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
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…
Sterilization process is critical in the Medical Device industry…. I do not know what industry you are working in, but if you are selling sterilized products then the sterilization process is actually an outsourcing of your organization’s manufacturing. Now how often do you internally audit your own manufacturing process ? At least once per year……..
While the world is fighting against the virus, company fighting about economical crisis, certificates are still expiring and notified bodies and auditing organizations have to look for new ways to work. Our partner GMED NA, has put in place exceptional provisions for certification audits impacted by this health crisis. Depending on the type of audit,…
Ya se publico la nueva norma ISO 13485:2016 !!! http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 Pregunta por nuestro curso ! info@symaconsulting.com
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…
Ya 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