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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
    • 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
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  • Procedures
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  • Procedures
  • GP-022 Document translation

GP-022 Document translation

Procedure flowchart​

Purpose​

Define the methodology for the translation of documentation related to the manufacturing of medical devices and provision of the services that we carry out.

Scope​

Documents pertaining to the QMS and documents related to the device, especially those documents whose innaccurate translation may affect how the device is used and therefore potentially compromise its safety and performance.

As a general rule, it will apply to translations from Spanish to English, or vice versa. The same procedure applies in case of need of translation to other languages.

Responsibilities​

JD-001​

Provide the organization and its members with the necessary resources to carry out their obligations in the most efficient way possible.

Directly supervise potential outsourced translation activities.

JD-003​

Review the translations carried out by the JD-004, either by their own means, or with the support of third parties specialized in this regard.

JD-004​

Carry out the required translations, or delegate to third parties, of the required documents.

JD-005​

Review the translations carried out by the JD-004, either by their own means, or with the support of third parties specialized in this regard.

Inputs​

Documents that need translation, including the technical documentation and the documents included in the QMS.

Outputs​

The translated documentation that can be presented in dual mode or in the language to be translated only. In other words: you may find some documents that include more than one language at once.

Development​

Translation process​

We identify two available translation methods:

  • Translation by a team member: when the person in charge of the translation has proven proficiency in the language (native knowledge or at least a B2 level). The language competence, when not native, will be recognized by certification of a language school or equivalent certificate.
  • Translation by external translators: outsourcing the translation to a specialized translation company is applied when the translation cannot be performed internally or requires a certified translation. In case of external translation, the translation company will be assessed and evaluated according to the procedure GP-010 Purchases and suppliers evaluation.
Using translation tools

You can use professional commercial translation tools as an aid, but the result of that translation will never be considered approved without a proper review of it.

When there is a need for translation, JD-004 will initiate and coordinate the translation process by identifying the suitable translation method according to the required language.

For the translation of Instructions for Use (IFU), JD-004 shall review the language requirements available in the MDR - language requirements for manufacturers document (published by the European Commission) to start the translation process and be compliant with Article 10(11), Article 41 of MDR 2017/745 and Article 5(11) of Regulation (EU) 2021/2226 on electronic IFU. Languages requirements shall be reviewed before placing the medical device into Member States market: once the countries where the medical device is planned to be sold are defined and the languages requirements are identified, the traslation process can start.

Everytime there is a sales opportunity on a new market of one of the Member States, the JD-004 shall be informed to evaluate the language requirements and availability of translated IFU. In the case the IFU in the required language are not available, JD-004 will start the translation process before making the medical device available to clients.

Translation review process​

When the translation is done internally, the translated document requires review.

The minimum level required for document review is C1 (Effective Operational Proficiency). In the event that the person responsible for the review (usually JD-004) does not have that level, a member of the organization who does, or external personnel, will be contacted to carry out the review.

Once reviewed, the document shall be managed according to teh requirements set ou in GP-001 Documents and records control.

In special cases, such as for regulatory stipulations, we will hire companies specialized in a specific domain of language, to carry out the appropriate translations for each specific case, as explain in the section above.

Naming standards​

When referring to language and countries identification, we follow ISO 20417.

When referring to languages, and specially when naming documents, we follow ISO 639-1. More specifically, we use the Alpha-2 code, which is a two letter lowercase word that represents a language.

For example, Spanish is expressed as es, while English is called en.

When we require to be more specific regarding a dialect or geographical localisation, we use ISO 3166-1, that defines codes for the names of countries, dependent territories, and special areas of geographical interest, and we append the ISO 3166-1 Alpha-2 code to the ISO 639-1 Alpha-2 code.

Examples​

ISO 639-1 codeISO 3166-1 codeResultMeaning
esESes_ESSpanish as spoken in Spain
esCOes_COSpanish as spoken in Colombia
Looking for the codes?
  • ISO 639-1, Codes for the representation of names of languages
  • ISO 3166-1, Codes for the representation of names of countries and their subdivisions

Availability of translated IFU​

Once the translated IFU are reviewed and approved, they will be made available in Legit.Health website. There, the users will be able to choose the IFU in the required language.

The IFU of the medical device are also accessible via a URL: when the IFU are displayed, the user can choose between the available languages.

The availability check of the translated IFU in the website and at the IFU URL is part of the IFU validation documented in T-001-006 IFU and label validation.

Associated documents​

  • GP-001 Documents and records 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
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GP-023 Change control management
  • Procedure flowchart
  • Purpose
  • Scope
  • Responsibilities
    • JD-001
    • JD-003
    • JD-004
    • JD-005
  • Inputs
  • Outputs
  • Development
    • Translation process
    • Translation review process
    • Naming standards
      • Examples
    • Availability of translated IFU
  • 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.)