ДСТУ EN 15224:2019 Системы управления качеством. EN ISO 9001:2015 в сфере здравоохранения (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