Risk Management Procedure SOP document template

AN EASY WAY TO GET YOUR Risk Management Procedure SOP document APPROVED IN ONE SHOT!

  • Need to Complete your Risk Assessment on time?
  • Want to be sure your Risk Assessment document will pass a regulatory inspection easily?
  • Do not have enough budget to hire a consulting company to complete your Risk Assessment?


Be in full compliance with the FDA/ICH regulations in a short time and with minor costs.




This Risk Management SOP template outlines the company procedures for a systematic approach to risk management and defines guidance on performing the Risk Assessment. The procedure template includes various tools and techniques to enable effective and consistent risk-based decisions and ensure that all the regulatory requirements regarding risk management are met

About this template

  • Versatile & easy to use Risk Management Procedure SOP document template
  • Immediate download
  • MS word, 49 pages ready to use Risk Management Procedure SOP document template
  • Based on the FMEA methodology
  • Clear instructions for use
  • Fits for FDA/Eu./ISO 13485/ISO 14971/HIPAA/GDPR regulations
  • Fit to Pharma/Medical/E-Health/Supplements and other industries

Your final Risk Assessment draft can be reviewed by our consultants- Optional


Understand how our risk assessment templates will support you best:

Best methodology and practice that fits your industry, products, and regulatory requirements

Have a template that is being used daily by our consultants in international FDA/CE/Eu audits

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Pass FDA/CE/Eu audits and submissions easily*

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Be independent and keep professionalism in-house.

In Addition

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