A philosophy of production that emphasizes the minimization of the amount of all the resources (including time) used in the various activities of the enterprise. It involves identifying and eliminating non-value-adding activities in design, production, supply chain management, and dealing with the customers. Lean producers employ teams of multi-skilled workers at all levels of the organization and use highly flexible, increasingly automated machines to produce volumes of products in potentially enormous variety. It contains a set of principles and practices to reduce cost through the relentless removal of waste and through the simplification of all manufacturing and support processes. (Source: http://www.apics.org/)
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November 23rd, 2013
ISO 9001:2015
Unlike ISO 9001:2008 revision which was primarily semantic changes, the 2015 revision seems to include some major changes similar to transition from 1994 to 2000 edition. The release of the new 2015 standard probably will not happen until later 2015 or early 2016, but it is worth while to take a look at the proposed …
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November 1st, 2013
Health Canada, Medical Device Single Audit Program (MDSAP)
Starting January 2014 Health Canada will be participating in a pilot program by launching the Medical Device Single Audit Program (MDSAP)together with the Australian Therapeutic Goods Administration of Australia (TGA), the Brazilian Nacional de vigilancia sanitaria (ANVISA) and United States Food and Drug Administration (FDA). This program is intended to provide similar assessment system as …
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October 19th, 2011
What’s new in Health Canada Regulations
Health Canada has made substantial changes to Medical Device Regulations and supporting guidance documents that should be considered by organizations that are involved with medical devices in form of Medical Device Establishment License (MDEL) or Medical Device License (MDL). These changes include: – September 21, 2011 – Medical Device Regulations MDR – October 3, 2011 …
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November 23rd, 2013
ISO 9001:2015
Recent Posts
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November 23, 2013
ISO 9001:2015
Unlike ISO 9001:2008 revision which was primarily semantic changes,... more » -
November 1, 2013
Health Canada, Medical Device Single Audit Program (MDSAP)
Starting January 2014 Health Canada will be participating in... more » -
October 19, 2011
What’s new in Health Canada Regulations
Health Canada has made substantial changes to Medical Device... more »
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November 23, 2013