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
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.
Services
Qualified AM Readiness Check
The Qualified AM Readiness Check enables organizations to assess their additive manufacturing maturity based on internationally recognized AM standards and industry regulations. The entire process is supported digitally through the QamX-RISK software module, generating structured and verifiable readiness reports.
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 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…
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…
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…
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,…
LCA – Life Cycle Assessment
We adhere to the principles outlined in ISO 14040, ISO 14044, and ISO 14067 standards to provide transparent and reliable LCA studies. These standards guide our approach from the initial goal and scope definition to the final interpretation of the LCA results, ensuring that every aspect of the AM process is meticulously evaluated.
Documentation Support
Simplify and optimize your documentation processes to ensure regulatory compliance and operational excellence. Our team assists in creating, managing, and maintaining thorough documentation that meets industry requirements, ensuring transparency and accountability throughout your AM projects.
Production Performance Review
Maximize efficiency and quality across your AM production line. Our hands-on/senior experts provide insights and actionable strategies to enhance performance, reduce production costs, and streamline workflows to consistently deliver high-quality results in line with international standards.
Health & Safety Assessment
Ensure compliance and safety in your additive manufacturing environment. Our health and safety services focus on aligning your production processes with industry standards, minimizing risks, and promoting a safe workspace for your team and stakeholders.
Business Model Coaching
Unlock the full potential of your additive manufacturing operations with tailored business model strategies. We help you refine and optimize your business models to drive sustainable growth, market differentiation, and increased profitability in the competitive industrial landscape.