Overcoming AM Complexity with Proven Expertise
Whether you’re navigating the complexities of AM production, ensuring regulatory compliance, or looking to enhance operational efficiency, we provide tailored solutions that address your unique challenges. Our goal is to empower your organization with the knowledge, tools, and strategies needed to unlock the full potential of AM technologies, ensuring long-term scalability and growth.
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.
Services
Qualified AM Readiness Check
The Qualified AM Readiness Check provides a focused, standards-based decision foundation by systematically identifying qualification gaps, reducing trial-and-error, and prioritizing investments that directly impact production readiness and certification progress. As a short, target-oriented audit (not a full certification), it delivers rapid, focused insight into your current AM maturity - together with your team, ensuring that…
Preparation of Custom Working Instructions
Custom working instructions transform complex additive manufacturing processes into clear, standardized, and audit-ready execution steps. By combining Qualified AM expertise with QamX, operational know-how is translated into repeatable, traceable, and standards-aligned workflows, reducing variability and enabling consistent production quality at scale.
Quality Management System Implementation
Implement an additive manufacturing-specific Quality Management System that ensures traceability, audit readiness, and compliance with ISO/ASTM and industry standards - enabling stable, scalable, and high-quality production.
Validation Planning
Qualified AM enables structured, standards-aligned validation planning powered by QamX. By connecting validation steps, risks, requirements, and evidence into a reusable system, we reduce effort, increase transparency, and create a scalable foundation for audit-ready additive manufacturing production.
Conducting of Risk Assessments
Structured, state‑of‑the‑art AM risk assessments with QamX enable up to 20× faster qualification and validation while reducing cost, rework, and production risk - ensuring audit-ready, stable, and scalable AM processes.
Tailored Use Case Consultation
Qualified AM helps companies identify, evaluate, and implement high-value additive manufacturing use cases. Through structured analysis and tailored consultation, we translate ideas into feasible, scalable, and standards-aligned solutions with a clear path to implementation.
LCA – Life Cycle Assessment
Qualified AM enables structured Life Cycle Assessments tailored to additive manufacturing. By aligning with ISO/ASTM 52964 and integrating AM-specific data, we create transparent, comparable, and decision-ready sustainability analyses for scalable industrial production..
Documentation Support
Documentation Support transforms fragmented and manual documentation into a structured, standards-aligned, and fully traceable qualification system. By combining Qualified AM expertise with the QamX platform, documentation becomes a digital, audit-ready asset - linked to risks, validation, and process data - enabling faster certification, reduced effort, and scalable AM operations.
Production Performance Review
Qualified AM analyzes additive manufacturing operations to identify improvement opportunities in efficiency, process stability, utilization, and output quality. Through a structured and data-driven review, we help companies increase productivity, reduce costs, and achieve more stable and reliable AM production.
Health & Safety Assessment
Qualified AM enables structured, standards-aligned health & safety assessments for additive manufacturing. By identifying AM-specific hazards and connecting mitigation measures within QamX, we create transparent, compliant, and scalable safety frameworks for industrial AM operations.
Business Model Coaching
Qualified AM supports additive manufacturing businesses in developing and optimizing scalable business models. By identifying growth opportunities, refining value propositions, and aligning strategy with market dynamics, we help companies achieve long-term profitability and competitive advantage.