generic model of iso 9000
DESCRIPTION
GENERIC MODEL OF ISO 9000. Be The Best Through Process Improvement. US QUALITY Military Standards MIL-Q-9058 A. NATO Quality Standards AQAPI (1970). British Standards 5750 (1979). ISO 9000 (A Series of Standards). ISO 9000 QMS. Be The Best Through Process Improvement. - PowerPoint PPT PresentationTRANSCRIPT
GENERIC MODEL OF ISO 9000Be The Best ThroughProcess Improvement
US QUALITYMilitary Standards
MIL-Q-9058 A
NATOQuality Standards
AQAPI (1970)
BritishStandards 5750
(1979)
ISO 9000(A Series of Standards)
ISO 9000 QMSBe The Best ThroughProcess Improvement
Say what you do
Do What you say
Prove it
Describe your quality system
Make your system work
Have your system certified byan independent third part?
STAIR - CASE FUNCTION FOR STANDARD FORMATION
Be The Best ThroughProcess Improvement
ABLE
LEADERSHIPNew Proposals (NP)
Working Draft (WD)
Committee Draft (CD)
ISO Technical Committee (TS)
Draft International Standard (DIS)
75% Voting Required of Member Bodies
Establishment of ISO Standard
Refinemen
t & Im
provement
DEVELOPMENT OF QUALITY MANAGEMENT STANDARDS
Year Standard Country
1963 MIL Q 9857A US Military
1969 NATO AQAP NATO
1970 US 10 CFR 50 US Fed. Regulations
1971 ASME Boiler Code (Mech. Eng.) USA
1972 BS 4891 UK
1973 Defence Standards 05-21 et seq UK Modif
1975 CSA Z.299 Canadian
AS 1821/22/23 Australia
AS 1821/22/23 Revision “
BS 5179 UK
1979 US ANSI/ASQC Z1.15 USA
BS 5750 Parts 1-3 United Kingdom
1981 BS 5750 Parts 4-6 United Kingdom
1985 CSA Z.299 Revision Canadian
1987 ISO 9000, AS 3900, BS 5750 Revision, NZS 5600 (later renumbered as NZS
9000), US/ANSI/ASQC Q90-94 )later renumbered as Q9000)
1994 ISO 9000 revised Geneva, Switzerland
Be The Best ThroughProcess Improvement
BENEFITS OF ISO 9000
EXTERNAL BENEFITS
Competitive edge
World Wide Recognition
Better Company Image
Higher Perceived Quality
Improved Customer Satisfaction
Able to stay in business
Quality Benefits
Consistency in Product / Services
Stepping Stone for TQM
Documentation. Communication, Standardization
Be The Best ThroughProcess Improvement
INTERNAL BENEFITS
Role Clarity, Responsibility, accountability
Better Management Control
Better Work Efficiency
Increase On-time Delivery
Constant Skill Level
Building Block for Quality Culture
KAIZEN Improvement
COMMON MISUNDERSTANDINGS
ISO 9000 applies only to certain products
ISO 9000 is only one standard
ISO 9000 can be achieved by only preparing certain types of documents
ISO 9000 is Total Quality Control (TQC)
ISO 9000 is only a burden and an additional cost
It’s a matter of days or weeks to achieve the certification
Implementing ISO 9000 involves only a few managers
Quality audit is done only once
ISO requires extra staff
ISO is to steel our technology
ISO restricts our exports
Document rubbish and get certification
Be The Best ThroughProcess Improvement
THE 20 ELEMENTS OF THE ISO 9000 MODELS
Be The Best ThroughProcess Improvement
NO ELEMENTS ISO 9001 ISO 9002 ISO 90031. Management Responsibility
2. Quality System
3. Contract Review
4. Design Control
5. Document and Date Control
6. Purchasing
7. Control of customer-supplied product
8. Product identification and traceability9. Process Control
10. Inspection and testing
11. Control of inspection, measuring and test equipment
12. Inspection and test status
13. Control of nonconforming product
14. Corrective and preventive action
15. Handling, storage, packaging, preservation and delivery
16. Control of quality records
17. Internal Quality Audits
18. Training
19. Servicing
20. Statistical Techniques
Element present Element present but less stringent Element NOT Present
A SIMPLE EXAMPLE OFPROCESS ANALYSIS
Be The Best ThroughProcess Improvement
QualityManual
Procedures
Work Instructions(functional, departmental)
Other documentation(forms & records, process sheets, visual aids, posted
instructions, test & inspection sheets)
Level 1DefinesApproach andResponsibility
Level 2Defines who,What, When
Level 3Answers How
Level 4Results: Showsthat the systemis operating
THE STEPS TOWARDS ISO 9000
Be The Best ThroughProcess Improvement
Decide to go forISO 9000
Decide to go forISO 9000
ACTIONACTION
AppointQuality Manager
AppointQuality Manager
Write PolicyWrite Policy
DefineResponsibilities
DefineResponsibilities
Describe ProcessesDescribe Processes
Writeprocedures
Writeprocedures
Implementquality system
Implementquality system
Audit the systemAudit the system
Get registeredGet registered
Publicizesyour success
Publicizesyour success
Select ISO 9001or ISO 9002
Select ISO 9001or ISO 9002
Set up anISO 9000 group
Set up anISO 9000 group
Get staffcommitment
Get staffcommitment
Involvestaff
Involvestaff
Get staff to adoptnew procedures
Get staff to adoptnew procedures
Train auditorsTrain auditors
Maintainthe systemMaintain
the system
Quality PolicyQuality Policy
Job descriptionJob description
ProceduresProcedures
Organization chartOrganization chart
ManualManual
Audit reportsAudit reports
ISO 9000Certification
ISO 9000Certification
OUTPUTSOUTPUTS
AUDIT PROCESS FLOW SHEET
Be The Best ThroughProcess Improvement
Plan AuditPlan Audit
ProductionService
ProductionService
ProblemFound
ProblemFound
DO AuditDO Audit
DetermineCause
DetermineCause
Issue NonconformanceReport
Issue NonconformanceReport
Take CorrectiveAction
Take CorrectiveAction
IssueReport
IssueReport
Be The Best ThroughProcess Improvement
TYPES OF CERTIFICATION
Accredited Certification (Registration)
Independent Certification (Third)
Customer Certification (Second)
Self Certification (First)
Cost
Leve
l of Q
ualit
y
The Process of Certification and Surveillance
Be The Best ThroughProcess Improvement Contact several
certification bodies
Contact severalcertification bodies
Apply for certificationApply for certification
Complete questionnaire;get quotations
Complete questionnaire;get quotations
Selectcertification bodies
Selectcertification bodies
Certification bodychecks your manual
Agree date for assessmentAgree date for assessment
Certification bodychecks your system
Get ISO 9000certification
Regular surveillancevisits for 3 years
Make ChangesMake Changes
Make ChangesMake Changes
PASS
FAIL
PASS
FAIL
Make ChangesMake ChangesFAIL
Flow Chart of Customer Complaint Form
Be The Best ThroughProcess Improvement
MRMR
YES
NO
ISSUANCE OF CCF
Receipt of Customer Complaint from the PlanningReceipt of Customer Complaint from the Planning
Q.CQ.C
Mark to Concerned Deptt.Mark to Concerned Deptt.
Prepare the Investigation ReportsPrepare the Investigation Reports
InvestigationInvestigation
Discussed with PM (CL)Discussed with PM (CL)
Is the Investigation satisfactoryIs the Investigation satisfactory
Sent to MRSent to MR
Discussed in Cust. Complaint meetingDiscussed in Cust. Complaint meeting
Minutes of Meeting Circulated + CarsMinutes of Meeting Circulated + Cars Feed back to
Customer by Sales
Feed back toCustomer by Sales
PROCESS APPROACHBe The Best ThroughProcess Improvement
The systematic identification and management of the processes employed by an organization, and the interactions between such processes.
(QMS-GUIDELINES FOR PERFORMANCE IMPROVEMENT ISO/DIS 9004)
ISO 9004-1: 1994 ISO 9004-2: 1991 ISO 9004-3: 1993 ISO 9004-4: 1993 ISO 9004-4/Cor.1: 1994
Be The Best ThroughProcess Improvement
INTEGRATION OF ISO 9000 SERIES INTO FOURPRIMARY STANDARDS
ISO 9000: Quality Management System-Concepts and vocabulary
ISO 9001: Quality Management System: Requirements
ISO 10011: Guidelines for Auditing Quality System
ISO 9000 : REV 2000
ISO 9004: Quality Management System: Guidelines
System Requirements / Structure of the Standard
Provision of resources
Human resources
Infrastructures
Work environment
6 Resource Management
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 Management Responsibility
8 Measurement Analysis & improvement
4 Quality Management System
7 Product Realization
General
Monitoring & measurement
Control of NCP
Analysis of data
Improvements
Application of the Elements in Departments
COMPANY – WIDE
Department
Department
4.1; 4.2
5.1; 5.3
5.4; 5.6
6.1; 6.2
6.3; 6.4;
7.5
8.4; 8.5
5.2; 7.1; 7.2Sales
7.4Design
7.4Purchase
7.1; 7.5 Production
7.6; 8.1; 8.28.3; 8.4Testing
7.5Stores
5.5Administration
7.2Service
Be The Best ThroughProcess Improvement
EIGHT POINT AGENDA OF REV 2000
QM Principles
Customer Focus
Involvementof People
Mutually beneficialsupplier Relationship
System Approachto Management
Leadership
Factual Approachto decision Making
Process Approach
Continual Improvement
Be The Best ThroughProcess Improvement
SEVEN STEPS ACTION PLAN FORTRANSFORMATION TO ISO 9001:2000
Conduct Mgt Review + Internal AuditConduct Mgt Review + Internal Audit
Revise DocumentationRevise Documentation
Review Quality Policy + ObjectivesReview Quality Policy + Objectives
Increase Human SkillsIncrease Human Skills
Do Process MappingDo Process Mapping
Conduct Gap Analysis Conduct Gap Analysis
Create AwarenessCreate Awareness
Be The Best ThroughProcess Improvement
ACTION STEPS FOR CONTINUAL IMPROVEMENT
Reason for Improvement Current Situation Analysis Search Alternative Solutions Evaluation of Effects Standardization of New Solution Evaluation for efficiency of process & effectiveness of Improvement action.
Be The Best ThroughProcess Improvement
Customer Needs TreeNeeds
AvailabilityMaintainability
Reliability
AgreedDelivery
EmergencyDelivery
Quick Correct
Supply chainAnalysis
Supply
ZeroInspection BEST
Defect FreeHigh
RunabilityAvailability
Delivery Response Matchbetweensupplier &customer
ConsistentSupplier
VMI CPI
Visible Hidden Visible Hidden
CurrentFuture
Be The Best ThroughProcess Improvement
KANO MODEL
Must be (one dimensional)
Attractive Quality
Customer’s Satisfaction
Basic Quality (Must be)
Customer’s Dissatisfaction
Quality
Expected Quality(one dimensional)
Be The Best ThroughProcess Improvement
Competence Needs
Existing NeedsCompetence
of People
Present Needsof Organization Govt. Policies Emerging Markets
Strategic & operationalfuture needs of organization Changing Standards Regulation &
Statutory Req.
Be The Best ThroughProcess Improvement
Legal Requirements
(Boiler Heating Area)(Water Consumption)
(Chemical flow)(Gases Emission)
(Dumping ofexplosive materials)
(Air/ / Noise Pollution)
(Safety Equip. /for Clean Area)
Products Processes Activities
Labour lawsPension Fund
OAEB (Old Age Employee)Social Security
Compensatory leave
Gazette Holiday
Ethical Issues
Work Hours
Promotion of ethical
• Benefits to interested parties• Role of organization in the protection of community interest• Promotion of ethical interpretation.
Be The Best ThroughProcess Improvement
Work Environment
Motivation, Employee Satisfaction,High performance of People
Physical Factors Human Factors
NoiseLight
HumidityHygiene
Air Flow
Vibration
Pollution (Air / Paper)
Cleanliness
Heat
Creative work methodology
Protective Equipment
Opportunities for greaterinvolvement
Greater earning opportunities
Special facilities (Night allowance,Conveyance allowance, TAPA,Heat allowance Compensatoryleave, overtime
Safety rules
Ergonomics
Be The Best ThroughProcess Improvement
COMMUNICATION TOOLS
• Team briefings and other meetings• Notice Boards• In-house Journals / magazines (HELLO, etc)• Audio-visual and electronic Media.• SAP Mail• Internal mail / CC mail• On-site briefings
Be The Best ThroughProcess Improvement
INFORMATION
Needs for security
Innovation
Information
Knowledge Base
Factual Decisions
Need forConfidentiality
Innovation
++
++
+ve
+ve
Be The Best ThroughProcess Improvement
Training
Awareness
Competence
Core
Core
Core
Training
Skill
Education
Experience
HumanResource
Be The Best ThroughProcess Improvement
TRAINING CYCLE
1. Define Training Needs
MONITOR
3. Provide for Training
2. Design and plan training
4. Evaluate training outcomes
Be The Best ThroughProcess Improvement
Information
Needs
External sourceof information
Strategic DevelopmentHelps in Factual DecisionsEffective CommunicationExplore potential improvement
Internal sourceof Information
Appropriate SecurityConfidentiality
Be The Best ThroughProcess Improvement
LEADERSHIP HEXAGON
Unity of Purpose (vision)
Dire
ctio
n (P
ath)
Car
eer P
ath
Internal
Environment
(co-here
nce)
Hanging Objectives Linked
Role Model
Policies
Culture
Motivate
Turnover
System
Behaviour
Be The Best ThroughProcess Improvement
FUNDAMENTAL APPROACHES FOR IMPROVEMENT
Innovative Approach.(System Approach)
•Defining objectives and outline for improvement
•Analysis of existing as-is process and realizing opportunities for innovative change (Process Mapping)
•Planning of process improvement
•Implementation of improvement
Kaizen (SSCI)(Stair case function Approach)
•QCC
•Natural Work Groups
•QIT
Be The Best ThroughProcess Improvement
CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000
DESCRIPTION DESCRIPTION0 Introduction 0 Introduction
0.1 General
0.2 Process approach
Fig 1 Quality Management Process Model
0.3 Relationship with ISO 9004
0.4 Compatibility with other management systems
1 Scope 1 Scope1
a) and b) parts 1.1 General
1.2 Application
2 Normative Reference 2 Normative references2
3 Definitions 3 Terms and definitions3
3.1 Product
3.2 Tender
3.2 Contract
4 Quality system requirements 4 Quality management system requirements4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual (Part of 4.2.1)
4.2.3 Control of documents
Be The Best ThroughProcess Improvement
CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000
DESCRIPTION DESCRIPTION4.2.4 Control of records
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality Policy
5.4 Planning (Part of 4.1.1)
4.1.2.3 Management representative 5.4.1 Objectives (Part of 4.1.1)5.5.2
Management review 5.4.2 Quality management system planning (Part of 4.1.1)
5.5 Responsibility, authority and communication
4.1.2 General 5.5.1 Responsibility and authority4.1+4.2.22
4.2.2 Quality system procedures 5.5.2 Management representative4.2.1
4.2.3 Quality Planning
4.3 Contract review
4.3.1 General
4.3.2 Review 5.6.3 Review input5.6.3 Review output
6 Resources management (Part of 4.1.2.2)
6.1 Provision of resources (Part of 4.1.2.2)
4.1 Management responsibility4.1.1 Quality policy 5.1+5.3+5.4.1
4.1.2 Organization Only
4.1.2 Responsibility and authority 5.5.1
4.1.2.2 Resources 6.1+6.2.1
4.1.3 5.6.1+8.5.1
Quality system4.2 Only
5.5.3 Internal communication (Part of 4.1.2)5.4.2+7.1
5.6 Management ReviewOnly5.6.1 General
5.2+7.2.1+7.2.2+7.2.3
4.3.3 Amendment to a contract 7.2.2
4.3.4 Records 7.2.2
4.4 Design control Only
4.4.1 General
4.4.2 Design and development planning 7.3.1
Be The Best ThroughProcess Improvement
CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000
DESCRIPTION DESCRIPTION6.2 Human resources (Part of 4.1.2.2)
6.2.1 General (Part of 4.1.2.1)
6.2.2 Competence, awareness and training (Part of 5.18)
6.3 Infrastructure
6.4 Work environment
4.4.9 Design changes 7 Product realization7.3.7
Document Control and data control 7.1 Planning of Product realization (Part of 4.9)
7.2 Customer-related processes
4.5.2 Document and data approval and issue 7.2.1 Determination of requirements related to the product4.2.3
4.5.3 Document and data changes 7.2.2 Review of requirements related to the product (Part of 4.3.2)4.2.3
4.6 Purchasing
4.6.1 General
4.6.2 Evaluation of subcontractors
4.6.3 Purchasing data 7.3.2 Design and development inputs7.3.3 Design and development outputs
7.3.6 Design and development validation
7.3.7 Control of design and development changes
4.4.4 Design input4.4.5 Design output 7.3.3
4.4.6 Design review 7.3.4
4.4.7 Design verification 7.3.5
4.4.8 Design validation 7.3.6
4.5 Only
General4.5.1 4.2.3
7.2.3 Customer communication (Note 9 Part of 4.3.4)Only
7.3 Design and development7.3.1 Design and development planning
7.4.2
4.6.4 Verification of purchased product 7.4.3
4.6.4.1 Supplier verification subcontractors premises 7.3.4
4.6.4.2 Customer verification of subcontracted product 7.3.5
4.7 Control of customer supplied product
4.8 Product identification and control 7.5.3
4.4.3 Organization and technical interfaces 7.3.1
7.2.1+7.3.2
7.4.1
Design and development reviewDesign and development verification
7.5.4
Be The Best ThroughProcess Improvement
CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000
DESCRIPTION DESCRIPTION7.4 Purchasing
7.4.1 Purchasing Process (General)
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service operations
4.10.2.3 7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
4.10.4 Final inspection and testing 7.5.5 Preservation of product8.2.4
4.10.5 Inspection and test records 7.6 Control of measuring and monitoring devices7.5.3+8.2.4
4.11 Control of inspection, measuring and
test equipment
4.11.1 General
4.11.2 Control procedures 8.1 General8.2 Monitoring and measurement
8.2.3 Monitoring and measurement Customer satisfaction
4.10 Inspection and testing4.10.1 General 7.1+8.1
4.10.2 Receiving inspection and testing 7.4.3+8.2.4
4.10.2.1
4.10.2.2
In-process inspection and testing4.10.3 8.2.4
Only
8 Measurement, analysis and improvement
7.6
4.12 Inspection and test status 7.5.3
4.13 Control of nonconforming product 8.2.1
4.13.1 General 8.2.2
4.13.2 Review and disposition of
Nonconforming product
4.9 Process control 6.3+6.4+7.5.1+7.5.2
Only
7.6
Customer satisfactionInternal audits
8.3
7.5.1 Control of production and service provision
Only
8.3
Be The Best ThroughProcess Improvement
CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000
DESCRIPTION DESCRIPTION8.2.4 Monitoring and measurement of Product
8.3 Control of nonconforming product
4.15.1 8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
4.15.4 Packaging 8.5.2 Corrective action7.5.5
4.15.5 Preservation 8.5.37.5.5
4.15.6 Delivery
Control of quality records
4.17 Internal quality audits
4.18 Training
4.14.1 General4.14.2 Corrective action 8.5.2
4.14.3 Preventive action 8.5.3
4.15
Storage4.15.3 7.5.5
7.5.1
6.2.2
4.19 Servicing 7.5.1
4.20 Statistical techniques
4.20.1 Identification of need
4.20.2 Procedures
4.14 Corrective and preventive action Only
8.5.2+8.5.3
8.2.2+8.2.3
8.1+8.2.3+8.2.3+8.4
Only
8.1+8.2.3+8.2.4+8.4
Handling, storage, packaging, Only
preservation and delivery
General
Handling4.15.2 7.5.5
4.2.44.16