Beruflich Dokumente
Kultur Dokumente
ISO 9001:2008 specifies six documented procedures. ISO 13485:2003 specifies additional documented
procedures for use in the planning, operation, control and monitoring of the 15 processes listed below.
Clause
Process
6.3
7.1
7.3
7.4
7.5.2.1
7.5.2.2
7.5.3.1
7.5.3.2.1
7.5.5
7.5.5
7.6
8.2.1
8.2.4.1
8.4
8.5.1
Process Owner
Please note: Other documented procedures are required as necessary for effective planning,
operation, control and monitoring of realization processes.
QMII