The document provides an overview and comparison of the key changes between ISO 9001:2008 and the 2015 draft version regarding leadership requirements. It outlines new definitions for top management and interested parties. Top management is now expected to take more accountability and ensure customer focus. The quality policy must be compatible with organizational strategy and context. While the management representative role is removed, associated responsibilities remain. Overall the changes emphasize leadership and strategic planning to achieve quality objectives.

1. ISO 9001:2015 DIS
Section 5, Leadership
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2. Overall Purpose of this presentation
• Provide a comparison between the comparable
requirements of ISO 9001:2008 clauses
• Provide an assessment of the intent
• Provide possible solutions for transition
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3. Overall purpose of ISO 9001 Section 5
The purpose of ISO 9001:2015 Section 5, Leadership, is to
establish the expectations and requirements for top
management to lead the organization through their
commitment to the quality management system and to
customer focus. This commitment is demonstrated
through:
– Managing the QMS as part of the strategic planning of the
organization while emphasizing effective processes,
– Establishing, maintaining and reviewing the quality policy,
– Ensuring customer focus meets all requirements,
– Defining and communicating roles, responsibilities and
authorities
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4. 2015 v. 2008 Comparison
ISO 9001:2015 DIS ISO 9001:2008
5. Leadership
5.1 Leadership and commitment
5. Management responsibility
5.1 Management commitment
Significant Differences
Adds: taking accountability of effectiveness; promoting awareness of process
approach; communicating importance of effectiveness and conforming to QMS
requirements; requirement to ensure QMS requirements are integrated with the
organization’s business processes. Establishes the differences between
management and leadership

5. ISO 9001:2015
A new definition for “top management” (3.05) states:
“person or group of people who directs and controls an
organization at the highest level.
Note 1 to entry: Top management has the power to delegate
authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system covers
only part of the organization, then top management refers to those
who direct and control that part of the organization.
The standard now recognizes the senior executives may
not be in involved in the scope of the registration.
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6. ISO 9001:2015
The primary requirements for top management have not
changed: now there is an emphasis on leadership
exhibited by top management to ensure the QMS is
adequately planned and the QMS processes perform to
achieve their planned results.
The standard now holds top management accountable
when the performance of the is not meeting all
requirements.
There is now an emphasis to ensure the QMS is part of the
strategic planning for the business and not an afterthought.
The use of risk assessment to ensure the organization’s
success.
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7. What do you need to do?
• If the context of the organization is such that top
management plays an active role in overseeing the
QMS and its processes, there will be little change.
• For those organizations where senior executives are not
included in the scope of registration, then the defined
“top management” of the QMS needs to take
accountability for planning, maintaining and improving
the QMS. Top management needs to ensure the QMS
is included in the strategic direction, driven by the senior
executives.
• For all “top management” regardless of context of the
organization, a more “hands on” approach is expected.
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8. 2015 v. 2008 Comparison
ISO 9001:2015 DIS ISO 9001:2008
5.1.2 Customer focus 5.2 Customer focus
7.2.1 c)
Significant Differences
Adds: Customer focus includes addressing risks and opportunities that can
affect conformity of products and services.
The requirement to delivering products and services that meet customer and
applicable regulatory and statutory requirements has moved to this section.
A new term: “interested party (3.02)” and it states: “person or organization that
can affect, be affected by, or perceive themselves to be affected by a decision
or activity”
Example: customers, owners, people in an organization, suppliers,
bankers, unions, partners or society that may include competitors or
opposing pressure groups.

9. ISO 9001:2015
Not much has changed as most organizations have a
strong customer focus and meet all requirements.
By moving the requirement for meeting customer,
regulatory and statutory requirements from Product
Realization to Leadership, it places the emphasis on top
management’s responsibility to ensure requirements can
and are achieved, and holds them accountable.
Now includes other interested parties that may be affected
by the product and services provided.
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10. What do you need to do?
• Regardless of the context of the organization, top
management needs to ensure customer focus is
communicated and understood throughout.
• All personnel need to understand what is necessary to
meet customer and statutory and regulatory
requirements and their contribution.
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11. 2015 v. 2008 Comparison
ISO 9001:2015 DIS ISO 9001:2008
5.2 Quality policy 5.3 Quality policy
Significant Differences
Adds: requirement to ensure the quality policy and quality objectives are
established and compatible with the strategic direction and the context of the
organization; the quality policy must also be “applied”

12. ISO 9001:2015
The quality policy now must be appropriate to the purpose
of the organization and its context (the role the QMS plays
in the overall structure of the organization) and it must be
applied.
The requirement to provide a framework for establishing
quality objectives which are reviewed to ensure that the
quality policy is being achieved remains as it was before.
The quality policy must still include a commitment to meet
all requirements, including those of the customer, and to
continually improve the QMS.
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13. ISO 9001:2015
The quality policy must be communicated to and
understood by all personnel.
Applying the quality policy means it is a part of the
organization’s culture: personnel understand it’s
importance and know what they do to achieve it, top
management refers to it and iterates it’s value and
meaning.
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14. What do you need to do?
• Review your quality policy to ensure that it is
appropriate to the context of the organization.
– For simple organizations, there will be no change
• Ensure it is measurable and provides a basis for the
quality objectives to ensure it is being achieved.
• Ensure that top management participates in its
development and review to maintain it.
• Ensure that all personnel in the scope of the registration
are aware of the quality policy and they are aware of
how they contribute to it in their day-to-day activities.
• Ensure it means more than just a poster on the wall to
look at during an audit.
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15. 2015 v. 2008 Comparison
ISO 9001:2015 DIS ISO 9001:2008
5.3 Organizational roles,
responsibilities and authorities
5.5.1 Responsibility and authority
5.5.2 Management representative
Significant Differences
Adds: clarifies requirements for achieving the effectiveness of the QMS and
the strategic direction of the organization.
Removes: the designation of “management representative”.

16. ISO 9001:2015
In order for QMS processes to achieve their planned
results, it is key that roles, responsibilities and authorities
be clearly defined, communicated and understood. This
includes identifying opportunities for improvement, ensuring
customer focus is maintained, and quality problems are
controlled and communicated to top management.
Through delegating responsibilities and authorities, top
management will need to ensure that the integrity of the
QMS is maintained when changes to the QMS are planned
and implemented.
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17. ISO 9001:2015
Although the standard no longer requires the recognition of
a position titled “management representative”, the
responsibilities remain unchanged.
It is also recognized that the responsibilities may be split
among several positions as appropriate to the organization.
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18. What do you need to do?
• Ensure that personnel are aware of their roles and
responsibilities.
• Ensure customer focus is understood and maintained
throughout the organization
• Ensure that top management is aware of QMS quality
issues when processes are ineffective and objectives
are not being achieved.
• Ensure the responsibilities for maintaining the integrity
of the QMS are known and acted upon.
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