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

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable FDA regulatory requirements. SBS Software tools help with efficient compliance to ISO 13485: SBS Product Key Features T-Med Database · Maintain training records · Record certification and re-certifications · Evaluate training effectiveness · Email delinquency notices · Manage training compliance · CFR 21 part 11 compliant Q-Med Database · Manage corrective actions (CARs) – Safety and Supplier CARs (SCARs) · Manage preventive actions (PARs) · Internal audit management · Document Quality Management System reviews · Manage continual improvement projects · Monitor and measure customer perceptions · Manage and assess risk … Continue reading ISO 13485

Founded in 2004, Sunday Business Systems provides cost effective quality management software and training services to improve compliance to quality standards such as ISO 9001, AS9100, TS16949, ISO 13485, ISO 14001, and API Q1. SBS provides QMS (Quality Management System) software solutions for: Document control Corrective and preventive action management Risk management (FMEA / SWOT) Non-conformance tracking Audit Management Control of calibrated equipment Employee training management Supplier management Preventive Maintenance Control of Calibrated Equipment Inspection Data management, control plans, and SPC Environmental Management System compliance (ISO 14001 EMS) Occupational Health and Safety (OH&S) Management System compliance (ISO 45001 OH&S) Context of the organization including interested parties Business Continuity Planning In addition to our standard products, we use our extensive manufacturing … Continue reading About Us