Design management is an area that is often overlooked; this can lead to waste and missed opportunities. BSI’s standards provide generic guidance on the management of a design function, whether that function is a design company, a design department within an organization, or a designer’s own project.
These standards include the BS 7000 and BS 7373 series, applicable to a variety of sectors for almost all products. BS 7000 and BS 7373 can be used by the medical product sector to develop their own design management standards. The BS 7000 series of standards addresses the issues surrounding design management from initial outset of the design of a product through to the end of its lifecycle and when it becomes obsolescent. In addition, BS 8888 provides the definitive set of requirements for technical product specifications. BS 8888 (and the associated BS ISOs on product specification) is a suite of standards on how a product, or part of a product, is specified for manufacture.
BS 8888:2006 is an authoritative standard that provides the definitive set of requirements for technical product specifications for any professional design engineer. It contains a wealth of information including normative and informative references that outline key criteria for best practice design work.
It provides designers, engineers, quality managers and metrologists with a set of requirements for the preparation of all forms of technical product documentation. The requirements are inter-linked substantially to international and European Standards, implemented as British Standards.
 BS EN ISO 14971:2007
Medical devices. Application of risk management to medical devices
|
BS EN 60601-1:2006
Medical electrical equipment, General requirements for basic safety and essential performance
|
|
|
BS 8887-1:2006
Design for manufacture, assembly, disassembly and end-of-life processing (MADE). General concepts, process and requirements |
BS 7000-6:2005
Design management systems. Managing inclusive design. Guide |
|
|
