Accreditation

Kvalitet a.d. performs management system certification according to

  • SRPS ISO 9001:2015
    Quality Management Systems (QMS)
  • SRPS ISO 14001:2015
    Environmental Management Systems(EMS)
  • SRPS OHSAS 18001:2008
    Occupational Health and Safety Management Systems (OHSAS)
  • SRPS EN ISO 22000:2007
    Food Safety Management Systems (FSMS)
  • CAC/RCP 1-1969, Rev. 4-2003 HACCP
  • SRPS EN ISO 13485:2014
    Medical Devices - Quality Management Systems(MD-QMS)
  • SRPS ISO/IEC 27001:2014
    Information Security Management Systems (ISMS)
  • SRPS ISO 22301:2014
    Business Continuity Management Systems (BCMS)


New editions of SRPS ISO 9001:2015 and SRPS ISO 14001:2015

Institute for Standardization of Serbia has published new editions of Serbian standards SRPS ISO 9001: 2015 and ISO 14001: 2015 on October 30th 2015.
The transition period from the previous version in all 3 years.
In Transition Planning Guidance for ISO 9001:2015, published by the IAF, describes the obligations of all parties to which the standard applies: accreditation bodies, certification bodies, organizations implementing standards.

Kvalitet a.d. performs auditing and certification of management systems according to the new editions of the above mentioned standards, and for more information please contact us.

Accreditation scope

Kvalitet a.d. is ACCREDITED organisation by ATS (Serbian Accreditation Body) for management system certification according to ISO 17021-1:2015.

Accreditation has confirmed the competence and impartiality of the certification body Kvalitet a.d.

Certification of the system that are outside of the scope of accreditation is carried out according to identical procedures as well as those that are under accreditation. The principles of competence, impartiality and objectivity are being respected in all audits and certifications.

For standard SRPS ISO 13485:2014

Main technical area Technical area Product categories covered by the technical area
Non-active medical devices General non-active, non-implantable medical devices
  • Non-active orthopedic and rehabilitation devices;
  • Non-active medical devices with measuring functions (non-sterile);
  • Non-active ophthalmology devices (frames and lences);
  • Non-active instruments;
  • Non-active medical disinfectants, cleaned and rinsing.
Non-active medical devices Wound care bandages and gauze (non-sterile)
Non-active medical devices Non-active dental tools and accessories Non-active dental devices / equipment and instruments
In-vitro diagnostic medical devices (IVD) Reagents and products reatenasa, calibrators and control materials for:
  • Clinical chemistry;
  • Immunochemistry (Immunology);
  • Hematology / Hemostasis / Immunohematology;
  • Microbiology;
  • Infectious immunology;
  • Histology / Cytology;
  • Genetic testing.


For standard SRPS ISO 14001:2015

EA code Name and description of activities NACE code
EA17 Manufacture of basic metals and fabricated metal products 24 except 24.46,
25 except 25.4,
33.11
EA18 Manufacture of machinery and equipment not mentioned elsewhere 25.4, 28, 30.4, 33.12, 33.2
EA19 Manufacture of electrical and optical equipment 26, 27, 33.13, 33.14, 95.1
EA28 Construction 41, 42, 43


For standard SRPS OHSAS 18001:2008

EA code Name and description of activities NACE code
EA17 Manufacture of basic metals and fabricated metal products 24 except 24.46,
25 except 25.4,
33.11
EA18 Manufacture of machinery and equipment not mentioned elsewhere 25.4, 28, 30.4, 33.12, 33.2
EA28 Construction 41, 42, 43


For standard SRPS ISO 9001:2015

EA code Name and description of activities NACE code
EA3 Manufacture of food products, beverages and tobacco DA
EA4 Manufacture of textiles and textile products DB
EA6 Manufacture of wood and wood products DD
EA7 Manufacture of pulp, paper and paper products DE 21
EA9 Printing and service activities related to printing. Reproduction of recorded media DE 22.2, 22.3
EA14 Manufacture of rubber and plastic products DH
EA15 Manufacture of other non-metallic minerals except manufacture of cement, lime and plaster and manufacture of concrete, cement and plaster DI 26 except 26.5,
6
EA16 Production of cement, lime and gypsum. Manufacture of concrete, cement and plaster DI 26.5, 26.6
EA17 Manufacture of basic metals and fabricated metal products DJ
EA18 Manufacture of machinery and equipment not mentioned elsewhere DK
EA19 Manufacture of electrical and optical equipment DL
EA23 Furniture production; production of various products, not mentioned elsewhere DN 36
EA27 Collection, purification and distribution of water. Production and distribution of steam and water Supplements. 35.3, 36
EA28 Construction F
EA29 Wholesale and retail trade; repair of motor vehicles, motorcycles and personal and household goods G
EA31 Transport, storage and communication I
EA33 Computing and related activities K72
EA34 Research & Development. Architectural and engineering activities and technical advice K 73, 74.2
EA35 Other business activities except architectural and engineering activities and technical advice K 74 except 74.2
EA36 Public administration and defense; compulsory social security L
EA39 Other community, social and personal service activities O