Comparación ISO 9001:2008 vs ISO 9001:2015
Nuestros consultores han trabajado en prepararles un análisis de las diferencias entre las 2 normas.
Para descargarla: entren a http://www.symaconsulting.com/iso-90012015/
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Root Cause Analysis: nice article !
BySylvieHey, Ms. Auditee: Did Mickey Mouse Do Your Root Cause Analysis?: http://www.qualitydigest.com/inside/quality-insider-article/hello-mr-auditee-did-mickey-mouse-do-your-root-cause-analysis.html
New Guidance for PMCF – MDR
BySylvie4 new guidances related to Clinical investigation and evaluation were recently published on the commission website including a template for the PMCF, the guidance on sufficient clinical evidence for legacy devices and a guidance for equivalent devices ! https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
What are some best practices for Root Cause Analysis and Preventive Action?
BySylvieOur recommendation in terms of effective corrective and preventive action plans is to be very systematic in every step…. 1) First of a all VERY good definition of the defect…. If not defined correctly the action plan will not be effective. 2) Define corrections and containment actions. Make sure everybody understands the difference between those…
Is it mandatory for the Internal quality auditors to be certified by QMS certifying agency or in house training is good enough?
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FDIS ISO 13485:2016
BySylvieYa estamos estudiando el FDIS de la ISO 13485:2016. El borrador se encuentra http://www.iso.org/iso/fr/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 La publicación de la versión final está todavía programada en Marzo 2016. Quedense al pendiente de nuestro gap analysis ! Más información info@symaconsulting.com
ISO 13485:2015 to be published early 2016
BySylvieReference: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2011 A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it…