SBS Quality Management Software tools enable efficient compliance to ISO 15189. ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. SBS Quality Management Software tools: 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) · … Continue reading ISO 15189

  KEY FEATURES   Control of Calibrated Equipment Record calibration / validation history Generate a Recall Report for “Out of Cal” Equipment Record calibration / validation measurement values Document responses when measuring equipment is found to be unfit for its intended purpose Generate calibration certificates Review detailed calibration reports Preventive Maintenance Create Preventive Maintenance Schedules Define Preventive Maintenance Checklists Track Unscheduled Maintenance Generate Fix-It-Tickets Control Miscellaneous Assets Rich set of reports for detailed analysis Install on your local server or leverage our Cloud QMS solution BENEFITS Build a simple and effective Quality Management System (QMS / eQMS) Efficient and Cost Effective Simple, low cost solution Saves time and improves efficiency Reduce risk through proper preventive maintenance Effective QMS Control calibrated … Continue reading Asset Tracking Database

KEY FEATURES SBS Training Database is ISO 9001 compliant software used to track employee training events, position requirements, certification, and re-certification. Report training gaps and key metrics. Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by employee (special training for each employee) for the release of controlled documents Certification Requirements Re-Certification Requirements Document revisions trigger training requirements Email Reports directly to affected employees User login: define user passwords and privileges Install on your local server or leverage our Cloud QMS solution Compare the Training Database to the T-Med Database BENEFITS Build a simple and efficient Quality Management System (QMS / eQMS) Efficient and cost effective Simple, low cost … Continue reading Training Database

KEY FEATURES SBS Ground Control is your Document Control and Employee Training Management solution. Document Control Complete document lifecycle management Controls any electronic document including Microsoft Office files, Word, Excel, PowerPoint, PDF, AutoCAD, SolidWorks, etc. Control document releases New documents Document Revisions Expired and Obsolete documents Ensure approvals are documented Capture electronic signatures Email alerts to notify reviewers Organize electronic documents Organize by Type, Department, and Owner Group related documents for quick reference Document releases trigger training requirements User login: define user passwords and privileges Simple, effective reports Ensure the effectiveness of your document control system   Training Management Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by … Continue reading Ground Control

KEY FEATURES ISO 9001 compliant vendor management software used to establish criteria for selection, evaluation and re-evaluation of suppliers: Develop Vendor or Supplier qualification plans Record qualification results Maintain your Approved Vendor List (AVL / ASL) Establish criteria for selection, evaluation and re-evaluation of suppliers Maintain a supplier qualification history / supplier performance records Generate vendor ratings or graded score cards Link electronic files (paperless system) A rich set of reports for Vendor status, gaps, and performance Define user passwords and privileges for secure log in Install on your local server or leverage our Cloud QMS solution BENEFITS Build a simple and efficient Quality Management System (QMS): Comply with standard Purchasing requirements of ISO 9001:2015 AS9100 IATF 16949:2016 ISO 13485 … Continue reading Vendor Management

ISO / IEC 17025, General requirements for the competence of testing and calibration laboratories, is the international reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver reliable results. SBS Software tools help with efficient compliance to ISO/IEC 17025: 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) · Document and analyze Nonconformances · Safety and Supplier CARs (SCARs) · Preventive actions (PARs) · Internal audit management · Document Quality Management System reviews · Continual improvement projects · Monitor and measure customer perceptions · Manage and … Continue reading ISO / IEC 17025

You’ve invested hundreds of hours in establishing and maintaining your Quality Management System (QMS). Now what?  Continual improvement! You are obligated to continually improve each component of your QMS.  You can approach continual improvement several different ways. Listen to your customers (external customers as well as coworkers and colleagues) and make a list of common complaints. Is your system too awkward, bulky, time-consuming? Do people fill out too many forms and move too much paper? Are there too many approvals and reviews? Determine which inefficient manual processes are built into your systems.  Use process maps and flowcharts to analyze processes and required resources. Ask yourself where can computer software streamline and improve the effectiveness of the system? Consider the length … Continue reading Improve your QMS

18-Dec-2016 Sunday Business Systems, a leader in affordable and efficient software tools for quality management systems (QMS), is proud to announce the latest release of Ground Control.  This new release is ideal for small to mid-size companies struggling to meet the requirements of quality management standards (ISO 9001:2015, API Q1, AS 9100, and TS16949).  The new release (Version 1.36) has significantly optimized and improved report formats for simplicity and readability. Ground Control is an ISO 9001 compliant program used to Control documents and manage employee training (training requirements and training events or classes).   The program has a rich set of reports including employee training history for periodic evaluations or reviews. Measure training effectiveness with a click of a button.  These … Continue reading New SBS Ground Control version released

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

DOCUMENT CONTROL & EMPLOYEE TRAINING MANAGEMENT Complete document life cycle management Controls any electronic document including Microsoft office files: Word, Excel, PowerPoint, PDF, AutoCAD, SolidWorks Control document releases Ensure approvals are documented Organize Electronic Documents New releases reset training requirements Simple, effective reports Measure the effectiveness of your document control system Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements Manage a Training Schedule Certification Requirements Re-Certification Requirements Document revisions trigger training requirements Email Reports directly to affected employees BENEFITS A vital tool to ensure ISO 9001:2015, AS9100, and ISO/TS 16949, API Q1 compliance Efficient and cost effective Simple document life cycle management Build a simple and efficient Quality Management System (QMS)

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