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.

Our Services

Advisory Services

Preparation of Custom Working Instructions

Qualified AM develops clear, practical, and precise working instructions customized specifically for your additive manufacturing processes. Drawing from extensive industry experience, our team creates step-by-step guidelines that seamlessly integrate into your existing Quality Management System. These tailored instructions ensure consistent execution of critical process steps, enhanced repeatability, and reduced operator error, ultimately elevating the overall quality and reliability of your production. Using proven methods and specialized tools developed in-house, we deliver instructions designed specifically for your team’s needs, setting you up for continuous improvement and sustained production excellence.

Service compliant with:
Quality management standards, such as ISO/ASTM 52920, ISO 13485, AS EN 9100, ISO 9001, etc.

Quality Management System Implementation

Qualified AM helps you establish a robust Quality Management System (QMS) specifically tailored to additive manufacturing environments. Leveraging our extensive AM production experience, we structure your QMS to include efficient documentation, traceability of processes and products, personnel qualification, continuous improvement measures, and effective management of non-conformities. Our proven approach ensures your production meets industry-leading quality standards, reduces variability, and consistently delivers compliant, high-quality parts, empowering your business to excel in industrial additive manufacturing.

Service compliant with:
Quality management standards, such as ISO/ASTM 52920, ISO 13485, AS EN 9100, ISO 9001, etc.

Validation Planning

Qualified AM supports you in comprehensive validation planning tailored specifically to your additive manufacturing operations. Our experts assist you and systematically map your production processes and develop a structured master validation plan with you that defines clear steps, activities, and verification measures. This service ensures consistent quality, repeatable manufacturing outcomes, and provides the foundation for seamless industrial AM production. With Qualified AM’s validation planning, you will have clearly documented processes, improved transparency, and greater confidence in achieving stable, reliable production.

Service compliant with:
Quality management standards, such as ISO/ASTM 52920, ISO 13485, AS EN 9100, ISO 9001, etc.

Conducting of Risk Assessments

The Qualified AM Team is experienced in performing risk assessments compliant with state-of-the-art practices to elevate your production to the highest level and enable continuous process improvement. Years of hands-on AM experience enable us to rapidly identify and mitigate risks specific to your processes and production environment. With a Qualified AM risk assessment you can be proactive and achieve viewer defects, less rework, improved reliability and reduced downtime.

Service compliant with:
Quality management standards, such as ISO/ASTM 52920, ISO 13485, AS EN 9100, ISO 9001, etc.

Tailored Use Case Consultation

Qualified AM provides individualized consultation to identify and implement optimal additive manufacturing solutions tailored precisely to your specific product, process, or industry application. Collaboratively, we explore the full potential of AM for your particular use case, evaluate feasibility, performance benefits, and economic viability, and develop a clear roadmap for implementation. By partnering with Qualified AM, you leverage targeted expertise to unlock innovation, efficiency, and new opportunities uniquely suited to your business.

LCA – Life Cycle Assessment

Qualified AM guides you through the creation of cutting-edge Life Cycle Assessments specifically tailored to additive manufacturing. As active contributors in writing the upcoming industry standard for AM-specific LCA, our team holds unparalleled knowledge and insight into its exact requirements and best practices. This unique position enables us to deliver LCAs that are already fully aligned with the latest draft standards, ensuring immediate compliance, unmatched transparency, and credibility. By partnering with Qualified AM, you gain an exceptional competitive advantage through foresight and early adoption, strengthening your commitment to sustainability and positioning your organization at the forefront of additive manufacturing excellence.

Service compliant with:
Upcoming AM LCA standard ISO/ASTM 52964

Production Performance Review

Qualified AM thoroughly analyzes your additive manufacturing operations to pinpoint performance improvements and optimization opportunities. By closely collaborating with your team, we evaluate production efficiency, process stability, utilization rates, and overall output quality. Leveraging our extensive hands-on experience, we deliver practical recommendations to enhance your productivity, reduce operational costs, and achieve higher consistency and reliability in your AM processes.

Health & Safety Assessment

Qualified AM conducts thorough health and safety assessments specifically designed for additive manufacturing environments. Our experts closely collaborate with your staff to identify hazards unique to AM processes, materials, and machinery, ensuring comprehensive regulatory compliance. Through our practical recommendations, you can confidently establish safer workplaces, reduce risks, safeguard employee health, and maintain seamless production operations.

Service compliant with:
Upcoming AM H&S standard ISO/ASTM 52931

Business Model Coaching

Qualified AM provides strategic coaching tailored specifically to additive manufacturing businesses aiming for growth and competitive differentiation. Together, we evaluate your existing business model, identify new opportunities, and create actionable strategies to expand into new markets, develop innovative services, or optimize pricing and cost structures. With our expert guidance, your AM business will build long-term profitability, resilience, and a clear competitive advantage in a rapidly evolving market.

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
The first step involves identifying and clarifying the specific requirements for your additive manufacturing process. Linking your needs to the best matching ISO/ASTM standards. We work with you to determine the exact scope, including material properties, system configurations, and part complexity, ensuring that your qualification pathway is tailored to meet your operational and regulatory needs.
1. month
Assessment of the Status Quo
We assess the current state of your systems and processes to evaluate their readiness for qualification. This includes a review of your existing quality management systems, production capabilities, and adherence to relevant industry standards, providing a clear picture of where improvements are needed to get you ready for the stage 1 audit.
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
During the Stage 1 audit, we perform a preliminary evaluation of your systems and processes to ensure they meet the foundational requirements of the qualification. This audit identifies any gaps or areas for improvement, allowing for corrective actions before the final certification audit. A detailed audit report containing a gap analysis is issued to you…
5. month
GAP Closing Support
Following the Stage 1 audit, we provide dedicated support to help you address any identified gaps. Our (expert) team works closely with you to implement the necessary changes and improvements, ensuring your systems are fully aligned with qualification standards and ready for final review.
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.