Flat-Fee · QMSR & ISO 13485
A QMS gap assessment identifies exactly where your quality system documentation and records fall short of QMSR (21 CFR Part 820) and ISO 13485:2016 requirements — before an FDA inspector or ISO auditor does. Two flat-fee stages. Published pricing. Remote delivery standard.
Start the Gap AssessmentPublished Pricing
Both stages are flat-fee, published, and delivered remotely. Stage 1 reviews your documents. Stage 2 goes deeper into your records. Neither bills hourly.
Stage 1: Documentation & Forms Gap Assessment
flat fee · approximately 1.5 assessment days · remote
This stage answers: do our documents meet the requirements?
Stage 2: Records-Level Deep-Dive Assessment
flat fee · 2 to 3 assessment days · remote
This stage answers: do our records prove we follow the procedures?
Choosing the Right Stage
The two stages address different questions. Understanding which one fits your situation takes about two minutes.
Stage 1 is the starting point for most companies. It reviews your quality manual, SOPs, work instructions, and forms clause by clause against QMSR and ISO 13485. It answers: do our documents say the right things?
Stage 1 is appropriate when you are building or updating your QMS, preparing for an initial ISO 13485 certification audit, or simply want to know your document-level gaps before committing to remediation.
Stage 2 goes beyond the documents to ask: do the records prove the procedures are being followed? It includes everything in Stage 1, plus sampling and review of records across CAPA, complaints, supplier qualification, training, and device history files.
Stage 2 is appropriate for companies preparing for an FDA inspection, an ISO surveillance audit, or those responding to a prior audit finding that procedures exist but are not consistently followed.
Additional Services
The gap assessment identifies what needs to change. The services below address the work that follows. Each is scoped and quoted separately based on what the report finds.
These services are quoted after the gap assessment report, when the scope is defined. No dollar amounts are published here because the right scope depends on what the report finds.
Assessment Scope
The assessment reviews your quality system against the clause structure of QMSR (21 CFR Part 820) and ISO 13485:2016. The clause areas below define the scope of review.
Common Questions
A QMS gap assessment is a systematic review of your quality management system against the requirements of QMSR (21 CFR Part 820) and ISO 13485:2016. The assessment identifies where your quality system documentation, procedures, and — at the records level — your implementation fall short of regulatory expectations. The output is a written report with findings classified by severity and a prioritized corrective action matrix.
QMSR is FDA's revised Quality System Regulation — 21 CFR Part 820 — which took effect February 2, 2026. The revision substantially harmonizes the US regulatory requirement with ISO 13485:2016 by incorporating ISO 13485 by reference. Devices marketed in the US must comply with QMSR; ISO 13485 certification is required for CE marking and market access in many other jurisdictions. Companies pursuing both US and international markets typically address both frameworks in the same gap assessment.
Stage 1 answers the question 'do our documents meet the requirements?' — it is a review of your quality manual, SOPs, and forms against QMSR and ISO 13485 clause by clause. Stage 2 answers 'do our records prove we follow the procedures?' — it adds sampling and review of records such as CAPAs, complaints, nonconformances, training records, supplier files, and device history records. Most companies start with Stage 1; companies preparing for an FDA inspection, ISO audit, or responding to prior findings typically need Stage 2.
Yes. Both Stage 1 and Stage 2 are conducted remotely — your documentation and records are shared securely, reviewed off-site, and findings are delivered in a written report with a review call included. On-site assessment is available for companies that prefer it or have documentation that cannot be shared electronically; travel and expenses are billed at cost and quoted before engagement.
Stage 1 is approximately 1.5 assessment days and the written report is typically delivered within two to three weeks of kickoff. Stage 2 takes two to three assessment days and report delivery is typically three to four weeks from kickoff, depending on the volume of records sampled. The timeline is confirmed at kickoff based on your current documentation and the scope of records access.
Both stages deliver a written gap assessment report with findings classified by severity — major gap, minor gap, or opportunity for improvement — and a prioritized corrective action matrix identifying what needs to change and in what order. Stage 2 additionally includes record-level findings showing whether procedures are implemented and effective. The report is designed to serve as your internal remediation roadmap and to demonstrate to an auditor that gaps have been identified and addressed.
Get Started
Submit your details and we will confirm the right stage and next steps within one business day.
Sending your request…
Or reach us directly: (888) 450-8607 · info@adbccro.com
Not Sure Where to Start?
A free 20-minute call covers where your QMS stands, what an FDA inspector or ISO auditor would look at first, and whether Stage 1, Stage 2, or a different service fits your situation.