Standardization as the Key to Scaling: how the Qualified AM Standard is Transforming the Industry

The Challenge of Scaling in Additive Manufacturing
Additive manufacturing has firmly established itself as an efficient method for producing prototypes. However, transitioning this technology to full-scale series production introduces a new level of complexity. It’s no longer just about successfully manufacturing a prototype — companies must also produce it under industrial conditions with consistently high quality and efficiency.

Key factors for successfully scaling additive manufacturing include:

• Achieving reproducible quality across various components and production batches
• Efficiently documenting processes to ensure transparency, traceability, and cost control
• Implementing validated and flexible processes to fully leverage AM’s strengths, such as batch size one and on-demand production

The Qualified AM Standard: Your Key to Scaling Successfully
To help companies meet these challenges, Qualified AM has developed a standardized qualification framework that enables additive manufacturing to meet industrial demands while optimizing production processes.

The Phases of the Qualified AM Standard:

1. Process Analysis and Current State Assessment
   We start with a focused analysis of the company’s existing production processes and target business areas. What’s already working? Where is there potential for improvement?

2. Standardization and Process Documentation
   Next, we define all relevant standards for each process phase, customized to the company's operations and growth objectives.

3. Standardized Quality Management (QM) Documentation, Including Templates
   We provide ready-to-use QM templates, complete with draft content tailored to the company’s needs. Businesses only need to review and fine-tune them — saving up to 80% of the typical time required for QM documentation development.

4. Audit Stage 1 & Stage 2, with Ongoing Monitoring
   Our most experienced auditors focus exclusively on the production areas that matter. Following each audit, a structured improvement process is initiated. Combining an on-site physical audit (Stage 1) with digital monitoring audits (Stage 2 and follow-up audits) makes our program the most cost-efficient solution on the market.

The Benefits of Scaling with the Qualified AM Standard
Our structured and standardized approach offers companies numerous advantages:

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• Efficient implementation of the ISO/ASTM 529XX standards series

• Significant reduction in production errors, failures, and scrap rates

• Lower operational costs through optimized processes and material usage

• Faster time-to-market thanks to an optimized scaling strategy

• Improved market access and readiness, especially within regulated industries

Standardized Qualification Creates New Business Flexibility
Moving from prototyping to series production requires not only clearly defined standards but also secure and cost-efficient documentation processes. By implementing qualified processes, companies can not only streamline their production workflows but also significantly strengthen their competitive edge in the market.