Process Risk Management Procedure

$139.00
$139.00
Unavailable
per item

The ISO 14971 Process Risk Management Procedure governs production related risks. The ISO 14971 Process Risk Management Procedure is made part of the overall medical device risk management system. 

  • ISO 14971:2019 Compliant
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • Includes Related Forms
  • MS Word and Excel Formats
  • Digital Content - Instant Download
SKU: SOP 7-031

Process Risk Management Procedure

The ISO 14971:2019 compliant Process Risk Management Procedure defines the process for identifying and mitigating risks associated with manufacturing processes used to manufacture of medical devices. 

Process  Risk Management Procedure Overview

​The Process Risk Management Procedure provides detailed instruction on the following steps:
  • ​Preparation Steps
  • Risk Identification
  • Risk Estimation
  • ​Preliminary Risk Level 
  • Risk Control Measures
  • ​Re-Estimation of Risk Post Implementation of Controls
​​The Process Risk Management Procedure includes excel spreadsheets and related forms with instructions for each step of the process.

Process Risk Management Procedure Compliance

The Process Risk Management Procedure is ISO 14971:2019, FDA QSR and ISO 13485:2016 compliant.

To learn more about our ISO 14971 Process Risk Management Procedure contact us at [email protected]​

RELATED LINKS

​​Risk Management Procedure Bundle
Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN PLUS
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
ISO 14971 Procss Risk Management Procedure
Production Risk Management

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