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.
An audit is an "independent examination of financial information of any entity, whether profit oriented or not, irrespective of its size or legal form when such an examination is conducted with a view to express an opinion thereon." Auditing also attempts to ensure that the books of accounts are properly maintained by the concern as required by law. Auditors consider the propositions before them, obtain evidence, roll forward prior year working papers, and evaluate the propositions in their auditing report.
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.
Clinical governance is a systematic approach to maintaining and improving the quality of patient care within the National Health Service (NHS) and private sector health care. Clinical governance became important in health care after the Bristol heart scandal in 1995, during which an anaesthetist, Dr Stephen Bolsin, exposed the high mortality rate for paediatric cardiac surgery at the Bristol Royal Infirmary. It was originally elaborated within the United Kingdom National Health Service (NHS), and its most widely cited formal definition describes it as:
A framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.
Data quality refers to the state of qualitative or quantitative pieces of information. There are many definitions of data quality, but data is generally considered high quality if it is "fit for [its] intended uses in operations, decision making and planning". Moreover, data is deemed of high quality if it correctly represents the real-world construct to which it refers. Furthermore, apart from these definitions, as the number of data sources increases, the question of internal data consistency becomes significant, regardless of fitness for use for any particular external purpose. People's views on data quality can often be in disagreement, even when discussing the same set of data used for the same purpose. When this is the case, data governance is used to form agreed upon definitions and standards for data quality. In such cases, data cleansing, including standardization, may be required in order to ensure data quality.
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.
Business process re-engineering (BPR) is a business management strategy originally pioneered in the early 1990s, focusing on the analysis and design of workflows and business processes within an organization. BPR aims to help organizations fundamentally rethink how they do their work in order to improve customer service, cut operational costs, and become world-class competitors.
Clinical audit is a process that has been defined as a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change
Business analysis is a professional discipline focused on identifying business needs and determining solutions to business problems. Solutions may include a software-systems development component, process improvements, or organizational changes, and may involve extensive analysis, strategic planning and policy development. A person dedicated to carrying out these tasks within an organization is called a business analyst or BA.
Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization's operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes. Internal auditing might achieve this goal by providing insight and recommendations based on analyses and assessments of data and business processes. With commitment to integrity and accountability, internal auditing provides value to governing bodies and senior management as an objective source of independent advice. Professionals called internal auditors are employed by organizations to perform the internal auditing activity.
IT portfolio management is the application of systematic management to the investments, projects and activities of enterprise Information Technology (IT) departments. Examples of IT portfolios would be planned initiatives, projects, and ongoing IT services. The promise of IT portfolio management is the quantification of previously informal IT efforts, enabling measurement and objective evaluation of investment scenarios.
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.
Internal control, as defined by accounting and auditing, is a process for assuring of an organization's objectives in operational effectiveness and efficiency, reliable financial reporting, and compliance with laws, regulations and policies. A broad concept, internal control involves everything that controls risks to an organization.
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.
A continual improvement process, also often called a continuous improvement process, is an ongoing effort to improve products, services, or processes. These efforts can seek "incremental" improvement over time or "breakthrough" improvement all at once. Delivery processes are constantly evaluated and improved in the light of their efficiency, effectiveness and flexibility.
Continuous auditing is an automatic method used to perform auditing activities, such as control and risk assessments, on a more frequent basis. Technology plays a key role in continuous audit activities by helping to automate the identification of exceptions or anomalies, analyze patterns within the digits of key numeric fields, review trends, and test controls, among other activities.
In software engineering, a software development process is a process of planning and managing software development. It typically involves dividing software development work into smaller, parallel, or sequential steps or sub-processes to improve design and/or product management. It is also known as a software development life cycle (SDLC). The methodology may include the pre-definition of specific deliverables and artifacts that are created and completed by a project team to develop or maintain an application.
Project assurance or programme assurance is a discipline that seeks to provide an independent and objective oversight of the likely future performance of major projects for those responsible for sanctioning, financing or insuring such undertakings. The discipline has emerged as a response to consistent problems in major projects and the need to provide confidence for project or programme stakeholders of technologically advanced, high capital or high risk projects.
IT risk management is the application of risk management methods to information technology in order to manage IT risk, i.e.:
The European Foundation for Quality in eLearning (EFQUEL) was a not-for-profit organisation which was legally established on June 30, 2005, and is based in Brussels, Belgium. It was a worldwide membership network with over 120 member organisations including universities, corporations and national agencies. The purpose of the foundation was to create a European community of users and experts to share experiences of eLearning. Two of the main initiatives of the foundation were the "UNIQUe" accreditation for Quality in e-Learning and the annual EFQUEL Forum.
