CHAPTER IV

QUALITY MANAGEMENT

Quality system for blood establishments
Article 11
1
Member States shall take all necessary measures to ensure that each blood establishment establishes and maintains a quality system for blood establishments based on the principles of good practice.
2
The Commission shall establish the Community standards and specifications referred to in Article 29(h) for the activities relating to a quality system to be carried out by a blood establishment.

Documentation
Article 12
1
Member States shall take all necessary measures in order to ensure that blood establishments maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms.
2
Member States shall take all necessary measures in order to ensure that access is provided to these documents for officials entrusted with inspection and control measures referred to in Article 8.

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.