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.

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 The first successful audited deployment of the SBS QMS suite in support of 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

  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 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

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

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 audit management · Document Quality Management System reviews · Manage continual improvement projects · Monitor and measure customer perceptions · Manage and assess risk (FMEA / SWOT analysis) Q-Med Database · Ideal for FDA regulated industries · Manage corrective actions (CARs) · … Continue reading Demos

27-Mar-2017 – SBS releases version 4.56 of our Quality Database. This new release includes a new CAR prompt to update Risk Analysis components for ISO 9001:2015 compliance, a new global action report, and minor bug fixes. 23-Jan-2017 – SBS is proud to announce the latest release of the Vendor Management Database.  Version 1.13 has significantly improved user interface, new reports and minor bug fixes. 18-Dec-2016 – SBS is proud to announce the latest release of SBS Ground Control.  Version 1.36 has significantly optimized and improved report formats for simplicity and readability. 13-Dec-2016 – SBS is proud to announce the latest release of SBS Training Database.  Version 3.26 has significantly optimized and improved report formats for simplicity and readability. 13-Oct-2016 – … Continue reading New Product Releases

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

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