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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. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management 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 19011 audit regime applies to both and deals with quality and sustainability and their integration.
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".
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 and vocabulary 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/TS 9002 offers guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.
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.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection Procedure in place to ensure consistent checking. Inspections are usually non-destructive.
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.
Reliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability is defined as the probability that a product, system, or service will perform its intended function adequately for a specified period of time, OR will operate in a defined environment without failure. Reliability is closely related to availability, which is typically described as the ability of a component or system to function at a specified moment or interval of time.
Software quality assurance (SQA) is a means and practice of monitoring all software engineering processes, methods, and work products to ensure compliance against defined standards. It may include ensuring conformance to standards or models, such as ISO/IEC 9126, SPICE or CMMI.
Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation, but has similarities to Design for Six Sigma (DFSS).
Software assurance (SwA) is a critical process in software development that ensures the reliability, safety, and security of software products. It involves a variety of activities, including requirements analysis, design reviews, code inspections, testing, and formal verification. One crucial component of software assurance is secure coding practices, which follow industry-accepted standards and best practices, such as those outlined by the Software Engineering Institute (SEI) in their CERT Secure Coding Standards (SCS).
Software safety is an engineering discipline that aims to ensure that software, which is used in safety-related systems, does not contribute to any hazards such a system might pose. There are numerous standards that govern the way how safety-related software should be developed and assured in various domains. Most of them classify software according to their criticality and propose techniques and measures that should be employed during the development and assurance:
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.
Corrective and preventive action consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. Non-conformance may be a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. The Eight disciplines problem solving method, or 8D framework, can be used as an effective method of structuring a CAPA.
Software Quality Management (SQM) is a management process that aims to develop and manage the quality of software in such a way so as to best ensure that the product meets the quality standards expected by the customer while also meeting any necessary regulatory and developer requirements, if any. Software quality managers require software to be tested before it is released to the market, and they do this using a cyclical process-based quality assessment in order to reveal and fix bugs before release. Their job is not only to ensure their software is in good shape for the consumer but also to encourage a culture of quality throughout the enterprise.
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 high quality standard.
The Canadian Welding Bureau is a certification and registration organization for companies involved in the welding of steel structures. Welders in Canada are required to be retested every two years by the Canadian Welding Bureau. The CWB Group was formed in 1947 to administer the then, new W47.1 welding standard for structural steel. The CWB has today expanded its scope well beyond the original structural steel roots and is accredited by the Standards Council of Canada as a Certification Body for the administration of CSA Standards including W47.1, W47.2, W55.3, W186, W178.1 and W48 to industries across Canada and internationally for:
Acceptance sampling uses statistical sampling to determine whether to accept or reject a production lot of material. It has been a common quality control technique used in industry.
The testing, inspection and certification (TIC) sector consists of conformity assessment bodies who provide services ranging from auditing and inspection, to testing, verification, quality assurance and certification. The sector consists of both in-house and outsourced services.
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- ↑ CAN3-Z299.0-86: Guide for Selecting and Implementing the CAN3-Z299-85 Quality Assurance Program Standards, p. 13