ISO Documentation & Training Services

Preparing for ISO 9001, ISO 13485, or ISO TS 16949 is a major company-wide effort, but it doesn’t have to disrupt your day-to-day business. Quality Solutions cuts through the roadblocks and minimizes the time it takes to develop your Quality Manual, Standard Operating Procedures, and Records Systems. We realize you have a business to run. Our proven, systematic and efficient approach will give you the freedom to do just that.

Deliverables

Our documentation assistance is supported by custom designed templates. These templates incorporate the best practices employed by many world-class companies who have achieved certification and are recognized for their business performance. Our templates have been validated by registrars for over 20 years and through hundreds of certification and surveillance audits.

Our experience and commitment to serve as an extension of your organization makes it significantly easier to move beyond documentation to implementation, which results in improved efficiency, effectiveness and customer satisfaction.

Quality Solutions is committed to providing cost-effective, customized ISO 9001 consulting services to meet the needs of our clients.

Our experience includes the design and development of the following:

  • A fully automated quality management system for document and record control
  • Quality policy manual
  • Quality systems procedures
  • Format for work instructions
  • Quality/Control plans
  • Key Performance Indicators ( KPIs)
  • Document control system
  • Systems for corrective actions, customer complaints, non conformity reporting, and supplier management
  • Calibration systems
  • Process maps (flowcharts)
  • Risk management tools
  • Internal audit checklists
  • Support by a certified ISO 9001 Lead Auditor or Certified ISO 13485 or TS 16949 Quality Systems Trainer/Consultant
  • On-site implementation support as well as rapid response to questions and customer support
  • Custom designed tags, stickers, and stamps to support your system
  • Assistance in the selection of the most appropriate registrar for your company
  • Internal audit support and internal auditor training
  • Development of the forms, automated templates and procedures to support a preventive maintenance system