ISO 13485 QMS Setup & Optimization
We design, implement and improve quality systems that auditors respect and teams can run - from first certification through scale-up and remediation.
Where we help
New implementation: blueprint, documentation set, records, and certification preparation.
Scale-up & optimisation: streamline processes, close gaps, align multi-site operations.
Remediation: post-audit findings, CAPAs, and rapid stabilisation.
Integration: risk (ISO 14971), usability (IEC 62366), software (IEC 62304), and regulatory route (UKCA/MDR).
Outcome: a robust QMS with clear ownership, usable records, and predictable audits.
Scope
We tailor depth and tools to your environment (cloud, on-prem, PLM/ALM, GxP where needed).
- Quality Manual & Policy
- Design & Development control (requirements, reviews, traceability)
- Risk management linkage (ISO 14971)
- Supplier management (qualification, monitoring, re-evaluation)
- Document & record control (lifecycle, permissions, retention)
- Training & competence (roles, curricula, effectiveness)
- CAPA & nonconformance (root cause, effectiveness checks)
- Complaints, vigilance & field actions
- Change control (engineering, software, labelling)
- Internal audit & management review
- Metrics & dashboards (leading/lagging indicators)
- Data integrity & traceability (where applicable: Annex 11/Part 11)
Two delivery models
Model A - Full Implementation
System design workshops → process map → documentation set
Tools setup (Drive/SharePoint/PLM/ALM) and permissions
Training, pilot run, first internal audit & management review
Certification preparation (evidence tour, mock interviews)
Model B - Optimisation & Remediation
Gap assessment against ISO 13485 + inspector expectations
Rewrite/trim/add procedures where needed; normalise records
Close findings with documented CAPAs and effectiveness checks
Stabilise metrics; prepare for surveillance/recertification
Implementation approach
Define
Current state, sites, systems, roles, regulatory scope; agree on metrics.
Build
Write/optimise procedures, configure forms and records; align design files and risk.
Embed
Train by role, pilot, run internal audit & management review, finalise evidence pack.
Deliverables
Quality Manual and procedure set (editable)
Records & forms aligned to your workflow/tools
Process map & RACI (who owns what)
Audit evidence pack (what to show, in what order)
Training sessions & recordings
90-day operating plan (cadence for reviews, audits, metrics)
FAQs
Yes. We design the system, deliver documents and records, train teams, run the internal audit and management review, and prepare you for the external audit.
Absolutely. We preserve what works, fix what doesn’t, and close gaps. We can operate within your tools (Drive, SharePoint, PLM/ALM) and existing templates.
Yes. We align ISO 13485 with ISO 14971, IEC 62366 and IEC 62304 so traceability and evidence flow cleanly.
We implement complaint handling and post-market processes that satisfy regulators and are practical to operate, including escalation and effectiveness checks.
We agree a realistic RACI. Typical cadence: short workshops, document reviews, then training and a pilot. We can carry more load if capacity is tight.
Yes. We provide periodic internal audits, management review support, CAPA coaching, and updates as products and regulations evolve.
As standard, all documents are client-owned and delivered in editable form.
