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/
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…
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…
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…
When 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…
La 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….
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…