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 complete our Request for a Quote or call us today to discuss your specific ISO 13485 2003 quality management system needs!