By being ISO certified in multiple quality processes, Excel Translations is able to work closely with our life science and corporate customers to provide language services that are compliant with the strict regulatory standards of the medical device, biotech, and pharmaceutical industries.
The Advantages of an ISO Certified Translation Company
- ISO 9001 Certified
- ISO 13485 Certified
- ISO 17100 Certified
- ISO 14971 Compliant
- ASTM F 2575 Compliant
Excel Translations’ registrar is BSI, a leading business services provider for organizations worldwide, offering a range of services in management system certification, product testing and certification, and standardization. BSI operates in a range of sectors as diverse as building and construction, medical devices and aerospace. For more information, go to: http://www.bsigroup.com/
ISO 9001 Certified Translation Company
Advantages at a Glance
Excel Translations’ medical translation services and technical translation services are ISO certified to the 9001:2008 standard. The following key ISO 9001:2008 sections govern our Quality Assurance Processes:
Section 5 — Management Responsibility
Our vision, policies and strategic objectives are built around, among others, the following ISO certified translations management principles:
- Customer Focus
- Process Approach
- Continual Improvement
Section 6 — Resource Management
Excel Translations allocates and directs its resources – personnel, infrastructure, information, partners, finances – for the operation and continuous improvement of its production process, as well as the full satisfaction of its customers.
Section 7 — Product Realization
The Quality Management System we’ve designed ensures the effective and efficient operation of linguistic and supportive processes, providing the quality guidelines necessary to satisfy our customers and to ensure that we are an ISO certified translations company.
Section 8 — Measurement, Analysis & Improvement
Measurement data are important in making fact-based decisions. We can ensure the effective and efficient measurement, collection and validation of data to ensure its performance and the satisfaction of its customers.
“Due to compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an ‘important outsourced service’…This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971.” – KEMA
ISO 13485:2003 Advantages
We are ISO certified to the ISO 13485:2003 standard. This is a quality management system, which details requirements for companies that provide medical devices and related services.
It is important to note that the process requirements of ISO 13485:2003, which are applicable to medical devices, also specify that work performed in conjunction with the medical device or service by an outside vendor remains the responsibility of the medical device organization.
Therefore, by working with an ISO 13425-certified translation company, medical device organizations can reduce costs and lower risks regarding Notified Body Inspections, and likely minimize the number of non-conformities during the audit process.
Below are some of the primary reasons why more and more medical device companies opt to outsource their medical translations to an ISO certified translation company.
The quality system of the medical device manufacturer and the quality system of the ISO 13485 certified translation company will be seamlessly integrated and harmonized.
By outsourcing their medical translations to an ISO 13485 certified translation company, medical device manufacturers can improve risk mitigation during their ISO 13485 audits.
Translation Vendor Qualification
Medical device manufacturers can introduce a shorter qualifying process and significantly reduce their resource allocation for supplier qualification and control.
Working with an ISO 17100 Certified Translation CompanyIn addition to its ISO 9001 and ISO 13485 certifications, Excel Translations is certified to the ISO 17100 standard. It is a quality standard for technical, medical, and life sciences translation services. ISO 17100:2015 provides requirements for the core processes, resources, and other aspects necessary for the delivery of a quality translation service that meets applicable specifications.
A Standard Specifically Designed for the Translation Industry
ISO 17100 is a standard specifically designed with the translation industry in mind, including life sciences translation. It covers all aspects of the translation process and defines basic parameters for a quality translation process. ISO 17100 demystifies and explains the critical components associated with the translation process.
ISO 17100 aims to standardize terminology, define basic requirements for services, and create a framework for interaction between customers and services providers.
Identify Requirements and Evaluate Suppliers
ISO 17100 offers clients guidance to the services offered by translation service providers, especially for those companies that are new to translation or about to enter a foreign market.
Benchmarking and Assessment Tool
ISO 17100 also provides clients with a reference point (a benchmark) for quality. The standard is widely used as a tool to evaluate Translation Service Providers and assess their quality performance.
By working with a translation company that is certified to ISO 17100 and competent in life sciences translation, you, your customers and other stakeholders can have confidence that the translated documents and software that accompany your products are meeting quality and service requirements that the translation industry believes to be necessary for the successful completion of a translation.
Working with an ISO 14971 Compliant Translation Company
Due to compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an ‘important outsourced service’…This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971. – KEMA
ISO 14971-2007 at a Glance
First, let’s define what the ISO 14971 standard specifies. According to the International Organization for Standardization (ISO), “ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life cycle of a medical device.” The translation of labeling literature, which conveys critical information about the device, is now considered by most Notified Bodies as a key activity in the life cycle of a device. The ability for a ISO certified translation provider to assess and mitigate issues inherent to the translation of labeling and product information, and to incorporate it in its quality system, aligning it with the quality system of the device manufacturer, is key in this regard.
Risk Assessment, Risk Mitigation, and Risk Management
ISO 14971 is all about risk management. When working with an ISO 14971- compliant Translation Service Provider, the risks involved in the translation of labeling, software and device documentation will be thoroughly assessed and addressed in a comprehensive and adequate manner, and will be integrated in the quality system of the translation supplier. Device manufacturers can be certain that the language-related risks associated with marketing their products overseas will be acknowledged and mitigated.
Just like the hazards associated with manufacturing medical devices (and the English documents and software that accompany them), translations are never without some level of risk. Doing business with an ISO 14971-compliant Translation Service Provider offers the assurance that a structured discipline is in place to ensure that risk is minimized. It confirms the TSP’s commitment and involvement in the risk management process. In addition, it provides an excellent risk management model that focuses on the entire life-cycle of translations.
Satisfaction for all Stakeholders
Device manufacturers will know that the same systematic attention and resources they apply to identify, assess, evaluate and control risks associated with their products are applied to the translations that are required to market them overseas.
This “peace of mind” will be shared not only by device manufacturers and their purchasing, quality and regulatory departments, but by all stakeholders in the process: patients, operators, medical practitioners, distributors, regulatory agencies and notified bodies.
Note: The 14971 Risk Management Standard is recognized by the EU, Health Canada, Japan and the FDA.
Working with an ASTM F 2575 Compliant Translation Company
The prevailing idea behind the US standard ASTM F 2575-06 (Standard Guide for Quality Assurance in Translation) is cooperation between the client and the document translation service provider. ASTM F 2575 offers an educational tool that provides hands-on information and “how-to” guidance to educate buyers of document translation services. The guide helps them facilitate communication and reach established goals in timing, cost and quality during the life of a document translation project.
ASTM F 2575 can serve as a road map to a translation company that is new to document translation or about to enter a foreign market. It itemizes a sequence of steps that will increase their chance to obtain their goal of high-quality translation products and services.
- Selecting a translation service provider
- Defining project specifications
- Production (Terminology Management, Translation, Editing, Formatting, Proofreading, and Quality Control)
- Post-project review
The graphic above (click to enlarge) describes how and where the various standards come into play between Excel Translations and a device company, utilizing the ASTM F 2575-06 standard.
Quality Assurance Processes
Excel Translations has established, documented, and maintains Quality Assurance Processes to ensure a quality program that supports its efforts to provide customers with quality products and services. Excel Translations’ quality assurance strategy is based on the following principles:
- We maintain a documented Quality Management System designed to meet the requirements of ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, ISO 17100, and ASTM F 2575-06. It is through the implementation of this Quality System that our Quality Policy commitments are realized.
- Through the use of documented and repeatable processes, quality plans, corrective and preventative actions, internal audits and effective management reviews, Excel Translations strives to provide the necessary tools and skills for its employees to continuously make improvements in the quality and consistency of products and services.
Quality System Documents
- The procedures and documents that make up the Quality Management System are defined and described in the Excel Translations Quality Manual.
- These documents collectively define a Quality System that complies with ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, ISO 17100, and ASTM F 2575-06 and identifies the methodology for implementing the company’s quality policy commitments.
Quality System Implementation
- All personnel who manage, perform, and verify work that affects quality are responsible for implementing the company’s quality system.
- Implementation of the quality system is assessed regularly by internal and external audits and frequently reviewed by management.
- Our requirements for quality planning are met by documenting specific procedures, practices, tasks and activities for all production and production-supporting processes. Implementation of and adherence to these documents guarantee quality products and services. The quality documentation includes meeting contractual requirements, and understanding and meeting customer needs – with an emphasis on problem prevention.
- Changes to the Quality System are made as needed. Written quality and audit plans are prepared for these changes, which will be consistent with all other requirements of the company’s quality management system.
Control and Supervision
At the heart of our Quality Assurance Process is a double-check mechanism. Simply put, every action is double-checked by a second person, following defined procedures and authorization levels. Though deceptively simple, the logistics of organizing a double-check procedure are daunting.
For example, a nine-language project containing three documents may undergo seven actions. That totals 189 discreet tasks (9 x 3 x 7) to be performed and checked! Excel Translations’ process builds in a sophisticated infrastructure to organize this effort, ensure completion of each action, and to collect data, thereby assuring that the final deliverable matches the expectation set forth in the initial project planning.
We make certain that our ISO certified quality systems are appropriate for every client’s needs. If necessary, we can also customize our project approach to better meet specific customer requirements.