Quality and safety

Quality and safety

Quality Management System (QMS)
ISO 9001

ISO 9001 is an international standard for quality management systems. medi.global holds a certificate of conformity with this standard.

Having a certified quality management system in place is a testimony to our capability to ensure continued service consistent with the requirements of our clients, which greatly contributes to client satisfaction.

When implementing the ISO 9001-compliant QMS, we developed a range of dedicated operational procedures adapted to the needs of CROs and other organisations from the medical and pharmaceutical sectors. Our procedures regulate vendor recruitment, response times, order processing, and complaint handling, among others.

Our certified QMS covers the following areas:

  • creation and circulation of documented information,
  • managing operating context and risks,
  • auditing and management reviews,
  • human resources and vendor management,
  • infrastructure supervision,
  • service provision,
  • customer satisfaction monitoring and complaint handling,
  • detection and recording of non-compliance incidents and implementation of corrective measures.

Our organisation undergoes annual audits by an accredited third-party auditor. We also regularly implement internal audits.

The benefits of having in place a quality management system compliant with ISO 9001 include:

validating medi.global’s dependability as a language service provider
ensuring consistent, reliable procedures and improved governance
implementing procedures adapted to the needs of the industries we work with
Quality and safety

Requirements for translation services
ISO 17100

ISO 17100 is a gold standard in translation services. medi.global has held a certificate of compliance with this standard from the very beginning of its business activity.

ISO 17100 defines the scope of applicability, human, technical and technological resources, processes, feedback handling, and administration activities, among other things. The standard also defines the principal concepts related to the translation process and its participants.

ISO 17100 also defines the professional competences of a translator, which include: translation, linguistic, research, cultural, technical and domain competence.

Translators are required to have at least:

  • a university diploma in the field of translation,
  • a university diploma in another field plus two years of full-time translation practice, or
  • five years of full-time translation experience.

As a language service provider specialising in life sciences, we go above and beyond the requirements defined in ISO 17100, which we believe to be insufficient from the point of view of our target industries. medi.global is one of the very few LSPs to raise the bar even higher, recruiting vendors (translators, revisers, proofreaders) who offer:

  • the necessary educational background (e.g. medicine, pharmacology, chemistry, biology),
  • professional experience in their respective field (medical specialisation, CRO experience, academic research).

The benefits of having in place a translation service quality management system compliant with ISO 17100 include:

using approved processes recognised internationally by industry experts
applying minimum requirements in vendor recruitment
regular audits to eliminate any instances of non-compliance
Quality and safety

Information Safety Management System (ISMS)
ISO 27001

We know that confidentiality and information security are a top priority for our clients. This is why at medi.global, we have implemented an information security management system compliant with ISO 27001.

ISO 27001 defines the requirements for implementing, maintaining, monitoring, and continually improving an information security management system. Having an information security management system in place is an absolute must when working with CROs and pharma companies. Sadly, most LSPs who declare themselves experts in these industries today still do not have a certified ISMS compliant with ISO 27001.

At medi.global, our ISMS requires using legal (e.g. non-disclosure agreements), technological (e.g. access rights, strong passwords and biometric authentication), cryptographic (e.g. Transport Layer Security, hard disc encryption), and administrative safeguards(e.g. clean desk and screen policies).

An information security management system brings a number of benefits to the organisation, most notably:

  • compliance with applicable regulations,
  • improved identification and mitigation of risks,
  • information system security at the organisational level,
  • continued improvement of service quality,
  • confidentiality, integrity and accessibility of information, and
  • supervision over information processing.

The benefits of having in place an information security management system include:

ensuring greater information and data security owing to legal, technical and administrative safeguards
minimising the risk of inadvertent data loss and tampering
demonstrating the appropriate level of security regarding the confidential information of our clients
Quality and safety

Client audits

As a preferred provider of many CRO and pharma companies, medi.global regularly undergoes initial and periodical client auditsconducted by the quality departments of our business partners.

As part of these audits, they inspect our resources, including technical facilities, operational procedures and providers.

If you are a new client interested in forming a business relationship with us, we will be happy for you to perform this type of audit — contact us to arrange any details or dates.

Quality and safety

Personal data processing
GDPR

At medi.global, we have fully implemented the requirements of the General Data Protection Regulation of 27 April 2016 (GDPR).

Our information clause regarding personal data processing is available on our website.

Our certificates