Role of accreditation in this sector
This sector includes numerous services that help to improve safety and quality in the medical and healthcare sector. In these often sensitive areas, accreditation serves as an important instrument to enable competent examination, analysis or certification services and to strengthen quality assurance measures. The goal: to promote good health, minimise risks and create processes that are as effective as they are efficient.
The range of conformity assessments covered by this sector is broad. Many medical decisions, for example, are based on the test results of medical laboratories. Accreditation in this area is a tried and tested procedure for designing medical laboratory diagnostics competently and enabling reliable compliance with applicable quality requirements.
The certification of both management systems and personnel in the area of health protection and public health are assigned to this sector, as are conformity assessments relating to hygiene, medicinal products, medical devices and aids. Pathological or veterinary medical examinations are also included.
The area of health also includes accredited prequalification bodies that verify the suitability of providers of medical aids in accordance with Section 126 of the Fifth Book of the Social Code (SGB V). These service providers must fulfil certain requirements in order to conclude contracts with the statutory health insurance funds, enabling them to provide patients with statutory health insurance with medical aids.
Our technical units in the Medicine and Health sector
Electrical Engineering | Telecommunication | EMC | Active Medical Devices
This technical unit accredits on the basis of DIN EN ISO/IEC 17025, DIN EN ISO/IEC 17065 and DIN EN ISO/IEC 17020 in the areas of electrical engineering, telecommunications, EMC and active medical devices.
Consumer Health Protection | Veterinary Medicine
The Consumer Protection and Product Labelling (Non-Food) technical unit grants accreditations in accordance with DIN EN ISO/IEC 17025, DIN EN ISO/IEC 17065 and DIN EN ISO/IEC 17020.
Medicine | Pharmacy | Non Active Medical Devices
The focus of this technical unit is on accreditation in accordance with DIN EN ISO/IEC 17025 in the areas of non-active medical devices, pharmaceuticals and active ingredients and health care. In addition, this technical unit also covers biobanks in the medical environment, which are accredited in accordance with DIN EN ISO 20387, and accreditation in accordance with DIN EN ISO 17021-1 in the area of non-active medical devices (DIN EN ISO 13485).
This technical unit processes accreditations in the area of medical laboratory diagnostics and pathology. It also accredits proficiency testing providers. The accreditation of medical laboratories is in accordance with the standard DIN EN ISO 15189. Accreditations are granted in the fields of pathology, neuropathology and dermatohistology on the basis of the standard DIN EN ISO/IEC 17020. The accreditation of proficiency testing providers is carried out in accordance with DIN EN ISO/IEC 17043.
Certification of Persons and Management systems (cross-sector)
The Certification of Persons and Management Systems (Cross-Sector) technical unit manages the accreditation of certification bodies for management systems in accordance with DIN EN ISO/IEC 17021-1 for various management system certification standards and for persons in accordance with DIN EN ISO/IEC 17024.
Water | Drinking Water | Water Supply
This technical unit covers a wide range of activities relevant to accreditation and relating to the characterisation, use and protection of water. Accreditations in accordance with for example DIN EN ISO/IEC 17025, DIN EN ISO/IEC 17043, DIN EN ISO/IEC 17065, DIN EN ISO 17034 and DIN EN ISO/IEC 17020 are possible.
Financial, Competition and Procurement Systems | Prevention of Corruption and Money Laundering | Trade | Craft
The Financial, Competition and Procurement Systems | Prevention of Corruption and Money Laundering | Trade | Craft technical unit accredits on the basis of DIN EN ISO/IEC 17065, DIN EN ISO/IEC 17021 and DIN EN ISO/IEC 17024.
Health | Rehabilitation | Pharmacies
This technical unit handles cases of accreditation in the areas of quality management systems / services in health care, BAR (Federal Association for Rehabilitation) procedures, specialists in health care, specialists pursuant to NiSV (German ordinance on protection against harmful effects of non-ionising radiation) and certification of fitness studios.
Application examples of accredited services in this field of activity
- Conduct of medical diagnostic examinations
- Expert assessment of physicians in the fields of pathology, neuropathology and dermatohistology
- Testing from the medical environment outside patient diagnostics
- Testing of in vitro diagnostic medical devices
- Examinations in the area of animal health
- Testing of medicinal products and for manufacturers of medicinal products
- Biobanks from the medical environment (DIN EN ISO 20387)
- Certification of quality management systems for organisations providing medical devices and related services (DIN EN ISO 13485)
- Certification of quality management systems / services in healthcare in accordance with DIN 15224 in hospitals, pharmacies, care facilities or rescue services
- Certification of quality management systems in rehabilitation facilities
- Personnel certifications of healthcare professionals and within the scope of NiSV, the German ordinance on protection against harmful effects of non-ionising radiation in human applications
- Proficiency testing of providers of medical aids (such as medical supply shops or audiologists) in accordance with Section 126 SGB V (Fifth Book of the German Social Code)