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Audit Program

Audit template

Audit Program for medical device internal and supplier audits

Use this editable Audit Program to plan, execute and close audits with clear findings, conclusions and corrective actions.

Plan audits systematicallyDefine scope, criteria, schedule and auditor independence.
Document objective evidenceRecord findings with references to standards and procedures.
Drive CAPA closureTrack corrective actions from identification to effectiveness check.

  • 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.
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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 Program template defines how we plan a risk-based annual audit schedule, with clear audit scope, audit objectives, audit criteria, and audit frequency.

  • Set audit scope boundaries (sites, functions, processes, certificate scope).

  • Define audit objectives (compliance, risk/opportunity, CAPA effectiveness).

  • Specify audit criteria (standards, regulations, agreements).

  • Use inputs from prior results, management review, and quality objectives.

  • Set frequency: key product-realization processes at least annually; others at least every two years.

Your needs:

  • audit program template

  • audit program template for ISO 13485, MDR compliance

  • Reduce audit rework, prevent missed coverage, and improve readiness.

Use this template when building or updating your audit plan for internal, supplier, and economic operator audits within the QMS.

An audit scope is the extent and boundaries of an audit; it matters because it prevents gaps. Audit criteria are the requirements used to judge evidence; they matter because they anchor findings.

  • Define scope, objectives, criteria, and schedule in one controlled program.

  • Apply risk-based frequency based on status and importance of processes.

  • Include supplier and EO audits per applicable procedures and planned inspections where relevant.

  • Ensure auditor competence and independence using the defined approach.

  • Link outcomes to CAPA initiation and follow-up expectations.

At Lexqara, we help implement audit programs, checklists, CAPA linkage, and training so your audit evidence stays consistent and inspection-ready. 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]. Request a short gap assessment.

Template preview

Template preview: Audit Program

Review the key sections included in the Audit Program template before downloading it. This preview shows the structure and content you will receive in the editable file.

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Sheet: Audit Program

Audit Program 2024-AP rev.1
Form number: FORM-AUD-001 rev.1
Item Audit Scope Audit Objective Audit Criteria Related QMS Processes Audit Methods Planned Duration Resources (Lead “L”, Expert “E”, Observer “O”) Schedule / Activity Performed Reporting to
X Y Z E Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
#1 Location, equipment, etc. ISO13485 compliance, supplier agreement compliance, etc. ISO 13485 §X.X and related MDSAP requirements, etc. Design control [XXX], Production [XXX], etc Onsite, internal audit 2h, 1 day, etc. L E planned date / date when performed planned date / date when performed R&D manager
#2
#3
#4
#5
#6
#7
#8
#9
#10
#11
#12
#13
#14
Items below are optional but recommended by ISO 19011
Risks that may result in failure to achieve the audit objectives Opportunities identified for audit program improvement
Item Description Action Plan Status Item Description Status
#1 #1
Name: Signature:
Position:
Date:

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SKU FORM-AUD-001 rev.1 Category
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