Talk:ISO 13485

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The majority of this page was copied verbatim from both the official ISO page and this website. I've removed those portions. — Hex (❝?!❞) 00:34, 5 November 2006 (UTC)

Info about the topic of System suitability test....[edit]

-- (talk) 03:23, 11 April 2010 (UTC)

The following info helps Ref 1.....[edit]

-- (talk) 02:17, 12 April 2010 (UTC)

info? from other page[edit]

HI all, I deleted that from Patient_management_software, as it has nothing to do there. Maybe somebody here wants to copy somethign over to the main article? "ISO 13485 is an international quality standard that focuses on process as opposed to product. The purpose of quality standards is to ensure that products being developed follow a known set of requirements within the organization to ensure safety and quality. The ISO 13485 standard is a derivative of the ISO 9001 standard. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to those devices and services. Besides an emphasis on meeting regulatory and customer requirements, ISO 13485 focuses on risk management and maintaining effective process on the safe design, manufacture and distribution of medical devices. It is expected that organizations and manufacturers that are ISO 13485 compliant should experience a reduction in the number of failures with their products. Some of the requirements of ISO 13485 obligate organizations to (a) maintain a set of key documents; (b) assign defined management responsibilities; (c) maintain a focus on quality, throughout the development of human and infrastructure resources, and; (d) utilize relevant communication processes, such as customer complaint procedures and advisory notices." Cheers

--MarmotteiNoZ 23:21, 28 February 2013 (UTC)


The first sentence of the 2nd paragraph is not actually quite clear. The point is that the standard itself, right at the beginning, Clause 0.1, says: "This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, AND the design, development, and provision of related services."

The point is that it says "AND" not "OR". Therefore to be eligible for 13485, an organisation must be designing and/or manufacturing medical devices (or subcontracting out the design or manufacture as outsourced processes). If an organisation were not doing (or subcontracting out) design or manufacture then it would not be eligible. So for example, a firm of consultants providing general advice on medical devices, but not explicitly offering design as a service, would not be eligible for 13485.

Maybe I'm wrong but that's my understanding. — Preceding unsigned comment added by (talk) 09:11, 30 January 2016 (UTC)