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

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

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

SBS offers Cloud Based eQMS solutions: Virtual server with secure login 3 levels of security Ability to login from any Internet connected computer (Mac or PC) and run the SBS QMS Suite Access to the full SBS eQMS suite for an unlimited number of users The Quality Database or Q-Med Database corrective actions preventive actions risk management audit management nonconformance tracking meeting manager continual improvement project management Ground Control document control employee training management Asset Tracking database calibration control preventive maintenance Vendor Management vendor qualification File Storage (configurable) Secure data backups Seamless product upgrades eQMS: Electronic Quality Management System

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 product … 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 actions, … Continue reading Quality Database

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 Non-conformance 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