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.
KEY FEATURES 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) Implement risk based thinking required by ISO 9001:2015 Easy to use Collaborative platform Simple, menu driven user interface Easy to train users Convenient, intuitive forms Can restrict users to control data integrity Rich set … Continue reading FMEA Database
KEY FEATURES Nonconformance Tracking Escalate a Nonconformance to a Corrective Action Corrective Actions (CA) 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 product reliability … Continue reading Q-Med Database
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