What is ISO 13485 Certification in Tanzania? ISO 13485 certification in Tanzania is the international standard for Quality Management Systems (QMS) in the clinical tool enterprise. It covers all levels of the product lifecycle, from layout and production to distribution and servicing. In Tanzania, ISO 13485 certification is essential for groups that need to: Meet Tanzania Bureau of Standards (TBS) and global requirements Access export markets in Europe, the Middle East, and Asia Gain consider from health