Certifications
Three quality systems run our factory: IATF 16949:2016 for automotive, ISO 13485 for medical devices and ISO 9001 for general quality management. 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.
ISO 13485
Medical device quality management — 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.
ISO 13485 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: molds built in our own tool shop, 21 Sodick injection machines run with controlled parameters, CNC holding ±0.005 mm, inserts positioned to ±0.02 mm, and every shipment accompanied by inspection data where requested. For comparison, First Mold describes itself as ISO 9001 certified and IATF 16949 compliant with 100+ supported materials (firstmold.com) — the certification baseline among serious Chinese suppliers is real, and you should ask to see the scope statement either way.
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, ISO 13485 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 ISO 13485, 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 ISO 13485-aligned process control with controlled handling and packaging; confirm cleanroom classification requirements in your RFQ and we will scope them.