The Q-Med Database is an ISO 13485 compliant database to efficiently manage corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Document QMS review meetings and results. Cloud based or locally installed options are available. The Q-Med Database is ideal for small businesses striving for ISO 13485 compliance.
The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Define context of the organization and risks and opportunities for interested parties. Manage Environmental Health and Safety Issues with a safety incident tracker and job hazard assessment. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001, API Q1, AS9100, or ISO/TS 16949 compliance. Free demo downloads are available from our website so you may try before your buy.
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
KEY FEATURES Non-conformance Tracking and Analysis Corrective Actions Supplier Corrective Actions (SCAR) Safety Corrective Actions Preventive Actions Risk Management – FMEA and SWOT Analysis Internal audits Document Management Review Meetings Customer Satisfaction Surveys Email reports directly to employees Define user passwords and privileges BENEFITS A vital software tool to ensure ISO 9001:2015, AS9100, ISO/TS 16949, API Q1 compliance Improve Customer satisfaction Build a simple and efficient Quality Management System (QMS) Paperless QMS Efficient and cost effective
Risk is the possibility of events or activities impeding the achievement of an organization’s strategic and operational objectives. With ISO 9001:2015, the organization must consider the risks and opportunities in optimizing the Quality Management System (QMS) SBS offers several tools to implements Risk assessment in QMS: –The SBS FMEA database A stand-alone tool for analyzing processes or items for failure mechanisms and implementing actions to improve the process and reduce overall risk –The SBS Quality Database Containing tools for Failure Modes and Effects Analysis (FMEA), SWOT analysis, and Preventive Actions. –The Q-Med Database Containing tools for Failure Modes and Effects Analysis (FMEA), SWOT analysis, and Preventive Actions. Ideal for FDA regulated industries
SBS offers Cloud Based Quality Management Systems (QMS) solutions accessible from any internet enabled device
ISO 9001 (Quality management systems — Requirements) 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 … Continue reading ISO 9001:2015
