Quality Management Software for ISO & Regulatory Compliance
Sunday Business Systems provides affordable Quality Management System (QMS) software designed to help organizations achieve and maintain compliance with ISO and industry quality standards. SBS QMS software supports ISO 9001, AS9100, ISO 13485, IATF 16949, ISO/IEC 17025, ISO 14001, ISO 45001, API Q1 and other quality management requirements.
Our integrated QMS software helps organizations manage corrective actions, nonconformances, audits, document control, employee training, calibration, preventive maintenance, supplier quality, risk management and inspection data. SBS QMS solutions may be purchased individually or as an integrated suite and can be deployed locally or in the cloud.
ISO 9001 (Quality management systems — Requirements) defines the required 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 (manufacturing, design/development, or service provider). SBS Quality Management software is a valuable tool to help companies comply with the ISO 9001 standard. The Quality Database offers solutions for: The Ground Control Database offers solutions for: The Asset Tracking Database offers solutions for: The Vendor Management Database offers solutions for: The SBS Inspection Database offers solutions for: SBS QMS Software is sold as individual products or as a suite of tools with options for concurrent user licensing. Our software may be install locally …
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 …
AS9100 is an aerospace standard based on the ISO 9001 quality system requirements. AS9100 supplements the ISO 9001 requirements with additional quality system requirements established by the aerospace industry to satisfy DOD, NASA, and FAA regulations. SBS Software tools help with efficient compliance to AS9100: 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: …
IATF 16949 (formerly ISO/TS 16949) is a technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. IATF 16949 applies to the design/development, production, and installation and servicing of automotive-related products. SBS Software tools help with efficient compliance to IATF 16949: SBS Product Key Features Training Database · Develop training requirements / training plans · Maintain training records · Record certification and re-certifications · Document Self-paced Training · Evaluate training effectiveness · Email delinquency notices · Manage training compliance Quality Database · Manage corrective actions (CARs) · Safety and Supplier CARs (SCARs) · Manage preventive actions (PARs) · Internal audit management · …
SBS QMS software supports ISO 45001 Occupational Health and Safety (OH&S) management systems by providing integrated tools to manage workplace safety, risk, training, documentation, corrective actions and continual improvement.
The SBS QMS Suite helps organizations:
Identify and manage workplace hazards, EHS/HSE issues and OH&S risks
Document incidents, nonconformances and corrective actions
Perform risk assessments and track actions to reduce risk
Schedule and document internal audits and audit findings
Control safety policies, procedures and work instructions
Manage employee training, competency, certifications and recertification
Track preventive maintenance and equipment-related safety issues
Assign responsibilities and monitor open safety-related actions
Document management reviews and continual improvement activities
Maintain objective records to support ISO 45001 audits and compliance
SBS provides a practical, affordable platform for integrating ISO 45001 requirements with an organization’s existing Quality Management System.
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) · …
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 …
API Q1 defines Quality Management System requirements for manufacturing organizations in the petroleum and natural gas industry. SBS Software tools help with efficient compliance to API Q1: 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) · Track 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 assess risk (FMEA / SWOT analysis) · CFR 21 part 11 compliant Ground Control · …
ISO 14001 sets out the criteria for an environmental management system. It maps out a framework that a company or organization can follow to set up an effective environmental management system (EMS). It can be used by any organization regardless of its activity or sector. The SBS Quality Database is ideal for documenting risk hazards, safety/environmental meetings, audit results, and corrective actions. The Quality Database is a great software tool to establish and maintain ISO 14001 compliance. SBS Software tools help with efficient compliance to ISO 14001:2015: SBS Product Key Features Quality Database · Manage corrective actions (CARs) · Safety and Supplier CARs (SCARs) · Manage preventive actions (PARs) · Document Safety Incidents · Define the EMS Context of …