INTERNAL AUDIT • MDSAP • QMSR
Internal audits that test how your system actually performs
Our ISO 13485 internal audits and MDSAP readiness reviews examine how processes work together, product risk and the effectiveness of corrective actions. We turn the evidence into clear findings and priorities your team can act on.
The right fit
Who this service is for
- Medical device manufacturers preparing for MDSAP or FDA QMSR inspections
- Organizations needing an independent annual or internal audit of individual processes
- Manufacturers transitioning from ISO 9001:2015 to ISO 9001:2026
- Organizations integrating quality, environmental and occupational health and safety systems
Scope & expertise
What we can assess or deliver
- ISO 13485:2016 process and regulatory internal audits, including design controls where applicable, supplier controls, production, complaint handling and CAPA
- MDSAP readiness assessment using applicable jurisdictional requirements and the process approach to auditing
- FDA QMSR gap reviews against applicable 21 CFR Part 820 and incorporated ISO 13485 requirements
- ISO 9001:2015 / 2026 transition gap assessments and process audits
- ISO 14001:2026 and ISO 45001:2018 internal audits, including operational controls and compliance evaluation
- Targeted follow up audits to verify implementation and effectiveness of previous actions
A clear way forward
How the engagement works
Scope and independence
Confirm products, sites, regulatory markets, applicable standards, audit objectives, and conflicts.
Plan around risk
Prioritize processes with higher risk, recent complaints, supplier performance and significant changes.
Review the evidence
Interview process owners, sample records, trace actual transactions and observe operations where needed.
Actionable report
Issue clear findings, objective evidence, associated requirements and practical improvement opportunities.
Follow up
Where commissioned, review corrective actions and sample evidence of effectiveness.
Tangible deliverables
Typical project outputs
- Agreed audit objectives, scope and agenda
- Process evidence and concise nonconformity statements
- Prioritized audit report with strengths, gaps and risk considerations
- Optional CAPA follow up and management briefing
Remote auditing can reduce cost for document review processes, but physical manufacturing controls may require onsite verification.
Start a conversation
Request a tailored proposal
Only company name, contact person and email are required. Choose the options that apply; there is no need to write a lengthy specification.