View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. NN Translations
13 January 2022

Why ISO 9001 is Important and How Does it Relate to Translation? (Part 4)

5.3 Roles, responsibilities and powers

The roles, responsibilities and powers of the staff are defined in the Quality Management System (QMS) documents and in the job descriptions for a specific job.

Disclosure of roles, responsibilities and powers is guaranteed by familiarization with job descriptions when hiring and changing, by disseminating current QMS documents and training staff to meet certain requirements.

In addition to his main responsibilities, the Manager has the responsibilities and powers for:

  • ensuring the compliance of the QMS with the standard requirements;
  • ensuring that the processes provide the envisaged output elements;
  • evaluating the effectiveness of the QMS and identifying opportunities for improvement;
  • ensuring understanding and compliance with customer requirements and regulatory requirements by the whole company staff;
  • providing consultations and methodological guidance on all issues related to the implementation of the requirements of the QMS;
  • ensuring that the integrity of the QMS is maintained when amendments are planned and implemented.
  • making decisions on problems related to the QMS in carrying out the overall activities of the company.

6 Planning

6.1 Actions to manage risks and opportunities

When planning the Quality Management System (QMS), the Manager determines the risks and opportunities, taking into account the definitions in item 4.1 of this Manual, external and internal context of the company, as well as the defined needs and expectations of the interested parties in item 4.2.

The identified risks and opportunities related to the conformity of the products (translation and interpreting) and the services and the main processes in the company, as well as the actions for their management are documented in Appendix No 4 – Risks and opportunities and actions for their management.

A review of the actuality of the identified risks and an assessment of the effectiveness of the identified actions is performed during a review of the QMS by the Management.

6.2 Quality objectives and planning of activities to achieve them

Strategic quality objectives are defined in the Quality Policy.

Measurable objectives for the respective functions, levels and processes in the company, necessary for the QMS are defined in Appendix No 5 – Program for implementation of the quality objectives.

The objectives have been developed in accordance with the Quality Policy and, where possible, are measurable.

The defined objectives are updated as necessary and reported for review by management.

The resources, the responsible persons, the deadline for implementation, as well as the indicators for measurement and criteria for evaluation of the implementation of each goal are determined.

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

At NN Translations our specialty is medical and pharmaceutical translation. We can provide you with accurate translations from English into any of the Balkan languages,...
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena