Why ISO 9001 is Important and How Does it Relate to Translation? (Part 2) - Clinical Trials Arena
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Why ISO 9001 is Important and How Does it Relate to Translation? (Part 2)

11th November 2021

4.3 Scope of the quality management system

The quality management system at NN TRANSLATIONS EOOD is designed to:

  • meet the requirements of the BDS EN ISO 9001: 2015 standard
  • ensure that the country legislation is followed carrying out the main activities for the provision of translation and interpreting services;
  • provide an opportunity for periodic presentation, evaluation and improvement of the result and effectiveness of QMS in terms of the quality of the provided translations and services, in order to satisfy the clients.

The quality management system is applied with the following scope and limits of applicability:

Translation and interpreting of materials in the fields of medicine and pharmacy, biotechnology and clinical research, as well as in the fields of economics and finance, business and marketing, fashion and cosmetics. Linguistic validation of texts in the field of clinical trials. Cognitive debriefing and readability of patient leaflets.

The quality management system covers all processes and activities of the company and meets the requirements of the clauses of BDS EN ISO 9001: 2015, however the limits of applicability of QMS do not include:

– Design and development of products (translation and interpreting) and services, according to the scope described above – the processes are carried out on the basis of the requirements of CRO and international rules for translation into the native language.

– Accounting activities that are subject to national legislation and international and national accounting standards.

The Manager shall ensure that all staff has access to the scope of the QMS through the dissemination of this document.

4.4 Quality management system and its processes

QMS processes and their interrelationships are defined in Appendix № 1 – QMS processes and their interrelationships.

For each process the following is defined:

– Necessary input elements and expected output elements;

– Criteria and methods (including monitoring, measuring and the associated with them result indicators) necessary to ensure the efficient operation and management of these processes;

– Responsibilities and powers for carrying out the process.

When conducting QMS review meetings, the Manager:

– defines the resources needed for these processes and provides their availability

– evaluates these processes and identifies actions to make any necessary changes to ensure that these processes deliver the expected results;

– sets out measures to improve these processes and QMS.

The manager determines the methods and responsibilities for:

– maintaining up-to-date documented information necessary for the functioning of the QMS processes;

– storage of documented information to ensure that processes take place as planned.

 

Contact us for more information on how we can help you with your translation or cognitive debriefing needs today!

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