Procurement Guide
2026-04-18

Three Industry Certifications Compared: IATF 16949 vs AS9100 vs ISO 13485

ISO 9001 is the foundation, but entering high-margin automotive, aerospace, and medical markets requires industry-specific certifications. We compare IATF 16949, AS9100, and ISO 13485 — differences, difficulty, and which supplier size fits each.

Three Industry Certifications Compared: IATF 16949 vs AS9100 vs ISO 13485

"What certifications does our supplier need?" is one of the most common B2B procurement questions. The answer isn't "as many as possible" — it's "the right ones for the right customers".

Common foundation: ISO 9001

All three industry certifications build on ISO 9001. Get 9001 first, then add industry-specific layers.

IATF 16949 — Automotive

Replaced TS 16949 in 2016. Required by Toyota, Ford, VW, GM Tier 1/2 suppliers. Adds: process approach, FMEA, control plans, SPC, PPAP (production part approval), batch traceability. 12-18 months to obtain.

AS9100 — Aerospace

By SAE/IAQG. Standard for Boeing, Airbus, Lockheed supply chains. Adds: product safety, FOD control, key characteristics, AS9102 First Article Inspection, counterfeit parts prevention. 12-24 months — most rigorous of the three.

ISO 13485 — Medical Devices

Required for Stryker, Medtronic, J&J supply chains and EU MDR market access. Adds: ISO 14971 risk management, sterile/clean environments, UDI traceability, adverse event tracking. 9-15 months.

Which to invest in?

Decision driver: customer mix, not technology. Don't invest in IATF if you don't have automotive OEM customers — annual costs add up. Three typical strategies:

  1. Customer concentration in one industry → invest in matching certification
  2. Mixed customer base → ISO 9001 + customer supply-chain coverage (most common for mid-size shops)
  3. Aftermarket only → industry cert pressure low

Weiyon's positioning

ISO 9001 certified. We support automotive Tier 2/3, AS9100 Tier 1 OEM partners, ISO 13485 medical customers, and API/NORSOK oil & gas supply chains via integrated material traceability, FAI reports, and full batch records — the substance behind the certifications.

Call NowGet a Quote
LINE