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Marie Colwell Health Program Manager SAI Global
Governance in action - the experience of the first year of the National Standards
Governance in action - the experience of the first year of the National Standards
Areas Covered: Key features of our program
Preferred approach Regulatory variation Benefits of an ISO approach Integrated Certification/Accreditation provided by SAI Global Quality in Health Steps to Accreditation A Snapshot of activity
What have we learned?
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Preferred approach
Preferred approach: Combined ISO 9001:2008 Plus NS&QHS Standards • To integrate the 2 standards NS&QHS Standards plus ISO 9001:2008 for
audit and reporting purposes • The National Standards are strongly accordant with ISO 9001 and will
supply the evidence required for many criteria in ISO 9001:2008. • For example: NSQHS Standard 1 is very ISO centric and directly addresses ISO 9001
Standards 5, 6 and 8 • Criteria will be audited once and reported once. The NS&QHS Standards
take precedence and therefore if audited and reported in NS&QHS Standards it will be referenced in the ISO 9001 report.
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Regulatory variation
Accreditation to NS&QHS Standards • Variation between jurisdictions eg. Vic, NSW, SA have required NS&QHS
Standards accreditation only while Qld and WA require an organisation wide accreditation plus NSQHS Standards
• State Private Hospital Licensing may have no requirement for accreditation BUT the PHI Act requires accreditation to Health Service Standards. This is to be re-worded and will require NSQHS Standards
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Benefits of an ISO approach
• ISO trained auditors are well prepared for this model and used to providing evidence for conclusions reached
• ISO auditors recognise ‘developing’ system with commitment to continuous improvement
Non Clinical Services • With ISO 9001:2008 accreditation to National Standards it becomes easy
to extend the scope of accreditation to non clinical areas while maintaining the same Governance of the Quality Management System
• It is possible to obtain ISO 9001:2008 accreditation for non clinical areas independent of the clinical model.
• Integrated accreditation is possible with ISO certification
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Integrated Certification/Accreditation provided by SAI Global
ISO 14001 Environmental Management System
ISO 18001 OH&S
HACCP, Food Safety
ISO 27001, Information Security Management Safety
Health Service Standards • NSQHS Standards Plus Vic Nutrition • Core Standards for Safety & Quality
in Healthcare • Mental Health Standards • Palliative Care Standards:2005 • SDSV:2007 • Diagnostic Imaging Standards (sub-
contract) • Laboratory Standards (NATA)Safety
Business Excellence
ISO 9001:2008 Quality Management Standard The Foundation standard for organisational wide Quality Management
ABC Health Service Business Management System
Quality in Health
SAI Global has responded to the new national Accreditation scheme by launching a 2 tiered program that meets new compliance requirements and offers health services
the opportunity to participate in a journey towards excellence.
Tier 1 – Quality in Health Incorporates all of the requirements of ISO 9001 and the National Safety & Quality Health Service Standards
Quality in Health develops operational efficiency & effectiveness Tier 2 – Excellence in Health Incorporates all of the requirements of ISO 9001 and the National Safety & Quality Health Service Standards, and in addition brings in key and sector relevant elements from the Business Excellence Framework.
Excellence in Health develops organisational efficiency & effectiveness
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Steps to Accreditation Receipt of Application
Self Evaluation
Stage 1 Audit
Stage 2 Certification Audit Evaluation
Follow-Up Audit (if required) Submission & Registration
Surveillance Audits
Introductory Visit (Optional)
Document Audit (Optional)
Gap Analysis (Optional)
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A Management System program offers a step-by-step approach aimed at providing you with confidence in your system’s capability to meet the needs of the organisation and your customers. This process addresses the philosophies of good management practice covered by the Standard.
A Snapshot of activity
Audits 2013 Number Not mets Met with merit
Surveillance audits 60 400 6
Initial certification NSQHS standards 60 31
Initial certification ISO 9001 plus NSQHS standards 20 0
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What have we learned
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• We don’t know what we don’t know • Interpretation/Interrater reliability? • Durations??
What have we learned: We don’t know what we don’t know
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The six documented procedures as required by the standard include: • Corrective and Preventive Action – Policy and Flowchart • Control of Non Conforming service • Internal Auditing • Records Management • Document Control
Governance in action - the experience of the first year of the National Standards
Thank You
Contact details Marie Colwell Health Program Manager 03 9693 3594 [email protected]
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