What to Check for a CNC Supplier’s ISO 13485 Certification? Avoid Compliance Fraud

Created on 10.11

For mechanical engineers, design engineers, and procurement managers in medical device R&D—from diagnostic instruments to orthopedic tools—ISO 13485 certification isn’t just a “nice-to-have”: it’s a regulatory must. But not all “ISO 13485-certified” CNC suppliers are legitimate. Some use expired certificates, generic credentials (that don’t cover CNC machining), or even fake documents—putting your medical parts at risk of non-compliance, product recalls, or delayed market launches. To protect your project, here are 4 critical things to verify, plus how Marigold Rapid (www.marigold-rapid.com) proves its authentic ISO 13485 status.​

1. Check Certification Validity & Authorized Issuer​

A valid ISO 13485 certificate needs two key elements—active expiration date and recognized certification body:​

Expiration Date: Avoid suppliers with “expired 6+ months” certificates or vague “renewal pending” claims. Ask for a copy showing the current validity period (typically 3 years) and latest renewal date.

Authorized Issuer: Only trust certificates from globally recognized bodies like SGS, BSI, or DNV. Unheard-of local issuers (e.g., “China Local Quality Institute”) often issue unaccredited credentials.

Marigold Rapid’s ISO 13485 certificate is issued by SGS (a top global auditor) and valid through 2026—we share the full, verifiable document upfront (not just a cropped photo).​

2. Confirm the Scope Covers “CNC Machining for Medical Parts”​

Many suppliers have ISO 13485—but their certification scope excludes CNC machining, or only covers “assembly” (not part production). For example:​

A supplier with scope “medical device assembly” can’t legally claim ISO 13485 for CNC-machined orthopedic brackets.

How to Verify: Look for the “Scope” section on the certificate—must include phrases like “custom CNC machining of medical device components” or “precision CNC parts for orthopedic instruments.”​

Our ISO 13485 scope explicitly covers “CNC milling, turning, and finishing of medical/orthopedic CNC parts”—matching your exact needs.​

3. Ask for Recent Surveillance Audit Reports​

ISO 13485 isn’t a one-time award: suppliers must pass annual surveillance audits to maintain certification. These reports reveal if the supplier actually follows the standard (not just “earned the certificate once”):​

Check for “non-conformities” (e.g., poor material traceability for CNC parts) and how they were fixed.

Avoid suppliers who refuse to share audit reports—this is a red flag for “paper-only” compliance.

Marigold Rapid provides our 2024 SGS surveillance audit report on request, showing zero major non-conformities and full compliance with medical CNC process rules.​

4. Validate “Certification vs. Practice” (Don’t Stop at the Paper)​

The biggest risk is “certificate fraud”—suppliers have the document but ignore ISO 13485 in daily production. To test this:​

Ask for material traceability records: ISO 13485 requires batch-level tracking for medical CNC parts (e.g., 316L stainless steel for surgical tools). A legitimate supplier will share CoCs (Certificates of Conformance) linked to your order.

Inspect process controls: Ask how they monitor CNC machining parameters (e.g., cutting speed for titanium parts) to ensure consistency—ISO 13485 mandates documented process checks.

At Marigold Rapid, every medical CNC order includes:​

Traceability docs for raw materials (linked to ISO 13485 requirements).

CNC process logs (e.g., coolant levels, tool changes) to prove compliance.

Why Marigold Rapid’s ISO 13485 Certification Is You Can Trust​

We built our medical CNC service around genuine compliance—not just a certificate:​

SGS-issued, scope-aligned certification: Covers all medical CNC processes you need.

Transparent proof: Share full certificates, audit reports, and traceability docs upfront.

Practice matches paper: Our CNC shops follow ISO 13485 checklists for every order (e.g., separate workstations for medical vs. non-medical parts to avoid contamination).

For medical device teams tired of compliance fraud, Marigold Rapid is your reliable partner. Contact us today to review our ISO 13485 credentials and discuss your medical CNC part needs!