1

2

3

4

100% quality assurance for translation processes


As a matter of course, mpü complies with established industry standards and meets all DIN EN ISO 17100 guidelines. We are also DIN EN ISO 9001 certified.

However, because these standards are not adequate for the stringent requirements of the medical sector, mpü uses a highly process-oriented approach and has established its own processes and tools appropriate for different types of documents.



These are, of course, applied in accordance with customer requirements, the purpose of the translations and the regulations.

REVISION OF THE INITIAL TRANSLATION IN ACCORDANCE WITH DIN EN ISO 17100

An essential component of quality assurance (according to DIN 17100) is the revision of the initial translation by a second independent language expert.

This includes:
Linguistic review sentence by sentence
Review/adaptation appropriate to the target group and target market
Interpretations, spelling and grammar
Taking into account glossaries, terminology and consistency

The translation is finalised by the initial translator, taking into account the corrections and suggestions.

TECHNICAL REVIEW OF THE DIN 17100 TRANSLATION


Single-language technical review of the translation by an independent third subject expert (in the field of medical technology, dental and laboratory technology, electrical engineering, IT, medicine, chemistry, etc.) in the particular discipline in terms of

Technical understanding,
Accuracy,
Misinterpretation and
Specialist terminology.


QUALITY ASSURANCE CHECKS IN A MULTI-STEP SYSTEM


Depending on the type of project and document, electronic quality tools and/or expert-based quality testing is carried out to identify and correct any errors in the translation.
It is essential to offer and be able to integrate a comprehensive range of diverse checks and quality assurance steps because checking the translation quality occurs throughout the entire translation and correction process in a variety of ways.

Standardised methods to measure the translation quality and quality parameters such as LISA QA and DIN 17100 are used as the basis of categorisation.

Tools mean that the modern translation and language process is manageable, transparent and more efficient – that is, faster, more cost effective and of higher quality.


AUTOMATED QUALITY CONTROL

STEP 1

Completeness / grammar, punctuation / numbers and number formats / spelling and spelling differences / product names and terminology checks such as

Terminology consistency (against existing customer-specific terminology databases, if necessary)
Compliance with technical terminology (e.g. STED (IMDRF), MDD 93/42/EEC, IVDD 98/79/EEC, etc.)
Compliance with labelling symbols pursuant to MD (EN ISO 15223-1:2013-02) and much more...

Depending on the project requirements, all steps are used to implement error checking and quality assessment for the initial or DIN translation and are carried out, processed, evaluated and corrected by the project manager/reviewer using electronic quality tools.


EXPERT-BASED QUALITY CONTROL

STEP 2

References
Customer-specifications such as standard sentences, etc.
Style guides - stylistic fluency
Terminology check for factual accuracy and regulatory requirements (EEC, FDA, etc.) EN1041:2008
Active substances and substance names (pharmacopoeias, etc.)
Checking abbreviations to determine any need for linguistic adaptation or localisation
(corresponding to the source text, customer requirements and target group)
Formatting in accordance with regulatory or customer-specific requirements
Back translations and comparison with the source text and much more...


REVIEW, EVALUATION AND
ADAPTATION OF SOURCE TEXTS
IN PREPARATION FOR A QUALIFIED TRANSLATION OUTCOME



The analysis of a text to be translated prior to the translation by an experienced expert generally has a positive effect on the efficiency and outcome of the translation process. If the source text is already conducive to translation, that is, it is formulated so that it is

consistent,
linguistically and materially correct and
unambiguous,

this substantially helps to produce a high-quality translation outcome. We are happy to help you in this regard, even during your editorial process, and/or advise you of any possible optimisations.


REVIEWS AND LINGUISTIC
ASSESSMENTS OF EXISTING TRANSLATIONS
IN A THREE-STEP SYSTEM



Your in-house translations or even external translations, that is, any existing translations, can be checked, corrected, adapted and commented on using a range of linguistic and expert reviews/proofreading or analyses/assessments with QA tools carried out by independent third technical and/or language experts or linguists, translators, medical practitioners or medical writers who evaluate the various parameters.

Any errors detected are reviewed and categorised, including weighting, and these processes are included in a report on the translation quality.

Examples of such parameters include:

Corporate language and terminology
Consistency
Technical or lay language
Regulatory requirements
Claims


Our three-step review methodology includes:

1. A rapid electronic check to provide an initial assessment of the quality
2. Involvement of one or, if necessary, several experienced reviewers who are native speakers of
the target language and experts in the particular discipline
3. Error analysis and assessment with subsequent correction of the text by the reviewer


QUALITY ASSURANCE
TERMINOLOGY VALIDATION


The bilingual or multilingual glossary for a translation project is checked and validated by a technical and/or language expert in regards to the source text. Terminology adaptations can be directly integrated into any existing translations if required so that the terminology is consistent throughout.

Claims review and user tests Marketing translations in particular require a translation process that is specifically tailored to this type of text.

Claims and advertising messages in particular require not only a detailed briefing but also a multi-step process that ensures that any statements can also be completely transferred across to the target language(s). User and association tests conducted with members of the target group in the target country provide reassurance that any symbolism, ambiguity or the content and wit embodied in the statement are not lost in translation.

A professional team is the foundation – project manager, translator, language and subject experts The mpü project management team is made up of subject and methodologically trained project managers who are familiar with both the processes in the healthcare sector and management of small, moderate and large volumes into and out of all languages.

mpü project management is interdisciplinary in nature and is made up of:
Translators with language studies
Scientists
Management scientists
IT specialists


Only selected and verified experts who meet the following requirements are entrusted with carrying out translations:

Native speakers of the target language
Specialist medical translators
Medical and scientific subject experts (medical practitioners, pharmacists, chemists, biologists, biochemists,
physicists, medical technicians, engineers, etc.) with a relevant degree and profound
communication and linguistic experience
Long-standing experience with the relevant types of documents within the translation and language industry


We are also happy to provide you with anonymised CVs at the start of a project. At the beginning of our collaboration, we establish a pool of translators and experts specifically for you so that we can assure you of consistent quality. These translators are specifically trained to meet your requirements and are familiarised with your products.

Quality sustained over the long term is assured using a multi-step assessment process after every project.

KPIs in the translation process – transparency and measurability Our aim is to continuously improve our performance and to incorporate an ongoing improvement process.

Measuring our performance is the foundation of this process. Quantitatively recording key performance indicators (KPIs) is therefore part of every project and our collaborations with our customers.

Time, costs or cost savings and the quality of the individual delivery are central parameters used to assess our performance. At least twice a year we provide our customers with a summary of the results in a report that includes suggestions for optimisation. Data security in the translation process – security standards at the highest level Special security and non-disclosure standards are absolutely essential for the healthcare sector and are therefore par for the course for us.

We are accustomed to handling sensitive data and managing it securely. Data security has two aspects:


protecting data against unauthorised access and against loss. Both aspects are self-evident for us and your data. Continuously updated and repeatedly tested data security and disaster recovery/business continuity plans document the measures we have adopted to protect your data. Redundant systems that are backed up at different sites, strict separation of customer data and, if requested, encrypted email communication are part of our standard repertoire of data security measures.

We are happy to provide you with more detailed information and to adjust our services to your requirements.