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ISO 13485 Consulting on-line

Development of new QMS
Optimization of an existing QMS
Internal and supplier ISO 13485 audits
Assistance with certification audits
Implementation of documentation systems
ISO 13485 Consultant


ISO 13485 2003 Consulting On-line

Quality Works offers ISO 13485 on-line consulting programs to assist organizations in developing and implementing an effective Quality Management System that meet the requirements of ISO 13485, MDD 93/42/EEC and Canadian Medical Device Regulation requirements. Our ISO 13485 consultants with extensive international experience provide a full range of services such as:

  • Development and implementation of a new ISO 13485 quality management system,

  • Upgrade of existing QMS to establish compliance with additional standards and regulations,

  • Conduct internal and supplier audits,

  • Development and implementation of efficient documentation systems,

  • Assistance in your ISO 13485 2003 certification audits

Our on-line ISO 13485 consulting program is suitable for those organizations that need minimum disruption of their operation and would like to save consultant's travel expenses. Our on-line service is similar to on-site consulting, except for most communication between our experienced consultants and clients is by phone, Skype or e-mail. So to use this service, you will need internet access and an e-mail address. With on-line ISO 13485 consulting we will: 

  • Based on information you submit, provide you with a proposal and a quote similar to this example,

  • Develop an implementation plan similar to this example,

  • Include free of charge any of our publications needed to document your ISO 13485 quality management system,

  • Assist you in development of the top level documentation: Quality Manual and supporting procedures,

  • Review your procedures, process maps, instructions and records,

  • Based on the information you provide, issue monthly reports to ensure compliance with your ISO 13485 project implementation plan and timely completion of your project. 

For a free no obligation proposal and quote, please call us today to discuss your specific ISO 13485 2003 quality management system needs!

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