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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
      • Templates
        • T-006-004 Stakeholder NC Notification Template
    • 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
  • Pricing
  • Public tenders
  • Procedures
  • GP-006 Non-conformity, Corrective and Preventive actions
  • Templates
  • T-006-004 Stakeholder NC Notification Template

T-006-004 Stakeholder NC Notification Template

Document Information​

FieldValue
NC Reference[NC-YYYY-XXX]
NC Criticality[ ] High / [ ] Medium / [ ] Low
Notification Date[YYYY-MM-DD]
Notification Method[ ] Email / [ ] Phone / [ ] Portal / [ ] Official Letter / [ ] Regulatory Submission System / [ ] Other
Prepared by[Name, Role]
Approved by (JD-004)[Name]
Stakeholder Type[ ] Customer / [ ] Notified Body (NB) / [ ] Competent Authority (CA) / [ ] Distributor / [ ] Partner / [ ] Other

Stakeholder Information​

FieldValue
Organization Name[Organization/Authority name]
Stakeholder Type[ ] Customer / [ ] Notified Body / [ ] Competent Authority / [ ] Distributor / [ ] Partner / [ ] Other
Contact Person[Contact name]
Title/Role[Title or role]
Email[Email address]
Phone[Phone number]
Address[Official address, if applicable]
NB/CA Reference Number[NB ID or CA reference, if applicable]
Affected Product(s)[Product name/version/UDI]
Certificate Reference[EC Certificate number, if applicable]

Notification Content​

Subject Line​

Adapt subject line based on stakeholder type
  • For Customers: [IMPORTANT] Legit Health Product Notification - [Brief NC Description] - Reference: [NC-YYYY-XXX]
  • For Notified Bodies: Manufacturer Notification - Non-Conformity Report - [Product Name] - EC Certificate [Cert No.] - Reference: [NC-YYYY-XXX]
  • For Competent Authorities: Manufacturer Notification per MDR Article [XX] - [Product Name] - Reference: [NC-YYYY-XXX]

Notification Body​

Dear [Contact Name / To whom it may concern],

Stakeholder-specific opening

For Customers: We are writing to inform you of a non-conformity that has been identified which may affect your use of [Product Name].

For Notified Bodies: In accordance with our obligations under MDR 2017/745 and the terms of our Quality Management System certification, we hereby notify you of a non-conformity identified in relation to [Product Name], covered under EC Certificate [Certificate Number].

For Competent Authorities: In accordance with our obligations under MDR 2017/745 Article [XX], we hereby notify [Authority Name] of a non-conformity identified in relation to [Product Name].

1. Product Identification​

FieldValue
Product Name[Product name]
Product Version/Model[Version]
UDI-DI[UDI-DI if applicable]
EC Certificate Number[Certificate number]
Risk Class[Class I / IIa / IIb / III]
Notified Body[NB name and ID]

2. Description of the Non-Conformity​

[Provide a clear description of the non-conformity. For regulatory stakeholders, include technical details. For customers, use non-technical language where appropriate.]

  • Date of Detection: [YYYY-MM-DD]
  • Detection Method: [How the NC was discovered - internal audit, customer complaint, post-market surveillance, etc.]
  • Affected Units/Scope: [Number of affected units, software versions, geographical scope, etc.]

3. Risk Assessment​

AspectAssessment
Severity[Critical / Major / Minor]
Probability[High / Medium / Low]
Risk Level[High / Medium / Low]
Patient Safety Impact[Description of potential patient safety impact]
Regulatory Impact[Impact on compliance with essential requirements]

4. Root Cause Analysis​

[Summary of root cause analysis. Include methodology used (e.g., 5 Whys, Fishbone) and conclusions.]

5. Actions Taken and Planned​

Immediate Actions (Containment):

  1. [Immediate action taken]
  2. [Additional containment measures]

Corrective Actions:

ActionResponsibleTarget DateStatus
[CA 1][Name][Date][Status]
[CA 2][Name][Date][Status]

Preventive Actions:

ActionResponsibleTarget DateStatus
[PA 1][Name][Date][Status]
[PA 2][Name][Date][Status]
  • Expected Full Resolution Date: [YYYY-MM-DD]

6. Impact on Certified QMS / Technical Documentation​

For Notified Bodies and Competent Authorities only

[Describe any impact on the certified Quality Management System or Technical Documentation. Indicate if updates to the Technical File are required.]

  • No impact on QMS certification
  • QMS documentation updated (specify documents)
  • Technical Documentation updated (specify sections)
  • Risk Management File updated
  • Clinical Evaluation updated

7. Interim Measures / Customer Guidance​

For Customers

While we work on the permanent resolution, we recommend the following interim measures:

  1. [Workaround or temporary measure, if applicable]
  2. [Additional guidance]

If no interim measures are applicable, state: "No interim measures are required at this time."

8. Contact Information​

For any questions or concerns regarding this notification:

  • Quality Manager (JD-004): [Name], [Email], [Phone]
  • Regulatory Affairs (JD-005): [Name], [Email], [Phone]
  • General Contact: [support email]

We remain committed to ensuring the safety and performance of our products and appreciate your attention to this matter.

Best regards,

[Name]
[Role]
Legit Health
[Address]

Internal Use Only​

Notification Tracking​

FieldValue
Stakeholder Type[ ] Customer / [ ] NB / [ ] CA / [ ] Distributor / [ ] Other
Required Notification Time[24h / 72h / 5 days / As per regulation]
Actual Notification Time[X hours/days]
Within Timeframe?[ ] Yes / [ ] No
Acknowledgment Received[ ] Yes / [ ] No
Acknowledgment Date[YYYY-MM-DD]
Follow-up Required by NB/CA?[ ] Yes / [ ] No
Additional Information Requested[ ] Yes / [ ] No - Details: [...]

Regulatory Notification Requirements​

Stakeholder TypeRegulatory BasisTimeframe
Notified BodyMDR 2017/745, QMS AgreementAs per agreement / Without undue delay
Competent AuthorityMDR 2017/745 Art. 10(12), Art. 83-86As per incident type
CustomerGP-006 Internal PolicyHigh: 24h / Medium: 72h / Low: 5 days

Follow-up Actions​

DateActionResponsibleStatus
[Date][Follow-up action][Name][Status]
[Date][Response to NB/CA queries][Name][Status]
[Date][Resolution confirmation][Name][Status]
[Date][Stakeholder satisfaction check][Name][Status]

Linked Records​

  • NC Report: T-006-001 Reference: [NC-YYYY-XXX]
  • CAPA Report: T-006-003 Reference: [CAPA-YYYY-XXX] (if applicable)
  • Vigilance Report: GP-004 Reference: [If applicable]
  • FSCA/FSN: [Field Safety Corrective Action / Field Safety Notice reference, if applicable]

Template Signature Meaning​

info

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

  • Author: JD-004
  • Review: JD-005
  • Approval: JD-001

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
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Templates
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GP-007 Post-market surveillance
  • Document Information
  • Stakeholder Information
  • Notification Content
    • Subject Line
    • Notification Body
      • 1. Product Identification
      • 2. Description of the Non-Conformity
      • 3. Risk Assessment
      • 4. Root Cause Analysis
      • 5. Actions Taken and Planned
      • 6. Impact on Certified QMS / Technical Documentation
      • 7. Interim Measures / Customer Guidance
      • 8. Contact Information
  • Internal Use Only
    • Notification Tracking
    • Regulatory Notification Requirements
    • Follow-up Actions
    • Linked Records
  • 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.)