1.Member States shall take all necessary measures to ensure that each tissue establishment puts in place and updates a quality system based on the principles of good practice.
2.The Commission shall establish the Community standards and specifications referred to in Article 28(c) for activities relating to a quality system.
3.Tissue establishments shall take all necessary measures to ensure that the quality system includes at least the following documentation:
standard operating procedures,
guidelines,
training and reference manuals,
reporting forms,
donor records,
information on the final destination of tissues or cells.
4.Tissue establishments shall take all necessary measures to ensure that this documentation is available for inspection by the competent authority or authorities.
5.Tissue establishments shall keep the data necessary to ensure traceability in accordance with Article 8.