Qualified AM

About Qualified AM

Qualified AM GmbH: Your Partner in Advanced Manufacturing At Qualified AM GmbH, we specialize in providing comprehensive qualification, validation, and certification services within the Advanced Manufacturing segment, with a particular focus on Additive Manufacturing (AM) and Additive Construction (AC). Our services are grounded in international standards such as DIN, ISO, and ASTM, ensuring that your solutions meet the highest industry benchmarks. Our Expertise Includes: • Gap Identification: We identify gaps between your current solutions and state-of-the-art AM standards, including ISO/ASTM 52920, 52901, 52930, 52904, 52928, 52907, and 52954. • Quality Management Systems: We assist in setting up AM & AC Quality Management Systems, conducting audits, and achieving certification. Our focus is on high-demand, critical applications and serialization use cases. • Audits and Reports: We perform thorough audits and generate detailed reports to ensure conformity with the latest AM quality standards. Detailed Services: • AM Part Requirements: We check AM part requirements and define the scope of qualification and validation plans, along with quality assurance documentation. • Training and Workshops: We provide training, workshops, and templates to ensure a clear roadmap towards approval. • Quality Management Preparation: We prepare and document quality management processes, including defining a spare parts approval process. • Standards Integration: We integrate state-of-the-art AM standards and lead risk assessment projects based on AM process-specific risks. • Certification Preparation: We prepare your organization for certifications such as ISO/ASTM 9001, 13485, IATF 16949, 9100.

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