Committee 210 drafts the International Standard ISO 13485 and revisions. ISO 13485 is a stand-alone document for the medical device sector concurrent with the format of ISO 9001:2008. As it did in ISO 13485 additional requirements are specific to this sector, among the decisions taken. Example, GHTF TC 210 modified the language in ISO 9001:2000 from focusing "customer satisfaction" and "continual improvement" to compliance and fulfilling regulatory requirements. This supports the fact that certification to ISO 13485 is a management tool assisting in fulfillment of regulatory requirements and legal obligations. Canada has set the stage wherein ISO 13485 is a requirement under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and accreditation protocols include the GOB | GCC Accreditation - Recognition Platform as well national accreditation bodies.

The view within TC 210 is that, while these concepts of customer focus and improvement may be appropriate for a business excellence model, they do not belong in a baseline standard for a quality system that will become a tool for regulation in many jurisdictions abiding to safety, litigation, and product concerns. In lieu the product safety and effectiveness focus remains as bearer of ISO 13485. While ISO 9001:2000 significantly reduces these procedure requirements, ISO 13485:2003 retains the same number of documented procedure that previous versions of ISO 13485 (and ISO 13488) required.