Accreditation for MS

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 ISO 45001:2018
    Occupational health and safety management systems
  • SRPS EN ISO 22000:2007
    Food Safety Management Systems (FSMS)
  • CAC/RCP 1-1969, Rev. 5-2020 HACCP
  • SRPS EN ISO 13485:2017
    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)

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 13485:2017

Main technical area
Technical area
Product category within technical areas

Non-active medical devices

General non-active, non-implantable medical devices

  • Inactive anesthetics, emergencies and intensive care
  • Inactive means for injection, infusion, transfusion and dialysis
  • Inactive orthopedic and rehabilitation aids
  • Inactive ophthalmic agents
  • Inactive instruments
  • Inactive medical means for disinfection, cleaning, rinsing

Inactive implants

  • Inactive orthopedic implants

Wound care products

  • Bandages
  • Non-active dental tools and accessories

Non-active dental tools and accessories

  • Non-active dental tools / equipment and instruments
  • Dental materials
  • Dental implants

Other inactive medical devices not mentioned above

  • Inactive gastroenterological-urological disposable medical devices
  • General disposable surgical medical devices

Active medical devices (non-implantable)

General active medical devices

  • Stimulants or inhibitors
  • Respiratory devices, devices that include hyperbaric chambers for oxygen therapy, inhalation anesthesia
  • Active surgical devices
  • Software
  • Medical gas supply systems and parts thereof

Devices for monitoring

Devices for monitoring vital physiological parameters

Devices for radiation therapy and heat therapy

Devices that use non-ionizing radiation

In-vitro diagnostic medical devices (IVD)

Reagents and reagent products, calibrators and control materials for:

  • Clinical chemistry
  • Immunochemistry (Immunology)
  • Hematology / Hemostasis / Immunohematology
  • Microbiology
  • Infectious immunology
  • Histology / Cytology
  • Genetic testing

In vitro diagnostic instruments and software

Parts or services

Components

Electrical components, fasteners, molded raw materials, processed raw materials and molded plastics

Sub-assemblies

Electronic subassemblies, mechanical subassemblies made according to drawings and/or operating instructions

Maintenance services

Electrical and mechanical repair services

For standard SRPS ISO/IEC 27001:2022

Referent standard is SRPS ISO/IEC 27001:2022 Information security, cybersecurity and privacy protection – Information security management systems

Note: our certification body is accredited according to the requirements of the standard SRPS ISO/IEC 17021-1:2015 and SRPS ISO/IEC 27006:2017, SRPS ISO/IEC 27006:2015/Amd. 1:2020.

For standard SRPS ISO 14001:2015

No *
Description of economic sector/activity
NACE Rev. 2 Code

17

Basic metals and fabricated metal products

24 изузев 24.46, 25 изузев 25.4, 33.11

18

Machinery and equipment

25.4, 28, 30.4, 33.12, 33.2

19

Electrical and optical equipment

26, 27, 33.13, 33.14, 95.1

28

Construction

41, 42, 43

29

Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods

45, 46, 47, 95.2

31

Transport, storage and communication

49, 50, 51, 52, 53, 61

34

Engineering services

71, 72, 74 изузев 74.2 i 74.3

 

For standard SRPS ISO 45001:2018

No *
Description of economic sector/activity
NACE Rev. 2 Code

17

Basic metals and fabricated metal products

24 изузев 24.46, 25 изузев 25.4, 33.11

18

Machinery and equipment

25.4, 28, 30.4, 33.12, 33.2

19

Electrical and optical equipment

26, 27, 33.13, 33.14, 95.1

28

Construction

41, 42, 43

29

Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods

45, 46, 47, 95.2

31

Transport, storage and communication

49, 50, 51, 52, 53, 61

34

Engineering services

71, 72, 74 изузев 74.2 i 74.3

For standard SRPS ISO 9001:2015

No *
Description of economic sector/activity
NACE Rev. 2 Code

3

Food products, beverages and tobacco

10, 11, 12

4

Textiles and textile products

13, 14

6

Wood and wood products

16

7

Pulp, paper and paper products

17

9

Printing companies

18

14

Rubber and plastic products

22

15

Non-metallic mineral products

23 изузев 23.5 i 23.6

16

Concrete, cement, lime, plaster etc

23.5, 23.6

17

Basic metals and fabricated metal products

24 изузев 24.46, 25 изузев 25.4, 33.11

18

Machinery and equipment

25.4, 28, 30.4, 33.12, 33.2

19

Electrical and optical equipment

26, 27, 33.13, 33.14, 95.1

23

Manufacturing not elsewhere classified

31, 32, 33.19

27

Water supply

35.3, 36

28

Construction

41, 42, 43

29

Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods

45, 46, 47, 95.2

31

Transport, storage and communication

49, 50, 51, 52, 53, 61

33

Information technology

58.2, 62, 63.1

34

Engineering services

71, 72, 74 изузев 74.2 i 74.3

35

Other services

69, 70, 73, 74.2, 74.3, 78, 80, 81, 82

36

Public administration

84

39

Other social services

37,38.1.38.2, 39, 59.1, 60, 63.9, 79, 90, 91, 92, 93, 94, 96

* Note: Based on IAF ID 1:2014.