ДСТУ EN 15224:2019 Системи управління якістю. EN ISO 9001:2015 у сфері охорони здоров’я (EN 15224:2016, IDT)
ДСТУ EN 15224:2019
(EN 15224:2016, IDT)
Системи управління якістю.
EN ISO 9001:2015 у сфері охорони здоров’я
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)
Contents
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided healthcare processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annex A (informative) Clarification of new structure, terminology and concepts
Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176
Annex C (informative) Correlation matrix EN 15224:2012 to EN ISO 9001:2015 to EN 15224:2016
Annex D (informative) Quality requirements and quality characteristics in healthcare
Annex E (informative) Guidance for process approach in healthcare
Bibliography
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