ISO 7101:2023 Healthcare Organization Management - PDF

INTERNATIONAL ISO STANDARD 7101 First edition 2023-10 Healthcare organization management — Man...

INTERNATIONAL ISO STANDARD 7101 First edition 2023-10 Healthcare organization management — Management systems for quality in healthcare organizations — Requirements Management des organisations de soins de santé — Systèmes de management pour la qualité dans les organisations de soins de santé — Exigences Reference number ISO 7101:2023(E) © ISO 2023 ISO 7101:2023(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2023 Website: www.iso.org ii © ISO 2023 – All rights reserved  ISO 7101:2023(E) Contents Foreword..........................................................................................................................................................................................................................................v Introduction.............................................................................................................................................................................................................................. vi 1 Scope................................................................................................................................................................................................................................. 1 2 Normative references..................................................................................................................................................................................... 1.................................................................................................................................................................................... 1 4 Context of the organization...................................................................................................................................................................... 7..................................................................................................... 7......................................................................................................................................................................................................................................................................................................................................... 5 Leadership.................................................................................................................................................................................................................. 9................................................................................................................................................................................................................................................................................................................ 10........................................................................................................................... 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Competence.................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... 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16....................................................................... 17 7.5.6 Audit of records................................................................................................................................................................ 17 8 Operation.................................................................................................................................................................................................................. 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Improvement......................................................................................................................................................................................................... 32............................................................................................................................................................... 32............................................................................................................................. 33..................................................................................................................................................................................... 33.................................................................. 33 Bibliography............................................................................................................................................................................................................................. 35 iv © ISO 2023 – All rights reserved  ISO 7101:2023(E) Foreword www.iso.org/directives). www.iso.org/iso/foreword.html. Healthcare organization management. www.iso.org/members.html. © ISO 2023 – All rights reserved v ISO 7101:2023(E) Introduction 0.1 General 0.2 Aim of a management system for quality in healthcare organizations vi © ISO 2023 – All rights reserved  ISO 7101:2023(E) 0.3 Success factors 0.4 Plan-Do-Study-Act model Figure 1 ). ). ). ). Figure 1 — Elements of a management system for quality in healthcare organizations © ISO 2023 – All rights reserved vii INTERNATIONAL STANDARD ISO 7101:2023(E) Healthcare organization management — Management systems for quality in healthcare organizations — Requirements 1 Scope it provides. 2 Normative references https://www.iso.org/obp https://www.org/ 3.1 organization objectives (3.6) healthcare (3.23 management system ( ). healthcare (3.23 healthcare (3.23) workforces (3.30 © ISO 2023 – All rights reserved 1 ISO 7101:2023(E) 3.2 stakeholder person or organization (3.1 service users ( ). 3.3 top management organization (3.1 management system ( 3.4 management system organization (3.1 policies (3.5 objectives (3.6 processes ( objectives (3.6) 3.5 policy organization (3.1 top management (3.3) 3.6 objective process ( ). healthcare (3.23 healthcare (3.23 management systems ( healthcare (3.23 organization (3.1 healthcare (3.23 policy (3.5 3.7 risk 2 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 3.8 process of the reference. 3.9 competence 3.10 documented information organization (3.1 management system ( processes ( 3.11 performance processes ( organizations (3.1). 3.12 continual improvement performance (3.11) 3.13 effectiveness 3.14 effective 3.15 requirement organization (3.1 stakeholders (3.2 documented information (3.10). © ISO 2023 – All rights reserved 3 ISO 7101:2023(E) 3.16 conformity requirement (3.15) 3.17 nonconformity requirement (3.15) 3.18 corrective action nonconformity (3.17 3.19 audit process ( organization (3.1 3.20 measurement process ( 3.21 monitoring process ( 3.22 safe free from risk (3.7 healthcare (3.23 stakeholders (3.2 3.23 healthcare wellbeing ( ) 3.24 wellbeing health (3.32) 3.25 health (3.32 healthcare (3.23 objectives (3.6) 4 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 3.26 equitable healthcare (3.23 3.27 people-centred care healthcare (3.23 3.28 service user person or stakeholder (3.2 person or stakeholder (3.2) healthcare (3.23 3.29 service user experience service user ( service 3.30 workforce personnel organization (3.1) 3.31 universal health coverage health (3.32 3.32 health wellbeing ( 3.33 co-production healthcare (3.23 healthcare (3.23 service users ( 3.34 health literacy health (3.32 © ISO 2023 – All rights reserved 5 ISO 7101:2023(E) 3.35 dignity 3.36 risk assessment process ( ) of risk (3.7 3.37 risk management policies (3.5 monitoring (3.21) risk (3.7) 3.38 health indicator health (3.32) or healthcare (3.23 performance (3.11) 3.39 knowledge management performance (3.11) 3.40 just culture healthcare (3.23 service users ( ) 3.41 patient safety processes ( healthcare (3.23 risks (3.7 harm ( error ( when it does occur healthcare (3.23). 3.42 incident harm ( 6 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 3.43 credentialing process ( 3.44 privileging healthcare (3.23) organization (3.1) 3.45 compassionate care desire to help 3.46 error incident ( ) 3.47 harm health (3.32 3.48 environmentally friendly policies (3.5 harm ( 3.49 intelligent kindness service users ( wellbeing ( 3.50 human factors ergonomics organizations (3.1 3.51 healthcare associated infection healthcare (3.23 4 Context of the organization 4.1 Understanding the organization and its context © ISO 2023 – All rights reserved 7 ISO 7101:2023(E) 4.2 Understanding the needs and expectations of stakeholders 4.3 Determining the scope of the management system for quality in healthcare organizations 4.4 Management system for quality in healthcare organizations 8 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 5 Leadership 5.1 Leadership and commitment © ISO 2023 – All rights reserved 9 ISO 7101:2023(E) 5.2 Healthcare quality policy 5.3 Roles, responsibilities and authorities 5.4 Service user focus 10 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 5.5 Access to care 6 Planning 6.1 Actions to address risks and opportunities 6.1.1 General b) how to © ISO 2023 – All rights reserved 11 ISO 7101:2023(E) 6.1.2 Risk culture 6.1.3 Risk management processes 6.2 Healthcare quality objectives and planning to achieve them 12 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 6.3 Planning of changes 7 Support 7.1 Resources © ISO 2023 – All rights reserved 13 ISO 7101:2023(E) 7.2 Competence 7.3 Awareness 7.4 Communication 7.4.1 General 14 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 7.4.2 Service user communication 7.4.3 Clinical communication 7.4.4 External communications 7.5 Documented information 7.5.1 General — the competence of persons. © ISO 2023 – All rights reserved 15 ISO 7101:2023(E) 7.5.2 Creating and updating documented information 7.5.3 Control of documented information 7.5.4 Information management systems 16 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 7.5.5 Control and management of electronic information 7.5.6 Audit of records © ISO 2023 – All rights reserved 17 ISO 7101:2023(E) 8 Operation 8.1 Operational planning and control 8.2 Healthcare facilities management and maintenance 8.2.1 General 18 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 8.2.2 Contingency planning for facilities and services 8.2.3 Equipment © ISO 2023 – All rights reserved 19 ISO 7101:2023(E) 8.3 Waste management 8.3.1 General 8.3.2 Waste reduction 8.3.3 Environmental responsibility environment including: 8.4 Handling and storage of materials 20 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 8.5 Service user belongings 8.6 Emerging technologies use of such technologies. emerging technologies. 8.7 Service design in healthcare © ISO 2023 – All rights reserved 21 ISO 7101:2023(E) 8.8 Supplies and services from external providers 22 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 8.9 Provision of services 8.10 People-centred care 8.10.1 General 8.10.2 Service user experience 8.10.2.1 General © ISO 2023 – All rights reserved 23 ISO 7101:2023(E) 8.10.2.2 Service user experience assessment 8.10.3 Compassionate care 8.10.4 Inclusivity and diversity 24 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 8.10.5 Health literacy 8.10.6 Co-production providers. 8.10.7 Workforce wellbeing © ISO 2023 – All rights reserved 25 ISO 7101:2023(E) 8.11 Ethics 8.12 Patient safety 8.12.1 General settings in which it provides services. 6.1). 8.12.2 Knowledge and learning in safety 26 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 8.12.4 Medication safety 8.12.5 Surgical safety 8.12.6 Infection prevention and control (IPC) © ISO 2023 – All rights reserved 27 ISO 7101:2023(E) 8.12.7 Prevention of falls, pressure ulcers and thromboembolism 8.12.8 Diagnostic safety 8.12.9 Blood transfusions 28 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 9 Performance evaluation 9.1 Monitoring, measurement, analysis, and evaluation 9.1.1 General © ISO 2023 – All rights reserved 29 ISO 7101:2023(E) 9.1.2 Healthcare quality indicators include: 9.1.3 Methods 9.1.4 Results 30 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 9.2 Internal audit 9.2.1 General 9.2.2 Internal audit programme 9.3 Management review 9.3.1 General 9.3.2 Management review inputs © ISO 2023 – All rights reserved 31 ISO 7101:2023(E) 9.3.3 Management review results 10 Improvement 10.1 Continual improvement review to determine opportunities for improvement. 32 © ISO 2023 – All rights reserved  ISO 7101:2023(E) 10.2 Nonconformity and corrective action 10.2.1 General 10.2.2 Management of nonconformity and corrective action © ISO 2023 – All rights reserved 33 ISO 7101:2023(E) 34 © ISO 2023 – All rights reserved  ISO 7101:2023(E) Bibliography Safety aspects — Guidelines for their inclusion in standards Guide to the development and inclusion of aspects of safety in International Standards for medical devices Risk management — Vocabulary Medical laboratories — Requirements for quality and competence Guidelines for auditing management systems Healthcare organization management — Vocabulary Human resource management — Vocabulary Risk management — Vocabulary https:// thservices.who.int/ -home N S D https://sdgs.un.org/ H O H O https://www.who.int/ -promotion/ -wellbeing/ninth -conference/ H O https://www.who.int/ -topics/ = _1 © ISO 2023 – All rights reserved 35 ISO 7101:2023(E) © ISO 2023 – All rights reserved