SO 9001:2015 requires to address the risks and opportunities in each process of the QMS. The principal questions of risk management are: - Key Risks Wording and - Risk Treatment Areas Examples for 'Management Review', 'Technical Maintenance', and 'Control of Personnel' processes. Use in ISO 9001:2015 Internal auditors and personnel training.

1. President Risk Manager
ISO 9001:2015 cl. 4.4.1.f; 6.1.2.b.1
Risk Treatment Areas:
• regularity and depth of Context of
Organization analysis,
communication and consideration for
the decision-making;
• analysis and review of QMS
processes resources, including
resources for monitoring and
measuring;
• improvement of planning methods…
Key Risks Wording
• failure to achieve strategic
goals;
• failure to fulfill quality
objectives;
• slowdown in company activity
performance indicator growth;
• undesirable and not timely
recognized QMS changes…
Management
Review
More information in Risk Management in QMS Processes
Quick Reference Guide
www.c-bg.com
info@c-bg.com
© CBG Inc. 2015

2. Risk Manager
Risk Treatment Areas:
• maintenance programs correction,
including the period between
scheduled repairs;
• improvement of equipment tuning
methods;
• improvement of technical equipment
and materials for maintenance …
Process Owner
Technical
Maintenance
Key Risks Wording
• emergency stops;
• exceeding the period of
technical maintenance and
equipment repair;
• failure to observe
maintenance schedule;…
www.c-bg.com
info@c-bg.com
© CBG Inc. 2015
ISO 9001:2015 cl. 4.4.1.f; 6.1.2.b.1
More information in Risk Management in QMS Processes
Quick Reference Guide

3. Risk Manager
Risk Treatment Areas:
• correction of procedures for
determining the necessary
expertise;
• correction of hiring
procedure, including New
employee orientations;
• use of mentoring;
• …
Process Owner
Control of
Personnel
Key Risks Wording
• suboptimal personnel
competence (including education,
confirmed qualification, additional
training, work experience);
• inadequate system of motivation
and stimulation;
• lack of employee awareness;
• …
www.c-bg.com
info@c-bg.com
© CBG Inc. 2015
ISO 9001:2015 cl. 4.4.1.f; 6.1.2.b.1
More information in Risk Management in QMS Processes
Quick Reference Guide