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
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
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
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,…
You can certainly have an internal auditor auditing a process without need of technical support, BUT in some cases your auditors may need support of technical experts. See ISO 19011:2002 Guidelines for Quality Management System auditing 3.10 Definition of Technical Expert: person who provides specific knowledge or expertise to the audit team. We often see…
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…