KEY FEATURES FMEA = Failure Modes and Effects Analysis Risk Assessment: Failure Modes and Effects Analysis (FMEA) Implement risk based strategies for ISO 9001:2015, ISO 14971 Identify failure modes for each process or item Identify effects and severity Identify causes and frequency Identify current controls and detection levels Develop multiple actions associated with this failure mode Assign owners and due dates Establish verification and validation criteria Electronic signature for management approval User login: define user passwords and privileges Rich set of reports Track open actions and delinquent due dates ADVANTAGES Build a simple and efficient Quality Management System (QMS) Install on your local server or leverage our Cloud QMS solution Implement risk based thinking required by ISO 9001:2015 Easy to … Continue reading FMEA Database

The SBS Quality Database has been upgraded to better meet the requirements of  ISO 9001:2015.  In addition to the existing features like Corrective Actions, Non-conformance Management, Audit management, etc. we have added a module for Risk Management. Changes to Address Risk and Opportunities The 2015 version of the standard requires the organization promote the use of the risk-based thinking and to determine the risks and opportunities when planning the Quality Management System (QMS).  To help ensure good customer satisfaction, the organization must address the risks and opportunities that can affect product or service conformity.  The organization must then take actions to address the risks and opportunities and ensure these actions are proportionate to the potential impact.  Finally, the organization must … Continue reading The SBS Quality Database for ISO 9001:2015