Can Neway provide inspection reports that comply with specific standards?
At Neway, we fully understand that precision manufacturing is only one part of the equation for highly regulated industries. The ability to provide comprehensive, traceable, and fully compliant inspection documentation is equally critical. We can unequivocally state that yes, Neway provides detailed inspection reports that rigorously comply with the stringent requirements of both the aerospace and medical industries. Our quality management system and metrology processes are designed to meet and exceed these exacting standards.
Adherence to Aerospace Standards (AS9100 & NADCAP)
The aerospace sector demands an uncompromising commitment to quality, traceability, and failure prevention. Our processes are aligned to support these requirements.
1. AS9100 Quality Management System
Our operations are underpinned by an AS9100-compliant quality system. This framework ensures that every step, from initial Precision Machining Service to final inspection, is controlled, documented, and repeatable. An inspection report for an aerospace component will include:
Full Part Number and Revision Traceability: Linking the part directly to the approved engineering drawing.
Raw Material Certification: Mill certificates for materials like Titanium CNC Machining alloys or Superalloy CNC Machining stock, verifying composition and properties.
First Article Inspection (FAI) per AS9102: Comprehensive reports that validate every design characteristic on the first part produced, which is often essential for CNC Machining, Prototyping, and new production runs.
Certificate of Conformance (C of C): A formal declaration that the part meets all specified requirements.
2. Specialized Process Validation
For critical aerospace components, our reports document compliance with specific standards. This includes verification of special processes, which are often scrutinized under NADCAP (National Aerospace and Defense Contractors Accreditation Program) audits. This covers details for processes performed on parts from our Multi-Axis Machining Service, as well as specific heat treatment or coating specifications.
Compliance with Medical Device Regulations (ISO 13485 & FDA)
The medical device industry requires a rigorous quality system that focuses on patient safety, with a complete device history and thorough validation.
1. ISO 13485 Quality Management System
Our quality system is designed to meet the ISO 13485 international standard for medical devices. Inspection reports for medical components, such as those for Medical Device applications, are part of a controlled Device History Record (DHR) and include:
Unique Device Identification (UDI) Traceability: Where required, facilitating tracking throughout the supply chain.
Biocompatibility Material Verification: Certificates for materials such as stainless steel SUS316L or implant-grade Ti-6Al-4V ELI (Grade 23), confirming they meet relevant ISO and ASTM standards.
Dimensional Reports with Cpk Analysis: For critical features, we provide statistical process control data to demonstrate that the manufacturing process is stable and capable over time, which is crucial for the Mass Production Service of medical components.
Cleanliness and Packaging Verification: Documentation certifying that parts were cleaned and packaged in a controlled environment to prevent contamination.
2. Validation for Sterilization and Function
Our reports can also validate post-processing steps crucial to the function of medical devices. This includes documentation for surface finishes that ensure cleanability, such as Electropolishing for Precision Parts, or coatings that enhance performance.
The Structure of Our Compliant Inspection Reports
A typical standards-compliant report from Neway is not merely a list of dimensions. It is a comprehensive package that provides full traceability and proof of conformity, which is also vital for sectors such as automotive and Power Generation.
Cover Page: With company information, part details, and a signature of approval from a certified quality engineer.
Summary of Processes: A listing of all manufacturing and CNC Part Polishing Service steps performed.
Detailed Dimensional Data: Often supported by layout sheets with ballooned drawings and actual measurement values, linked to the specific inspection equipment used (e.g., CMM, optical comparator).
Supporting Certifications: Material certificates, heat treat records, and surface treatment certifications (e.g., for anodizing) are included as appendices.
Non-Conformance Reporting: In the rare event of a discrepancy, it is documented in accordance with standard procedures, along with clear containment and disposition actions.
In conclusion, our commitment to quality extends far beyond the machine shop. We provide the robust, audit-ready documentation that aerospace and medical clients require to meet their regulatory obligations and ensure the utmost safety and reliability in their products.
