RISK MANAGEMENT SOP GROUP

RISK MANAGEMENT SOP GROUP

This SOP group contains procedures for a compliant risk management program including Hazard Analysis following ISO14971, FMEA and critical manufacturing operations analysis.


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This SOP group contains procedures for a compliant risk management program including Hazard Analysis following ISO14971, FMEA and critical manufacturing operations analysis.

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$500.00
This SOP is a higher level document describing COMPANY risk management policy and coordinating Hazard Analysis and FMEA which are described in their own SOP's (following this SOP). ISO standards are integrated into the SOP. A Risk Analysis Plan form, Risk Analysis Report form and a Risk Management Index form is included. (11 pages + 3 forms)
$150.00

This SOP describes methods for conducting Hazard Analysis following ISO 14971 to establish product risks, prioritize risk reduction efforts and conduct and validate mitigations. Latest ISO TR (24971) is integrated into the SOP.Two matrix forms to guide Hazard Analysis are included as well as a report template.(15 pages + 3 forms)

Webinar slides which explain the SOP and the context of the SOP are included. These could be used for training.

$150.00
This SOP describes methods to conduct a FMEA which is used to reduce medical device product risk and failure. Two matrix forms are included with the SOP to guide the FMEA.(14 pages + 2 report forms)
$150.00
This SOP provides guidelines for the identification and control of critical manufacturing operations .It explains how to conduct a process Hazard Analysis and includes forms to document the Hazard Analysis and the identification of the critical manufacturing operations (9 pages +3 forms)
$150.00