This report details how Sunday Business Systems software can be used effectively and efficiently to meet the rigorous requirements of ISO 9001:2015. Key sections of the ISO 9001 specification are broken out and overlaid or matched to our products key features. From this report, you can see how well our eQMS products serve ISO 9001 compliance. Download the full report by clicking here.
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.
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
SBS Consulting SBS provides consulting services including: ISO 9001:2015 implementation gap analysis eQMS Software implementation Spec writing Risk analysis Process mapping final implementation Registration audit management with follow-up actions Quality Management System design and implementation Document Control Employee Training CAPA Risk Analysis Internal Audits Vendor management and more Custom Database implementation Database integration Contact us for more information at firstname.lastname@example.org
Corrective and Preventive Actions Follow an 8D problem solving process to fix problems (corrective actions) so they never happen again. Reduce the risk of future problems (preventive actions) by asking “what can go wrong?” and fixing the issue before it harms the organization. Rick set of reports to track and analyze performance drive actions to completion trend CARs and associated cost CAPA (Corrective And Preventive Actions) modules are available in both the SBS Q-Med Database and the SBS Quality Database: The SBS Q-Med Database is ideal for FDA regulated industries (Medical Device, Pharmaceuticals) The SBS Quality Database is designed for Manufacturing, Aerospace, Service and other industries. Click here for a full list of features and a detailed comparison of the … Continue reading Corrective And Preventive Actions
KEY FEATURES Nonconformance Tracking Escalate a Nonconformance to a Corrective Action Corrective Actions (CAPA) Safety, Supplier, Internal Audit CARs With Validation and Verification Approvals require electronic signatures Preventive Actions (PA) Audit management Record audit findings Manage Audit Schedules Escalate to a Corrective Action or Preventive Action Meeting management Project management Customer satisfaction surveys CFR21 part 11 compliant security, activity logs, audit trails BENEFITS Complies with requirements of ISO 13485, 21 CFR Part 820, ISO 14971 ISO 9001:2015 AS9100 ISO/TS 16949 Provides a concise, electronic record of historical events, actions, and improvement No paper to get lost Efficiently maintains quality records Internal audits Corrective Action results Preventive Action results Management review or MRB meetings Nonconformances Customer satisfaction surveys Improve … Continue reading Q-Med Database
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 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 … Continue reading Quality Database