ISO 13485:2016
ISO 13485 Quality Management System
A medical-device QMS that passes audits — built around how your team actually works.
What you get
- Quality Manual & documented procedures
- Design & Development controls (Clause 7.3)
- Risk-based supplier qualification
- CAPA, NCR & internal audit programs
- Management Review & KPI dashboards
- Document & Record control (eQMS support)
- Training matrix & competency records
- Post-market & complaint handling procedures
Our Process
01
Gap Analysis
Audit current state vs ISO 13485:2016
02
QMS Design
Tailored procedures, forms & SOPs
03
Implementation
Roll-out, training & internal audit
04
Certification
Stage 1 & 2 audit support
Frequently Asked Questions
From scratch, typically 6–9 months including Stage 1 + Stage 2 audits. Existing ISO 9001 systems can transition in 3–4 months.