22-Feb-2019 Sunday Business Systems is proud to announce the latest release of the Quality Database (version 4.85). This new release is designed to improve the user experience by adding a dashboard of key performance indicators (KPI), configurable smart close feature, with performance enhancements and minor bug fixes. The SBS Quality Database is a simple, inexpensive ISO 9001 compliant program that allows small businesses to efficiency manage the Quality System. The database tracks corrective actions, preventive actions (CAPA), internal audit tracking, safety improvement, supplier corrective actions, continual improvement projects. Document QMS review meetings and results. Comply with ISO 9001:2015 using the risk management (FMEA) module. The latest release includes: New key performance monitoring Dashboard Add Classification to affected FMEA reports Implement … Continue reading SBS Quality Database Version 4.85 Released

22- Aug-2016    Sunday Business Systems, a leader in affordable and efficient software tools for quality management systems, is proud to announce the first successful audited deployment of the SBS QMS suite in support of ISO 9001:2015. The new ISO 9001:2015 standard has brought several important changes to QMS (Quality Management System) requirements.  In particular, eliminating preventive actions and emphasizing risk management has led to considerable consternation and controversy.  Sunday Business Systems software is uniquely designed to meet the new requirements of the 2015 standard. SBS consulting services were contracted to begin the process of implementing a fully compliant QMS at an electronics manufacturer in Northern California. The SBS QMS suite was deployed: Asset Tracking, Quality Database, Ground Control, and the … Continue reading SBS QMS Suite: First deployment for ISO 9001:2015

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

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

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

ISO 9001 defines the 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 (production/development/service). SBS Software tools help with efficient compliance to ISO 9001:2015. The Quality Database offers solutions for: Corrective actions Preventive Actions Nonconformance Management Audit Management Risk Analysis (FMEA) Customer perception measurement The Ground Control Database offers solutions for: Document Control Employee Training Management (also sold separately) The Asset Tracking Database offers solutions for: Calibration Control and recall Preventive Maintenance The Vendor Management Database offers solutions for: Approved Vendor’s List (AVL) Vendor Qualification and Management SBS QMS Software is sold as individual products or as a suite of tools … Continue reading ISO 9001:2015

ISO 14001:2015 sets out the criteria for an environmental management system. It maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization regardless of its activity or sector. The SBS Quality Database is ideal for documenting risk hazards, safety/environmental meetings, audit results, and corrective actions.  The Quality Database is a great software tool to establish and maintain ISO 14001 compliance. SBS Software tools help with efficient compliance to ISO 14001:2015:     SBS Product Key Features Quality Database · Manage corrective actions (CARs) · Safety and Supplier CARs (SCARs) · Manage preventive actions (PARs) · Document Safety Incidents · Define the EMS Context of … Continue reading ISO 14001