title: Risk assessment and quality control: be ready for the new guidance.
authors.affiliation: Quality Systems Division, Bio-Rad Laboratories.
authors.forename: Max
authors.initials: M
authors.lastname: Williams
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D017408:Guidelines as Topic; D006801:Humans; D007753:Laboratories / Q000592:standards*; D019095:Point-of-Care Systems / Q000592:standards; D011786:Quality Control; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D014481:United States