• Planning ISO 13485 certification?

• Need help with developing your quality management system?

• 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!  Our ISO 13485 Certification program will assist you in all stages of your ISO 13485 certification process.  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.

Your project consultant will work with you to provide custom hands-on project planning, gap analysis reports, requirements interpretation, document reviews and edits, audit and management review program set-up, ISO 13485 training, implementation guidance and more.  Your certification consultant will provide professional advice, project planning support, subject matter expertise, selection of your registrar and pre-certification audit support.

This ISO 13485 certification program will ensures that your project is successful and completed on budget.  At the same time, your staff will develop the skills necessary to maintain your new ISO 13485 quality management system after you achieve your certification.

Call us today to discuss your specific ISO management system needs!