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ISO 13485 Consulting on-site

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


ISO 13485 2003 Consulting On-site

Quality Works offers ISO 13485 on-site consulting programs to assist your organization in developing and implementing an effective Quality Management System (QMS) that meet the requirements of ISO 13485, Council Directive 93/42/EEC for CE marking of medical devices, and Canadian Medical Device Regulations (CMDR). Our experienced consultants provide a full range of services such as:

  • Development and implementation of the new ISO 13485 QMS,

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

  • Conducting internal and supplier audits, including pre-certification audits,

  • Development, implementation and optimization of documentation systems,

  • Assistance in certification audits.

When you choose Quality Works to assist you in development of your ISO 13485 2003 quality management system, your consultant will:

  • Conduct detailed gap analysis of your current quality management system,

  • Review your lower level procedures and records,

  • Develop your ISO 13485 project implementation plan similar to this example,

  • Include free of charge any of Quality Works documentation needed for your ISO 13485 quality management system,

  • Assist you in development of the top level documentation: ISO 13485 or integrated Quality Manual and second level procedures,

  • Issue monthly progress reports to ensure compliance with the project plan and timely completion of your ISO 13485 implementation project,

  • Provide necessary training,

  • Conduct auditor training,

  • Conduct your pre-certification audit to ensure readiness of your quality management system and all employees for your certification audit,

  • Provide certification audit support.

For a free, no obligation proposal and a quote for your ISO 13485 2003 project, call us today to discuss your specific needs.

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