ISO 13485 specifies additional documented procedures

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

Maintaining facilities and equipment that affect the quality of medical

devices

7.1

Managing risk in the realization of medical devices (including their

distribution, installation and servicing)

7.3

Designing and developing medical devices and associated installation,

maintenance and disposal or recycling information

7.4

Purchasing goods and services for the design, manufacture and

distribution of medical devices

7.5.2.1

Validating the use of computer software

7.5.2.2

Validating sterilization processes

7.5.3.1

Identifying and controlling medical devices according to their status

7.5.3.2.1

Maintaining the traceability of medical devices and their components

7.5.5

Preserving medical devices and constituent parts

7.5.5

Controlling products requiring special storage conditions

7.6

Using and calibrating monitoring and measuring equipment for

manufacture, installation, use and servicing of medical devices

8.2.1

Gathering and using medical device customer feedback

8.2.4.1

Inspecting and testing medical devices and their components

8.4

Determining, collecting and analyzing medical device QMS data

8.5.1

Issuing and implementing Advisory Notices

Process Owner

Please note: Other documented procedures are required as necessary for effective planning,
operation, control and monitoring of realization processes.
QMII