This is a Provision for the management of measuring instruments in a form consistent with the FDA QSR.
By clarifying the management method of measuring instruments, it is possible to standardize within the company.
By standardizing the management method, it is possible to smoothly respond to FDA inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K72 Inspection, measuring, and test equipment Management Provision

Table of Contents

Provision

1 Objective.
2 scope (of a document)
3 List of measuring instruments, etc.
4 Management of measuring instruments, etc.
5 Identification of measuring instruments, etc.
6 Calibration of measuring instruments, etc.
6.1 Calibration Standard
6.2 Status of calibration of measuring instruments, etc.
6.3 Calibration Frequency
6.4 calibration record
7 Adjustment, readjustment, maintenance, etc. of measuring instruments, etc.
8 Handling and storage of measuring instruments, etc.
9 Measures to be taken in the event of measurement equipment failure or calibration failure
10 Computer Software Validation
11 reference
12 by-laws