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    Company NewsNews > Company News > BQC Conducted The Annual Review Of ISO13485/14001 From June 17 To June 19    

    BQC Conducted The Annual Review Of ISO13485/14001 From June 17 To June 19

    Hits:1  Add Date:2022/6/25

    The full name of ISO14001 certification is ISO14001 environmental management system certification, which refers to the conformity assessment activities implemented by a third-party certification body according to ISO14001 standards.

    ISO14001 certification is applicable to any organization, including enterprises, institutions and relevant government units. After passing the certification, it can be proved that the organization has reached the international level in environmental management, can ensure that the control of various pollutants in various processes, products and activities of the enterprise meets the relevant requirements, and help the enterprise establish a good social image.

    ISO14000 series standards are conducive to improving the environmental awareness of the whole nation and establishing the idea of sustainable development; It is conducive to improving people's awareness of law-abiding and the implementation of environmental laws and regulations; It is conducive to mobilizing the initiative of enterprises to prevent and control environmental pollution, and promoting enterprises to continuously improve environmental management; It is conducive to promoting the conservation of resources and energy and realizing their rational utilization; It is conducive to the realization of bilateral and multilateral environmental certification among countries and the elimination of technical barriers to trade.

    The full name of ISO13485:2003 standard is medical device quality management system requirements for regulation, which clearly means the quality management system requirements for regulations. In the world, medical devices are not only general listed commodities operating in the business environment, but also subject to the supervision and management of national and regional laws and regulations, such as the FDA of the United States, the MDD of the European Union (EU medical device directive), and China's medical device regulation. Therefore, the standard must be subject to legal constraints and operate in a regulatory environment. At the same time, it must fully consider the risks of medical devices and require risk management in the whole process of the realization of medical devices. This standard is applicable to the design, development, production, installation and service of medical devices or the design, development and provision of related services. The medical device defined in the standard refers to the instrument, equipment, appliance, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related articles that the manufacturer's intended use is for human use for one or more of the following specific purposes, whether used alone or in combination.

    BQC conducted the annual review of iso13485/14001 from June 17 to June 19.

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