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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
      • Templates
        • T-003-001 Audit program_YYYY_nnn
        • T-003-002 Internal auditor qualification
        • T-003-003 Internal audit plan
        • T-003-004 Internal audit checklist
        • T-003-005 Internal audit report
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
  • Pricing
  • Public tenders
  • Procedures
  • GP-003 Audits
  • Templates
  • T-003-003 Internal audit plan

T-003-003 Internal audit plan

External auditors

This template is intended for internal audits performed by our own qualified personnel. When the internal audit is conducted by an external auditing company, they may use their own audit plan templates. In such cases, the external auditor's documentation will be collected and archived by JD-004 with the same validity as our internal templates, as established in GP-003.

Audit details​

Purpose​

Scope​

Audit criteria​

Audit methodology​

Audit date​

Site to audit​

Audit team​

Lead auditor​

Audit staff​

Observer​

Audit plan​

Day 1​

PROCESSInterlocutorAudit teamSchedule
INITIAL MEETING
LEADERSHIP
QUALITY MANAGEMENT
Break
HUMAN RESOURCES MANAGEMENT
DESIGN, REDESIGN AND DEVELOPMENT
POST-MARKET SURVEILLANCE

Day 2​

PROCESSInterlocutorAudit teamSchedule
SALES
PURCHASES AND SUPPLIERS EVALUATION
TECHNICAL ASSISTANCE SERVICE
Break
PRODUCTION AND SERVICE PROVISION, QUALITY CONTROL
OPERATIONS. TRACEABILITY. DATA INTEGRITY
OTHER AUDITS, NC, CAPAs
FINAL MEETING

Record signature meaning​

  • Author: JD-004 Author name
  • Review: JD-005 Reviewer name
  • Approval: JD-001 Approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 Andy Aguilar ㅤ ㅤ
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T-003-002 Internal auditor qualification
Next
T-003-004 Internal audit checklist
  • Audit details
    • Purpose
    • Scope
    • Audit criteria
    • Audit methodology
    • Audit date
    • Site to audit
    • Audit team
      • Lead auditor
      • Audit staff
      • Observer
  • Audit plan
    • Day 1
    • Day 2
  • Record signature meaning
  • Template signature meaning
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)