Worksheet

Record map for a small device maker

This map is a single table with four columns, covering record name, owner, where it lives today and the time taken to retrieve it. Rows cover the device file, history record, complaint file, CAPA log, supplier list, training matrix, calibration list and document register, and the last column marks every gap you find.

Name: ______________________   Business: ______________________   Date: ______________

Scroll the table sideways to see every column.

Cross out or rewrite any heading that does not fit your business. From the guide “ISO 13485 records explained for small device makers”, www.gullysystem.com/blog/iso-13485-records-explained-for-small-device-makers