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ASTM International’s Additive Manufacturing Center of Excellence (AM CoE) launched a new manufacturer certification program designed to enhance quality assurance, regulatory compliance and process control across the additive manufacturing (AM) supply chain.
While traditional quality management system (QMS) standards (e.g. ISO 9001, AS9100, ISO 13485, IATF-16949) have been critical to industry, they are not designed to focus specifically on the needs of additive manufacturing. Building upon these historical requirements, the AM CoE purpose-built a new manufacturer certification program developed by industry leaders to certify the specific processes, materials, and risks unique to AM operations.
To develop this program, the AM CoE the Additive Manufacturing Certification Committee (AMCC) with over 25 end users, including Johnson & Johnson MedTech, JRI Orthopaedics, Medtronic, Smith+Nephew and Stryker. The resulting AM certification program provides the assurance that customers need to build trust across their supply chains by validating AM-specific activities, in place of more general QMS programs.
The mission of the AM certification program is to define shared expectations for manufacturer quality in AM and to create a certification framework that is both technically rigorous and practical. Tailored with OEM-specific requirements to ensure relevance across sectors, the audit criteria are built on top of internationally recognized standards, including ISO/ASTM 52901, ISO/ASTM 52904, and ISO/ASTM 52920.
“By aligning end-user requirements and providing third-party assurance, this initiative helps unlock the full potential of AM in high-performance applications,” said Dr. Martin White, director of technical operations for ASTM International. “This program closes a critical gap in qualifying manufacturers that need to meet industry and regulatory demands.”
With this new certification offering, ASTM International and the AMCC aim to help manufacturers:
- Save time and money by reducing redundant audits
- Facilitate compliance by improving transparency between OEMs and suppliers
- Accelerate time-to-market with AM technologies that meet the highest standards of quality and safety.
The AM certification program joins the family of ASTM AM CoE certification programs that includes AMQ (ISO/ASTM 52920) for additively manufactured parts (ISO/ASTM 52901) and metal PBF-LB processes (ISO/ASTM 52904), as well as AM facility safety certification (ISO/ASTM 52931), and numerous personnel certifications (e.g., ISO/ASTM 52942, ISO/ASTM 52926).
Source: ASTM International
