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Compliance Solutions

QSi BoxShot Are you looking to achieve and maintain compliance to quality management standards like ISO 9000?

If so you may be interested in QSi Systems - a suite of software products based on IBM Lotus Notes technology offering ease-of-use, performance and coverage of standards’ requirements. QSi Systems, with over 2,000 deployments, remain the most popular compliance management systems on the market and are the benchmark by which other compliance management products are judged.

Download:
QSi System Overview


Scroll down for a summary of each product or click on the blue links for a product brochure.

The QSi System product family includes:

QSi Quality Management (ISO 9001:2008)
QSi Quality Management/Automotive (ISO/TS 16949:2002)
QSi System for Environmental Management (ISO 140001:2004)
QSi System for Occupational Health & Safety (BSI OHSAS 18001:1999)
QSi FDA Document Control & CAPA (21 CFR Part 11)
QSi Reports


QSi BoxShot Lindsey Walsh, one of Polymorphs consultants involved with the QSi product set, receives a certificate of achievement from Dan Riordan, VP of Marketing for IBS America at the IBS offices in Boston, USA, following an intensive week long training course in the QSI product suite.

QSi System for Quality Management (ISO 9001:2008)

Designed specifically to meet the requirements of ISO 9001:2008, the QSi System for Quality Management helps your organisation reap the benefits of ISO certification, including improved customer satisfaction and reduced costs.

With this integrated product, create a seamless, paper-free Quality Management System across the enterprise for managing every aspect of compliance with ISO 9001 and a number of industry standards and government regulations. Functions include:

  • Document Control
  • CAPA (CARs, PARs, SCARs)
  • Nonconformances
  • Change Management
  • Customer and Supplier Management
  • Employee Training
  • Internal & Supplier Assessments
  • Management Reviews
  • Design Process Management
  • Inspection and Testing
  • Calibration & Preventative Maintenance

QSi System for Quality Management/Automotive (ISO/TS 16949:2002)

Realise the benefits of ISO/TS 16949:2002 certification. QSi System for Quality Management/Automotive helps companies in the automotive industry achieve compliance while improving customer satisfaction and lowering costs. Create a comprehensive quality system for managing all aspects of automotive quality. In addition to the core functionality found in the QSi System for Quality Management, the following functions are also included:

  • Business Plan
  • Contingency Plans
  • Automotive Process Change Management
  • Gage R&R
  • APQP
  • FMEA
  • PPAP
  • Transportation Carrier Performance
  • Customer Survey

QSi System for Environmental Management (ISO 14000)

QSi System for Environmental Management fosters compliance with a range of standards, including ISO 14001. Improve environmental record-keeping standards, correct environmental issues, and promote a safer, more positive workplace. This flexible quality management software addresses all aspects of environmental management. In addition to the core functionality found in the QSi System for Quality Management, the following functions are also included:

  • MSDS/HAZMAT
  • Emergency Preparedness
  • Legal Register
  • EMS Aspects and Impacts
  • EMS Targets and Objectives
  • EMS Monitoring
  • EMS Policy Manual

QSi System for Occupational Health and Safety (BSI OHSAS 18001:1999)

QSi System for Occupational Health and Safety streamlines compliance with regulations like OHSAS 18001, BS8800, and ANSI/AIHA Z10-2005. With this software, create the complete occupational, health and safety system. Track and address workplace incidents, sharpen emergency preparedness and response, and effectively manage your policies and records. Minimise risk to employees while enhancing your organisation’s image in the community and in the marketplace. In addition to the core functionality found in the QSi System for Quality Management, the following functions are also included:

  • Accident and Incident Reporting
  • Chemical and Risk Assessment
  • Claims Management
  • OH&S Policy Manual
  • Emergency Preparedness
  • MSDS/HAZMAT
  • Monitoring and Test Records
  • Legal Register

QSi System for FDA Document Control

QSi System for FDA Document Control is purpose-built to address FDA requirements. In accordance with the requirements of FDA 21 CFR Part 11, the QSi System for FDA Document Control requires the use of dual passwords for all document reviewers and approvers with password sizes and time-outs selectable by the system Password Administrator. An optional Draft Documents area automatically provides an audit trail that records time-sequenced development and modification of documents.

The QSi System for FDA Document Control provides users with flexible serial or parallel workflow options for reviewing and approving documents. Every released document is automatically archived and stored. Users can define the release dates for approved documents to allow for training.

Features include:

  • Automated alpha or numeric choices for document versioning.
  • Document review and auditing schedule.
  • Automated status tracking for each document and template.
  • Automatic email notifications and distribution of documents upon approval.
  • Automatic updating of training records prior to document release.
  • Audit trail documenting time-sequenced development and modification of documents.
  • Electronic signatures automatically record date, time and time zone.

QSi Reports

Purpose-built to satisfy the most stringent reporting requirements, QSi Reports provides your organisation the foundation it needs to demonstrate and manage the process of continual improvement.

This reporting tool gives you fast, intuitive access to your data, powerful ad hoc analysis and reliable reports that will enable you to make better decisions faster. These graphs and charts simplify the presentation of complex data and highlight important trends and exceptional conditions for real time business information.

Features include:

  • Over 140 predefined reports
  • Online analytical processing (OLAP) with 2,800 drill-down options with graphics designed for the QSi System product family
  • Multiple user network accessibility
  • Spreadsheet integration
  • Ability to view, create and modify interactive data reports
  • Easy formatting of data into line, bar or bar charts, histograms, pareto diagrams as well as basic tables
  • The ability to create and view reports using a web browser
  • Ability to create your own personal dashboard

Training Dates:

Boston, US - Aug 3rd-6th 2009
UK Dates TBC

Please contact us for QSi product training.

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