【FDA CFR 820 QSR Compliance】Inspection, measuring, and test equipment Management Procedure, and Forms

$300

【FDA CFR 820 QSR Compliance】Inspection, measuring, and test equipment Management  Procedure, and Forms

【FDA CFR 820 QSR Compliance】Inspection, measuring, and test equipment Management Procedure, and Forms

$300

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This is a procedure for the control of measuring instruments in a form consistent with the FDA QSR.

List of Forms
The following forms are included with your purchase.
・MD-QMS-S7201 Inspection, measuring, and test equipment Management Procedure
・MD-QMS-F7201 Application Form for Registration, Change, or Exclusion of Measuring Equipment
・MD-QMS-F7202 Calibration Request Form for Measuring Equipment
・MD-QMS-F7203 Instrument Calibration Card
・MD-QMS-F7204 Calibration cycle review notice for measuring instruments
・MD-QMS-F7205 Measurement device abnormality report
・MD-QMS-F7206 Instrument List


 

Table of Contents

Procedure

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Measurement device management implementation procedures
5.1 Registration of measuring instruments
5.2 Management of measuring instruments
5.3 Change or discontinuation of measuring instruments
6 Calibration of measuring instruments
6.1 In-house proofreading
6.2 proofreading by an outside party
6.3 Post-calibration actions (display of calibration status, protection of calibration status, review of calibration cycle, etc.)
6.4 Periodic calibration of measuring instruments Preparation
6.5 Measures to be taken in the event of measurement equipment failure or calibration failure
7 Record keeping
8 Management of calibration workers
9 form
10 reference
11 by-laws