Sam Lazzara Method for ISO 13485:2016 Quality System Design

Risk management is the air we breath...

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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 14971:2012 Impact Assessment

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Link to Sam Lazzara's EN ISO 14971:2012 Flow Chart  Still trying to figure out what to do about EN ISO 14971:2012? The ASQ Biomedical Division just published an article I wrote called Risky Business - Demystifying EN ISO 14971:2012 . To view the article, go here . Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net Summary EN ISO 14971:2012 became a European harmonized standard on August 30, 2012. The normative content is still in accordance with ISO 14791:2007. However, the relationship between ISO 14971 and the European Directives has changed as described in Annex ZA, ZB and ZC. Compliance with the normative clauses in ISO 14971 does not ensure conformity with the Essential Requirements (ERs) of the Directives. The Z Annexes list “content deviations” between ISO 14...
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