Audit template
Audit Plan Form for medical device internal and supplier audits
Use this editable Audit Plan to plan, execute and close audits with clear findings, conclusions and corrective actions.
- Best for: internal audits, supplier audits, MDR/ISO 13485 audit programmes and audit reporting.
- Includes: editable sections for audit programme, plan, report, findings and conclusion.
- Format: editable template available through the standard WooCommerce download flow.
Lexqara prepares manufacturers and suppliers for medical device audits with practical tools and hands-on support. Explore the Resource Center or review our Quality Management System Audit Services.
Description:
This Audit Plan template defines how we document and control a planned audit, including objectives, scope, criteria, logistics, and a time-based schedule aligned to ISO 19011:2018.
-
Control the plan with APYYYY-XXX rev.Z, Document Number, Revision, Date, Approval, and Change History.
-
Define the audit method in the Audit procedure (process approach, evidence-based conformity, sampling limits).
-
Specify Audit objective, Audit scope, and Audit criteria (standards/regulations/agreements).
-
Record audit Location, Targeted audit dates, and key Contact details for coordination.
-
Assign Lead auditor and Auditor roles and capture auditor approvals/signatures.
-
Document any Requirements excluded from the audit with clear justification.
-
Build a multi-day Audit schedule (Day 1/Day 2/Day 3) with time slots, Audit Activities / Areas, and Resources.
-
Include supplier-side approval blocks when applicable (e.g., supplier audit sign-off).
Your needs:
-
Audit plan template
-
Audit plan template for ISO 13485, MDR compliance
-
Reduce rework, keep audits on-schedule, and strengthen inspection-ready evidence.
Use this template before executing any audit (especially external or supplier audits) to align stakeholders on criteria, agenda, sampling expectations, and deliverables.
It standardizes planning terminology. Audit criteria are the requirements we audit against; they matter because they anchor findings. A process approach means auditing end-to-end workflows rather than isolated documents; it matters because it reveals systemic gaps.
-
Define objective/scope/criteria and maintain controlled approvals.
-
Ensure auditor roles and signatures are documented.
-
Confirm locations, dates, and contacts for traceable logistics.
-
Identify exclusions and justify them before the audit starts.
-
Set a time-based agenda with resources to support efficient sampling.
-
Document that the audit is evidence-based and sampling-based.
At Lexqara, we help you implement audit planning that stays consistent across internal, supplier, and regulatory readiness audits—supported by checklists, training, and CAPA linkage. Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. ISO 19011 [https://www.iso.org/standard/70017.html]. Download the template or request a short gap assessment.
Template preview
Template preview: Audit Plan
Review the key sections included in the Audit Plan template before downloading it. This preview shows the structure and content you will receive in the editable file.
The complete template content is displayed above. The editable file is available after adding the product to cart.
