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/
Similar Posts
ISO 9001:2008, Clause 8.3 “Control of nonconforming product”
BySylvieWhen one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from specified product requirements, it fails to conform. Nonconforming products must be identified and controlled to prevent unintended use or delivery. Nonconforming product is defined as product that does not…
COVID-19
BySylvieWhile 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,…
Gestión de Riesgos ISO 9001 ISO 31000
BySylvieLa ISO 9001, en su próxima versión del 2015, nos exigirá una gestión de riesgos. Una de las metodologías a aplicar puede ser ISO 31000. Se trata de una norma que establece los principios para diseñar, implementar y mantener una gestión de riesgos sistemática y transparente de cualquier forma de riesgo y en cualquier contexto….
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…
Ya está la nueva ISO13485:2016 !!!
BySylvieYa 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
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