ISO 9001:2015

4.0 Context of the Organization

2014 Cavendish Scott, Inc.

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Overall Purpose

Two new requirements introduced in ISO 9001:2015

DIS Section 4
Sections 4.1 Understanding the organization and its
context
Section 4.2 Understanding the needs and expectations of
interested parties (new definition added)

Requirements that were implicated in 2008 are now

more explicit in DIS 2015.
What has not changed: This section is still about
planning the quality management system for the
organization.
2014 Cavendish Scott, Inc.
www.CavendishScott.com

2015 DIS v. 2008 Comparison

ISO 9001:2015 DIS
4. Context of the Organization
4.1 Understanding the organization
and its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the
quality management system
4.4 Quality management system and
its processes

ISO 9001:2008
4 Quality management system
4.1 General requirements

Significant Differences
Determine internal and external issues that are relevant to its purpose
Determine interested parties that are relevant
Boundaries and applicability of requirements (available and maintained as
documented information)
Determine process inputs, outputs, sequence and interaction

4.1 Understanding the organization and

its context

New Requirement
Organizations shall determine and monitor external
and internal issues that are relevant to its strategic
direction and purpose, and that have the ability to
affect the achievement of the intended results of the
quality management system.
The strategic direction of the organization is in line
with the quality policy and objectives to continue to
drive improvement.

2014 Cavendish Scott, Inc.

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4.2 Understanding the needs and

expectations of interested parties

New Requirement
The organization shall determine
the interested parties that are relevant to the quality
management system
the requirements of the interested parties that are relevant to
the quality management system

The organization shall monitor and review the information

about these interested parties and their relevant
requirements.

2014 Cavendish Scott, Inc.

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4.3 Determining the scope of the quality

management system

Not New, but more explicit

Continues with the topics in sections 4.1 and 4.2 for
consideration of external and internal issues, as well as
requirements of relevant interested parties when
determining the scope of the management system.
More explicit with consideration to products and services
offered
If a requirement within the determined scope can be
applied, then it shall be applied by the organization

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4.4 Quality Management system and its

processes

Not completely new, but more explicit

Explicit emphasis on the process approach
Adds focus on risks and opportunities
Less documentation requirements - i.e., documented
information to the extent necessary to support the
operation of processes
No Quality Manual Required

2014 Cavendish Scott, Inc.

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What do you need to do?

Formalize process measures that support strategic

direction of organization
Identify interested parties / relevance
Determine external and internal issues (aka, risk
management) and a plan to address
Ensure scope statement is clearly defined
Ensure management system is process-based
with clear inputs and outputs identified
Identify Risks and Opportunities

2014 Cavendish Scott, Inc.

www.CavendishScott.com

We are here to help!

For more information please contact us!

Colin Gray
colin@cavendishscott.com

303 668 2500

Emily Myers
emily@cavendishscott.com 720 226 5968

Dave Moskal
dave@cavendishscott.com 303 386 6788

Diana Lough
diana@cavendishscott.com 720 212 7300

Or visit our Website for current status:

www.cavendishscott.com
2014 Cavendish Scott, Inc.
www.CavendishScott.com