Qualified AM and AC Standards for Scalable Excellence
Standards in additive manufacturing facilitate faster production, lower costs, and improved product quality.
Standardized Qualified AM Program
The standardized Qualified AM Program is designed to enable growth and scalability in additive manufacturing (AM). It ensures success within the industrial AM space by preparing manufacturers to establish qualified processes that meet the approval requirements of regulated and demanding industries. This program enhances accountability and scalability of AM solutions.
Standards in additive manufacturing facilitate faster production, lower costs, and improved product quality. To achieve consistent quality, standardized protocols are essential. Adopting these standards ensures that parts are produced to the highest level of quality.
1 – 2 Weeks
Defining the Scope of the Qualification
Define a clear and standards-aligned qualification scope by linking your requirements to relevant ISO/ASTM frameworks - ensuring a structured, traceable, and efficient start into your qualification process.
1. month
Assessment of the Status Quo
A structured, QamX-supported assessment of your current systems, processes, and quality framework - providing full transparency on your qualification readiness, identifying gaps early, and delivering a clear roadmap toward Stage 1 audit readiness.
1–3 month
Ramp-up Support
To help you achieve qualification efficiently, we offer hands-on guidance during the critical ramp-up phase. Our experts assist in the implementation of necessary changes, ensuring that your processes are optimized for compliance and performance from the start, setting you up for success in the upcoming audits.
4. month
Stage 1 Audit
The Stage 1 audit provides a structured evaluation of your systems and processes, identifying gaps and delivering a clear, traceable foundation for targeted improvements before moving into Stage 2 certification.
5. month
GAP Closing Support
Systematically close all gaps identified in Stage 1 - ensuring full alignment, traceability, and readiness for a successful Stage 2 audit and certification.
6. month
Stage 2 Audit
The Stage 2 audit is a comprehensive evaluation of your entire production and quality management system. This audit verifies that all corrective actions have been successfully implemented, and that your processes fully comply with the required standards, moving you one step closer to certification.
7. month
Certification
Upon successful completion of the Stage 2 audit, you will be awarded certification. This formal recognition confirms that your additive manufacturing processes meet the highest industry standards, enabling you to confidently enter regulated markets with a qualified and trusted production system.
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