title: The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals.
abstract: OBJECTIVE
  To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals.
  
  
  METHODS
  A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways.
  
  
  METHODS
  Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey.
  
  
  METHODS
  Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways.
  
  
  RESULTS
  Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke).
  
  
  CONCLUSIONS
  Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.
authors.affiliation: * Centre for Clinical Governance Research, University of New South Wales, Sydney, Australia. cdshaw@btinternet.com.
authors.forename: Charles D
authors.initials: CD
authors.lastname: Shaw
authors.forename: Oliver
authors.initials: O
authors.lastname: Groene
authors.forename: Daan
authors.initials: D
authors.lastname: Botje
authors.forename: Rosa
authors.initials: R
authors.lastname: Sunol
authors.forename: Basia
authors.initials: B
authors.lastname: Kutryba
authors.forename: Niek
authors.initials: N
authors.lastname: Klazinga
authors.forename: Charles
authors.initials: C
authors.lastname: Bruneau
authors.forename: Antje
authors.initials: A
authors.lastname: Hammer
authors.forename: Aolin
authors.initials: A
authors.lastname: Wang
authors.forename: Onyebuchi A
authors.initials: OA
authors.lastname: Arah
authors.forename: Cordula
authors.initials: C
authors.lastname: Wagner
mesh_terms: D000068:Accreditation; D019091:Critical Pathways / Q000592:standards*; D003430:Cross-Sectional Studies; D005060:Europe; D006761:Hospitals / Q000592:standards; D006801:Humans; D061214:Patient Safety; D011785:Quality Assurance, Health Care / Q000379:methods*; D019984:Quality Indicators, Health Care / Q000706:statistics & numerical data; D014421:Turkey
keywords: accreditation; certification; health care quality assessment; patient safety; quality management