Hazard Analysis SOP

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Hazard Analysis Program SOP


This Standard Operating Procedure (SOP) describes in detail all the key steps to implement for a consistent, reliable and effective Hazard Analysis Program. This program is a requirement by the agencies not mattering if FDA or EMA. It is essential to identify, mitigate and control risks associated with the development of medical devices.



This Standard Operating Procedure (SOP) describes the program developed for performing the Hazard Analysis (HA) during the development of Medical Devices under Device Control in order to identify, understand, control, and prevent potential risks in the use of COMPANY Medical Devices. The Hazard Analysis is conducted throughout product design, development as well as marketing/distribution. This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP and supports the overall Design Control process. This SOP applies to all Medical Devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such Medical Devices. This program does not apply to medical devices in very early stage of development such as early concept or feasibility stages.


Regulatory basis, reference documents

  • 21 CFR Part 820 - Quality System Regulation, Subpart C - Design Controls, 820.30 Design controls
  • HE75:2009 Human factors engineering – Design of medical devices
  • ISO 13485:2016: Medical Devices - Quality management systems Requirements for regulatory purposes
  • FDA/CDRH - Design Control Guidance for Medical Device Manufacturers, March 11, 1997
  • 21 CFR Part 820-Quality System Regulation, Subpart G- Production and Process Controls
  • ISO 14971 Medical Devices: Application of Risk Management to Medical Devices


Table of Content

1          Purpose          

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Design Review Committee

4.3       Quality Assurance

4.4       Project Leader (PL) / Head of Engineering (HE)

4.5       Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1       General

7.2       Human Factors Engineering

7.3       Hazard Analysis

7.4       Severity

7.5       Probability

7.6       Risk Index

7.7       Hazard Analysis Project team

7.8       Using the Hazard Analysis Matrix Form “Details”

7.9       Using the Hazard Analysis Matrix Form “Summary”

8          Attachments

Attachment 1: Hazard Analysis Matrix Summary (1 page)

Attachment 2: Hazard Analysis Matrix Details (1 page)

Attachment 3: Generic Risk Management graph (1 page)

9          SOP distribution

10        Health, safety and environmental considerations


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 16 pages procedure
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