Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
      • R-023-001_001 Change control
      • R-023-001_002 Change control
      • R-023-001_003 Change control
      • R-023-001_004 Change control
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-023 Change control management
  • R-023-001_002 Change control

R-023-001_002 Change control

Description​

  • Change name: Change in documenting Nonconformity (NC) and Corrective Actions Preventive Actions (CAPA)
  • Change description: currently the same template is used for documenting Nonconformity and CAPA and this sometimes makes it difficult to understand which nonconformities are closed, which nonconformities led to a CAPA. Therefore, it's advisible to split the template and, as a result, have one template for nonconformity records and one template for CAPA records.
  • Source of change: Nonconformity coming from ISO 13485:2016 BSI audit (second stage). Nonconformity reference: R006001-66, CAPA reference: R006001-67

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities)
    • No (it does not require notification to Regulatory Authorities): it is a change to improve an internal process (NC and CAPA process)
  • Risk analysys impact: the proposed change does not modify any existing risks and does not introduce new risks in the nonconformities and CAPA process.
  • Quality documentation impact: GP-006, T-006-001, T-006-002, R-019-001_001

Approval​

The change is approved.

Plan​

  • Creation of a new template for documenting CAPA (T-006-003) - Quality department
  • Modify template for documenting nonconformity (T-006-001) to remove the fields related to CAPA - Quality department
  • Update the nonconformity workflow in Jira - Quality department
  • Update the CAPA workflow in Jira - Quality department
  • Update T-006-002 in Jira - Quality department
  • Update GP-006 - Nonconformities, CAPA to update the NC and CAPA workflow and include the new template for CAPA - Quality department
  • Validation of new/modified templates (R-019-001_001) - Quality department

Implementation​

Implementation date: 2023-03-04

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, JD-004
  • Approver: JD-005
Previous
R-023-001_001 Change control
Next
R-023-001_003 Change control
  • Description
  • Impact analysis
  • Approval
  • Plan
  • Implementation
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.)