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Quality Management System
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). 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. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Business Process
A business process, business method, or business function is a collection of related, structured activities or tasks performed by people or equipment in which a specific sequence produces a service or product (that serves a particular business goal) for a particular customer or customers. Business processes occur at all organizational levels and may or may not be visible to the customers. A business process may often be visualized (modeled) as a flowchart of a sequence of activities with interleaving decision points or as a process matrix of a sequence of activities with relevance rules based on data in the process. The benefits of using business processes include improved customer satisfaction and improved agility for reacting to rapid market change. Process-oriented organizations break down the barriers of structural departments and try to avoid functional silos. Overview A business process begins with a mission objective (an external event) and ends with achievement of the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Industrial Revolution
The Industrial Revolution, sometimes divided into the First Industrial Revolution and Second Industrial Revolution, was a transitional period of the global economy toward more widespread, efficient and stable manufacturing processes, succeeding the Second Agricultural Revolution. Beginning in Kingdom of Great Britain, Great Britain around 1760, the Industrial Revolution had spread to continental Europe and the United States by about 1840. This transition included going from craft production, hand production methods to machines; new Chemical industry, chemical manufacturing and Puddling (metallurgy), iron production processes; the increasing use of Hydropower, water power and Steam engine, steam power; the development of machine tools; and rise of the mechanisation, mechanised factory system. Output greatly increased, and the result was an unprecedented rise in population and population growth. The textile industry was the first to use modern production methods, and textiles b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Good Manufacturing Practice
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 manageme ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Regulation (EU) 2017/745
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD). The regulation was published on 5 April 2017 and came into force on 25 May 2017. Changes Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by notified bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements, and increased postmarketing surveillance activities. Scope and classification Compared to the MDD, the scope of the MDR has been expanded to cover not only the active implantable medical devices previously covere ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
21 CFR 820
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 manageme ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
ISO 13485
ISO 13485 ''Medical 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 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016. Background Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Engineering
Engineering is the practice of using natural science, mathematics, and the engineering design process to Problem solving#Engineering, solve problems within technology, increase efficiency and productivity, and improve Systems engineering, systems. Modern engineering comprises many subfields which include designing and improving infrastructure, machinery, vehicles, electronics, Materials engineering, materials, and energy systems. The Academic discipline, discipline of engineering encompasses a broad range of more Academic specialization, specialized fields of engineering, each with a more specific emphasis for applications of applied mathematics, mathematics and applied science, science. See glossary of engineering. The word '':wikt:engineering, engineering'' is derived from the Latin . Definition The American Engineers' Council for Professional Development (the predecessor of the Accreditation Board for Engineering and Technology aka ABET) has defined "engineering" as: ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Accounting
Accounting, also known as accountancy, is the process of recording and processing information about economic entity, economic entities, such as businesses and corporations. Accounting measures the results of an organization's economic activities and conveys this information to a variety of stakeholders, including investors, creditors, management, and Regulatory agency, regulators. Practitioners of accounting are known as accountants. The terms "accounting" and "financial reporting" are often used interchangeably. Accounting can be divided into several fields including financial accounting, management accounting, tax accounting and cost accounting. Financial accounting focuses on the reporting of an organization's financial information, including the preparation of financial statements, to the external users of the information, such as investors, regulators and suppliers. Management accounting focuses on the measurement, analysis and reporting of information for internal use by ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Medicine
Medicine is the science and Praxis (process), practice of caring for patients, managing the Medical diagnosis, diagnosis, prognosis, Preventive medicine, prevention, therapy, treatment, Palliative care, palliation of their injury or disease, and Health promotion, promoting their health. Medicine encompasses a variety of health care practices evolved to maintain and restore health by the prevention (medical), prevention and treatment of illness. Contemporary medicine applies biomedical sciences, biomedical research, medical genetics, genetics, and medical technology to diagnosis (medical), diagnose, treat, and prevent injury and disease, typically through pharmaceuticals or surgery, but also through therapies as diverse as psychotherapy, splint (medicine), external splints and traction, medical devices, biologic medical product, biologics, and Radiation (medicine), ionizing radiation, amongst others. Medicine has been practiced since Prehistoric medicine, prehistoric times, and ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Quality Control
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". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introductio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Joseph M
Joseph is a common male name, derived from the Hebrew (). "Joseph" is used, along with " Josef", mostly in English, French and partially German languages. This spelling is also found as a variant in the languages of the modern-day Nordic countries. In Portuguese and Spanish, the name is "José". In Arabic, including in the Quran, the name is spelled , . In Kurdish (''Kurdî''), the name is , Persian, the name is , and in Turkish it is . In Pashto the name is spelled ''Esaf'' (ايسپ) and in Malayalam it is spelled ''Ousep'' (ഔസേപ്പ്). In Tamil, it is spelled as ''Yosepu'' (யோசேப்பு). The name has enjoyed significant popularity in its many forms in numerous countries, and ''Joseph'' was one of the two names, along with ''Robert'', to have remained in the top 10 boys' names list in the US from 1925 to 1972. It is especially common in contemporary Israel, as either "Yossi" or "Yossef", and in Italy, where the name "Giuseppe" was the most commo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
Deming Prize
The Deming Prize is the longest-running national quality award and one of the highest awards in the world. It recognizes both individuals for their contributions to the field of quality and businesses that have successfully implemented exemplary systems that promote quality of goods and services. It was established in 1951 to honor W. Edwards Deming who contributed greatly to Japan’s proliferation of statistical quality control after World War II. His teachings helped Japan build its foundation by which the level of Japan’s product quality has been recognized as the highest in the world, was originally designed to reward Japanese companies for major advances in quality improvement. Over the years it has grown, under the guidance of the Japanese Union of Scientists and Engineers (JUSE) to where it is now also available to non-Japanese companies, albeit usually operating in Japan, and also to individuals recognized as having made major contributions to the advancement of qualit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] [Amazon] |
