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
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…
Reference: 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…
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…
Medical Devices Regulation postponed by a year in the EU. “With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by…
El curso de “Interpretación de la norma y Auditores Internos ISO/TS 16949” se llevará a cabo la semana del 16 de Noviembre en la Ciudad de México, D.F. Si deseas inscribirte puede hacerlo a través de este link http://goo.gl/forms/QAgQQzDOKf
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/