session 15 iso clause 5 6
TRANSCRIPT
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TOTALTOTAL
QUALITYQUALITY
MANAGEMENTMANAGEMENT
By:By:Zahid HussainZahid HussainMS-Total Quality ManagementMS-Total Quality Management
IRCA Lead Auditor ISO 9001-2000IRCA Lead Auditor ISO 9001-2000
IRCA Lead Auditor ISO 14001-2004IRCA Lead Auditor ISO 14001-2004
B.Sc Engineering (Chemical)B.Sc Engineering (Chemical)
PCBAUCPPCBAUCP
SESSION 15
(ISO-Clause 5-6)
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CUSTOMERS CU
ST
OMERS
Quality Management
System
5.Management
Responsibility
7. Product
Realization
6. Resource
Management
8. MeasurementAnalysis and
Improvement
Requirements
Satisfaction
Continual Improvement of
the Quality Management System
ConsumptionProduct
verv ew oISO9001:2008
ISO 9001 Model
KEYValue AddedActivities
Model of a Process BasedQuality Management System
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Provision of
resources
Human
resources
Infrastructures
Workenvironment
6 ResourceManagement
General
requirements
Documentation
Requirements
Planning
Customer
related
processes
Design &
development
Purchasing
Production &
service
provision
Management
Commitment
Customer focus
Quality policy
Planning
Responsibility,
authority &
communication
Management
Reviews
5 ManagementResponsibility 8Measurement
Analysis &
improvement
System Requirements / Structure of theSystem Requirements / Structure of the
StandardStandard
4 QualityManagement
System
7 ProductRealization
General
Monitoring &
measurement
Control of NCP
Analysis of data
Improvements
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5 Managementresponsibility
5.1 Management5.1 Management
commitmentcommitment
5.2 Customer focus5.2 Customer focus
5.3 Quality policy5.3 Quality policy 5.4 Planning5.4 Planning
5.4.1 Quality Objectives5.4.1 Quality Objectives
5.4.2 Quality5.4.2 Quality
Management SystemManagement SystemPlanningPlanning
5.5 Responsibility, Authorityand communication
5.5.1 Responsibility &authority
5.5.2 Managementrepresentative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General 5.6.2 Review input
5.6.3 Review Output
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5 ManagementResponsibility
5.1 Management commitmentTop management shall provide evidence of itscommitment to the development and implementation ofthe quality
management system and continually improving itseffectiveness bya) communicating to the organization the importance ofmeeting customer as well as statutory and regulatory
requirements,b) establishing the quality policy,c) ensuring that quality objectives are established,d) conducting management reviews, ande) ensuring the availability of resources.
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5 ManagementResponsibility
5.2 Customer focusTop management shall ensure that customerrequirements are determined and are met with the aimof enhancingcustomer satisfaction (see 7.2.1 and 8.2.1).
5.3 Quality policyTop management shall ensure that the quality policya) is appropriate to the purpose of the organization,b) includes a commitment to comply with requirements
and continually improve the effectiveness of the qualitymanagement system,c) provides a framework for establishing and reviewingquality objectives,d) is communicated and understood within theorganization, and
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5 ManagementResponsibility
5.4 Planning5.4.1 Quality objectivesTop management shall ensure that quality objectives,including those needed to meet requirements forproduct [see7.1 a)], are established at relevant functions and levelswithin the organization. The quality objectives shall bemeasurable and consistent with the quality policy.5.4.2 Quality management system planning
Top management shall ensure thata) the planning of the quality management system iscarried out in order to meet the requirements given in4.1, as
well as the quality objectives, andb) the integrity of the quality management system is
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5 ManagementResponsibility5.5 Responsibility, authority and communication
5.5.1 Responsibility and authorityTop management shall ensure that responsibilities andauthorities are defined and communicated within theorganization.
5.5.2 Management representativeTop management shall appoint a member oforganizations management who, irrespective of otherresponsibilities, shall have responsibility and authoritythat includesa) ensuring that processes needed for the qualitymanagement system are established, implemented andmaintained,b) reporting to top management on the performance of
the quality management system and any need for
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5 ManagementResponsibility
5.5.3 Internal communicationTop management shall ensure that appropriatecommunication processes are established within theorganization and that communication takes placeregarding the effectiveness of the quality management
system.5.6 Management review5.6.1 GeneralTop management shall review the organization's quality
management system, at planned intervals, to ensure itscontinuing suitability, adequacy and effectiveness. Thisreview shall include assessing opportunities forimprovementand the need for changes to the quality management
system, including the quality policy and quality
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5 ManagementResponsibility5.6.2 Review input
The input to management review shall includeinformation ona) results of audits,b) customer feedback,
c) process performance and product conformity,d) status of preventive and corrective actions,e) follow-up actions from previous management reviews,f) changes that could affect the quality managementsystem, andg) recommendations for improvement.5.6.3 Review outputThe output from the management review shall includeany decisions and actions related to
a) improvement of the effectiveness of the quality
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6. Resource Management6.1 Provision of resources
6.2 Human Resources6.2.1 General6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
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6. Resource Management6.1 Provision of resources
The organization shall determine and provide theresources neededa) to implement and maintain the quality managementsystem and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customerrequirements.
6.2 Human resources6.2.1 GeneralPersonnel performing work affecting product quality shallbe competent on the basis of appropriate education,training, skills and experience.
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6. Resource Management6.2.2 Competence, awareness and training
The organization shalla) determine the necessary competence for personnelperforming work affecting product quality,b) provide training or take other actions to satisfy these
needs,c) evaluate the effectiveness of the actions taken,d) ensure that its personnel are aware of the relevanceand importance of their activities and how they contributetothe achievement of the quality objectives, ande) maintain appropriate records of education, training,skills and experience (see 4.2.4).
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6. Resource Management6.3 Infrastructure
The organization shall determine, provide and maintainthe infrastructure needed to achieve conformity toproductrequirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,b) process equipment (both hardware and software), andc) supporting services (such as transport orcommunication).
6.4 Work environmentThe organization shall determine and manage the workenvironment needed to achieve conformity to productrequirements.
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QUESTIONQUESTIONSS