ISO 13485 and CMDR Auditing Canadian CMDR supplier audits Medical devices internal audits Supplier management system programs Supplier development plans ISO 13485 quality management

ISO 13485

Canadian CMDR Supplier Audits

• Behind the schedule with your ISO 13485 and Canadian MDR supplier audits?

• Little time for supplier management?

• Suppliers are slow to respond to your corrective actions?

• Wish your auditors had better CMDR training?

• Little added value from your ISO 13485 and Canadian MDR audits?

We can help! Quality Works assisted dozens of companies in supplier auditing for compliance with ISO 13485 and Canadian CMDR Medical Devices Regulations. Our Health Canada certified Quality Management System auditors have worked with leading international registrars and focus on compliance and effectiveness of your Quality Management System. We will provide you with an expert advise on improvements of your supplier's quality management system, documentation, increase repeatability of their processes and identification of opportunities for improvement.

Implemented improvements in your supplier's ISO 13485 or Canadian CMDR quality management systems will reduce your incoming inspection reject rate, supplier corrective actions and finally degree of compliance of your quality management system with the medical device requirements. Our contract supplier auditing service will help you stay on your audit schedule, improve compliance with applicable medical devices regulations and provide a professional independent assessment of your and your suppliers' Canadian CMDR and ISO 13485 quality management system.

Call us today to discuss your specific ISO 13485 or Canadian CMDR Medical Devices Regulations management system needs!