Quality assurance
Medical and aerospace systems, in parallel
Two quality systems running in parallel, on metrology capability built up continuously since 2006.
Quality assurance
Medical and aerospace systems, in parallel
Medical device and aerospace quality systems have run in parallel for years. They make different demands on documentation, traceability and change control — satisfying both means the process runs to whichever is stricter.
| Standard | Scope | Held since |
|---|---|---|
| ISO 9001 | Quality management system | 2005 |
| AS9100 | Aerospace quality management system | 2008 |
| ISO 13485:2016 | Medical device quality management system | 2019 |
Metrology has been built up since the first semi-automatic CMM in 2006, followed by an in-house calibration centre in 2009 and a materials testing laboratory in 2010. Series production begins only after a full-dimension first-article report is signed off.
Building the quality system
- 2005First overseas shipment; ISO 9001 and ERP adopted
- 2006First semi-automatic CMM
- 2008AS9100 aerospace quality system adopted
- 2009Entered the medical sector; calibration centre established
- 2010Materials testing laboratory and in-house R&D centre established
- 2011Horizontal machining centres; named a Jiangsu High-Tech Enterprise
- 2017Nanjing surface treatment plant opened and AS9100-certified; Shengpu plant opened
- 2019ISO 13485:2016 certification achieved; New Hongji Training School founded
- 2021Asia's first high-mix low-volume flexible intelligent production line commissioned
Drawing to despatch, in five steps
Drawing & requirement review
- 01
Drawing & requirement review
Engineering reviews tolerances, material and finish requirements, confirms manufacturability and proposes process routes.
- 02
Quotation & process plan
A quotation accompanied by the machining route, fixturing approach and inspection method — not just a price.
- 03
First article & validation
Full-dimension first-article inspection, reported and signed off before series production begins.
- 04
Series production & process control
Scheduled on the flexible line, with AHP quality software across production and QA, and full traceability.
- 05
Finishing & final inspection
Anodising and other finishing in our own plant, then final inspection, packing and despatch.
Send us the part nobody else will quote
Thin walls, slender shafts, awkward geometry, micron tolerances. This is the work we have been doing for thirty-four years.
- Phone
- 0512-65916861
- sales@new-hongji.com
- Address
- No. 14 Xiangpu Road, Suzhou Industrial Park, Jiangsu, China