13-Oct-2016 SBS is proud to announce the release of version 4.45 of our Quality Database. This new release includes new SWOT Analysis features. 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 9001:2015 and ISO 13485 and complies with ISO 14971. Click here for free demo downloads.
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.
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 The first successful audited deployment of the SBS QMS suite in support of ISO 9001:2015
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
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
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