Skip to main content
QMSQMS
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-008 Product requirements
    • 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 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
      • Templates
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • 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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-023 Change control management

GP-023 Change control management

Flowchart (Design change)​

Purpose​

To define the applicable methodology to categorize and document the design changes during the lifetime of the product and changes to the QMS activities.

Scope​

This procedure applies to all the design changes, redesign and design maintenance processes for each product developed. This procedure also applies to changes to the QMS processes and activities.

Responsibilities​

JD-001​

To approve the proposed design and QMS changes and to provide the organization with a set of appropriate documents and resources to guarantee the clarity and precision of the information.

JD-005​

To document, supervise and control the communications and the design and QMS changes to verify the adequacy of the process. To notify the Notified Body as appropriate.

JD-003​

To evaluate the proposed design and QMS changes, establish their category (significant or non-significant) and approve them together with the JD-001.

JD-004​

To ensure that the change management is performed following this procedure, and that all the records required are properly generated, reviewed, approved and archived accordingly. To document QMS changes in the change control template T-023-001 Change control.

Inputs​

  • Design change necessity coming from users, regulatory, technical, security and other requirements that must be accomplished.
  • QMS change necessity coming from different sources: nonconfomrity, CAPA, post-market surveillance activities, company needs, new regulatory requirements, and so on.
  • NBOG 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
  • Medical Device Single Audit Program (MDSAP)
    • MDSAP AUDIT APPROACH.
      • Chapter 2: Device Marketing Authorization and Facility Registration.
        • Task 3: Notification of Changes to Marketed Devices or to the QMS

Outputs​

  • Communications with the Notified Body
  • A Design history file per product or family of products manufactured
  • Change control record

Development​

Design change​

The significance of the change in relation to the functionality, performance, usability, safety, and applicable regulatory requirements of the medical device and its intended purpose can be significant or non-significant, corresponding the significant one to the major requirements, and the non-significant one to the minor or functional requirements (see GP-012 Design, redesign and development procedure).

Change typeRequirement type
SignificantMajor
Non-significantMinor or functional

This means that every time we detect the need of a change, we will follow the GP-012 Design, redesign and development procedure to document and manage the change:

  • The need of change will be communicated to the affected responsible and the top management, to evaluate the feasibility and the consequences for the company and the product, including the certification according to the Medical Device Regulation (MDR) 2017/745 and MDR 120.
  • Then a new requirement will be noted down at the DHF, and the significance of the change will be determined by the requirement category. These new entries in the design files also contain the possible new version of the design that it would give rise to.
  • When reviewing the changes, we must evaluate the impact of the changes over the product, over inputs and outputs of risk management (following GP-013 Risk Management) and over the processes of product delivery (GP-011 Provision of services). This information is also part of template for requirements (T-012-001 Requirements), as defined in GP-012 Design, redesign and development.
  • Before starting the implementation of the change, JD-003 and JD-001 shall review the change and change's impact and approve it.
  • Design and development changes must then be implemented, reviewed, verified,validated and approved for use before their release as they are managed as new requirements.

This information is part of template for requirements (T-012-001 Requirements), as defined in GP-012 Design, redesign and development.

The list of all the changes performed along the different versions releases are recorded in the cover of the DHF following the template T-012-005 Design change control.

The JD-004 or JD-005 will contact the Notified Body to update the information once every year in the absence of significant changes, and occasionally when significant changes occur.

QMS changes​

In case of changes in quality activities (e.g. supplier change, QMS software change, change in Notified Body, etc.), the change will be documented in the T-023-001 Change control. When a need of change is identified, JD-004 shall fill in the T-023-001 Change control template providing a description of the change and performing an impact analysis (regulatory impact, risk analysis impact, quality documentation impact). During the regulatory impact assessment, JD-004 shall analyze whether the QMS change is a significant change to be notified to the regulatory authorities or non-significant change (the latter does not require notification to regulatory authorities). To determine the significance of the change, the following is taken into account:

  1. Changes related to the manufacturer's organization (administrative changes) such as
    • Changes in the name, address or legal form of the manufacturer, including a merger or acquisition involving the manufacturer
    • Changes in relation to the authorised representative
  2. Changes to the QMS such as
    • Changes in monitoring and control of production
    • Changes in operating environment
  3. Changes in PRRC and/or Technical Responsible.

The change control form (T-023-001 Change control) shall be reviewed by JD-005, JD-001and JD-003 for their approval or rejection. This decision is documented in the Change approval section of the template T-023-001 Change control.

If the change is approved, JD-004 shall list all the activities required for the successfull implementation of the change and follow up with their implementation.

In case of significant changes, JD-004 or JD-005 will contact the Notified Body, and when required the Competent Authority (e.g. AEMPS for changes in Technical Responsible), to notify the change and ask for approval.

Associated documents​

  • GP-011 Service provision
  • GP-012 Design, redesign and development
  • GP-013 Risk management
  • T-012-001 Requirements
  • T-012-005 Design change control
  • T-023-001 Change control

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-001
Previous
GP-022 Document translation
Next
T-023-001 Change control
  • Flowchart (Design change)
  • Purpose
  • Scope
  • Responsibilities
    • JD-001
    • JD-005
    • JD-003
    • JD-004
  • Inputs
  • Outputs
  • Development
    • Design change
    • QMS changes
  • Associated documents
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.)