I am a certified business administrator and ISO 9001 auditor with more than twelve years of experience in the industry and business consulting, including more than five years of experience as a QA Manager of a US manufacturer of medical devices.
I have prepared the entire ISO 9001, ISO 13485, OHSAS/ISO45001, etc. documentation for various companies around the world (USA, UK, Australia, Asia, Africa) from different fields of activity (food, medical devices, hospitality, energy, etc.). I can prepare your management system documentation as needed.
I'm estimating that I would need 20 h to complete the ISO 9001 documentation and then we can add any additional requirements you have for the RISQ's accreditation.
I have experience in communicating with the FDA, Health Canada, TGA Australia, etc., and successfully completing FDA inspections on medical devices and I am also a certified business administrator and ISO 9001 and ISO 22000 auditor.
As a QA Manager, I have created and implemented the QMS documentation compliant with ISO 9001, ISO 13485, ISO 14001, and ISO 22000, as well as the USA, Canada, Australia, and EU regulatory requirements for medical devices, cosmetics, consumer goods, and food. Also, I have registered devices in various countries, including Canada and Australia.