What is the ISO 13485 standard?
ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. Though it is tailored to the industry’s quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard.
Instead of just focusing on product quality and continuous improvement (as in ISO:9001 and ISO 17100), ISO 13485 is based on a process-approach to quality management in which the inputs and outputs of linked processes must be identified and managed.
Why does a translation company need a medical device quality standard?
As a translation company, the vast majority of the procedures required by the ISO 13485 standard are not applicable to us, but the procedure that describes our translation process when we translate for clients who manufacture medical devices is.
This standard recognizes that translations play a vital role in the quality system of medical devices and it specifies that there is a need to manage the translation requirements.
What types of medical device documents do we translate?
The medical device documentation that we translate includes, but is not limited to, the following: Instructions for Use, Operating Manuals, Installation Manuals, Regulatory Compliance Documents, Software Applications, Package Inserts and Labels, Patents, Manufacturing Procedures, Data sheets etc.
What does the ISO 13485 certification mean for our clients?
- We are using a quality management system in our ISO 13485 translation process to prevent misuse and ensure that your medical devices are safe for their intended purpose.
- We are using strict linguist selection criteria for ISO 13485 medical device translations. You can rest assured that your projects are handled by qualified professionals that have extensive experience in Life Sciences translations and follow strictly defined processes which leave minimum margin for mistakes and customer complaints.
- We have an identification, traceability and version control process in place to ensure that product safety and accountability can be fully achieved.
- The ongoing effort to always comply with the standard requirements make the Commit Global team follow a professional development program and the well-defined processes and procedures they have to follow always keep them highly efficient.
“The addition of the ISO 13485 standard shows our commitment to quality, customer service and continuous improvement”, says Effie Salourou, Customer Operations & QA Manager at Commit Global. “Translation is a key outsourcing activity for many medical device manufacturers, and we understand that translations of medical devices could carry a potential risk to people’s health. Our goal was to minimize that risk and ensure product safety”.
The ISO 13485 certification for medical devices complements our list of ISO certificates that includes the ISO 9001 for a general quality management system, the ISO 17100 that specifies the quality requirements for translation agencies and the ISO 27001 that is the international best practice standard for information and data security.
If you want to learn how Commit Global’ s ISO 13485 translations can help safeguard your patients’ safety, contact us here.