The SBS QMS Suite is a system of 5 modules working together to provide a comprehensive quality compliance solution

  KEY FEATURES   Nonconformance Tracking and Analysis Closed loop Corrective Actions with Validation and Verification (CAPA) Audit Management Risk Management (FMEA and SWOT Analysis) Continual Improvement Projects Preventive Actions QMS Tools:  Context of the Organization, Interested Parties, QMS Scope Meeting Manager Customer Satisfaction Surveys Environmental Health and Safety (EHS / HSE) management email reminders for open CARs, open actions, etc. Rich set of reports and analysis tools for each module Locally installed or Cloud-based solutions available BENEFITS Build a simple and efficient Quality Management System (QMS) Improve 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 … Continue reading Quality Database

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

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

Q-MED 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

02-May-2018 – SBS is proud to announce the release of version 4.73 of our Quality Database. This new release is designed to improve the user experience by adding automatic tracking number configuration with configurable prefixes, several new Nonconformance reports and report improvements. It also includes performance enhancements and minor bug fixes. 17-Aug-2017 – SBS is proud to announce the release of version 4.57 of our Quality Database. This new release is designed to improve the user experience by adding new buttons to show key forms in datasheet view. It also included performance enhancements and minor bug fixes. 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 … Continue reading New Product Release Summary

SBS offers Cloud Based Quality Management Systems (QMS) solutions accessible from any internet enabled device