Organization Doc No :

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Title of Procedure Date :
Page :

1.0 Purpose
This document aims to define the process involved in identifying Risks and Opportunities on
the quality management system as required by ISO 9001:2015.
(To assess the risk and opportunities related to organizational context, related interested
parties, and the quality management system; to prioritize the risks in order to manage them
effectively and efficiently; to prevent or substantially limit the likelihood that the organization
does not detect its weakness; and to manage the risks efficiently and effectively)

2.0 Scope
This procedure describe the process of identifying, analyzing, evaluating and monitoring of
risks and opportunities and pertains to any and all risks organization (Your Organization)
may face.

3.0 Definitions
3.1 Risk
3.2 Risk and Opportunity
3.3 Significant Risk
3.4 Acceptable Risk
3.5 PESTLE
3.6 SWOT
3.7 PESTLE Study
3.8 SWOT Analysis

4.0 Reference Documents

4.1 Management Review Procedure
4.2 Corrective Action Procedure
4.3 Control of Non-Conforming Product and Service Procedure

5.0 Responsibility
5.1 Head of Deportment (HOD) shall be responsible for:

5.2 Top Management shall be responsible for:

5.2.1 Creating the Risk Management Team
5.2.2 Approving actions and Providing the necessary resources needed to address risks
and opportunities
5.2.3 Ensuring that status of risks and opportunities are reported during the
Management Review.
6.0 Procedure
7.0 Performance Indicators
8.0 Records

Prepared By : Manager Approved By : General Manager

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