title: ISO 9000. Policy implications for FDA. Taking the pulse of increasing global use of the ISO series of uniform quality standards by FDA regulated industries.
authors.affiliation: Office of Policy, United States Food and Drug Administration, Rockville, Maryland.
authors.forename: W L
authors.initials: WL
authors.lastname: Schwemer
authors.forename: M A
authors.initials: MA
authors.lastname: Lynch
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D007391:International Cooperation; D007564:Japan; D007880:Legislation, Drug; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards*