22-Sep-2016 SBS is proud to announce the release of version 1.10 of our FMEA Database. This new release includes a new user interface that improves the look and feel of the software. The release also includes new SWOT Analysis. SWOT Analysis analyzes a business’s Strengths, Weaknesses, Opportunities, and Threats, making it ideal for the new requirements of ISO 9001:2015. With FMEA (Failure modes Effects Analysis) used for process/product level risk analysis and SWOT analysis used for business opportunity analysis or competitive analysis, a company can easily demonstrate compliance to the risk management requirements of ISO 9001 and 13485. See our website for free demo downloads.
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 Nonconformance Tracking Corrective Actions (CA) Preventive Actions (PA) Audit management Risk Management – FMEA and SWOT Analysis Meeting management Project management Customer satisfaction surveys CFR21 part 11 compliant security, activity logs, audit trails User login: define user passwords and privileges BENEFITS Complies with requirements of ISO 13485 21 CFR Part 820 ISO 9001:2015 AS9100 ISO/TS 16949 API Q1 Provides a concise, electronic record of historical events, actions, and improvement Efficiently maintains quality records Improve product reliability and process performance Improve Customer Satisfaction Efficient and cost effective Simple Reports and analysis
27-Mar-2017 – SBS releases version 4.56 of our Quality Database. This new release includes a new CAR prompt to update Risk Analysis components for ISO 9001:2015 compliance, a new global action report, and minor bug fixes. 23-Jan-2017 – SBS is proud to announce the latest release of the Vendor Management Database. Version 1.13 has significantly improved user interface, new reports and minor bug fixes. 18-Dec-2016 – SBS is proud to announce the latest release of SBS Ground Control. Version 1.36 has significantly optimized and improved report formats for simplicity and readability. 13-Dec-2016 – SBS is proud to announce the latest release of SBS Training Database. Version 3.26 has significantly optimized and improved report formats for simplicity and readability. 13-Oct-2016 – … Continue reading New Product Releases
SBS offers Cloud Based eQMS solutions: Virtual server with secure login 3 levels of security Ability to login from any Internet connected computer (Mac or PC) and run the SBS QMS Suite Access to the full SBS eQMS suite for an unlimited number of users The Quality Database or Q-Med Database corrective actions preventive actions risk management audit management nonconformance tracking meeting manager continual improvement project management Ground Control document control employee training management Asset Tracking database calibration control preventive maintenance Vendor Management vendor qualification File Storage (configurable) Secure data backups Seamless product upgrades eQMS: Electronic Quality Management System
KEY FEATURES Nonconformance Tracking and Analysis Closed loop Corrective Actions with Validation and Verification Audit Management Risk Management (FMEA and SWOT Analysis) Continual Improvement Projects Preventive Actions Meeting Manager Customer Satisfaction Surveys Rich set of reports and analysis tools for each module BENEFITS Build a simple and efficient Quality Management System (QMS / eQMS) Customer satisfaction Quickly and effectively respond to customer complaints Rebuild customer confidence when things go wrong Monitor Customer Perceptions and take action to improve Efficient and cost effective Simple, low cost solution Saves time and improves efficiency Answers are a click away Quality effectiveness Analyze graphs, charts, and reports on demand Report corrective and preventive action (CAPA) performance metrics List open CAPA with pending actions, owners, … Continue reading Quality Database