Dokumeds - ISO 9001:2015 certified.


New version of ISO 9001 standard was published in September 2015, including changes from previous version: risk-based thinking, greater flexibility with documentation, greater focus on customer and achieving conformity of products and services.

Following the certification cycle of Dokumeds obtained ISO 9001 certificate (initial certificate dated 29-May-2013), re-certification audit as per ISO 9001:2015 requirements was performed in Riga office on 15-Apr-2016. Dokumeds has passed the audit and will be issued with a certificate of compliance to ISO 9001:2015 requirements.

Dedicated work and efforts in maintenance and continuous improvement of the Quality Management System involving different employees and departments at Dokumeds has allowed us to reach this important goal.

Currently Dokumeds is holder of the following ISO certificates:

  • ISO 9001:2015 certification in International Project Management for Clinical Research and Development of Pharmaceutical and Biotechnology Products (recertification passed in 2016);  
  • ISO 9001:2008 certification in International Project Management together with partners of Across Alliance (recertification passed in 2015);  
  • ISO 9001:2008 certification in Storage and logistics of medicinal products and other materials for clinical studies at Dokumeds local Depot in Moscow (certification passed in 2014);  
  • GOST ISO 9001-2011 certification in Storage and logistics of medicinal products and other materials for clinical studies at Dokumeds local Depot in Moscow (certification passed in 2014).
  • Dokumeds also holds the following certificates:
  • Good Distribution Practice certification in Storage and logistics of medicinal products and other materials for clinical studies at Dokumeds local Depot in Moscow (certification passed in 2014);  
  • Credit Reform Solvency Gold certificate (since 2013);  Certificate of Eligibility to French Research Tax Credit (since 2010).
  • ISO 9001:2008 and Good Distribution Practice surveillance audit took place in Dokumeds local Depot in Moscow on 15-Mar-2016 with good results supporting the maintenance of existing certificate. In 2017, recertification audit will be scheduled in Dokumeds local Depot in Moscow.

 


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