The road to certification w.r.t. ISO 13485 and MDSAP is certainly a long one, but with systematic planning and execution various milestones can be timely and successfully achieved.
For companies looking to get a Quality Management Systems (QMS) Certification in accordance with ISO 13485 or MDSAP (recognized by Canada, Japan, US, Australia and Brazil), the first step is to get a complete set of procedures, work instructions, and forms in place, and implement them, next step is to conduct internal audit, and then Management Review Meetings (MRM) to demonstrate management commitment for quality.
It’s important to know that each of these certifications come with yearly audits to show that the company can not only follow and integrate quality into its products, but can also continually improve with time.
Elexes continues to help companies maintain these critical certifications that allow sales in various countries across the world. What did your road to successful certification and maintenance look like?