ISO 13485 Implementation That Fits Your Team
A quality management system (QMS) built for your size: documented, operational, audit-ready.
Scope
What’s Included
- QMS gap analysis
- Quality manual and procedures
- Process mapping
- Document control
- Internal audit preparation
- Management review setup
- Certification readiness assessment
- CAPA (corrective and preventive action) system
Fit
Who It’s For
- Companies pursuing their first certification
- Teams transitioning from ISO 9001
- Companies entering the medical device sector
Deliverables
What You Receive
- A compliant, operational QMS
- Documented procedures
- A quality manual aligned with MDR 2017/745
- Audit-ready documentation
Limits
What’s Not Included
- The certification audit itself — performed by your certification body
- A permanent quality manager role — available as a separate arrangement
- Product-specific technical documentation — see Technical Documentation
Timing
Indicative Timelines
Typically 3–6 months to an audit-ready QMS, depending on your starting point and team availability.
Ready to Build Your QMS?
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Regulatory information last reviewed: 10 August 2026