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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • 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
      • Templates
        • T-010-001 Suppliers evaluation YYYY_nnn
        • T-010-002 Approved suppliers list
    • 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
  • Pricing
  • Public tenders
  • Procedures
  • GP-010 Purchases and suppliers evaluation
  • Templates
  • T-010-002 Approved suppliers list

T-010-002 Approved suppliers list

  • Governed by GP-010 Purchases and suppliers evaluation

Purpose​

This template provides a general list of all approved suppliers, their type, criticality classification, and current approval status. This list is reviewed and re-evaluated annually during the Management Review.

Approved suppliers list​

#CodeSupplier NameService/ProductTypeCriticalApproval DateNext ReviewStatus

Type classification​

TypeDescription
NIVNon-Impact Vendor
CIVControlled Impact Vendor
NISNon-Impact Subcontractor
CISControlled Impact Subcontractor
HRIVHigh-Risk Impact Vendor (cannot be approved)
HRISHigh-Risk Impact Subcontractor (cannot be approved)

Criticality​

CriticalDescription
YesSupplier directly impacts the safety, performance, or regulatory compliance of the medical device
NoSupplier does not directly impact the medical device quality

Status​

StatusDescription
ApprovedSupplier meets all requirements and is approved for use
Under ReviewSupplier is being evaluated or re-evaluated
SuspendedSupplier temporarily suspended pending investigation
DisqualifiedSupplier no longer meets requirements and is not approved

Notes​

Add any relevant notes about supplier changes, new additions, or pending evaluations.

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
Previous
T-010-001 Suppliers evaluation YYYY_nnn
Next
GP-011 Provision of service
  • Purpose
  • Approved suppliers list
    • Type classification
    • Criticality
    • Status
  • Notes
  • 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.)