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management resposibility
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Clause # 05
Management responsibility
ISO 9001 and 9004
National university of sciences and technology: Atta ur Rehman School of Applied Bio-sciences
RAFFIA SIDDIQUE ; UG4 batch ; Semester# 07 ; [email protected]
ISO 9001
ResponsibilityOf
Top ManagementIn establishing, implementing, maintaining and continually improving the organization’s QMS.
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ISO 9004
Guidancefor
Organization’s Top Managementfor its management and the organization
ISO 9004 is more extensive then ISO 900111/8/2014 Food safety and quality assurance 3
Clause # 05 Management Responsibility
5.1 Management Commitment
5.2 customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility
5.6 Management Review
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ISO 9001
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Clause # 05 Management Responsibility
5.1 General guidance
5.2 Needs and expectations of interested parties
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management Review
ISO 9004
Clause 5.1
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5.1 Management Commitment
Involvement of topmanagement isrequired
Purpose=commitment
required todeveloping,implementing, andcontinually improvingthe organization’s
quality managementsystem
ISO 9001
5.1 General guidance
5.1.1 Introduction
5.1.2 Issues to be consideredIntroductionprovides guidance onthe role ofmanagement’sleadership in theorganization’s QMS
5.1.2 recommends theorganization’s topmanagement to usethe 8 QMS principlesin developing,implementing QMS
ISO 9004
ISO 9001 Clause 5.1 ( Management Commitment)
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• With entire organization about
• Customer and statutory requirementsCommunicate
• Organization’s quality policy
• Management reviews
Establish
conduct
• Establishment of quality objectives
• Availability of resources for activities related to QMS.
Ensure
Clause 5.1.1 Introduction
Top management’s responsibilitiesshould include identifying certainmethods used for measuringperformance of organization
• Using financial info
• Using external information(bench marking, evaluation) by3rd party
• Measuring satisfaction ofemployees
Clause 5.1.2 Issues to be considered
Use of 8QMS principles for developing, implementing and managing QMS.
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ISO 9004 Clause 5.1 General guidance
Understa-nding
• Current and future needs, expectations and requirements
Planni-ng
• Future of organizations• Increasing awareness, motivation
Identif-ying
• Support process• Ensuring the effective operation of
organizations processes
Clause # 5.2
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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
ISO 9001 clause5.2 “CustomerFocus”
This clause ensures top management
ensure that the organization determines
and fulfills the requirements of its customers, with the
aim of enhancing
customer satisfaction.
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• 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
5.2.2 Needs and
expectations
• provides guidance relating to the organization’s knowledge of statutory and regulatory requirements that pertain to its products, processes, and activities.
5.2.3statutory and
regulatory requirements
ISO 9004 clause 5.2 “needs andinterests of expected parties”
There is no clause in ISO 9001 that corresponds to clause 5.2 of ISO
9004,which addresses the needs and
expectations of interested parties of an organization,
including its customer.
Clause # 5.3
ISO 9001
Quality Policy
ISO 9004
Quality Policy
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Clause 5.3 Quality policyISO 9001 clause 5.3 “quality policy”
ISO 9004 clause 5.3 “quality policy”
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Appropriate for purpose of organization,
communicated
Ensures commitment
of top management
Provides frame work for
quality objectives
Reviewed for continual suitability
Quality Policy
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,
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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ISO9001 Clause 5.4 “planning”
Clause 5.4.1 Quality objectives
Quality objectives specifies theresponsibility of topmanagement to ensure that theorganization’s quality objectivesare
• Established and documented
• quality objectives aremeasurable
• are consistent with theorganization’s quality policy.
Clause 5.4.2 Quality management system planning
• Planning must be carriedout in order that all therequirements of thequality managementsystem, as specified by thestandard, will beestablished
• all the requirementsspecified by the standardmust be maintained.
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ISO 9004 clause 5.4 planningClause 5.4.1 Quality objectives proposes that the strategic planning and
quality policy established by an organization’s management should be thebasis for its quality objectives.
Clause 5.4.2 Quality planning proposes that an organization’s managementshould take responsibility for quality planning, which should focus on meeting
the organization’s quality objectives
Clause # 5.5 (Responsibility)
Same for both ISO 9001 and ISO 9004
(Responsibility)
Management Representative
Internal Communication
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Responsibility and Authority
clause 5.5 “responsibility, authority and communication”
Clause 5.5.1 Responsibility and authority and for both ISO 9001 and 9004
specifies that top managementis responsible for defining theresponsibilities and authoritieswith respect to the variousprocesses within theorganization’s qualitymanagement system
Clause 5.5.2 Management representative for both ISO 9001 and 9004
Requires that top management
appoint a member of theorganization’s management whomust
• Establishing, implementing, andmaintaining the processes that arerequired for the organization’squality management system
• Reporting on the performance ofthe quality management system,
• Ensuring that awareness ofrequirements of the organization’scustomers
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Clause 5.5.3 Internal communicationspecifies top management’sresponsibilityto ensure that processes forcommunication are established withinthe organization.
Clause # 5.6 (Management review)same for both ISO 9001 and ISO 9004
General
Review Input
Review Output
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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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ISO 9001 and 9004 Clause 5.5
Clause 5.6.2 Review input
• Results of various types ofaudits of the organization’sQMS(e.g., internal audits,customer audits, third-partyaudits)
• Information obtained fromthe organization’s customers
• Information on theorganization’s preventiveactions and correctiveactions
Clause 5.6.3 Review output
• Improvement actionstoward the effectiveness ofthe organization’s QMS
• Improvement actionstoward the organization’sproducts
• Decisions regarding theneed for resources withinthe organization
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Thankyouvery much forthe patienceAnd yourquestions arewelcomed