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

Sunday Business Systems offers two very similar products for different levels of compliance.  The SBS Quality Database and the SBS Q-Med Database both offer solutions for Corrective and Preventive Actions (CAPA), Non-conformance management, audit management, etc. (refer to the Feature Comparison Table. The Quality Database was designed for basic compliance where there are less rigorous requirements.  The database is an excellent source of objective evidence that, for instance, corrective actions were completed and they were effective.  The recorded data is sufficient to show the results and efficacy of the Corrective action program. The SBS Q-Med Database was designed for rigorous compliance to FDA standards (21 CFR Part 820 and ISO 13485) with CFR21 Part 11 compliant electronic records and electronic … Continue reading Tech Note: SBS Quality Database and Q-Med Compared

ISO 9001 defines the required elements of an effective Quality Management System (QMS).  A QMS is a set of policies, processes, and procedures required for an organization to plan and execute it’s business (manufacturing, design/development, or service provider). SBS Quality Management software is a valuable tool to help companies comply with the ISO 9001 standard. The Quality Database offers solutions for: The Ground Control Database offers solutions for: The Asset Tracking Database offers solutions for: The Vendor Management Database offers solutions for: The SBS Inspection Database offers solutions for: SBS QMS Software is sold as individual products or as a suite of tools with options for concurrent user licensing.  Our software may be install locally or deployed on our cloud … Continue reading ISO 9001:2015