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8/7/2019 ISO AWARENESS- 90012008PPT FORMAT
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CM-21 Rev No:01, Date: 01.10.2001 1
ATOZ QUALITY MANAGEMENT
PVT.LTD
ISO 9001:2008Awareness
WELCOME TO ALLWELCOME TO ALL
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CM-21 Rev No:01, Date: 01.10.2001 2
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
Todays AgendaTodays Agenda
Introduction to Quality Management System
Evolution of Quality Management System Standards
Process Approach towards QMS.
Requirements of ISO 9001:2000.
Benefits of implementing ISO 9000
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CM-21 Rev No:01, Date: 01.10.2001 3
Evolution of Quality Management System Standards.Evolution of Quality Management System Standards.
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
BS 5750BS 5750 Base Standard
ISO 9000ISO 9000 Developed in 1987 by ISO body
ISO 9000ISO 9000 Revised in 1994
ISO 9000ISO 9000Revised in 2000
These standards are
developed by ISO
ISO means Equal
These standards are
generic.
Applicable all types of
organizations
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CM-21 Rev No:01, Date: 01.10.2001 4
4.0 Quality Management System
4.1 General Requirements
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
Identify Process Determine SequenceDetermine Method
to Control
Ensure ResourcesAvailable
Measure, Monitor& Analysis
CA/PA & CI
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CM-21 Rev No:01, Date: 01.10.2001 5
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
4.0 Quality Management System Contd.
4.2 Documentation Requirements
Documented statements of Quality Policy & Objectives
Document process as required
Document in any form.
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CM-21 Rev No:01, Date: 01.10.2001 6
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ISO 9001:2000 Awareness
4.0 Quality Management System Contd.
4.2.2 Quality Manual
Define Quality Policy
Define Process within the organization
Define interfaces between the processes identified
Define Scope & Justification for Exclusions of requirements
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CM-21 Rev No:01, Date: 01.10.2001 7
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ISO 9001:2008 Awareness
4.0 Quality Management System Contd.
4.2.3 Control of Documents
Approve documents for adequacy prior to issue
Review and update as necessary
Maintain Record of Change
Update all documents
Prevent unintended use of obsolete documents
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CM-21 Rev No:01, Date: 01.10.2001 8
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
4.0 Quality Management System Contd.
4.2.3 Control of Records
Identify
Legible
Storage & Preservation
Retain records to meet Customer & Legal requirements
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CM-21 Rev No:01, Date: 01.10.2001 9
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
5.0 Management Responsibility Contd.
CustomerCustomerFocusFocus
LeadershipLeadership8
Management
Principals
InvolvementInvolvementof peopleof people
ProcessProcessApproachApproach
SystemSystemapproach toapproach to
managementmanagement
ContinualContinualImprovemenImprovemen
tt
Mutual beneficialMutual beneficialsuppliersupplier
relationshipsrelationships
FactualFactualapproach toapproach to
decisiondecisionmakingmaking
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CM-21 Rev No:01, Date: 01.10.2001 10
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
5.0 Management Responsibility
Define Quality Policy
Appropriate to the purpose of organization
provide framework for establishing and reviewingobjectives
POLICYPOLICY
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CM-21 Rev No:01, Date: 01.10.2001 11
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
5.0 Management Responsibility Contd.
Define Quality Objectives
S - Specific
M - Measurable
A - Attainable
R - Realistic
T - Time Bound
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CM-21 Rev No:01, Date: 01.10.2001 12
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
5.0 Management Responsibility Contd.
Define Responsibility & Authority
Assign Responsibility for Quality
Provide Authority to Stop Production in case of NC.
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CM-21 Rev No:01, Date: 01.10.2001 13
ATOZ QUALITY MANAGEMENTISO
9001:2000 Awareness
5.0 Management Responsibility Contd.
Management Review to address
PerformancePerformance of ofQualityQuality SystemSystem
Cost of QualityCost of Quality
Achievement ofAchievement of
Quality PolicyQuality Policyand Objectiveand ObjectiveAll Elements ofAll Elements of
Quality SystemQuality System
CustomerCustomerSatisfactionSatisfaction
Field Failure & ItsField Failure & Itsimpact on Safetyimpact on Safety
& Environment& Environment
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CM-21 Rev No:01, Date: 01.10.2001 14
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ISO 9001:2000 Awareness
6.0 Resource Management
Assign Competent Personnel for work affecting Quality
Define Competency Level for each Job.
Provide training and evaluate effectiveness
Designers to be skilled in applicable tools
Define JobDefine Job
SpecificationsSpecifications
DOE, QFD,DOE, QFD,
DFMEA, etc.DFMEA, etc.
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CM-21 Rev No:01, Date: 01.10.2001 15
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ISO 9001:2000 Awareness
6.0 Resource Management Contd.
Cleanliness of Premises Ensure Premises maintained in the
state of orderliness.
Maintain 5SMaintain 5S
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CM-21 Rev No:01, Date: 01.10.2001 16
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ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Plan & identify the processes required for product realization
nderstand customerUnderstand customer
requirementsrequirementsDesign & DevelopmentDesign & Development Purchase & StorePurchase & Store
ProductionProductionInspectionInspection
DispatchD
ispatch
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CM-21 Rev No:01, Date: 01.10.2001 17
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Maintain confidentiality to customer contracted product.
Process to manage the changes in the Product & Process
Determine quality objectives and requirement of the product
Establish processes, documents and provide resources specific
to the product.
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CM-21 Rev No:01, Date: 01.10.2001 18
ATOZ QUALITY MANAGEMENTISO
9001:2000 Awareness
7.0 Product Realization Contd.
Customer Related Process:-
Customer designated Special Characteristics Compliance in
terms of designation, control and monitoring
Critical productCritical product
characteristicscharacteristics
Implement SPC/Implement SPC/
PokeYokePokeYoke
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ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Purchasing:-
Purchase material used in product to comply with all Govt.
Safety / Environmental Regulation
Customer approved sources Purchase from customer approved
source, if part of contract.
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CM-21 Rev No:01, Date: 01.10.2001 20
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Incoming Product Quality Acceptance of incoming material
can be based on following
Receiving inspection Receipt and evaluation of Statistical data
Part evaluation by external lab
Any other method agreed with the customer.
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CM-21 Rev No:01, Date: 01.10.2001 21
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ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Monitor supplier performance:-
Delivered partDelivered part
quality performancequality performanceincluding lineincluding linerejectionrejection
DeliveryDeliveryperformanceperformance
CustomerCustomercomplaints duecomplaints due
to Suppliersto Supplierspartpart
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ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Identification & Traceability
Mandatory to identify the products at various stages of
Product realization.
Customer owned tooling Identify visually
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CM-21 Rev No:01, Date: 01.10.2001 23
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ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Storage & Inventory
Periodically assess the condition of the stock
Use Inventory Management system to optimize inventorylevels.
Use FIFO, where applicable.
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ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
7.0 Product Realization Contd.
Control of Monitoring and Measuring Devices.
Calibrate all Measuring devices..
CalibrationCalibration
RecordsRecords
As receivedAs received
conditioncondition
Gage revisionGage revision
statusstatusStatement ofStatement of
conformanceconformance
Out ofOut of
CalibrationCalibration
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CM-21 Rev No:01, Date: 01.10.2001 25
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
8.0 Measurement, Analysis and Improvement
Identify & Implement Statistical Techniques
Impart basic Knowledge on Statistical tools to all employees
Knowledge of Variation, Control, Stability & Capability.
7 QC
Tools
SPC
Charts
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CM-21 Rev No:01, Date: 01.10.2001 26
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
8.0 Measurement, Analysis and Improvement
Customer Satisfaction Measurement
Field ReturnsField ReturnsDeliveredDeliveredpart Qualitypart Quality
PerformancePerformance
Customers
DeliveryDelivery
PerformancePerformance
CustomerCustomer
complaints /complaints /
feedbackfeedback
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ISO 9001:2000 Awareness
8.0 Measurement, Analysis and Improvement
Internal Audits
Internal Auditor Should be Qualified
System AuditSystem Audit
Internal Audits
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CM-21 Rev No:01, Date: 01.10.2001 28
ATOZ QUALITY MANAGEMENTISO
9001:2000 Awareness
8.0 Measurement, Analysis and Improvement
Control of Nonconformance Product
Nonconformance
SuspectSuspect
productproduct -- NCNC
ReworkRework
InstructionInstruction
for R/wfor R/w
InformInform
customer ifcustomer if
NC isNC is
shippedshipped
CustomerCustomer
deviationdeviation--maintain recordmaintain record
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CM-21 Rev No:01, Date: 01.10.2001 29
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
8.0 Measurement, Analysis and Improvement
Analysis of Data
Identify Key Quality & Organizational performance data
Monitor the performance
Timely reporting of the performance
Monitor trends in performance .
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ISO 9001:2000 Awareness
8.0 Measurement, Analysis and Improvement
Improvement
Define Process for Continual Improvement
Focus on reduction of variation in product / processparameters.
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ISO 9001:2000 Awareness
8.0 Measurement, Analysis and Improvement
Corrective Actions
To avoid recurrence of the non-conformance.
Preventive Actions
To avoid potential failures / non-conformance.
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CM-21 Rev No:01, Date: 01.10.2001 32
ATOZ QUALITY MANAGEMENT
ISO 9001:2000 Awareness
THANK YOUFOR FURTHER DETAILS PLEASE CONTACT
MR.JIVAN KATHE(Lead Auditor for QMS/HOD)
(9930141710)