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization's operations. For instance, an environmental management system enables organizations to improve their environmental performance, and an occupational safety and health management system enables an organization to control its occupational health and safety risks.
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a shift left since it focuses on quality efforts earlier in product development and production and on avoiding defects in the first place rather than correcting them after the fact.
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function.
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
IATF 16949:2016 is a technical specification aimed at the development of a quality management system which provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999. IATF 16949:2016 replaced ISO/TS 16949 in October 2016.
ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
Dental laboratories manufacture or customize a variety of products to assist in the provision of oral health care by a licensed dentist. These products include crowns, bridges, dentures and other dental products. Dental lab technicians follow a prescription from a licensed dentist when manufacturing these items, which include prosthetic devices and therapeutic devices. The FDA regulates these products as medical devices and they are therefore subject to FDA's good manufacturing practice ("GMP") and quality system ("QS") requirements. In most cases, however, they are exempt from manufacturer registration requirements. Some of the most common restorations manufactured include crowns, bridges, dentures, and dental implants. Dental implants is one of the most advanced dental technologies in the field of dentistry.
Quality engineering is the discipline of engineering concerned with the principles and practice of product and service quality assurance and control. In software development, it is the management, development, operation and maintenance of IT systems and enterprise architectures with a high quality standard.
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something ; it is also defined as being suitable for the intended purpose while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable. In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures.
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard.
British Approvals Service for Cables is an independent accredited certification body headquartered in Milton Keynes, United Kingdom. Here, the organization's dedicated testing laboratory also operates which is believed to be the largest of its type in Europe. BASEC was established in 1971 and principally provides product certification services for all types of cable and wire, ancillary products and management systems within the cable industry. The organization maintains operations throughout the world including Africa, Middle East, America, Asia and Europe.
Patient management software (PMS) is referred to as software that is regulated as a medical device. It is software that is used to acquire medical information from a medical device to be used in the treatment or diagnosis of a patient. It can also be software that is an adjunct to a medical device and directly contributes to the treatment of the patient by performing analysis, or providing treatment or diagnosis functionality that replaces the decision and judgment of a physician.
The Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed-upon high level structure, identical core text and common terms and core definitions. The aim being that all ISO Type A MSS are aligned and the compatibility of these standards is enhanced.
↑ Lee, R.G.; Dale, B.G. (1998). "Business process management: a review and evaluation". Business Process Management Journal. 4 (3): 214–225. doi:10.1108/14637159810224322.
↑ Poksinska, Bozena; Dahlgaard, Jens Jörn; Antoni, Marc (2002). "The state of ISO 9000 certification: A study of Swedish organizations". The TQM Magazine. 14 (5): 297. doi:10.1108/09544780210439734.
↑ Anton, Doug; Carole Anton (2006). ISO 9001 Survival Guide, Third Edition. AEM Consulting Group, Inc. p.100. ISBN978-0-9672170-8-6.
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