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1 CE Certificate EN CE marking (originally EC mark) is a mandatory conformity mark for products placed on the market in the European Economic. . Area (EEA). With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives. The letters "CE" stand for "Conformité Européenne" ("European Conformity").

Legally, the CE marking is no quality mark. But depending on the applicable directive the CE marking factually can be considered to be a quality mark. Deviating from sectoral directives regulating other industrial goods, medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC, according to which medical devices have to be not only safe but also function in a medical-technical way as described in the manufacturer's "intended purpose". Compliance with these requirements is proved within a certified quality management system according to EN ISO 13485.
2 ISO 14001:2004 ISO ISO 14001:2004 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to establish, implement, maintain and improve an environmental management system, to assure itself of conformity with its stated environmental policy, and to demonstrate conformity with ISO 14001:2004 by a) making a self-determination and self-declaration, or b) seeking confirmation of its conformance by parties having an interest in the organization, such as customers, or c) seeking confirmation of its self-declaration by a party external to the organization, or d) seeking certification/registration of its environmental management system by an external organization. All the requirements in ISO 14001:2004 are intended to be incorporated into any environmental management system. The extent of the application will depend on factors such as the environmental policy of the organization, the nature of its activities, products and services and the location where and the conditions in which it functions.
3 ISO 14004:2004 ISO ISO 14004:2004 provides guidance on the establishment, implementation, maintenance and improvement of an environmental management system and its coordination with other management systems. The guidelines in ISO 14004:2004 are applicable to any organization, regardless of its size, type, location or level of maturity. While the guidelines in ISO 14004:2004 are consistent with the ISO 14001:2004 environmental management system model, they are not intended to provide interpretations of the requirements of ISO 14001:2004.
4 ISO 17799:2005 ISO ISO/IEC 17799:2005 establishes guidelines and general principles for initiating, implementing, maintaining, and improving information security management in an organization. The objectives outlined provide general guidance on the commonly accepted goals of information security management. ISO/IEC 17799:2005 contains best practices of control objectives and controls in the following areas of information security management: -organization of information security; -asset management; -human resources security; -physical and environmental security; -communications and operations management; access control; -information systems acquisition, development and maintenance; The control objectives and controls in ISO/IEC 17799:2005 are intended to be implemented to meet the requirements identified by a risk assessment. ISO/IEC 17799:2005 is intended as a common basis and practical guideline for developing organizational security standards and effective security management practices, and to help build confidence in inter-organizational activities.
5 ISO 9000:1987 ISO ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization. ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management - which was likely the actual intent.
6 ISO 9000:1994 ISO ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system. Differences between ISO 9000:1994 and ISO 9001:2000: The ISO 9001:2000 series was created after extensive consultation with users. It is simpler, more flexible for organisations to adopt and embraces the use of Plan-Do-Check-Act principles and Process Management. The single most significant change to ISO 9001 is the movement away from a procedurally based approach to management (stating how you control your activities) to a process based approach (which is more about what you do). This shift enables organisations to link business objectives with business effectiveness more directly. The revitalised standard focuses not only on the familiar clauses of the ISO 9000 series, but extends them to view the organisation as a series of interacting processes - the very processes which produce the products and services customers buy.
7 ISO 9001:2000 ISO ISO 9001:2000 specifies requirements for a quality management system where an organization

1.needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
2.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 regulatory requirements.
8 ISO 9001:2008 ISO ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. The rules are updated, as the requirements motivate changes over time. Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000 family) include: a) a set of procedures that cover all key processes in the business; b) monitoring processes to ensure they are effective; c) keeping adequate records; d) checking output for defects, with appropriate and corrective action where necessary; e) regularly reviewing individual processes and the quality system itself for effectiveness;
9 ISO 9004:2009 ISO ISO 9004:2009, Managing for the sustained success of an organization - A quality management approach, is the third edition of the standard first published in 1987. It is intended to support the achievement of sustained success by any organization, regardless of size, type or activity, by a quality management approach.
10 ISO/IEC 17025:2005 ISO ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.

ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
11 ISO/TS 16949:2002 ISO The ISO/TS16949 is an international standard aiming to the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. TS16949 applies to the design/development, production and, when relevant, installation and servicing of automotive-related products. It is based on ISO9001. The requirements are intended to be applied throughout the supply chain. For the first time vehicle assembly plants will be encouraged to seek ISO/TS16949 certification.
12 ISO/TS 16949:2009 ISO ISO/TS 16949:2009, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. ISO/TS 16949:2009 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to ISO/TS 16949:2009. ISO/TS 16949:2009 can be applied throughout the automotive supply chain
13 OHSAS 18001 OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks. It was devloped in response to widespread demand for a recognized standard against which to be certified and assessed.
14 QS-9000 AIAG QS9000 is a quality standard developed by a joint effort of the "Big Three" automakers, General Motors, Chrysler and Ford. It was introduced to the industry in 1994. It has been adopted by several heavy truck manufacturers in the U.S. as well. Essentially all suppliers to the automotive industry need to implement a QS9000 system. The standard is divided into three sections with the first section being ISO 9001 plus some automotive requirements.
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