ISO 13485 (Medical Device Quality)

ISO 13485 certifies a medical-device quality management system with risk-based controls, traceability, and documented processes for regulated manufacturing and suppliers.

Overview

ISO 13485 is a quality management system (QMS) standard tailored to medical devices and related services. It focuses on risk management, documented processes, validation of special processes, traceability, control of outsourced work, and strong corrective/preventive action—aligned to regulatory expectations for consistent, auditable production.

Choose ISO 13485 suppliers when your part, subassembly, or service will be used in a regulated medical device supply chain, especially where you need lot traceability, controlled inspection/measurement, device history records, and change control. It’s common for contract manufacturers, machine shops, injection molders, and sterilization/packaging vendors supporting Class I–III devices.

Tradeoffs: ISO 13485 typically adds overhead—more documentation, longer onboarding, stricter purchasing controls, and formal validation requirements—so unit cost and lead time can increase. The payoff is predictable compliance posture, better audit readiness, and reduced risk when issues or recalls occur.

Common Materials

  • 316L stainless steel
  • Titanium Grade 5
  • PEEK
  • Polycarbonate
  • Aluminum 6061
  • Silicone

Tolerances

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Applications

  • Orthopedic implant components
  • Surgical instrument subassemblies
  • Catheter hubs and connectors
  • Drug-delivery device housings
  • Sterile packaging trays and seals
  • IVD consumable plastic components

When to Choose ISO 13485 (Medical Device Quality)

Choose ISO 13485 when the part will be used in a medical device or IVD product and you need controlled documentation, traceability, and audit-ready manufacturing records. It fits programs with defined quality plans, inspection/verification requirements, and change control that must be sustained across builds and suppliers.

vs ISO 9001 (Quality Management)

Choose ISO 13485 when your customer or regulatory pathway expects medical-device-specific controls like risk management, traceability, and validation of special processes. ISO 9001 can be sufficient for general industrial work, but it often won’t satisfy medical OEM supplier qualification requirements.

vs AS9100 (Aerospace Quality)

Choose ISO 13485 when the end use is a regulated medical device and you need device-history-style records, cleanliness/contamination controls, and medical risk-based quality planning. AS9100 is optimized for aerospace configuration control and airworthiness-driven expectations, which don’t map cleanly to medical regulatory audits.

vs IATF 16949 (Automotive Quality)

Choose ISO 13485 for medical programs where traceability, documented verification, and controlled changes are geared toward patient safety and regulatory compliance. IATF 16949 is built around high-volume automotive production systems, PPAP-style deliverables, and automotive customer-specific requirements.

vs NADCAP (Special Process)

Choose ISO 13485 when you need a compliant medical QMS across the full operation (purchasing, inspection, training, traceability, nonconformance, CAPA). NADCAP is targeted to specific special processes; it may be required for aerospace primes but doesn’t replace medical-device QMS expectations.

vs ISO 14001 (Environmental Management)

Choose ISO 13485 when quality system controls and medical traceability are the driver. ISO 14001 focuses on environmental management and sustainability controls; it can be complementary but won’t qualify a supplier for medical device quality requirements on its own.

Design Considerations

  • Define traceability expectations upfront (lot/serial level, material certs, traveler requirements, and record retention period).
  • Call out inspection requirements clearly (critical dimensions, sampling plan, gage R&R expectations, CMM reports, or first-article format).
  • Control changes with clear revision rules (drawing rev, approved alternates, and deviation/waiver process).
  • Specify cleanliness, handling, and packaging requirements (particulate limits, ESD, cleanroom needs, double-bagging, labeling).
  • Identify any special processes that require validation (bonding, welding, cleaning, sterilization, coating) and who owns the validation package.
  • Provide complete device/customer requirements at RFQ (UDI/labeling text, material/biocompatibility constraints, and acceptance criteria) to avoid re-quoting and delays.