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In reference to ISO 9002, it was last revised in 1994 and was titled: Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. It was very applicable for contract manufacturing. Organizations now use ISO 9001 standard and take exception to certain clauses of the standard which involve the design of products and/or service. So there is no longer a need for ISO9002:1994.
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Recently published was ISO/TS 9002:2016 Quality management systems -- Guidelines for the application of ISO 9001:2015. Originally to have been published simultaneously with the revised ISO 9001 Standard in September 2015, there has been a delay and publication eventually happened in late 2016.
ISO 9002:2016 helps give insight into what the developers of ISO 9001:2015 had in mind when preparing the revised Standard. And the lack of specificity, for which ISO 9001:2015 has so often been criticised, is no longer such a problem.
ISO/TS 9002:2016 runs to 57 pages of guidance such as this. We like this ISO 9001 Certification aid very much. While its content cannot be considered to constitute requirements, and it is just one of a number of guidance documents, it gives example after example of what constitutes adequate objective evidence of compliance, clause-by-clause. It is an invaluable companion to ISO 9001:2016.
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Steps in ISO 9000 Registration1. Selection of appropriate standard from ISO 9001, ISO 9002 and ISO 9003 using the guidelines given in ISO 9000.2. Preparation of quality manual to cover all the elements in the selected model.3. Preparation of procedures and shop floor instructions which are used at the time of implementing the system. Also document these items.4. Self-auditing to check compliance of the selected model.5. Selection of a registrar and making application to obtain certificate for the selected model.
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service.[1] ISO 9000 deals with the fundamentals of QMS,[2] including the seven quality management principles that underlie the family of standards.[2][3][4] ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.[5] ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test.[6] ISO 9004 gives guidance on achieving sustained organizational success.[7]
The global adoption of ISO 9001 may be attributable to several factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations, such as contractors and design activities, as the basis of contractual arrangements with their suppliers. This helped reduce the need for subcontract supplier quality development by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending on the complexity of the product, business type (design responsibility, manufacture only, distribution, servicing, etc.), and risk to the procurer. If a chosen supplier was weak in the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. Adopting a single quality assurance requirement also leads to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.
ISO 9001:2000 replaced all three former standards of 1994 issues, ISO 9001, ISO 9002, and ISO 9003. Design and development procedures were required only if a company does, in fact, engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and center the concept of process management (the monitoring and optimization of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.
Dytz argues that ISO 9001 certification is based on 7 management principles and that companies are free to develop their internal tools and working methods, however, the model adopted to audit and certify companies does not evaluate the effectiveness of these methods. Even when there is still a superficial analysis of this effectiveness, mainly due to the time available to audit these companies, the certifications do not distinguish two companies with the same business model, with regard to their internal capacity and quality of management.[61]
Download free management system templates for a range of standards including ISO 9001 quality, ISO 14001 environmental, ISO 13485 medical device quality, ISO 45001 health and safety, ISO 22000 food safety, AS9100D aerospace quality, and IATF 16949 automotive quality to give a head start...
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ISO/TS 9002:2016 provides guidance on the intent of the requirements in ISO 9001:2015, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements.
Patients with a histologically confirmed locally advanced/ advanced stage solid malignancy at any site, weight loss of at least 5% in 12 months or body mass index (BMI) < 20 kg/m2, and were contained 3 of the following; which were deceased muscle strength, fatigue, anorexia, low fat-free muscle index, and abnormal biochemistry (increased inflammatory markers; CRP or IL-6, Anemia; Hb
Curcumin and placebo were provided from THAI HERBAL PRODUCTS CO., LTD in 400 mg per caplet form. Each capsule was contained 240 mg of curcuminoids. The corn starch was ingredient in placebo capsule. The Good Manufacturing Practice (GMP) and quality control standards by mean of International Organization for Standardization (ISO) 9002 were used for all products. 153554b96e
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