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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-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
      • Templates
      • Deprecated
    • 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
    • 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-011 Provision of service

GP-011 Provision of service

Procedure flowchart​

Purpose​

To define the methodology to establish activities of production, preservation, storage and delivery of our medical devices.

Scope​

All medical devices developed and distributed by us, as well as other products that require a similar process.

Responsibilities​

JD-005​

To directly supervise internal and/or outsourced manufacturing activities. To release the manufactured product.

JD-003​

To manage and control the manufacturing and the production process related to our medical devices.

JD-002​

To directly supervise all the documentation regarding purchase, production and sales orders.

JD-004​

To ensure all the documents and records related to the process are properly created, reviewed and archived according to our procedures.

Inputs​

  • Contract with clients
  • ISO 13485:2016, especially 7.5 Production and service provision.

Outputs​

  • T-011-001 Device OAuth Order
  • T-011-003 Acces Key Order
  • T-012-012 Customer product version control

Development​

Due to the nature of our product as a software, the production phase of the device does not start when a client request the product, but the product is already developed, tested, validated and released according to the GP-012 Design, redesign and development.

When a customer hires access to our products, according to the procedure GP-009 Sales, once they have signed the service provision contract and all the legal and financial steps are solved, they need to access the product.

In order to allow customers to access our product, we need to provide them with the necessary credentials. To issue the credentials, we send a document to the legal representative of the client. This document is a record of the request from the customer to create OAuth credentials. In this document, it is the customer who requests the creation of the credentials, and specfiies the email addresses that will receive the credentials.

Depending on the product, this record can stem from T-011-001 Device OAuth Order or T-011-003 Acces Key Order. The former is for the medical devices, and the latter is for other products.

The body of the email that we send out is specified at the documents.

Service provision control​

As it is detailed at the GP-012 Design, redesign and development, we aim at all customers using use the latest version version of products. We keep a record of customers that have not transitioned to the new versions in the corresponding T-012-012 Customers product version control document.

Reworking process​

According to the nature of the product, rework is not required. In case of non-compliance we will follow the GP-006 Non-conformity, Corrective and Preventive actions and, if necessary, the GP-004 Vigilance system.

Cleaning and decontamination​

Due to the nature of the product, this section is not required.

Preservation conditions and storage process​

Due to the nature of the product, this section is not required.

Expedition​

Due to the nature of the product, the service provision is done virtually.

Associated documents​

  • T-011-001 Device OAuth Order
  • T-011-003 T-011-003 Acces Key Order
  • T-012-012 Customers product version control
  • GP-004 Vigilance system
  • GP-006 Non-compliance. Preventive and corrective actions
  • GP-012 Design, redesign and development

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
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T-010-001 Suppliers evaluation YYYY_nnn
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Templates
  • Procedure flowchart
  • Purpose
  • Scope
  • Responsibilities
    • JD-005
    • JD-003
    • JD-002
    • JD-004
  • Inputs
  • Outputs
  • Development
    • Service provision control
    • Reworking process
    • Cleaning and decontamination
    • Preservation conditions and storage process
    • Expedition
  • 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.)