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ISO 13485 Quality Management System


  • Manufacturing medical devices?

  • Need to establish compliance with regulatory requirements?

  • Clients ask for ISO 13485 certificate?

  • Folks on the floor do not always follow procedures?

  • Wish you could do things right the first time?

We can help! Quality Works team has developed and offers documentation templates for ISO 13485 Quality Management System (QMS).  Use of templates is a widely used approach to establishing and documenting quality management systems. Quality Works assisted dozens of companies around the World in establishing and implementing effective Quality Management Systems. Our documentation sets will save you time and money in documenting your ISO 13485 quality management system.


Feel free to compare our documentation with others: you will find that our products are the most effective, simple and yet addressing all the requirements of ISO 13485 standard.  Quality Works team designed our documentation to truly improve effectiveness of your documentation system and reduce paperwork.  Our documentation is user-friendly, easy to understand and makes good business sense.  Check out our ISO 13485 Documentation Set List of Documents to see samples of our documents. While our ISO 13485 quality management system documents are easy to customize and implement, our team is always here to assist you in your project.  Check our Consulting, Training and Auditing pages to learn how our experts can give you a jump-start in developing and implementing your ISO 13485 quality management system.


Visit our Product page to order your ISO 13485 Documents or Call us today to discuss your specific ISO 13485 quality management system needs!

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