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ISO 13485 Implementation

Gap analysis
Implementation project planning
Documentation review
On-line support
Certification audit assistance
ISO 13485 Implementation


ISO 13485 Implementation Program

  • Ready to start your ISO 13485 implementation?

  • Puzzled where to start?

  • Not clear on how to interpret ISO 13485 requirements?

  • Wondering which registrar is the best for your business?

  • Need to train executive staff and folks on the floor?

Quality Works can help!  In addition to our Documentation set, Quality Works offers assistance to jump start your ISO 13485 implementation project.  Our consultants will help you to assess what you already have in place, develop an implementation plan, interpret requirements of ISO 13485 standard and show you the best way to add new processes in order to meet the requirements of ISO 13485 standard. The program includes hands-on project support from your very own ISO 13485 consultant plus our entire documentation set and training tools. This program is designed to maximize your limited resources by using tested tools and the subject matter expertise of our consultants. This 10 hour on-line program includes:

  • ISO 13485 Documentation Set,

  • The Perfect Manual book,

  • ISO 13485 Executive Overview, 

  • Gap analysis

  • Project Implementation Plan

  • Set-up of your documentation structure,

  • Guidance on customization of your key processes.

Our on-line programs are conducted on the phone or Skype and can be customized to meet your company's specific needs. This ISO 13485 implementation program will ensure that your project is successful and your staff develop the skills necessary to implement and maintain your new ISO 13485 quality management system.

Order your Implementation Program today or Call us to discuss your specific ISO 13485 quality management system needs!

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