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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
    • 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-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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-017 Technical assistance service

GP-017 Technical assistance service

Purpose​

To establish the methodology to implement the technical assistance service.

Scope​

This procedure encompases all the activities related to the technical assistance requirements received from our customers.

Responsibilities​

JD-003​

To manage the necessary resources to guarantee that the customers petitions are managed according to the established periods to ensure their satisfaction.

JD-005​

To control the trends of the claims related to the medical device, and to perform all the technical assistance activities required from customers to solve their issues.

JD-004​

To document the non-conformity process that can arise from technical assistance requests.

Inputs​

Customer requests for technical assistance

Outputs​

  • T-006-001 Non-conformity report

Development​

Implementation and technical assistance activities​

The implementation of the service is described at the GP-009 Sales procedure.

The implementation of the startup and the assistance activities are carried out in both cases if the product is sold by us directly (final customer) or by a distributor.

  • Distributor: in the case of products sold by a distributor, as stated in the contract, the possible maintenance and technical assistance regarding the medical device is offered directly by us. The distributor manager must communicate to us all the claims, non-conformities or other problems to allow the post-market surveillance of the device. The distributor will also provide us all the user contact details.

  • Final customer: in the case of products sold to final customers directly by us, the Technical Assistance Services include the implementation of the medical device and the technical assistance.

Service levels, rankings, and priority​

In those cases in which the customers that are using our products, sold directly to the client or by a distributor, need to receive technical assistance to solve a breakdown or malfunction, the distributor or the customer contact us to request technical advice. They have direct communication channels with us: they can use the email or the webpage form, which immediately notifies the development team.

We will also include this service details at the "Server Level Agreement" signed with each customer to ensure they properly understand the timelines established for the services needs.

Incidents types​

When reporting incidents, there are three types:

TypeDescription
!BugHigh severity bugs and issues
?SupportLow severity problems, including doubts.
+New featureRequests for new product features

Priority​

Response times depend on severity level:

Security levelDescriptionTarget response
1OutageSaaS server downImmediate
2CriticalHigh risk of server downtimeImmediate
3UrgentEnd-user impact initiatedWithin 2 hours
4ImportantPotential for performance impact if not addressedWithin one business day
5MonitorIssue addressed but potentially impactful in the futureWithin one business day
6InformationalInquiry for informationWithin 48 hours

Technical assistance procedure and records​

All the communications received from our customers will be recorded within the customers management tool (Hubspot) in place as detailed at the GP-014 Feedback and complaints. We evaluate all the communications received to treat them properly. If it is considered a technical assistance service requirement, the person receiving the communication noted it down as a ticket and assigned it to the technical responsible to solve the incidence.

When a communication was considered a non-conformity, registration and follow up must be performed according to GP-006 Non-Conformities. Corrective and preventive actions.

When required, the technical service team directly will contact the owner of the request and will establish the actions to carry out, that will also be recorded at the corresponding ticket.

All information contained in these records will be used for the Post-market surveillance, (GP-007 Post-market surveillance) to extract important information for the Technical File update.

Assessment of complaints​

If the communication is considered a customer complaint it will be registered as a complaint within the customers management tool and it will also be assigned to the JD-005 to perform the complaint evaluation and the following steps that required as it is specified at the GP-014 Feedback and complaints procedure.

The JD-005 will also determine if it is required to notify the incident to the National Competent Authorities (NCA) or Notified Bodies (NBs), following the corresponding GP-004 Vigilance system and GP-007 Post-market surveillance procedures.

Associated documents​

  • GP-004 Vigilance system
  • GP-006 Non-Conformities. Corrective and preventive actions
  • GP-007 Post-market surveillance procedures
  • GP-009 Sales
  • GP-014 Feedback and complaints
  • T-006-001 Non-conformity report

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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GP-016 Traceability and identification
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GP-018 Infrastructure and facilities
  • Purpose
  • Scope
  • Responsibilities
    • JD-003
    • JD-005
    • JD-004
  • Inputs
  • Outputs
  • Development
    • Implementation and technical assistance activities
    • Service levels, rankings, and priority
      • Incidents types
      • Priority
      • Technical assistance procedure and records
      • Assessment of complaints
  • 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.)