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
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 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.