CHAPTER IV

QUALITY MANAGEMENT

Record keeping
Article 13
1
Member States shall take all necessary measures to ensure that blood establishments maintain records of the information required in Annexes II and IV and under Article 29(b), (c) and (d). The records shall be kept for a minimum of 15 years.
2
The competent authority shall keep records of the data received from the blood establishments according to Articles 5, 7, 8, 9 and 15.