Root Cause Analysis: nice article !
Hey, 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
Cambios en Francia para la comercialización de dispositivos medicos estériles con uso para bebes, recién nacidos y prematuros. Con aplicación mandatoria en los 6 próximos meses ! Para más información info@symaconsulting.com y: ansm – ETO
Our 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…
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/
It is NOT mandatory. However, Section 6.2.2 requires the organization to a) Determine the necessary competence for personnel performing work affecting conformity to product requirements, b) Where applicable, provide training or take other actions to achieve the necessary competence, c) Evaluate the effectiveness of the actions taken, d) Ensure that its personnel are aware of…
4 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
English below Noticias de Regulaciones en Dispositivos Medicos: EU publica EN ISO 13485:2012 La norma europea, EN ISO 13485:2012 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, fue publicada después de su aprobación por la CEN el 24 de Enero de 2012. Esta norma reemplaza la EN ISO13485: 2003, aunque el texto global de la…