ISO 9001:2015 vs. ISO 9001:2008
La norma ISO 9001 está evolucionando ! En 2015 se publicará la nueva versión de la norma, ya están preparados al cambio ?
Registrate a nuestro curso en Polanco DF: info@symaconsulting.com
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GMED designated under Regulation (EU) 2017/745 on medical devices
BySylvieGMED official publication on linkedin: GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency for Medicines and Health Products Safety (ANSM). Equipped with this designation since July 8 2020, GMED has mobilized its teams to offer manufacturers with certification services according to the Regulation…
Rework vs Repair
BySylvieRepair vs Rework A general rule applied by many in automotive is: Rework puts the part into the same condition that a first run good part would be. Repair puts the part into functional suitable condition, but it is apparent that some additional work was done. Rework Definition : Correcting of defective, failed, or non-conforming item,…
Medical Devices – Harmonized Standards MDD – New Listing
BySylvieIn March this year, a new list of harmonized standard was published, see the new list in this link: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/ You need to download the files now in order to see the list.
FDIS ISO 13485:2016
BySylvieYa 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
ISO14971: Gestión de Riesgos Dispositivos Medicos / Medical Devices Risk Management
BySylvieCurso Abierto – Cupo Limitado – Abril 2015 Mexico DF ! Contacta info@symaconsulting.com
Super Oferta Curso ISO14001
BySylvieNos quedan algunos lugares para nuestra capacitación del 3 de Abril “Introducción en la Norma ISO 14001, Sistemas de Gestión Ambiental”. Para este curso, tenemos actualmente un 30% de descuento en el curso de un día en Polanco, DF. Interesados comunicarse con Adriana Gutiérrez: info@symaconsulting.com o teléfono: 15556623.