Ukrainian Scientific Institute of Certification
QMS certification

The limited liability company Uni-CERT is accredited for certification of quality management systems (QMS) in accordance with the following standards:

  • ISO 9001:2008 Quality management systems – Requirements
  • ДСТУ ISO 9001:2009 Системи управління. Вимоги (ISO 9001:2015, IDT) (DSTU ISO 9001:2009 Quality management systems – Requirements (ISO 9001:2008, IDT))
  • ISO 9001: 2015 Quality management systems – Requirements
  • ДСТУ ISO 9001:2015 Системи управління. Вимоги (ISO 9001:2015, IDT) (DSTU ISO 9001: 2015 Management Systems – Requirements (ISO 9001: 2015, IDT))
  • ISO 13485: 2003/Cor 1:2009 Medical devices – Quality management systems – Requirements for regulatory purposes
  • ДСТУ EN ISO 13485:2015 Медичні вироби. Система управління якістю. Вимоги до регулювання (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT) (DSTU ISO 13485: 2005 Medical products – Quality management systems – Requirements for regulation (ISO 13485: 2003, IDT))
  • EN ISO 13485: 2012 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485: 2003, IDT)
  • ДСТУ EN ISO 13485:2015 Медичні вироби. Система управління якістю. Вимоги до регулювання (EN ISO 13485:2012, IDT; ISO 13485:2003, IDT) (DSTU EN ISO 13485: 2015) Medical devices – Quality management system – Requirements for regulation (EN ISO 13485: 2012, IDT; ISO 13485: 2003, IDT).

A certified QMS provides the company with a range of advantages, namely:

  • optimizes and improves the effectiveness and performance of the processes;
  • enables the company to improve the quality of its products and/or services;
  • let the company become self-improving and self-developing, requiring less attention of the management;
  • increases the decision-making effectiveness;
  • reduces the administration costs;
  • improves the organisational activity, confidence and sustainability;
  • feedback with the customers increases loyalty and confidence in the company, helps to optimise the document flow

As a result of changes in the legislation applicable to medical devices, a new requirement the domestic manufacturers have to face is that a QMS must be in place in accordance with DSTU ISO 13485. This standard can be applied by organisations engaged in the design, development, production, installation and servicing of medical devices.

A company certification involves an audit of the QMS documentation and of the manufacturing site. On the basis of the audit conclusion, a QMS certificate is granted for a period of 3 years.

The procedure for certification of a quality management system, from the submission of an application until the issuance of a certificate, is shown below:

QMS certification procedure

Application form (download)