Certifications
Two quality systems run our factory: IATF 16949:2016 for automotive and ISO 9001 for general quality management. Medical programs are controlled to IATF 16949-level process discipline. Certificates and scopes are available on request.
IATF 16949:2016
Automotive quality management system — PPAP-style documentation, process control and corrective action across the whole manufacturing chain.
Medical Process Control
Medical device programs run under IATF 16949-level process control — documented process control, traceability and validation for precision medical components.
ISO 9001
Quality management foundation covering design, tooling, molding, inspection and delivery for every program.
Documentation on Request
Certificate copies, scope statements and sample inspection reports shared before you commit — no gatekeeping.
What Our Certifications Cover
IATF 16949:2016 is the automotive sector\u2019s quality management standard, built on ISO 9001 with automotive-specific requirements: product safety, PPAP, control plans, MSA, traceability and supplier management. It governs our automotive molding — interior, exterior and under-hood parts — and is the reason automotive buyers can rely on our dimensional reports and rejection-rate data.
Medical process control applies the same rigor to medical devices: documented process control, risk management, validation and traceability from incoming material to final release. It underpins our precision medtech manufacturing and LSR silicone programs, where batch traceability is not a nice-to-have but a regulatory requirement.
ISO 9001 is the foundation underneath both — documented procedures, internal audits, corrective action and continuous improvement that apply to every project, whatever the industry. Certificates, scope statements and audit history are available on request via the contact page.
How Certifications Affect Your Project
- Automotive: PPAP-style documentation, control plans, in-process sampling and batch traceability on every program.
- Medical: validated processes, material certs to ISO 10993 on request, and full traceability for device manufacturers.
- General: documented inspection data, corrective action on non-conformances, and a controlled change process for tooling and process updates.
- Audits: customer and third-party audits welcome — the systems are live, not shelf decorations.
Certifications matter most when something goes wrong: a field failure has to be traced to a batch, a process change has to be controlled, and evidence has to survive an audit. That is the difference between a certified factory and one that merely prints a logo. For a closer look at how the systems run on the floor, see our quality control page and the company background.
Beyond Certificates: What We Actually Do
A certificate proves a system exists; it does not prove parts are good. That is why certification at MOLDITQUICK sits on top of concrete practice: tooling managed under one accountable system from DFM to first shot, presses from 30 to 260 T run with controlled parameters, CNC holding ±0.005 mm, inserts positioned to ±0.02 mm, and every shipment accompanied by inspection data where requested. The certification baseline among serious Chinese suppliers — ISO 9001 and IATF 16949 compliant, 100+ supported materials — is real, and you should ask to see the scope statement either way.
Documentation Packages by Program Type
| Document | Automotive | Medical | General |
|---|---|---|---|
| Dimensional inspection report (full drawing) | Every batch | Every batch | On request |
| Material certificate (resin lot) | Yes | Yes + biocompatibility docs where graded | Yes |
| PPAP-style package (control plan, PFMEA, MSA) | Yes | Adaptable | — |
| Process parameter record (temperatures, pressures, cycle) | Yes | Yes | On request |
| Batch traceability (resin lot to press to shipment) | Yes | Required | Yes |
| RoHS / REACH declarations | On request | On request | On request |
Scope statements and certificate copies for both systems are shared before you commit — contact our team with the standard you need evidence against.
Frequently Asked Questions
Can you share your certificate copies?
Yes — certificate copies and scope statements are provided on request, before you commit, along with sample inspection reports.
Do you support customer audits?
Yes. Our IATF 16949 and ISO 9001 systems are live and audited; customer and third-party audits are welcome.
Which certification applies to my part?
Automotive parts run under IATF 16949, medical under IATF 16949-level process control, and all projects under ISO 9001. Mixed programs are handled under the strictest applicable system.
Is your medical molding cleanroom?
Medical components are molded under IATF 16949-level process control-aligned process control with controlled handling and packaging; confirm cleanroom classification requirements in your RFQ and we will scope them.