Quality Management
The quality system of the Austrian federal Office for Safety in Health Care is operated by the Austrian Medicines and Medical Devices Agency and implements the requirements of ISO 9001 (under exclusion of chapter 8.3). Additional standardised requirements are considered for many core processes:
- for testing activities of the OMCL: ISO 17025 | Quality Management Documents of the OMCL-network
- for inspections: ISO 17020 | Quality Systems Framework for GMP Inspectorates
- for the pharmacovigilance system: GVP Module I Pharmacovigilance systems and their quality systems | Commission Implementing Regulation (EU) No 520/2012
Certification in accordance with ISO 9001
On 06. Juli 2010, the quality management system of the Austrian Medicines and Medical Devices Agency was certified in accordance with ISO 9001:2015 under the registration number 09282/0. By granting this certification, Quality Austria confirms that BASG and the Austrian Medicines and Medical Devices Agency operate in accordance with and continues to further develop an effective quality management system.
- Certificate (ISO 9001)| 857 KB27/09/2022
Accreditation in accordance with ISO 17025
The laboratory activities of the Official Medicines Control Laboratory (OMCL) of the Austrian Federal Office for Safety in Health Care were accredited according to EN ISO/IEC 17025 in 2002 by the national accreditation service, Akkreditierung Austria. The laboratory for biological medicinal products (plasma products and vaccines, 1160 Vienna, Possingergasse 38) continues to keep its accreditation.
The current scope of accreditation is listed on a website of the accreditation service (search for the identification number 0198).
- Confirmation of Accreditation| 258 KB18/08/2022
- Scope of Accreditation| 5 MB18/08/2022
Mutual Joint Audit of OMCL Network
The OMCL of the Austrian Federal Office for Safety in Healthcare is regularily assessed by Mutual Joint Audits (MJA) of the OMCL-Network. Criteria for the MJA scheme are the requirements of ISO 17025, the European Pharmacopoeia and Quality Management Guidelines of the OMCL-Network.
- EDQM Audit Attestation 2021| 84 KB15/12/2021
- Scope of Assessment| 179 KB05/01/2022
BEMA (Benchmarking of European Medicines Agencies)
The Heads of Medicines Agencies (HMA) have established a benchmarking programme among the human and veterinary medicines agencies.
The Austrian Medicines and Medical Devices Agency had its BEMA V visit in March 2023.
For more information please visit HMA.
