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Review

Audits

Olga López-Villar  1 , Julie Dolva  2
Mahmoud Aljurf  1 , John A. Snowden  2 , Patrick Hayden  3 , Kim H. Orchard  4 , Eoin McGrath  5
, editors.
In: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: The JACIE Guide [Internet]. Cham (CH): Springer; 2021. Chapter 4.
.
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Free Books & Documents
Review

Audits

Olga López-Villar et al.
Free Books & Documents

Excerpt

There are different tools to measure the efficacy of the quality system and of its processes. Among them, internal audits are essential components since they cover all aspects of the program. Auditing is a systematic and documented process to ensure compliance with requirements. Preparing and planning are important parts of a good audit and the selection of the auditor must be based on expertise and competency. The appropriate analysis of the results of the audit and implementation of the corrective action, preventive action, or process improvements after the audit will help the program to improve year after year.

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References

    1. Eldrige P, Warkentin P, Saccardi R, Schwartz J, et al. International standards for hematopoietic cellular therapy product collection, processing, and administration. FACT-JACIE [Internet] 7th ed. 2018. Available at: https://www.ebmt.org/jacie-standards/7th-edition-effective-june-1st-2018.
    1. Eldrige P, Warkentin P, Saccardi R, Schwartz J, et al. International standards for hematopoietic cellular therapy product collection, processing, and administration. Accreditation manual. FACT-JACIE [Internet] 7th ed. 2018. Available at: https://www.ebmt.org/jacie-standards/7th-edition-effective-june-1st-2018.
    1. Atkins W et al. Quality handbook: a guide to implementing quality management in cellular therapy organizations. FACT [Internet]. 2nd ed. 2015. Available at: http://www.factwebsite.org/
    1. ISO.org [Internet]. ISO 9001: 2015. 5th ed. 2015. Available at: https://www.iso.org/standard/62085.html
    1. A practical guide to implement quality management in a Stem Cell Transplantation Programme. Quality Management Guide. 1st ed. JACIE 2008.

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