Risky Business – Demystifying EN ISO 14971:2012


The ASQ Biomedical Division asked me to write this article for the Biofeedback newsletter. 

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State of the Art

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net ISO 13485 requires the control of "documents of external origin" such as regulations, standards and guidelines that impact the quality management system (QMS). Changes to these external documents must be identified and appropriate actions taken to maintain "state of the art" medical devices. For example, Essential Requirement 2 of the European Medical Device Directive states: "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art." Keeping up to date with evolving international regulations, standards and guidelines is always a challenge. It is one thing to become aware of revised documents; it is something else to determine the impact of the revisions on your QMS and devices. Regulations, Standards, Guidan...
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ISO 13485:2016 Quality System Process Risk Management

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I SO 13485:2016 has a broader view of risk management than in the past. Risks are to be considered in terms of the impact on medical device safety and performance, and in terms of meeting regulatory requirements. For managing quality system process risks, rather than adding a Risk section to each Standard Operating Procedure (SOP) as some have suggested, I added a new section to my Quality Manual to address risks for each quality system process, i.e. each SOP. The front end of my new Quality Manual risk section is shown below.  A row is included in the table for each SOP. Since my Quality Manual already lists the SOPs, this makes sense to me. And by having all of the risk assessment and control information in this single document, it seems easier to manage than sprinkling risk assessment/control info into each SOP.  Sam Lazzara Resume LinkedIn Profile Documents Services
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(EN) ISO 13485:2016 Medical Device QMS Standard

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Put ISO 13485:2016 in your rear-view mirror We been waiting over a decade for this. It's not that often that I get excited about something, but this one has me standing at attention. My life's work revolves around developing hopefully-lean Quality Management Systems, mostly for small organizations. And now I have a new challenge... What fun you will have refining your QMS to align with the tweaked elements of the updated standard. After you compare and contrast the 2003 version with the 2016 version your upset stomach may resolve itself --- you may find that you already conform with some if not most of the revised requirements. As a simple first step, let's compare the numbering and titles for the requirements clauses. ISO 13485:2003, EN I SO 13485:2012 ISO 13485:2016, EN ISO 13485:2016 4 Quality management system 4.1 General requirements 4 Quality management system 4.1 General requirements 4.2 Documentation requirement...
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