Certification of quality management systems

Quality management systems are developed by the manufacturer, implemented and certified on a voluntary basis.

Standards defining requirements for quality management systems:

  • DSTU ISO 9001:2015 Quality Management Systems. Requirements (ISO 9001: 2015, IDT);
  • DSTU EN ISO 13485:2018 Medical Devices. Quality Management System. Requirements for Regulatory Purposes (EN ISO 13485: 2016, IDT; ISO 13485:2016, IDT).

The terms for these two standards are defined in DSTU ISO 9000:2015 Quality Management Systems. Fundamentals and Vocabulary (ISO 9000:2015, IDT).

There is a belief that availability of the certified quality management system contributes to more successful product promotion on the market and the company that implemented such a certified system has competitive advantages. However, such an advantage really exists when choosing a conformity assessment module in the technical regulation system of Ukraine.

If there is a certified quality management system, the manufacturer can use Module B+D or Module B+H when assessing conformity of products to specific technical regulations of Ukraine.

Module B+D is a combination of Module B (type verification) and Module D (quality assurance of the production process).

Module B+H is a combination of Module B (type verification) and module H (full quality assurance (ISO 9001).

The use of these two conformity assessment modules is the basis for issuing certificates of type and certificates of conformity that are valid for 5 to 10 years, depending on the requirements of a particular technical regulation.

When using other conformity assessment modules, certificates are usually valid for one year only.

UCPS, LLC provides consulting services for development and implementation of quality management systems according to requirements of the following standards: DSTU ISO 9001:2015 and DSTU EN ISO 13485:2018, as well as promotes certification of such systems by relevant certification authorities accredited by the National Accreditation Agency of Ukraine (NAAU).