Types of Regulatory Audits: 12 Examples and What to Expect

Regulatory audits can feel like a maze: different acronyms, shifting rules, and competing demands from customers, regulators and certification bodies. You’re asked for “evidence” before you’ve agreed the scope, you’re unsure who will actually turn up (customer assessor, regulator, or a certification body), and you need to know what “good” looks like so you can plan, budget and keep operations moving. Get it wrong and you face fines, shipment delays, stalled sales, or safety risks; get it right and you unlock trust, smoother contracts, and fewer fire drills.

This guide cuts through the noise with a clear, practical overview of 12 common regulatory audit types—covering dangerous goods transport (IATA/IMDG/ADR/RID), UK GDPR/Data Protection Act, ISO 27001, PCI DSS, SOC 1/2, SOX/statutory, health and safety (HSE/OSHA), environmental (Environment Agency/SEPA), AML (FCA/PRA, MLR 2017), HMRC tax, healthcare (HIPAA/NHS DSP Toolkit), and quality/GMP (ISO 9001, GxP). For each, you’ll learn the purpose and scope, who conducts it (first‑/second‑/third‑party), who it applies to, what the process involves, the evidence and deliverables to expect, and the essentials to prepare with confidence.

1. Dangerous goods transport compliance audits (IATA/IMDG/ADR/RID)

These audits confirm that dangerous goods are classified, packaged, marked/labelled, documented, handled and transported in line with the modal rules: IATA Dangerous Goods Regulations (air), IMDG Code (sea), ADR (road) and RID (rail). They reduce safety risk, prevent shipment delays, and demonstrate due diligence to regulators and customers.

Purpose and scope

Audits assess end‑to‑end compliance across shipments and support processes: training, procedures, supplier control, documentation, storage/segregation, incident handling and record‑keeping against the applicable code(s).

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal audits by shippers, freight forwarders, carriers or warehouse operators.
• Second‑party: Customer or prime‑contractor audits of their logistics partners.
• Third‑party: Independent compliance auditors; plus oversight inspections by competent authorities.

Who it applies to

Any organisation that ships, receives, stores, consolidates, loads, unloads or transports dangerous goods by air, sea, road or rail, including manufacturers, e‑commerce fulfilment, 3PLs, carriers and integrators.

What the audit process looks like

Auditors typically confirm scope, review documents, interview process owners, observe activities and sample shipments. Expect checks against the relevant modal rules and follow‑up on previous findings, with testing of both routine and exception handling.

Evidence and deliverables

• Typical evidence: DG policies/procedures, training records, shipment files (e.g., declarations, manifests), packaging evidence, SDS references, marking/labelling photos, segregation/stowage records, incident logs and internal audit reports.
• Deliverables: A written report highlighting conformities, nonconformities and recommendations, plus an agreed corrective action plan.

Preparation essentials

• Map scope to modes: Identify which rules apply (IATA, IMDG, ADR, RID) and where in your process they bite.
• Prove competence: Keep training current and documented; maintain clear roles and responsibilities.
• Make evidence findable: Organise recent shipment files and records; ensure version‑controlled procedures match practice.
• Close the loop: Track previous actions and show effective remediation.
• Run a rehearsal: Perform an internal readiness review using the same steps auditors will take.

2. Data protection and privacy audits (UK GDPR/Data Protection Act)

These audits test how your organisation collects, uses, shares and protects personal data against the UK GDPR and the Data Protection Act 2018. They focus on lawfulness, transparency, data minimisation, security controls, people’s rights, supplier oversight and breach handling — the foundations for avoiding penalties and maintaining customer and employee trust.

Purpose and scope

Audits assess whether your governance and day‑to‑day processing align with statutory requirements and your own policies. Expect attention on accountability (roles, ROPA), legal bases, privacy notices, data subject rights, retention/deletion, incident response and security over systems supporting processing.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal compliance or audit teams performing readiness reviews.
• Second‑party: Customer/vendor due diligence over processors and sub‑processors.
• Third‑party: Independent assessors; and regulatory audits or assessments by the Information Commissioner’s Office (ICO).

Who it applies to

Controllers and processors handling personal data about individuals in the UK — across every sector, including logistics providers, shippers and carriers processing customer, consignor and employee information.

What the audit process looks like

Following a standard compliance flow, auditors confirm scope, review documentation, interview process owners, observe key activities and test samples. Typical testing covers records of processing, privacy notices, DSAR workflows, DPIAs, retention and deletion evidence, supplier contracts, training completion, breach logs and selected technical/organisational controls. A draft report is reviewed before finalisation and follow‑up.

Evidence and deliverables

• Typical evidence: ROPA, privacy notices, lawful basis registers, DPIAs, DSAR logs, retention schedules, deletion proofs, incident/breach registers, processor agreements with data protection clauses, training records and internal audit reports.
• Deliverables: Findings with risk ratings, remediation actions and timelines; in regulator‑led work, a formal letter/report with required actions.

Preparation essentials

• Inventory and map: Keep an accurate, current ROPA and data flows.
• Prove lawfulness: Document legal bases and link them to notices and forms.
• Rights readiness: rehearse DSARs end‑to‑end; track deadlines and outcomes.
• Tidy retention: Apply schedules consistently; evidence deletion.
• Govern suppliers: Ensure contracts, due diligence and monitoring are complete.
• Train and test: Maintain training records; run an internal audit to close gaps before the real one.

3. Information security certification audits (ISO/IEC 27001)

ISO/IEC 27001 audits assess whether your information security management system (ISMS) is designed and operating effectively to manage risks to information assets. Beyond winning a certificate, these types of regulatory audits build stakeholder trust and often accelerate sales by evidencing mature security and governance.

Purpose and scope

The audit tests your governance, risk management and control execution against ISO/IEC 27001 requirements. Expect focus on ISMS scope, roles and accountability, risk assessment and treatment, policies and procedures, training and awareness, supplier oversight, incident management, and evidence that controls operate as intended.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal audits to check readiness and continual improvement.
• Second‑party: Customer/security due‑diligence over suppliers and processors.
• Third‑party: Independent auditors from certification bodies performing the formal certification audit.

Who it applies to

Any organisation seeking formal recognition of its ISMS. ISO audits are optional, but ideal for businesses that operate internationally, certify against multiple ISO frameworks, or are required by customers or partners to demonstrate robust security.

What the audit process looks like

Auditors confirm scope and plan, review documentation, interview control owners, observe processes, and test samples of control operation. Procedures generally follow the familiar flow of document review, walkthroughs, inspection and re‑performance where feasible, followed by a written report, management responses and a certification decision.

Evidence and deliverables

• Typical evidence: ISMS scope and policy, risk assessment/treatment records, security and acceptable‑use policies, access/change control artefacts, training and awareness logs, supplier due‑diligence and contracts, incident and corrective‑action records, internal audit reports and management review minutes.
• Deliverables: An audit report with findings and improvements; where requirements are met, a certification for the defined ISMS scope.

Preparation essentials

• Pin down scope: Define boundaries, assets and interfaces so evidence aligns to the audited ISMS.
• Prove accountability: Maintain clear roles, competencies and up‑to‑date training records.
• Show your risk engine: Keep risk registers current and link treatments to live controls.
• Evidence operation: Retain logs and artefacts (with log retention set to at least 366 days); ensure procedures match practice.
• Assure before you certify: Run internal audits and track corrective actions to closure; bring previous findings and remediation proof to the table.

4. Payment card data security audits (PCI DSS)

PCI DSS audits verify that your controls for handling cardholder data are designed and operating effectively to reduce fraud and protect customers. The PCI Security Standards Council was formed by the major card brands in 2006, and PCI DSS v4.0 is now the expected baseline (with v3.2.1 sunset by 2024), shaping how these assessments are conducted.

Purpose and scope

Audits examine your end‑to‑end payment processing: governance, policies, user access, change control, logging, risk management, incident response, supplier oversight and staff training. The aim is to confirm your practices meet the applicable PCI DSS requirements and that gaps are identified and remediated promptly.

Who conducts it (first‑, second‑, or third‑party)

Organisations use a blend of assurance approaches depending on their payment volumes and customer demands.

• First‑party: Internal readiness reviews against PCI DSS requirements.
• Second‑party: Customer or partner assessments of service providers handling payments.
• Third‑party: Independent compliance auditors; for larger programmes a formal external audit is expected.

Who it applies to

Any organisation that accepts, processes, stores or transmits payment card data must comply with PCI DSS. Those processing more than 6 million transactions annually are typically expected to undergo a formal third‑party audit; smaller entities must still maintain compliance even if not formally audited.

What the audit process looks like

Expect an agreed scope, document review, interviews with control owners, observation of key activities and targeted testing of control operation. Auditors sample evidence across policies, access, changes and incidents, follow up on previous findings, issue a draft report for comment, then finalise outcomes and actions. Some assessments require sign‑off by appropriately certified auditors.

Evidence and deliverables

• Typical evidence: Security and acceptable‑use policies, user access and change control records, training logs, incident/breach registers, supplier contracts with security clauses, risk assessments and internal audit reports.
• Deliverables: A written report with nonconformities and recommendations, plus an agreed corrective action plan and timelines; certain assessments require formal sign‑off by qualified third parties.

Preparation essentials

• Know your scope: Map where card data is handled and which systems and partners are in play.
• Align practice to policy: Ensure procedures match reality and records are current and findable.
• Evidence control operation: Retain logs and artefacts (set log retention to at least 366 days).
• Prove competence: Keep role definitions and training records up to date.
• Close prior gaps: Bring previous findings and remediation proof.
• Rehearse: Run an internal readiness review before inviting a third party in.

5. Service organisation control audits (SOC 2 and SOC 1)

SOC reports provide independent assurance over a service organisation’s controls. SOC 1 focuses on controls relevant to clients’ financial reporting (ICFR), while SOC 2 addresses controls aligned to the Trust Services Criteria: Security, Availability, Processing Integrity, Confidentiality and/or Privacy. Both frameworks were developed by the AICPA and help build customer trust and reduce sales friction.

Purpose and scope

SOC 1 attests to controls that could materially affect user entities’ financial statements. SOC 2 evaluates the design and operation of controls supporting the selected Trust Services Criteria. In both cases, auditors examine governance, policies, access and change control, monitoring, incident response, supplier oversight and training, anchored to the stated scope.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal readiness assessments to identify and close gaps.
• Second‑party: Customer due diligence, often requesting the SOC report.
• Third‑party: Independent audit by a firm qualified to issue SOC opinions; only CPAs can sign SOC reports.

Who it applies to

• SOC 1: Service organisations whose services can affect customers’ financial reporting (for example, payroll, transaction processing).
• SOC 2: Service providers to other businesses—especially SaaS and PaaS—seeking to demonstrate robust security and related criteria, or where customers/partners require it.

What the audit process looks like

Auditors confirm scope and criteria, review documentation, interview control owners, observe processes and test samples of control operation. They assess prior findings and remediation and compile a draft for management review before issuing the final report and opinion.

Evidence and deliverables

• Typical evidence: Control matrix and descriptions, security and acceptable‑use policies, user access and change records, logging/monitoring artefacts, incident and corrective‑action logs, supplier due‑diligence and contracts, training records, internal audit reports.
• Deliverables: A SOC 1 or SOC 2 report containing the auditor’s opinion, narrative of the system, tests performed and results, plus findings and recommendations.

Preparation essentials

• Define the system and scope: Services, locations, in‑scope systems and boundaries.
• Pick the right lens: SOC 1 for ICFR impact; SOC 2 for the chosen Trust Services Criteria.
• Map controls to criteria: Ensure policies match practice and controls produce evidence.
• Harden evidence: Retain logs and artefacts (set log retention to at least 366 days).
• Tighten supplier oversight: Contracts and monitoring aligned to your controls.
• Pre‑assess: Run an internal readiness review and close prior findings before the CPA arrives.

6. Financial reporting and internal controls audits (SOX and statutory)

These types of regulatory audits provide independent assurance that financial statements are complete and accurate and that key internal controls over financial reporting (ICFR) are working as intended. For SOX, executives certify the statements, so auditors focus on whether material transactions are reviewed, evidenced, and can be re‑performed to reach reasonable assurance.

Purpose and scope

Audits assess the preparation of financial statements and the effectiveness of ICFR. Scope typically includes significant processes (revenue, purchases, payroll, close and reporting), entity‑level controls, IT‑dependent controls, evidence of review/approval, and how deviations are handled and remediated.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal audit readiness reviews and ongoing testing.
• Third‑party: Independent external auditors (CPAs) issuing the formal audit opinion; compliance audits are performed by independent practitioners and result in a report or opinion.

Who it applies to

Publicly traded companies are audited annually, incorporating Sarbanes‑Oxley requirements. Statutory financial audits also apply where required by law or contract, and involve management and accounting firms engaged to perform the work.

What the audit process looks like

Auditors confirm scope, plan fieldwork, and review prior reports. They examine policies and work papers, interview control owners, observe processes, and test samples (for example, approvals on material transactions and reconciliations). Findings are discussed, management responses captured, and a final report/opinion is issued.

Evidence and deliverables

• Typical evidence: Accounting policies and procedures, control descriptions, approvals for material transactions, reconciliations, close checklists, access/change control artefacts supporting ICFR, training records, incident/deviation logs, and prior remediation evidence.
• Deliverables: A formal audit opinion over the financial statements and, where applicable, over ICFR; plus a report highlighting nonconformities and recommendations for improvement.

Preparation essentials

• Map critical processes: Identify significant accounts, related controls and where evidence is generated.
• Prove it happened: Retain clear, retrievable evidence of review and approval so auditors can independently replicate checks.
• Align policy and practice: Ensure procedures reflect how work is actually done; version‑control documents.
• Close prior gaps: Track corrective actions and be ready to show effectiveness.
• Rehearse internally: Run an internal audit against the planned scope to surface issues early and organise artifacts.

7. Health and safety compliance audits (HSE/OSHA)

Health and safety audits confirm your workplace is safe, well‑managed and compliant with applicable law and policy. Whether you’re in warehousing, manufacturing, transport or office environments, these types of regulatory audits help prevent incidents, protect people and keep operations moving. In the US, OSHA audits are aimed at fostering safe and healthy workspaces and can apply to all employers; UK organisations can expect comparable assurance activity aligned to HSE expectations.

Purpose and scope

Audits assess the adequacy and operation of your health and safety management: governance, policies, risk assessments, training and competence, equipment safety, workplace inspections, incident management and contractor control.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal safety teams or internal audit performing planned audits and walkthroughs.
• Second‑party: Customer audits of suppliers and sites (for example, logistics partners).
• Third‑party: Independent auditors/consultants; regulatory inspections by authorities (e.g., OSHA in the US).

Who it applies to

All employers, including warehouses, fulfilment centres, manufacturers, transport operators, offices and labs — any organisation with duties to protect employees, contractors and visitors.

What the audit process looks like

Auditors agree scope, review documents, interview duty‑holders and supervisors, and observe work areas and tasks. They sample evidence across training, inspections and incidents, follow up on previous actions and issue a draft report for factual accuracy before finalising outcomes and timelines.

Evidence and deliverables

• Typical evidence: H&S policy and procedures, risk assessments and method statements, induction and refresher training records, equipment maintenance/inspection logs, workplace inspection checklists, PPE issuance/records, incident and near‑miss logs, contractor controls and internal audit reports.
• Deliverables: A written report detailing conformities, findings and recommendations, with an agreed corrective action plan; regulator‑led work may set required actions.

Preparation essentials

• Keep it current: Up‑to‑date policies, risk assessments and training records.
• Make it visible: Housekeeping, signage, segregation and emergency equipment in place.
• Evidence maintenance: Retain inspection and servicing records for plant and equipment.
• Control contractors: Clear permits, inductions and supervision.
• Close the loop: Track and evidence remediation of prior findings.
• Rehearse: Run internal audits and safety walkdowns to surface issues before the visit.

8. Environmental compliance audits (Environment Agency/SEPA)

Environmental compliance audits check that operations meet legal and permit conditions for preventing pollution, handling waste, controlling emissions and managing incidents. Whether you run a warehouse with fuel storage, a manufacturing plant, or a distribution site, these types of regulatory audits minimise environmental risk and demonstrate responsible operations to regulators and customers.

Purpose and scope

Audits assess governance, permits and exemptions, operational controls, monitoring and reporting, training and competence, contractor management, incident preparedness and corrective action. Expect attention on storage/segregation, secondary containment, drainage plans, air/water/noise controls, waste classification and off‑site transfers.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal EHS or audit teams performing planned assurance and readiness checks.
• Second‑party: Customer assessments of suppliers/sites for ESG and compliance assurance.
• Third‑party: Independent auditors or consultancy reviews; regulatory inspections by the Environment Agency (England) or SEPA (Scotland).

Who it applies to

Any UK organisation with potential environmental impact or permit obligations: manufacturing, logistics and warehousing, utilities, labs, waste handlers, transport depots and sites storing fuels, chemicals or hazardous waste.

What the audit process looks like

Auditors confirm scope, review documentation, interview site leads and duty‑holders, then walk the site to observe controls. They sample monitoring records, waste movements and maintenance logs, follow up on previous findings and share a draft report for factual review before finalising actions and timelines.

Evidence and deliverables

• Typical evidence: Environmental policy and aspects/impacts register, permits/exemptions and conditions, monitoring plans and results, calibration/maintenance records for control equipment, spill response plans and logs, waste classification and consignment/transfer notes, training/competency records, contractor controls and internal audit reports.
• Deliverables: A written report with conformities, findings and risk‑rated actions; regulator‑led work may stipulate required actions and deadlines.

Preparation essentials

• Map obligations: List permits, limits and reporting duties and link them to controls and owners.
• Make it visible: Clearly labelled storage, intact bunding/secondary containment and clean yards/drains.
• Prove control: Up‑to‑date monitoring, calibrations and maintenance records for abatement and alarms.
• Waste right‑first‑time: Correct classification, secure storage and complete consignment/transfer notes.
• Be incident‑ready: Stocked spill kits, trained responders and exercised plans with logged learnings.
• Close prior actions: Track remediation and bring clear evidence of effectiveness to the audit.

9. Anti‑money laundering and financial services audits (FCA/PRA, MLR 2017)

AML audits check whether your controls to prevent money laundering and terrorist financing are designed and operating as regulators expect. They typically examine governance, risk assessment, customer due diligence, ongoing monitoring, incident handling and record‑keeping. Treated well, these types of regulatory audits strengthen customer confidence and reduce enforcement and reputational risk.

Purpose and scope

Audits assess the adequacy of your financial crime framework across products, channels and jurisdictions: policies, business‑wide risk assessment, onboarding and ongoing due diligence, screening, transaction monitoring, investigations and escalation, staff competence, supplier oversight and the quality of records.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Compliance monitoring and internal audit reviews against AML requirements.
• Second‑party: Customer or partner due diligence over firms providing financial services.
• Third‑party: Independent specialists; plus supervisory reviews and inspections by UK regulators such as the FCA and (for prudential aspects in dual‑regulated firms) the PRA.

Who it applies to

Authorised financial services firms and other entities in scope of AML obligations that handle financial transactions or related services, including institutions relying on partners and outsourced providers.

What the audit process looks like

Auditors confirm scope, review policies and prior reports, interview senior managers and control owners, walk through onboarding and monitoring processes, and test samples of customer files, alerts and escalations. They validate training and oversight, follow up on previous findings, issue a draft for factual accuracy, then finalise actions and timelines.

Evidence and deliverables

• Typical evidence: Financial crime policies and the business‑wide risk assessment, customer files (due diligence and ongoing reviews), screening and monitoring logs, investigation and reporting records, training and competency evidence, supplier oversight files and internal audit/assurance reports.
• Deliverables: A report with risk‑rated findings and an agreed remediation plan; supervisory work may specify required actions.

Preparation essentials

• Keep the risk assessment current: Link inherent risks to controls and monitoring.
• Make files complete: Ensure due diligence, review dates and rationales are documented and retrievable.
• Evidence control operation: Retain monitoring outputs, decisions and quality reviews.
• Prove competence and accountability: Clear roles, training records and management information.
• Tighten partner oversight: Document due diligence and ongoing monitoring of outsourced services.
• Close prior actions: Track remediation to effectiveness before the audit arrives.

10. Tax compliance audits (HMRC)

HMRC tax compliance checks examine whether you have filed correctly, paid the right amount at the right time, and kept sufficient records to substantiate positions taken. Treated as a routine governance activity, these types of regulatory audits reduce financial and reputational risk and keep the focus on running the business.

Purpose and scope

Audits assess the completeness and accuracy of filings and payments and whether underlying records and processes support them. Expect scrutiny of returns, calculations, adjustments, timing of payments, record‑keeping, and how identified errors are corrected and prevented from recurring.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal finance/internal audit readiness reviews before or during an enquiry.
• Third‑party: HMRC compliance checks and investigations as the statutory authority.

Who it applies to

All UK taxpayers — companies and sole traders — can be selected for an HMRC check. Reviews may be random or risk‑based and can cover a specific return, period, topic, or multiple returns.

What the audit process looks like

HMRC notifies scope and requests information. The case officer reviews returns and supporting records, may meet with finance leaders, and tests selected entries and adjustments. They consider any prior issues, evaluate your controls and remediation, then issue a position letter for discussion before closing with outcomes.

Evidence and deliverables

• Typical evidence: Filed returns and supporting computations, accounting records and source documents, payment evidence, reconciliations, board approvals for significant transactions, adviser correspondence, training/Procedure notes, and prior enquiry files.
• Deliverables: A closure letter confirming no further action or a formal assessment detailing under/over‑payments, interest and any penalties, plus agreed corrective actions.

Preparation essentials

• Reconcile and retain: Ensure filings reconcile to ledgers and source documents; make records complete and retrievable.
• Document judgements: Keep clear workings and rationale for estimates and positions.
• Show control: Up‑to‑date procedures, maker‑checker reviews and evidence of timely filings/payments.
• Triage historic issues: Track prior findings and demonstrate effective remediation.
• Nominate a point person: Coordinate responses and keep a log of all HMRC interactions.
• Run a pre‑check: Perform an internal review against the enquiry scope to surface and correct gaps before submission.

11. Healthcare data privacy and security audits (HIPAA and NHS DSP Toolkit)

Healthcare audits focus on how organisations protect sensitive health information and keep services safe and available. In the US, HIPAA is a federal law that requires Covered Entities and Business Associates to safeguard patient information; in the UK health and care sector, data security and protection is commonly evidenced through structured assessments aligned to NHS expectations. These types of regulatory audits build trust, reduce breach risk and keep patient services running.

Purpose and scope

Audits assess governance, policies, risk assessment, training and competence, supplier oversight, access management, incident/breach handling and records. Expect attention on how personal/health data is collected, processed, shared, retained and securely disposed of, and whether practices match stated policies.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal audits and compliance reviews to test readiness.
• Second‑party: Customer/commissioner due diligence across suppliers handling health data.
• Third‑party: Independent assessors; in the US, regulatory assessments can be performed under the US Department of Health and Human Services.

Who it applies to

• HIPAA: Covered Entities (e.g., providers) and Business Associates (third parties serving Covered Entities) must comply with relevant clauses of HIPAA.
• UK health and care: Organisations that process NHS data or provide services relying on that data may be expected to evidence data security and protection to sector requirements.

What the audit process looks like

Auditors confirm scope, review documentation, interview data owners and IT/security leads, observe key processes and test samples (for example, access changes, incident handling and training completion). Prior findings and remediation are revisited before a draft report is shared and finalised.

Evidence and deliverables

• Typical evidence: Information security and privacy policies, risk assessments, training records, access provisioning/review logs, incident/breach registers and responses, supplier agreements with data protection clauses, retention/deletion records and internal audit reports.
• Deliverables: A report with findings and risk‑rated actions; regulator‑led work can set required actions.

Preparation essentials

• Map data and systems: Maintain a current inventory of health data, systems and data flows.
• Align policy and practice: Ensure procedures reflect reality; keep versions controlled.
• Prove control operation: Retain access, change and incident artefacts; keep logs for at least 366 days.
• Strengthen supplier oversight: Document due diligence and ongoing monitoring where data is shared.
• Train and test: Keep training up to date and rehearse incident response.
• Close prior gaps: Track remediation through to effectiveness and bring evidence to the audit.

12. Quality and manufacturing compliance audits (ISO 9001, GMP/GxP)

Quality and manufacturing audits assure customers and regulators that you consistently deliver fit‑for‑purpose product and service. Whether you’re pursuing ISO 9001 certification for your quality management system (QMS) or demonstrating Good Manufacturing Practice/“GxP” discipline in regulated production, these types of regulatory audits reduce defect and recall risk, stabilise operations, and strengthen supply‑chain trust.

Purpose and scope

Audits evaluate how your QMS is governed and how it actually operates day to day. Expect focus on policy and objectives, process controls, risk‑based thinking, competence and training, supplier control, nonconformity and corrective action, documentation and records, traceability, inspection/testing and release, and how improvements are identified and embedded.

Who conducts it (first‑, second‑, or third‑party)

• First‑party: Internal audits to verify conformity and drive improvement.
• Second‑party: Customer audits of your sites and critical suppliers.
• Third‑party: Independent auditors for formal certification (ISO 9001) or external compliance assessments where required.

Who it applies to

Manufacturers, logistics and service organisations seeking recognised quality assurance (ISO 9001), and producers operating to industry or regulatory “GxP” expectations where product quality and patient/user safety are paramount.

What the audit process looks like

Auditors confirm scope and plan, review QMS documents, interview process owners and “walk the line” to observe processes. They sample records across the product/service lifecycle, follow up on previous findings, share a draft report for factual accuracy, then agree actions and timelines before closing.

Evidence and deliverables

• Typical evidence: Quality policy and objectives, process maps/procedures, training and competence records, supplier qualification and monitoring, change control, nonconformity/CAPA logs, calibration/maintenance records, inspection/testing and release records, internal audit reports and management review minutes.
• Deliverables: A written report with conformities and findings; where certification is in scope, a decision on certification for the defined scope.

Preparation essentials

• Align words and work: Ensure procedures match practice and are version‑controlled.
• Prove control and traceability: Keep complete, retrievable records from inputs to release.
• Show closed‑loop improvement: Evidenced nonconformity handling and effective CAPA.
• Demonstrate competence: Up‑to‑date training matrices and role clarity.
• Assure your supply chain: Current approvals, contracts and performance monitoring.
• Pre‑assess: Run internal audits and management review; bring prior actions and proof of effectiveness to the table.

Key takeaways and next steps

You now have a clear view of 12 audit types—why they happen, who runs them, what they test, the evidence they expect, and how to prepare. The winning pattern is consistent: fix scope, assign ownership, make evidence easy to find, and prove you closed prior gaps. Treat audits as part of business cadence, not a surprise event—reducing risk, keeping shipments and sales moving, and building trust.

• Centralise the plan: Maintain a single audit calendar with scope, owners, and due dates.
• Assign accountability: Define roles and RACI; brief process owners early and often.
• Harden your evidence: Standardise folders, version‑control procedures, and retain logs for at least 366 days.
• Pre‑assure: Run internal readiness reviews, close findings, and bring proof of effective remediation.
• Skill up where it counts: If dangerous goods are in scope, get practical training and coaching with Logicom Hub.