management resposibility

1. National university of sciences and technology: Atta ur Rehman School of Applied Bio-sciences
Clause # 05
Management responsibility
ISO 9001 and 9004
RAFFIA SIDDIQUE ; UG4 batch ; Semester# 07 ; raffiasiddique_93@hotmail.com

2. ISO 9001
Responsibility
Of
Top Management
In establishing, implementing, maintaining and
continually improving the organization’s QMS.
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3. ISO 9004
Guidance
for
Organization’s Top Management
for its management and the organization
ISO 9004 is more extensive
then ISO 9001
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4. Clause # 05 Management
Responsibility
5.1 Management
Commitment
5.6 Management
Review
5.5 Responsibility
5.3 Quality Policy
5.2 customer Focus
5.4 Planning
ISO
9001
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5. Clause # 05 Management
Responsibility
5.6 Management
Review ISO
9004
5.1 General
guidance
5.5 Responsibility,
authority and
communication
5.4 Planning
5.3 Quality Policy
5.2 Needs and
expectations of
interested parties
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6. Clause 5.1
ISO
9004
ISO
9001 5.1 General
5.1 Management
Commitment
Involvement of top
management is
required
Purpose=commitment
required to
developing,
implementing, and
continually improving
the organization’s
quality management
system
guidance
5.1.1 Introduction
5.1.2 Issues to be
considered
Introduction
provides guidance on
the role of
management’s
leadership in the
organization’s QMS
5.1.2 recommends the
organization’s top
management to use
the 8 QMS principles
in developing,
implementing QMS
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7. ISO 9001 Clause 5.1 ( Management
Commitment)
• With entire organization about
• Customer and statutory requirements Communicate
• Organization’s quality policy
• Management reviews
Establish
conduct
• Establishment of quality objectives
• Availability of resources for activities related
to QMS.
Ensure
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8. ISO 9004 Clause 5.1 General
guidance
• Current and future needs, expectations and
requirements
Clause 5.1.1 Understa
Introduction
Top management’s -nding
responsibilities
should include identifying certain
methods used for measuring
performance of organization
• Using financial Planni
info
• Using -external ng
information
• Future of organizations
• Increasing awareness, motivation
(bench marking, evaluation) by
3rd party
• Support process
• Ensuring the effective operation of
organizations processes
• Measuring satisfaction of
Identif
-ying
employees
Clause 5.1.2 Issues to be
considered
Use of 8QMS principles for
developing, implementing and
managing QMS.
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9. Clause # 5.2
ISO 9001- Clause#5.2 (customer Focus)
ISO 9004- Clause#5.2 ( Needs and
expectations of interested parties)
• 5.2.1 General
• 5.2.2 Needs and Expectations
• 5.2.3 Statutory and regulatory requirements
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10. ISO 9001 clause
5.2 “Customer
Focus”
This clause ensures
top management
There is no clause in ISO 9001
that corresponds to clause 5.2 of ISO
ensure that the
organization
determines
and fulfills the
requirements of its
customers, with the
aim of enhancing
which addresses the needs and
expectations of interested parties of an
including its customer.
customer
satisfaction.
ISO 9004 clause 5.2 “needs and
interests of expected parties”
• Identifies interested parties-end-users of the
organization’s products; owners, investors,
and shareholders; the organization’s
suppliers and partners; affected by the
organization or its products.
5.2.1
General
• The organization’s employees:
• The organization’s owners, investors, and
shareholders:
• The organization’s suppliers and partners
• Public health community
9004,
5.2.2 Needs
organization,
and
expectations
• provides guidance relating to the
organization’s knowledge of statutory and
regulatory requirements that pertain to its
products, processes, and activities.
5.2.3
statutory and
regulatory
requirements
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11. Clause # 5.3
ISO 9001
Quality
Policy
ISO 9004
Quality
Policy
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12. Clause 5.3 Quality policy
ISO 9001 clause 5.3 “quality
policy”
ISO 9004 clause 5.3 “quality
policy”
Appropriate
for purpose of
organization,
communicated
Ensures
commitment
of top
management
Provides
Quality
Policy
frame work for
quality
objectives
Reviewed for
continual
suitability
The quality policy should be used
by top management in its efforts
to improve the performance of
the organization.
The quality policy should be
an important and equal part
of the organization’s overall
policies.
Top management should
consider the needs and
expectations of all interested
parties,
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13. Clause # 5.4
ISO9001 5.4
Planning
5.4.1 Quality
objectives
5.4.2 QMS
Planning
ISO9004 5.4
Planning
5.4.1 Quality
objectives
5.4.2 Quality
Planning
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14. ISO9001 Clause 5.4 “planning”
Clause 5.4.1 Quality objectives
Quality objectives specifies the
responsibility of top
management to ensure that the
organization’s quality objectives
are
• Established and documented
• quality objectives are
Clause 5.4.1 Quality objectives proposes that the strategic planning and
quality policy established by an organization’s management should be the
Clause 5.4.2 Quality planning proposes that an organization’s management
should take responsibility for quality planning, which should focus on meeting
measurable
ISO 9004 clause 5.4 planning
basis for its quality objectives.
the organization’s quality objectives
• are consistent with the
organization’s quality policy.
Clause 5.4.2 Quality
management system planning
• Planning must be carried
out in order that all the
requirements of the
quality management
system, as specified by the
standard, will be
established
• all the requirements
specified by the standard
must be maintained.
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15. Clause # 5.5 (Responsibility)
Same for both ISO
9001 and ISO
9004
(Responsibility)
Responsibility
and Authority
Management
Representative
Internal
Communication
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16. clause 5.5 “responsibility, authority and
communication”
Clause 5.5.1 Responsibility and authority
and for both ISO 9001 and 9004
specifies that top management
is responsible for defining the
responsibilities and authorities
with respect to the various
processes within the
organization’s quality
management system
Clause 5.5.2 Management representative
for both ISO 9001 and 9004
Requires that top management
appoint a member of the
organization’s management who
must
• Establishing, implementing, and
maintaining the processes that are
required for the organization’s
quality management system
• Reporting on the performance of
the quality management system,
• Ensuring that awareness of
requirements of the organization’s
customers
Clause 5.5.3 Internal communication
specifies top management’s
responsibility
to ensure that processes for
communication are established within
the organization.
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17. Clause # 5.6 (Management review)
same for both ISO 9001 and ISO 9004
General
Review Input
Review
Output
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18. ISO 9004 and ISO 9001 clause 5.6
“management review”
Clause 5.6.1 General
• proposes that an organization’s top
management should develop management
review activities that go beyond verifying the
effectiveness and efficiency of the
organization’s quality management system.
• Reviews must evaluate improvement of the
organization’s quality management system,
and the need to make changes to the
organization’s existing quality policy,
quality objectives, and to the system.
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19. ISO 9001 and 9004 Clause 5.5
Clause 5.6.2 Review input
• Results of various types of
audits of the organization’s
QMS(e.g., internal audits,
customer audits, third-party
audits)
• Information obtained from
the organization’s customers
• Information on the
organization’s preventive
actions and corrective
actions
Clause 5.6.3 Review output
• Improvement actions
toward the effectiveness of
the organization’s QMS
• Improvement actions
toward the organization’s
products
• Decisions regarding the
need for resources within
the organization
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20. Thankyou
very much for
the patience
And your
questions are
welcomed
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