BSI PD CEN ISO/TR 4450:2022
$198.66
Quality management systems. Guidance for the application of ISO 19443:2018
| Published By | Publication Date | Number of Pages |
| BSI | 2022 | 68 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | European foreword Endorsement notice |
| 7 | Foreword |
| 8 | Introduction |
| 11 | 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 |
| 12 | 5 Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer focus 5.1.3 Nuclear safety culture |
| 13 | 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities |
| 16 | 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7 Support 7.1 Resources 7.1.1 General |
| 17 | 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources |
| 18 | 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information |
| 19 | 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information |
| 20 | 8 Operation 8.1 Operational planning and control 8.1.1 Provisions for Counterfeit, Fraudulent or Suspect (CFS) items 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determination of requirements related for products and services 8.2.3 Review of requirements related for products and services 8.2.4 Changes to requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.4.1 General |
| 21 | 8.4.2 Type and extent of control |
| 22 | 8.4.3 Information for external providers 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities |
| 23 | 8.5.6 Control of changes 8.6 Release of products and services 8.7 Control of nonconforming outputs 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review 9.3.1 General 9.3.2 Management review inputs 9.3.3 Management review outputs |
| 24 | 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement |
| 25 | Annex A (informative) Additional requirements of ISO 19443:2018 versus ISO 9001:2015 |
| 28 | Annex B (informative) How to perform a risk analysis for the project? |
| 32 | Annex C (informative) Determination of ITNS items and activities |
| 34 | Annex D (informative) Practical example of determination of ITNS items and activities |
| 37 | Annex E (informative) Typical (general) example for graded approach |
| 39 | Annex F (informative) Practical example of graded approach |
| 42 | Annex G (informative) Metrological guidelines |
| 45 | Annex H (informative) Competence and qualification |
| 48 | Annex I (informative) Awareness training for personnel |
| 52 | Annex J (informative) List of ISO 19443 additional requirements related to documented information |
| 55 | Annex K (informative) Good practices for 8.3 |
| 60 | Annex L (informative) Demonstration of the evidence of provisions for monitoring activities |
| 63 | Annex M (informative) Example of scheme for non-conformance information and request for approval along supply chain |
| 64 | Bibliography |
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