ISO/ASTM 52920:2023
Additive manufacturing — Qualification principles — Requirements for industrial additive manufacturing processes and production sites
The requirements in this document are for part manufacturers using additive manufacturing techniques and are independent of the used material and manufacturing method.
This document specifies criteria for AM relevant processes as well as quality-relevant characteristics and factors along the additive system operations and defines activities and sequences within an additive manufacturing production site.
This document is applicable to the additive manufacturing technologies defined in ISO/ASTM 52900 and defines quality assurance measures along the manufacturing process.
Environment, health and safety aspects are not covered comprehensively in this document. The corresponding content is addressed in the equipment manufacturer guidelines and ISO/ASTM 52931, ISO 27548, ISO/ASTM 52933 and ISO/ASTM 52938-1.
This document provides requirements that are additional to those provided by a quality management system (such as ISO 9001, ISO/TS 22163, ISO 19443, EN 9100, ISO 13485, I...
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Overview of AM related processes
5 Infrastructure of the part manufacturer
5.1 Environmental, health and safety (EHS)
5.2 Waste disposal
5.3 AM system installation
5.4 Ancillary equipment
5.5 Feedstock storage
5.6 IT infrastructure
5.7 Foreign object debris (FOD)
5.8 Provision of the process resources
5.9 Manufacturing management system
5.10 Maintenance/calibration system
6 Manufacturability assessment and review
6.1 General
6.2 Design assessment and review
6.3 Manufacturing assessment and review
6.3.1 Additive manufacturing process
6.3.2 Process finalization
6.3.3 Post processing
7 Qualification of the additive system operations
7.1 General
7.2 Scope of qualification
7.3 Validation planning
7.3.1 Process mapping
7.3.2 Risk assessment
7.3.3 Master validation plan
7.4 Qualification [installation, operation, and performance (IQ/OQ/PQ)]
7.5 Manufacturing plan specification
7.6 Documentation and tracing of the process steps
7.6.1 General
7.6.2 Manufacturing plan
7.6.3 IQ documents
7.6.4 OQ/PQ documents for the complete process
7.7 Relevant process steps within the additive system operations
7.7.1 Overview of additive system operations
7.7.2 Requirements for pre-process: data preparation
7.7.3 Requirements for feedstock management
7.7.4 Requirements for pre-process: system set-up
7.7.5 Requirements for additive manufacturing: build cycle
7.7.6 Requirements for AM-process: process finalization
8 Quality assurance
8.1 General
8.2 Personnel requirements
8.3 Non-conformities
8.3.1 General
8.3.2 Acceptance criteria
8.3.3 Handling of non-conformities
8.4 Continuous improvement process
8.5 Quality controls
8.5.1 General
8.5.2 Production run approval
8.5.3 Part approval
Annex A (informative) Requirements for Post-processing and part approval
Annex B (informative) Supplementary information
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Overview of AM related processes
5 Infrastructure of the part manufacturer
5.1 Environmental, health and safety (EHS)
5.2 Waste disposal
5.3 AM system installation
5.4 Ancillary equipment
5.5 Feedstock storage
5.6 IT infrastructure
5.7 Foreign object debris (FOD)
5.8 Provision of the process resources
5.9 Manufacturing management system
5.10 Maintenance/calibration system
6 Manufacturability assessment and review
6.1 General
6.2 Design assessment and review
6.3 Manufacturing assessment and review
6.3.1 Additive manufacturing process
6.3.2 Process finalization
6.3.3 Post processing
7 Qualification of the additive system operations
7.1 General
7.2 Scope of qualification
7.3 Validation planning
7.3.1 Process mapping
7.3.2 Risk assessment
7.3.3 Master validation plan
7.4 Qualification [installation, operation, and performance (IQ/OQ/PQ)]
7.5 Manufacturing plan specification
7.6 Documentation and tracing of the process steps
7.6.1 General
7.6.2 Manufacturing plan
7.6.3 IQ documents
7.6.4 OQ/PQ documents for the complete process
7.7 Relevant process steps within the additive system operations
7.7.1 Overview of additive system operations
7.7.2 Requirements for pre-process: data preparation
7.7.3 Requirements for feedstock management
7.7.4 Requirements for pre-process: system set-up
7.7.5 Requirements for additive manufacturing: build cycle
7.7.6 Requirements for AM-process: process finalization
8 Quality assurance
8.1 General
8.2 Personnel requirements
8.3 Non-conformities
8.3.1 General
8.3.2 Acceptance criteria
8.3.3 Handling of non-conformities
8.4 Continuous improvement process
8.5 Quality controls
8.5.1 General
8.5.2 Production run approval
8.5.3 Part approval
Annex A (informative) Requirements for Post-processing and part approval
Annex B (informative) Supplementary information
Bibliography