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   … 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 QMS Tools:  Context of the Organization, Interested Parties, QMS Scope Meeting Manager Customer Satisfaction Surveys Environmental Health and Safety (EHS / HSE) management email reminders for open CARs, open actions, etc. Rich set of reports and analysis tools for each module Locally installed or Cloud-based solutions available BENEFITS Build a simple and efficient Quality Management System (QMS) Improve 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 … Continue reading Quality Database

The FMEA Database is simple, inexpensive, ISO 9001 compliant software that uses Failure Mode and Effects Analysis (FMEA) as a risk management technique. It is ideal for the requirements of ISO 9001:2015.

05-Jan-2018 Sunday Business Systems is proud to announce the release of version 3.40 of our Training Database. This new release is designed to improve the user experience by adding new buttons to show key forms in datasheet view, new reports. The new release also includes performance enhancements and minor bug fixes. Click here for free demo downloads. Key changes: Add datasheet view to key forms Add buttons to standardize forms Add manager reassignment function (reassign employees to a new manager if manager leaves company) Add document revision field to Gaps reports Add new history, gap, and requirement reports organized by manager Add criticality field to align with risk based thinking of ISO 9001:2015 Background: The SBS Training Database is an … Continue reading SBS Training Database version 3.40 released

KEY FEATURES Implement Risk based strategies for ISO 9001:2015 Identify failure modes for each process or item Identify failure 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 Rich set of reports Track open actions and delinquent due dates BENEFITS Save time and reduce the cost of compliance to Quality Standards such as ISO 9001:2015 Implement Risk Based Thinking 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 of reports Easy to identify delinquencies, stalled actions … Continue reading Risk Management