Recently, Kexcelled New Material Technology (Suzhou) Co., Ltd. officially obtained the ISO 13485:2016 Medical Devices Quality Management System Certification and the IATF 16949:2016 Automotive Quality Management System Certification.
The simultaneous implementation of these two certifications signifies that Kexcelled’s quality management system is now fully aligned with international medical and automotive industry standards. More importantly, it grants multiple core products the "compliant identity" required to enter these two high-barrier supply chains.
Our Comprehensive Certification Matrix
To date, Kexcelled has established a multi-dimensional certification matrix covering quality, environment, occupational health and safety, medical applications, and automotive sectors:
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ISO 9001 Quality Management System Certification: The foundational certification for the company's quality management, covering the entire process of R&D, production, and sales to ensure products and services consistently meet customer requirements.
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ISO 14001 Environmental Management System Certification: Covers energy consumption management, closed-loop waste treatment, and environmental compliance control during production.
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ISO 45001 Occupational Health and Safety Management System Certification: Establishes a health and safety risk early-warning mechanism covering all positions to protect employees' occupational health.
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ISO 13485 Medical Devices Quality Management System Certification (New): Tailored for the medical device industry, emphasizing full-process risk control and product safety and efficacy.
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IATF 16949 Automotive Quality Management System Certification (New): Tailored for the automotive supply chain, emphasizing defect prevention, process control, and continuous improvement.
In addition, all materials have obtained international environmental certifications such as RoHS, meeting the environmental access requirements of the EU and major global markets.
Which Products Benefit Directly from the Certifications?
I. Medical Application Sector
- Medical-Grade PEEK Filament: Used for orthopedic surgical guides, personalized implant trial molds, and rehabilitation aids, featuring excellent biocompatibility and radiation sterilization resistance.
- Biocompatible Photosensitive Resin: Ideal for high-precision medical components such as dental models, hearing aid shells, and surgical guides.
- FDM Medical-Grade Filament (PLA/PETG, etc.): Managed with full-process traceability control, suitable for medical teaching models, customized orthopedic devices, and other scenarios.
II. Automotive Application Sector
- High-Temperature Nylon (PA6/PA12-based) Filament: Suitable for engine bay peripheral tooling, sensor housings, and wire harness clips, with long-term temperature resistance exceeding 180°C.
- Carbon Fiber Reinforced Composites (PA-CF/PEEK-CF): Used for lightweight structural parts, battery pack insulation brackets, and jigs/fixtures, balancing strength with weight reduction needs.
- Flexible TPU Series: Suitable for seals, cushions, and protective pipe sleeves, offering excellent oil and weather resistance.
Key Honors and Qualifications
Beyond the aforementioned system certifications, Kexcelled has also been awarded numerous prestigious corporate honors:
- National High-Tech Enterprise: Recognized consecutively, reflecting the company’s comprehensive strength in technological R&D and achievement transformation.
- "Specialized, Refined, Differential, and Innovational" (SRDI) SME of Jiangsu Province: Provincial-level recognition for long-term dedication to the additive manufacturing polymer materials field.
- Suzhou Enterprise Technology Center: Equipped with advanced R&D facilities and a top-tier research team capable of driving cutting-edge technological innovations.
- Suzhou Intellectual Property Key Enterprise: Accumulated 44 patent applications covering 3D printing material formulations, production processes, and application technologies.
- CE / RoHS / SGS Environmental Certifications: All materials comply with international environmental standards, satisfying entry requirements for global markets.
Practical Benefits for Us and Our Customers
- Smoother Customer Audits: During factory inspections by medical device/automotive manufacturers and Tier 1 suppliers, Kexcelled can directly provide dual certification certificates and corresponding system support documentation.
- More Standardized Product Development: The design and development of new products strictly follow the APQP (Advanced Product Quality Planning) process, allowing for rapid response to customized customer needs.
- More Reliable Quality Traceability: Every batch of material dispatched for medical or automotive applications can be traced back to its raw material batch number, production equipment, and inspection records, fully satisfying industry compliance requirements.
Securing this dual certification is a monumental milestone on Kexcelled’s journey toward systematic excellence. Moving forward, the company will continue to focus on two core pillars: product innovation and quality elevation.
In product innovation, we will continue to deeply cultivate the field of additive manufacturing polymer materials, developing higher-performance materials for a broader range of application scenarios to continuously expand the boundaries of 3D printing technology.
In quality elevation, we will adopt ISO 13485 and IATF 16949 as our new management benchmarks, embedding the philosophy of "fully controllable processes, fully traceable batches" into every product and every single procedure.