4-SYSTEM REQUIREMENTS Quality Management Systems Ships in Service Training Material A-M CHAUVEL

4-SYSTEM REQUIREMENTS

Quality Management Systems

Ships in Service Training Material A-M CHAUVEL

1- The organization shall define and manage

the processes necessary to ensure that

product and/or service conforms to

customer requirement.

Q M S REQUIREMENTSQ M S REQUIREMENTS

2- The organization shall establish a quality

management system covering all the

requirements of the ISO 9001 Standard.

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The system procedures depend upon :

1- Size and type of organization

2- Complexity and interaction of the processes

3- Methods used and skills and training of the

personnel involved in performing the work

3- The organization shall prepare quality

management procedures that describe

the processes required to implement

the quality system.

Q M S REQUIREMENTSQ M S REQUIREMENTSIS

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The system procedures shall include :

1- System level procedures that describe the

activities required to implement the QMS.

2- Procedures that describe the sequence

and interactive nature of the processes

necessary to ensure the conformity of the

product and/or service

3- Instructions that describe the operating

practice and control of process activities


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From Supplier to Organisation

ISO 9000 - 2000ISO 9001 - 1994

Subcontractor

Supplier

Client

Supplier

Client

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Define and managethe processes

Establish a qualitymanagement system

Prepare systemprocedures


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5-MANAGEMENT RESPONSIBILITY



5.1 General requirements

5.2 Customer requirements

5.3 Legal requirements

5.4 Policy

5.5 Planning

5.6 Quality management system

5.7 Management review

MANAGEMENT RESPONSIBILITY IS

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CustomerCustomerrequirementsrequirements

LegalLegalrequirementsrequirements

PlanningPlanning SystemSystem

QualityQualitymanagementmanagement

systemsystem

Generalrequirements

Management Management reviewreview

MANAGEMENT RESPONSIBILITY IS

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- Creating and maintaining awareness of the

importance to fulfil customer requirements

- Establishing the quality policy and the

quality objectives and planning

- Establishing a quality management system

- Performing management review

- Ensuring the availability of resources

GENERAL REQUIREMENTS IS

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Top management shall demonstrate

its commitment to :


UnderstoodUnderstood MetMet

721

CUSTOMER REQUIREMENTS

CustomerCustomerneedsneeds

CustomerCustomerexpectationsexpectations

CustomerCustomerrequirementsrequirements

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LEGAL REQUIREMENTSIS

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EstablishEstablish MaintainMaintain

Identify and have access to Identify and have access to legal requirementslegal requirements

applicable to qualityapplicable to qualityaspects of its aspects of its

products and/or servicesproducts and/or services

ProcedureProcedure

Continuingsuitability

Review

Meetingrequirements

Continualimprovement

Commitment

Establishingobjectives

Reviewingobjectives

Framework

Understood

Implemented

Communicated

Organisation

Organisationneeds

Customerneeds

Appropriate

POLICY

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PolicyPolicy

Requirementsfor productsand services

Requirementsfor productsand services

Commitmentfor continualimprovement

Commitmentfor continualimprovement

OBJECTIVESIS

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QUALITY PLANNING

ProcessProcessrequiredrequired

VerificationVerificationactivitiesactivities

Criteria forCriteria foracceptabilityacceptability

QualityQualityrecordsrecords

RealisationRealisationprocessesprocesses

ResourcesResourcesneededneeded

QualityQualityCharacteristicsCharacteristics

TO REACHTHE OBJECTIVE

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Planing shall covers :


Responsibilityand authority

Managementrepresentative

Internalcommunication

Quality manual

Control ofdocuments

Control ofrecords

QUALITY MANAGEMENT

SYSTEMISO

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560

QUALITY MANAGEMENT SYSTEMThe company shall establish a :


AuthorityAuthority

Degree ofDegree offreedomfreedom

ResponsibilityResponsibility

RESPONSIBILITY AND AUTHORITYIS

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MANAGEMENT REPRESENTATIVE

Top management shall appoint a member

of the management who shall have defined

authority that includes :

- reporting to top management on the performance

of the system including needs for improvement

- ensuring awareness of customer requirementsthroughout the organization

- ensuring that the system is implemented and

maintain

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INTERNAL COMMUNICATIONIS

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LEVELS ANDFUNCTIONS

EFFECTIVENESS


QUALITY MANUAL

The organization shall prepare a quality manual

which include :

- description of the elements of the system

- interaction of the elements of the system

- any reduction in the scope of the standard

The quality manual need not be

a stand-alone document

- system level procedures or reference thereto ISO

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CONTROL OF DOCUMENTS

RelevantRelevant

AdequacyAdequacy

ReleaseReleaseAvailableAvailable

Master listrevision status

Approved

ObsoleteObsoletedocumentsdocuments

Revision

Retained for legal purposes

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Identification, storage, retrieval, Identification, storage, retrieval, protection, retention time and protection, retention time and

dispositiondisposition

ConservationConservation

ConformanceConformancetoto

requirementsrequirements

EffectiveEffectiveoperation ofoperation ofthe systemthe system

CONTROL OF RECORDSIS

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CustomerCustomerfeedbackfeedback

Processes &Processes &product analysisproduct analysis

Preventive &Preventive &corrective actioncorrective action

Management reviewsManagement reviewsactions follow-upactions follow-up

ChangingChangingcircumstancescircumstances

Quality managementQuality managementsystem improvementsystem improvement

ResourceResourceneedsneeds

Results ofResults ofauditsaudits

MANAGEMENT REVIEWIS

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6-RESSOURCE MANAGEMENT



RESOURCE MANAGEMENT

The organisation shall

determine and

provide in a timely manner,

the resources needed

to establish and maintain

the quality management system.

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Human resources

Work environment

Information

Infrastructure

RESOURCE MANAGEMENT


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Education

Skills

Experience

Training

ASSIGNMENT OF PERSONNEL

621

Personnel shall be competent on the basis of :


IdentifyIdentifytraining needstraining needs

ProvideProvidetrainingtraining

EvaluateEvaluate effectivenesseffectiveness

MaintainMaintainrecordsrecords

COMPETENCE TRAINING QUALIFICATIONAND AWARENESS

AWARENESS

AWARENESS

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The organization shall establish and maintainprocedures to make employees aware of :

- Importance of conformance with the quality policy

- Significant impacts of their work activities on quality

- The benefits of improved personal performance


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The organization shall establish and maintainprocedures to make employees aware of :

- Their roles and responsibilities in achieving conformance with quality policy

- Potential consequences of departure from specified operating procedures


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??IS

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INFORMATION

ControlControlof processesof processes

EnsureEnsureconformityconformity

Necessary toNecessary toAccessAccess

ProtectionProtectionTo ensureTo ensure

The organizationshall determine


MaintenanceMaintenance

Supporting Supporting ServicesServices

WorkspaceWorkspace

AssociatedAssociatedfacilitiesfacilities

EquipmentEquipment

HardwareHardware SoftwareSoftware

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The organization shall define, provide and maintain the infrastructure needed to achievethe conformity of the product and/or service


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Health andHealth andsafetysafety

conditionsconditions

WorkWorkethicsethics

AmbientAmbientworkingworking

conditionsconditions

WorkWorkmethodsmethods

650

WORK ENVIRONMENTThe organization shall define and implement those human and physical factors needed to

achieve conformity of the product and/or service

7-PRODUCT / SERVICE REALIZATION



ProcessesProcesses

PRODUCT / SERVICE REALISATION

710710

implementedimplemented

SequencesSequences InteractionsInteractions

DeterminedDetermined

552Elementsoutput Planned Planned

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710

Results shall be maintain as quality records

Methods Practices


PRODUCT / SERVICE REALISATION

7.6 Measurement 7.6 Measurement

M1M1 M2M2 M3M3

Input Output

ControlControl7.5 Production7.5 Production

P1P1 P2P2 P3P3

Input Output

DoDo7.4 Purchasing 7.4 Purchasing

A1A1 A2A2 A3A3

Input Output

BuyBuy7.3 Design 7.3 Design

D1D1 D2D2 D3D3

Input Output

ConceiveConceive7.2 Clients 7.2 Clients

C1C1 C2C2 C3C3

Input Output

UnderstandUnderstand

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Verify that processes can be operated to achieveVerify that processes can be operated to achieveproduct / service conformanceproduct / service conformance

Implement arrangements for measurement, Implement arrangements for measurement, monitoring, and follow-up actionsmonitoring, and follow-up actions

Make available information and data necessaryMake available information and data necessary

MethodsMethods PracticesPractices CriteriaCriteria

Keep the results of process control measurementKeep the results of process control measurement

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s PRODUCT / SERVICE REALISATION

The organization shall determinate how eachprocess affects the ability to meet product

and/or service with customer requirements :


Identificationof the customer

requirements

Reviewof the customer

requirements

Customercommunication

To meet the customer requirementsTo meet the customer requirements

CUSTOMER-RELATED PROCESSESIS

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720A-M CHAUVEL - BUREAU VERITAS - DNS / DCO


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The customer requirementsThe customer requirements

Completeness of the customer product / service Completeness of the customer product / service requirementsrequirements

Requirements not specified but necessaryRequirements not specified but necessaryfor fitness for purposefor fitness for purpose

IDENTIFICATION OF CUSTOMERREQUIREMENTS

The organization shall establish a processto determine :

Obligations related to product / serviceObligations related to product / servicelegal and regulatory requirementslegal and regulatory requirements

Requirements for availability, delivery and support Requirements for availability, delivery and support of product / serviceof product / service


Before a commitment to supplyBefore a commitment to supplyproduct / serviceproduct / service

Requirements clearly definedRequirements clearly defined

Requirements confirmed before acceptanceRequirements confirmed before acceptance

Requirements differing from thoseRequirements differing from thosepreviously expressedpreviously expressed

Organisation ability to meet theOrganisation ability to meet thecustomer requirementscustomer requirements

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s REVIEW OF CUSTOMER REQUIREMENTS

722

The customer requirements, including anyrequested changes, shall be reviewed :


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With the aim of meeting customer requirements With the aim of meeting customer requirements

723

Product / service information Product / service information

Enquiry and order handlingEnquiry and order handlingincluding amendmentsincluding amendments

Customer complaints and actions relating to non Customer complaints and actions relating to non conforming product / serviceconforming product / service

Customer responses relating toCustomer responses relating toperformance of the product / serviceperformance of the product / service

CUSTOMER COMMUNICATION

The organization shall implement arrangements for communication with customers :


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730

- Responsibilities

and authorities

- Input

- Output

- Review

- Verification

- Validation

- Control of changes


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InputsInputs OutputsOutputs

Review

Controlof changes

Verification

Validation

DESIGN AND DEVELOPMENT

Interfaces between groups


InputsInputs

Performances requirementsPerformances requirements

Regulatory and legal requirementsRegulatory and legal requirements

Environmental requirementsEnvironmental requirements

Requirements from previous similar designsRequirements from previous similar designs

Other essential requirementsOther essential requirements

DESIGN AND DEVELOPMENT INPUTSIS

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Defined, review and recorded


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Meet the design input requirementsMeet the design input requirements

Contain or make reference toContain or make reference toproduct/service acceptance criteria product/service acceptance criteria

Define the essential characteristics forDefine the essential characteristics forsafe and proper use of the product / servicesafe and proper use of the product / service

DESIGN AND DEVELOPMENT OUTPUTS

Approved before released


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At suitable stages systematic reviewsAt suitable stages systematic reviewsshall be conducted to :shall be conducted to :

Evaluatecapability

to fulfilrequirements

Evaluatecapability

to fulfilrequirements

Identify(if any)

problems

Identify(if any)

problems

Propose solutionsPropose

solutions

DESIGN AND DEVELOPMENT REVIEW


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735

InputsInputs OutputsOutputs

PlannedPlanned performedperformed

DESIGN AND DEVELOPMENT VERIFICATION

Results must be recorded


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PerformedPerformed ConfirmConfirm

Capability of the Product / ServiceCapability of the Product / Servicein meeting the particular requirementsin meeting the particular requirementsfor a specific intended customer use.for a specific intended customer use.

DESIGN AND DEVELOPMENT VALIDATION

Prior its delivery or implementation



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s ApprovedApproved ImplementationImplementation

To determine the effect of changes on the:To determine the effect of changes on the:

Elements of the design and developmentElements of the design and development

Existing experience on upon post deliveryExisting experience on upon post delivery

737

Component parts of the product / serviceComponent parts of the product / service

CONTROL OF CHANGES

Need for carrying out re-verification orNeed for carrying out re-verification orre-validationre-validation



ISO

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741

PURCHASING

Evaluate and select supplierson their ability to supply product and/or service

In accordance with itsrequirements

Actions shall be recorded


ISO

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s Purchasing documents shall contain requirements for

approval or qualification of :

742

PURCHASING INFORMATION

- Product- Service- Procedures- Processes- Equipment and- Personnel

Including any managementsystem requirements

Prior to release


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Arrangements necessary Arrangements necessary for the verificationfor the verification

When the organisationWhen the organisationor the client proposesor the client proposes

to performto performverification activities at verification activities at the supplier’s premisesthe supplier’s premises

VERIFICATION OF PURCHASED P and/or S

The organization shall determine and implement the arrangements for verification of purchased

product and/or service

Method of product / Method of product / service releaseservice release

Shall be specified in the purchasing documents

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s PRODUCTION AND SERVICE OPERATIONS

750

CustomerCustomerpropertyproperty

IdentificationIdentificationand traceabilityand traceability

ValidationValidationof processesof processes

Handling, packaging, storage,preservation and delivery


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PRODUCTION AND SERVICE OPERATIONSThe organization shall

Production and service operationsincluding those undertaken after initial delivery

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Equipment

Production Maintenance

Installation

Activity

Measuring Monitoring

Verification

Specifications

Product Service

Instructions

Workenvironment

PRODUCTION AND SERVICE OPERATIONS

Methods

Release

Installation

Delivery

Through :

ISO

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752

Statusproduct / service

Any effect on the conformitywith requirements

And to componentparts if

With respect to required measurementsand verification activities

Suitable meansthroughout all processes

The organization shall make provision for identifying :


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Control and record

the unique identification

of the product / service

Throughout all processes

When required

ISO 9001

ISO 14001

ISMB.V

Supply - Production - Distribution

IDENTIFICATION AND TRACEABILITYThe organization shall


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753

CLIENTPROPRIETY

IdentificationIdentification

intellectual propriety

Product - Material - Equipment

CUSTOMER PROPERTYThe organization shall exercise care with:

VerificationVerification

StorageStorage

MaintenanceMaintenance

DeliveryDelivery

To final destination.

From internal operation

HandlingHandling

PreservationPreservation

StorageStorage

Documentation available and approvedDocumentation available and approved

PackagingPackaging

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s HANDLING TO DELIVERY


ISO

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s HANDLING TO DELIVERY

754

Product release and/or service deliveryshall not proceed until all the specified activities...

… have been satisfactorily completed and the related documentation is available and authorized


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755

AcceptabilityAcceptabilityEffectivenessEffectiveness

Re-validation

Qualificationof equipment

Qualificationof personnel

Specificrecords

Specificprocedures

Processesqualified prior use

VALIDATION OF PROCESSESWhen the resulting output cannot be readily oreconomical verified by subsequent monitoring

inspection and/or testing


ISO

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s CONTROL OF MEASURING AND MONITORING DEVICES

760

Devices

Control Calibration

Maintenance

Methods

Handling Preservation

Storage

Software

Validatedprior to use


ISO

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s UncertaintyUncertainty

CalibrationAdjustment

InternationalNational

PrecisionPrecision

Identificationstatus

Environmental conditions

AccuracyAccuracy

Results ofcalibration

Methods forcalibration

Validation of previous inspection

and test results

Safeguard againinvalidatedcalibration

SpecifiedIntervals

SpecifiedIntervals

760 a-g

CONTROL OF MEASURING ANDMONITORING DEVICES


8-MEASUREMENT ANALYSE IMPROVEMENT



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s MEASUREMENT, ANALYSIS ANDIMPROVEMENT

SystemSystemimprovementimprovement

Measurementand monitoring

Control ofControl ofnonconformitynonconformity

Analysis ofAnalysis ofdatadata


ISO

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SystemSystemperformanceperformance

InternalInternalauditaudit

Product /Product /serviceservice

CustomerCustomersatisfactionsatisfaction

ProcessesProcesses

820

MEASUREMENT AND MONITORING OF


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832

The organization shall ensure that productand/or service that does not conform

to requirements is controlled to preventunintended use or delivery

Hold Area

CONTROL OF NONCONFORMITY


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832

NONCONFORMITY REVIEW AND DISPOSITION

Responsibility and authority for the review andresolving of nonconformities

shall be defined

CorrectedCorrectedor adjustedor adjusted

Acceptedunder condition

Acceptedunder condition

RejectedRejectedunsuitableunsuitable

Re-assignedfor alternatives

The organization shall review nonconformitiesand determine the action to be taken


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Conformance

Requirements

Trends

Characteristics

Processes

Pertinence

Effectiveness

Adequacy

System

Characteristics

Product /service

DissatisfactionSatisfaction

Client

ANALYSIS OF DATA FOR IMPROVEMENT


ISO

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s Identification of a

nonconformity

Evaluation ofthe need for action

Implementation of theaction determined

Recording ofthe action taken

Review ofthe action

effectiveness

Determination ofthe causes

852

IMPROVEMENT

Corrective actionCorrective action


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Preventive actionPreventive action

853

Identification of a potential nonconformity

Determination of the preventive

action

Implementation of thepreventive action

Recording ofthe action taken

Review ofthe action

effectiveness

Determination ofthe causes

IMPROVEMENT


Documents

4-SYSTEM REQUIREMENTS Quality Management Systems Ships in Service Training Material A-M CHAUVEL