Risk Kontrolü ve Risk İzleme
Özet
Referanslar
Worlh Health Organisation. WHO guidelines on quality risk management: Annex 2. World Health Organisation Technical Report Series No 981; 2013. Erişim adresi: https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/ production/trs981-annex2-who-quality-risk-management.pdf
International Council For Harmonisation. ICH Harmonised Guideline: Quality Risk Management Q9(R1). European Medicines Agency, 2023. Erişim adresi: https://www.ema.europa.eu/en/ich-q9-quality-risk-management-scientific-guideline
International Organization for Standardization. ISO 22367:2020: Medical laboratories - Application of the risk management to medical laboratories. Geneva, Switzerland: International Organization for Standardization; 2020.
Clinical and Laboratory Standards Institute. CLSI document EP18-A2: Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline, 2nd Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
International Organization for Standardization. ISO 14971:2019 Medical devices- Application of risk management to medical devices. Geneva, Switzerland: International Organization for Standardization;2019.
Türkiye İlaç ve Tıbbi Cihaz Kurumu. İn vitro tanı amaçlı tıbbi cihaz yönetmeliği. Resmi Gazete,2 Haziran 2021.
Referanslar
Worlh Health Organisation. WHO guidelines on quality risk management: Annex 2. World Health Organisation Technical Report Series No 981; 2013. Erişim adresi: https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/ production/trs981-annex2-who-quality-risk-management.pdf
International Council For Harmonisation. ICH Harmonised Guideline: Quality Risk Management Q9(R1). European Medicines Agency, 2023. Erişim adresi: https://www.ema.europa.eu/en/ich-q9-quality-risk-management-scientific-guideline
International Organization for Standardization. ISO 22367:2020: Medical laboratories - Application of the risk management to medical laboratories. Geneva, Switzerland: International Organization for Standardization; 2020.
Clinical and Laboratory Standards Institute. CLSI document EP18-A2: Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline, 2nd Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
International Organization for Standardization. ISO 14971:2019 Medical devices- Application of risk management to medical devices. Geneva, Switzerland: International Organization for Standardization;2019.
Türkiye İlaç ve Tıbbi Cihaz Kurumu. İn vitro tanı amaçlı tıbbi cihaz yönetmeliği. Resmi Gazete,2 Haziran 2021.
