Vendor Audits That Actually Reduce Your Work

Vendor audits often feel like an obligation that produces binders—yet the

documentation rarely lines up with your intended use. You still run redundant

tests, rewrite SOPs, and scramble during inspections.

This playbook makes audits deliver operational value. We will set a risk-based

scope, map SOC/ISO evidence to your controls, and execute gap actions so you can

reuse vendor documentation confidently.

Why it matters

Regulators expect you to understand how supplier controls protect your products.

When vendor documentation does not match your use case, auditors conclude you are

not in control—leading to findings, delays, or forced revalidation. A smart audit

program saves time, strengthens compliance, and builds a cooperative relationship

with vendors.

The playbook

1. Audit scope

• Define scope based on intended use, criticality, previous issues, and

regulatory exposure. Differentiate between desk reviews, virtual walkthroughs,

and on-site audits.

• Use scoping templates to capture systems, data flows, change frequency, and

third-party dependencies. Engage Quality, IT, and business owners so no

assumptions stay hidden.

• Communicate scope and expectations to the vendor 30 days in advance. Provide

them with the agenda, evidence request list, and scoring rubric so they can

prepare meaningful responses.

2. SOC and ISO mapping

• Analyze vendor SOC2, ISO 13485/27001, or equivalent certifications. Map

controls to your risk assessment, highlighting what is covered, partially

covered, or out of scope.

• Request evidence for controls most relevant to your intended use—e.g., change

management, data integrity, incident response. Document traceability from the

vendor control to your requirement.

• Record test periods and sample sizes from the reports so you understand how

fresh and robust the evidence is. Capture open remediation commitments.

3. Gap actions

• For each gap, specify mitigations: additional vendor testing, delta testing

by you, configuration changes, or contractual clauses.

• Assign owners, timelines, and acceptance criteria. Integrate gap actions with

your CAPA or change-control system to ensure closure.

• Reassess residual risk once actions are complete and update the supplier

assurance scorecard.

Q&A highlights

• Can we accept vendor testing? Yes—when you can justify that it covers your use

case and you execute targeted delta tests.

• Evidence package essentials? Certificates, audit reports, change notices,

incident history, and control mappings aligned to your risk assessment.

• How often? Risk-based cadence: annually for high-risk systems; every

2–3 years for lower-risk, with interim evidence reviews.

Metrics and signals

Track time from audit close to action completion, number of residual gaps, and

reduction in duplicate testing. Monitor inspection questions about supplier

controls—fewer inquiries indicate regulators trust your approach.

30-day action plan

• Catalog critical vendors and rate them by risk, intended use, and regulatory

impact.

• Develop or refresh the scoping template and share it with stakeholders for

alignment.

• Pilot the refined audit on a moderate-risk vendor, documenting control mapping

and resulting gap actions.

Common pitfalls to avoid

• Copying generic checklists that ignore your specific use case.

• Accepting certificates without checking test scope and dates.

• Letting gap actions languish in spreadsheets with no ownership.

• Failing to update service agreements to reflect required controls.

Sustain the win

Review supplier assurance metrics quarterly, refresh mappings after system or

regulatory changes, and rotate audit leads to broaden expertise. Share success

stories—such as reduction in duplicate testing—to keep leadership support strong.