title: [Establishment and management of documentation within QMS of medical device enterprises].
abstract: The objectives of QMS for quality assurance of products are achieved by formulation, implement, and management of document system. Document (includes record) system is important constituent part of QMS. In this paper, the important issues and relative requirements of GMP on the establishment and management of documentation within quality management system (QMS) of medical device enterprises are discussed with the aim of providing reference for relative enterprises to build and improve their QMS and to implement GMP.
authors.affiliation: Center for Certification of Drug, China Food and Drug Administration, Beijing, 100061. sltian2@163.com
authors.forename: Shaolei
authors.initials: S
authors.lastname: Tian
mesh_terms: D004864:Equipment and Supplies; D005568:Forms and Records Control / Q000379:methods*; D011786:Quality Control