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BSI: British Standards Institution

BSI, the British Standards Institution, is a nonprofit organization that develops and publishes standards that oversee virtually every aspect of modern society. Headquartered in London, United Kingdom, BSI is the United Kingdom's national standards organization and its representative in the European CEN and the international ISO and IEC. The pioneer of standards for management systems, BSI is now the world's largest certification body. Standards from BSI are available both individually, directly through the ANSI webstore, and as part of a Standards Subscription. If you or your organization are interested in easy, managed, online access to standards that can be shared, a Standards Subscription may be what you need - please contact us at: [email protected] or 1-212-642-4980 or Request Proposal Price.

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BS 7671:2018

Requirements for Electrical Installations. IET Wiring Regulations (British Standard)

At around 500 pages long, BS 7671 Wiring Regulations is the UK’s main electrical safety standard. This must have document sets out requirements that detail how to perform electrical installations safely. First published in 1882, the 2018 version is the 18th edition of what in the Electrical sector is known as “the Regs.”





BS EN ISO 14971:2019

Medical devices. Application of risk management to medical devices (British Standard)

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.  The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.  The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.  This document does not apply to:  — decisions on the use of a medical device in the context of any particular clinical procedure; or  — business risk management.  This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.  Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.  NOTE Guidance on the application of this document can be found in ISO/TR 24971. 




BS ISO 45001 / ISO 9001 / ISO 14001 - Occupational Health and Safety Requirements Package

BS ISO 45001 / ISO 9001 / ISO 14001 - Occupational Health and Safety Requirements Package

BS ISO 45001 / ISO 9001 / ISO 14001 - Occupational Health and Safety Requirements Package provides the requirements to implement an environmental, quality and occupational health management system. This package enables BS ISO 45001 to be easily integrated into an existing environmental or quality management system while also providing the foundation to implement a new management system. BS ISO 45001 / ISO 9001 / ISO 14001 - Occupational Health and Safety Requirements Package includes:

 
     
  • BS ISO 45001:2018
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  • ISO 9001:2015
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  • ISO 14001:2015
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  • Improving Worker Safety in Global Supply Chains - (Value Added Content)
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  • ISO 9001:2015 and Beyond - (Value Added Content)
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  • ISO 9001:2015 for Small Enterprises - What to do? - (Value Added Content)
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  • ISO 14001:2015 - Environmental Management Systems - A Practical Guide for SMEs - (Value Added Content)

BS EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices (British Standard)

This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.


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