![]() There must not be a black hole within the value-added chain. ![]() The new standard specifies that it explicitly also applies to outsourced processes. However, a variety of small changes even affecting chapter structure makes it necessary to deal with this latest version of the standard intensely. First off: ISO 13485:2016 is an evolution of the previous versions having barely been altered since ISO13485:2003 – not a revolution.
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