session 15 iso clause 5 6

8/7/2019 Session 15 ISO Clause 5 6

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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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5.2 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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5.4 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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5.5.3 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

session 15 iso clause 5 6

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