How is a mock audit different from a gap assessment?

A gap assessment is a collaborative readiness review. A mock audit simulates actual certification audit conditions — formal entry meeting, documented audit trails, audit findings, and nonconformance reports (NCRs).

Does a mock internal audit satisfy ISO 13485 internal audit requirements?

A mock audit conducted by an external consultant does not replace your mandatory internal audit programme. However, it can complement your internal audits by providing an independent view before certification audits.

Will the mock auditor follow the same process as my notified body?

Yes, experienced ISO 13485 lead auditors follow the same clause-by-clause audit approach. Some providers have previous notified body or registrar experience and can closely simulate that audit style.

Book a Mock ISO 13485 Internal Audit (Remote)

Book a mock ISO 13485 internal audit (remote) online. Simulate a notified body or registrar audit and identify gaps before your certification surveillance. Instant pricing.

✓ 3 active providers available right now · USD 809 – 1,001

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What you can compare here

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Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 880	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 1,001	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 809	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

sitesCount (Required)
min 1
auditDays (Required)
1|2|3|5
processCoverage (Required)
core|standard|broad
desiredOutputs (Required)
min 1
buyerNotes (Optional)

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Format

Remote (document + interview)

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Output

Audit report + NCR findings

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Turnaround

10–20 business days

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Pricing

Per scope / per clause set

How it works

1

Describe your QMS scope and certification status

Tell us your device class, QMS scope, notified body or registrar, and when your next surveillance audit is.
2

Compare mock audit providers

View fees from ISO 13485 lead auditors who conduct mock internal audits against your exact certification scope.
3

Receive your audit report with nonconformances

Your auditor delivers an audit report with major/minor NCRs and observations, and a recommended CAPA plan.

How an ISO 13485 certification audit works

ISO 13485 certification is conducted by an accredited third-party certification body (also called a registrar). The process starts with a Stage 1 audit (documentation review — the auditor reviews your QMS manual, key procedures, and scope documentation to confirm readiness for Stage 2). Stage 2 is the on-site or remote audit where the auditor verifies that your QMS is implemented effectively across all required clauses. If no major nonconformances (NCRs) are identified, you are recommended for certification. After initial certification, surveillance audits occur at minimum annually, with a full recertification audit every three years. The mock audit simulates Stage 2 conditions — the most consequential part of the process.

What a mock ISO 13485 audit covers

A comprehensive mock audit reviews all major ISO 13485:2016 clause areas: Section 4 (Quality Management System — documents, records); Section 5 (Management Responsibility — quality policy, planning, review); Section 6 (Resource Management — personnel, infrastructure); Section 7 (Product Realization — design, purchasing, production, calibration, validation); and Section 8 (Measurement, Analysis, Improvement — internal audit, monitoring, CAPA, nonconforming product). The mock auditor selects records to sample, interviews responsible personnel, and identifies gaps in objective evidence — producing formal major and minor NCRs and observations in the same format as your certification body.

Common ISO 13485 NCRs found in mock audits

The most common major nonconformances found during mock ISO 13485 audits include: CAPA processes that do not include effectiveness verification or do not result in systemic corrections; internal audit programs that have not been conducted on schedule or whose records show auditor independence issues; management reviews that lack documented inputs or outputs per clause 5.6; supplier evaluation records that are missing or out-of-date; and design and development records that cannot demonstrate a clear linkage between user needs, design inputs, design outputs, and design verification and validation results. These are the same areas that live certification body auditors target first.

Turning mock audit NCRs into certification success

After a mock audit, prioritize closing major NCRs before your actual certification audit. Major NCRs — those indicating systematic failure of a QMS clause — will prevent certification if found by your registrar. Minor NCRs should be addressed but do not individually block certification. Create a time-bound CAPA for each major finding with a target closure date at least 4 weeks before your scheduled Stage 2 audit, to allow time for implementation evidence to accumulate (e.g., training records showing new procedure adoption). For observations (not formal NCRs), implement improvements where practical but do not delay your audit over them.

Frequently asked questions

How is a mock audit different from a gap assessment?: A gap assessment is a collaborative readiness review. A mock audit simulates actual certification audit conditions — formal entry meeting, documented audit trails, audit findings, and nonconformance reports (NCRs).
Does a mock internal audit satisfy ISO 13485 internal audit requirements?: A mock audit conducted by an external consultant does not replace your mandatory internal audit programme. However, it can complement your internal audits by providing an independent view before certification audits.
Will the mock auditor follow the same process as my notified body?: Yes, experienced ISO 13485 lead auditors follow the same clause-by-clause audit approach. Some providers have previous notified body or registrar experience and can closely simulate that audit style.

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