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 BENEFITS Build a simple and efficient Quality Management System (QMS / eQMS) 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 … Continue reading Quality Database

22- Aug-2016    Sunday Business Systems, a leader in affordable and efficient software tools for quality management systems, is proud to announce the first successful audited deployment of the SBS QMS suite in support of ISO 9001:2015. The new ISO 9001:2015 standard has brought several important changes to QMS (Quality Management System) requirements.  In particular, eliminating preventive actions and emphasizing risk management has led to considerable consternation and controversy.  Sunday Business Systems software is uniquely designed to meet the new requirements of the 2015 standard. SBS consulting services were contracted to begin the process of implementing a fully compliant QMS at an electronics manufacturer in Northern California. The SBS QMS suite was deployed: Asset Tracking, Quality Database, Ground Control, and the … Continue reading SBS QMS Suite: First deployment for ISO 9001:2015

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

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

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

Free Demo Downloads – try before you buy! We believe software must be experienced before you can make a good purchasing decision. Accordingly, we provide free, full-featured demo versions of our standard products that may be downloaded and evaluated prior to purchase. SBS Product Key Features Training Database · Maintain training records · Record certification and re-certifications · Evaluate training effectiveness · Email delinquency notices · Manage training compliance T-Med Database · Ideal for FDA regulated industries · Manage training compliance · Maintain training records · Record certification and re-certifications · Evaluate training effectiveness · Email delinquency notices · CFR 21 Part 11 compliant Quality Database · Manage corrective actions (CARs) · Manage preventive actions (PARs) · Track Non-conformances · Internal … Continue reading Demos

SBS offers Cloud Based Quality Management Systems (QMS) solutions accessible from any internet enabled device

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

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 Nonconformance Management Audit Management Risk Analysis (FMEA, SWOT, risk register) Customer perception measurement The Ground Control Database offers solutions for: Document Control Employee Training Management (Training Database 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 The SBS Inspection Database offers solutions for: Record incoming, … Continue reading ISO 9001:2015

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 Health and Safety (EHS / HSE) management Context of the organization including interested parties Business Continuity Planning Occupational Health and Safety compliance (ISO 45001) In addition to our standard products, we use our extensive manufacturing operations experience to … Continue reading About Us