ДСТУ ISO/TR 4450:2022 Системы менеджмента качества. Руководство по применению ISO 19443:2018 (ISO/TR 4450:2020, IDT)



ДСТУ ISO/TR 4450:2022
(ISO/TR 4450:2020, IDT)

Системи управління якістю. Настанови щодо застосування ISO 19443:2018

 
   
 
 
     
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

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 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) Additional requirements of ISO 19443:2018 versus ISO 9001:2015

Annex B (informative) How to perform a risk analysis for the project?

Annex C (informative) Determination of ITNS items and activities

Annex D (informative) Practical example of determination of ITNS items and activities

Annex E (informative) Typical (general) example for graded approach

Annex F (informative) Practical example of graded approach

Annex G (informative) Metrological guidelines

Annex H (informative) Competence and qualification

Annex I (informative) Awareness training for personnel

Annex J (informative) List of ISO 19443 additional requirements related to documented information

Annex K (informative) Good practices for 8.3

Annex L (informative) Demonstration of the evidence of provisions for monitoring activities

Annex M (informative) Example of scheme for non-conformance information and request for approval along supply chain

Bibliography