ISO 9000

CLAUSES OF ISO 9000:2008 Section 1.1 General • Again, “regulatory” has been changed to “statutory and regulatory.” a) Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. • Note 1 has been expanded, and a Note 2 has been added: Note 1 in this International Standard, the term “product” only applies to a) product intended for, or required by, a customer, b) Any intended output resulting from the product realization process. Note 2 Statutory and regulatory requirements can be expressed as legal requirements. Section 1.2 Applications • Again, “regulatory” has been changed to “statutory and regulatory.” Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization’s ability, or responsibility to provide product that meets customer and applicable statutory and regulatory requirements. Section 2 Normative References • ISO 9000:2000 has been changed to ISO 9000:2005, Quality Management Systems – Fundamentals and vocabulary. Section 3 Terms and Definitions • Explanation of the terms…

inspection from the customer to the supplier. At this time supplier were using 3rd party inspectors to guarantee products to customers and no inspections were being done in house. Finally, in 1979 the BSI organized meetings with industries to set common standards of quality assurance. Key industries agreed to drop their own standards and instead follow only the one set by the BSI. This helped to demonstrated that Industrial production was more controlled and reliable. (Bureau, 2016 ) Though…

identify problems that are causing unnecessary deaths to patients. This quality-improvement research tool will eliminate errors and save lives. Crago, M. G. (2002). Partnering to improve process management. Click (1532-0391), p. 8-14. Crago details the use of International Standards Organization (ISO) 9000 standards as the key to improving health care quality. In the early 2000s, the Institute of Medicine revealed medical errors placed U.S. hospitals between 5th and 9th leading cause of…

National Quality Award originally for US companies excelling in quality management and quality of achievement to education settings (Arcaro,1995) . The award criteria are based on core values and concepts of customer focus-driven quality,Leadership, continuous improvement, total participation, fast response, design quality and prevention, Long-range outlook, management by fact, partnership development, and community responsibility. Although Malcolm Baldrige model is slightly different from…

in this situation, may exhibit fewer budget imbalances than one with many divisions (Ray & Goldmanis, 2008). Evidently, each division from NMC acts as a profit center and therefore the goal is to maximize the profit for each of their division. It is a challenge for both divisional managers from Classic and New Wave to obtain goal congruence through management by objectives (MBO) (Hilton & Platt, 2014). Both of the divisions need to participate in setting goals that are expressed in financial or…

Diving into what makes a smaller company successful over years with consistency and with a lean mentality shows a stark difference. First, the pieces are made by the order. The process is done using an assembly line type method with one piece per section. Instead of quality control Total quality management or TQM is assuring quality at every step. Each section is fully equipped so it is not moved around. Everything not made in house is from a supplier which is suited just for them to improve…

Critical Review of the Personal Software Process Mihika Shah, Arizona State University Quality management is a very important part of software organizations, and it is imperative to produce good quality products. In order to do that, it is necessary for every individual involved in the team to do superior quality work. The Personal Software Process provides guidelines that would provide an engineer with a disciplined approach to solve problems, and complete products which are of high…

Furthermore, ISO 9000 helps organizations maintain an equal balance of fulfilling customer and stakeholders’ needs and producing different products without violating laws or regulations. This term is a quality management standard that ensures organizational procedures adhere to customer and regulatory requirements (Gray, Anand & Roth, 2014). Currently, organizations have the opportunity to acquire ISO 9000 certification to guarantee to customers and shareholders that they are consistently…

resources It’s said that the employees are a company’s most appreciated resource. In the standard, it is believed that the employees must be catered for in order to produce the quality the organisation desires. The standard states: The ISO 9001:2008 standard requires that personnel performing work affecting product quality must be competent, based on their education, training, skills and previous experience (Iso-9001-checklist.co.uk, 2012) It is essential that human resources are kept…

Currently, IT industry is going through a revolutionizing change. Competing market emphasizes us more on first time right delivery and zero delayed delivery. Also, the industry has changed a lot the way it operates or the technology it adapts. Now the question put forth is can the technology or the mode of operations help us to achieve the two goals stated above? Earlier people used to pedal a bicycle to reach their destination. At that point of time the problem was to reach a place with…