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.