• ISO13485 audit requirement

    Simple Guide for ISO13485 Auditing

    This document provides simple guidance and details you would need to set up your internal auditing process to comply with the ISO13485 standard and FDA regulations. You can contact us to get a word document of this procedure and the related forms.     1.0 Purpose: This procedure describes

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  • CAPA

    Simple Guide for Corrective and Preventative Action (CAPA)

    The following section describes a sample SOP (standard operating procedure) for corrective and preventive actions (CAPA) when using the Qualcy EQMS solution. Please contact us to get a Microsoft word file for this SOP and Referenced CAPA form and CAPA Risk Assessment Form. 1. Background This procedu

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