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Accreditation no: 10426
Overview of the organisation >
Contact info
Phone: 08-7500000
Website:
https://www.intertek.se
Postal address
Intertek Medical Notified Body AB
Box 1103
164 22 Kista
Visiting address
Intertek Medical Notified Body AB
Torshamnsgatan 43
164 40 Kista
Accreditation fields
Certification of management system, SS-EN ISO/IEC 17021-1:2015
Medical devices management system |
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Regulation
Title | Name |
---|---|
IAF MD 1:2023 | IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization |
IAF MD 11:2023 | IAF Mandatory Document for the Application of ISO/IEC 17021-1 for Audits of Integrated Management Systems |
IAF MD 2:2023 | IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems |
IAF MD 23:2023 | Control of Entities Operating on Behalf of Accredited Management Systems Certification Bodies |
IAF MD 28:2023 | IAF Mandatory Document for the Upload and Maintenance of Data on IAF Database |
IAF MD 4:2023 | IAF Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes |
IAF MD 5:2023 | Determination of Audit Time of Quality, Environmental and Occupational Health and Safety Management Systems |
IAF MD 9:2023 | Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485) |
SS-EN ISO/IEC 17021-3:2019 | |
STAFS 2020:1 | Swedac´s Regulations and General Guidelines on Accreditation |