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 […]

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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 […]

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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….. […]

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It is NOT mandatory. However, Section 6.2.2 requires the organization to a) Determine the necessary competence for personnel performing work affecting conformity to product requirements, b) Where applicable, provide training or take other actions to achieve the necessary competence, c) Evaluate the effectiveness of the actions taken, d) Ensure that its personnel are aware of […]

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Watch your thoughts; they become words. Watch your words; they become actions. Watch your actions; they become habits. Watch your habits; they become character. Watch your character; it becomes your destiny.  

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