Supporting the work of Quality

Professionals
www.c-bg.com

training@c-bg.com

Actions to address risks and opportunities in QMS

processes
Methodical Manual
This Methodical Manual summarizes 15 years of field risk
management experience at the workplace.

For the organization, the regulatory framework for actions to

address risks and opportunities in the Quality Management
System (QMS) consists of:

ISO 9001:2015 cl.6.1 requirements - relevant to the entire QMS,

ISO 9001:2015 cl.4.4.1.f requirements - relevant to the process,

ISO 31000 Guidelines - relevant to the entire QMS.

Based on the good industrial practice, it is advisable to carry out actions to address
risks and opportunities on two levels and, therefore, describe them in two documents.

Level 1 - the entire QMS

Document 1 - QSP 6.1-01 Actions to address risks and opportunities
Describes risk management process, including four sub-processes:
-

Planning of actions to address risks and opportunities. Project of risk

management framework;

Integration and implementation of actions to address risks and

opportunities into QMS processes;

Evaluation of the effectiveness of actions to address risks and

opportunities. Monitoring and analysis of risk management framework;

Achieving improvement.

Level 2 - the process

Document 2 This Methodology - MM 6.1-01-01 Actions to address
risks and opportunities in QMS processes

Actions to address risks and opportunities in QMS processes Methodical Manual

CBG Inc. 2016

Supporting the work of Quality

Professionals
www.c-bg.com

training@c-bg.com

The proposed Methodical Manual provides details for the implementation of the
second sub-process Integration and implementation of actions to address risks
and opportunities into QMS processes and is aimed at organizing of risk
management activities in each process of the QMS in compliance with ISO
9001:2015 cl.4.4.1.f requirements.

What is included in the package?

Preview

This Methodical Manual MM 6.1-01-01 Actions to address

risks and opportunities in QMS processes
MS Word, 13 pages

Preview Form MM 6.1-01-01-01 Quality Risk Register

MS Word, 1 page, fully editable, easy to use table format
Preview

Annex 2 to 6.1-01-01: Examples of Risk wording and

Risk reduction activities
PDF, 8 pages, easy to use table format

.ZIP archive contains 3 files

Type of delivery: Instant download

$149.00

Actions to address risks and opportunities in QMS processes Methodical Manual

CBG Inc. 2016