iso 9001 quality assurance planning life science

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Quality Assurance Planning 1 6/12/2012

CliniTrans Quality Assurance Planning

Certified for QualityWe are ISO:9001 and ISO:13485 certified, which means we are audited by an approved body (BSIGroup) to ensure that our quality assurance process is an integral part of our work and is continuallydirected towards a goal of process improvement to ensure customer satisfaction.

ISO (International Organization for Standardization) is a worldwide federation of national standardsbodies from over 110 countries. The ISO 9000 family of standards for quality management and qualityassurance represents an international consensus on the key components of a quality managementsystem.

At CliniTrans, quality assurance planning is incorporated at every milestone of a translation andlocalization project to successfully deliver a localized product that meets the expectations of both theclient and intended audience. Since quality in translation is sometimes subjective and evaluation is attimes relative, establishing shared quality objectives is critical to the success of the product and serviceswe deliver.

Since ISO QA processes are unique to each firm, actually quality can vary widely, especially in thetranslation industry where quality perceptions are often subjective. Operationally, we measure the qualityof our work using a proprietary version of the LISA (Localization Industry Standards Association) QAmetric. But our main ISO measurement is based on the feedback we get from our clients. Improving theclient experience is the fundamental intention of an ISO certified process and the fundamental measure ofsuccess for such a program.

To measure customer satisfaction we survey our clients on completion of every job, using an NPS (NetPromoters Score) metric, also audited, updated quarterly and posted on the home page of our website.

1-800-Translate is ranked number one for customer satisfaction in the entire translation industry, NPS95%, demonstrating the success of our quality assurance management process

This is because our ISO:9001 measures and documents quality assurance management at everytranslation milestone.

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QA MilestonesStaffingWe test, recruit and train a large staff of life science specialists for translation and editing tasks. Expertsare recruited based on accreditation in the American Translators Association or other recognizedprofessional linguist associations, as well as on recommendations, testing and specific industryexperience and backgrounds. We compensate above industry norms in order to recruit and motivate thebest cadre of translators we can find. Translators work only into their native language.

Assignments are based on translation and other professional experience. The translators’ experience inthe target industry, the degree to which they participate in the target culture, the past accuracy andthoroughness of previous work are reviewed and reassessed on every assignment. We welcomecustomer participation in this qualification process.

Translators and other linguists are recruited worldwide, since every assignment requires a customsolution where time zone, dialect, or in-country knowledge is considered along with skill set and industryexperience.

In-house project teams are formed for each job in the same way. Experienced professionals with specificindustry experience are the rule. A strong personal commitment to customer satisfaction remains themost important qualification for the CliniTrans team.

Steps before translation beginsWe collaborate with our clients to assist with multi-lingual project planning for the best return oninvestment. Like any production work, translation can be a complex process. Most work does not requirea great deal of client participation, but for other projects, intensive client input may be necessary.

The project team supervisor reviews source material on intake. Source errors caught before translationbegins save time and money.

The intake manager then:

1. Documents what should and should not be translated within files or hardcopy submitted;

2. Determines character set and file format requirements;

3. Determines any output requirements for print and other media;

4. Identifies existing translations, glossaries and translation memories that can be incorporated intothe translation;

5. Determines schedule and price.

6. A Letter of Engagement, defining every aspect of the project, is submitted for client review andapproval before we begin the assignment.



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Document style change requirements for each languageStyle and task sheets are updated as the project proceeds. Style-sheets, glossaries and translationmemory databases are maintained by the project team but remain client property. A web page, and insome cases, job-specific chat rooms, are used to provide real-time updates on work for clients whenrequired. All corrections are documented using the Localization Industry Standards Association (LISA)Quality Assurance Model 3.1.2.

Audience localizationGood translators, like good writers everywhere, write best when they know their readers. Demographicinfo such as age, sex, education, bilingualism, and cultural background help localization planners to writefor maximum impact and comprehension.

Marketing messages should be tested for regional acceptance and usability. And copywriting service isavailable when translations must deviate from source in order to motivate or inspire target audiences.

Control languageWhen working in several languages, usually content changes are only permitted in the designated sourcelanguage, known as the control language. Only after changes to the control language have beenapproved is translation authorized.

Every change is authorized in the control language and then documented in the operations managementsystem. We strive for early identification and correction of error in the workflow.

Version controlTranslation is a change process. Version control is maintained through database administration, time/datestamps and a detailed file-name protocol. Default version history is developed based on projectrequirements: (Automated TM file process is omitted from this list)

1. Source text

2. First draft of the translation

3. Editor’s draft of the translation (textual validation)

4. Project manager’s draft of the translation (validation review)

5. Client changes draft

6. Editor’s draft of client changes (textual validation and review)

7. Draft output



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8. Edit output (functional, production validation and review)

9. Client changes output file

10. Project expert’s output file (functional, production validation review)

Translation and localizationEach textual error is tracked within the file. The original translator, at the discretion of the project manageror editor, then reviews proposed changes. The translator may then choose to challenge an edit, with theproject manager responsible for challenge resolution.

Textual corrections are then integrated into translation memory and terminology management systemsautomatically, populating database structures so that consistency is preserved in future documents.

For reporting and training purposes, errors are then compiled using the Localization Industry StandardsAssociation Quality Assurance Model 3.1.2.

Quality assurance confirmationIf additional changes are made to our work after we submit to the client, we suggest that the client reviewthose changes with us.

The customer relations supervisor evaluates team performance at the conclusion of every job, based onresults of the best practice validation parameters and a customer satisfaction review.

The project manager’s chief responsibility is to insure that the work is submitted timely and as per client’sinstructions. Failure to do so constitutes a service failure. Service failures are investigated and correctiveactions are determined to prevent reoccurrence. Please contact us in the event of a service failure forprompt satisfaction.

After the job is completed and invoiced, clients are asked to complete one questions survey based on theNet Promoters Score metric. A low score triggers a mandatory investigation, and depending on findings,may require a corrective or preventive action.
