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GENERIC MODEL OF ISO 9000

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.

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GENERIC MODEL OF ISO 9000

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  1. GENERIC MODEL OF ISO 9000 Be The BestThrough ProcessImprovement US QUALITY Military Standards MIL-Q-9058 A NATO Quality Standards AQAPI (1970) British Standards 5750 (1979) ISO 9000 (A Series of Standards)

  2. ISO 9000 QMS Be The BestThrough ProcessImprovement Describe your quality system Make your system work Have your system certified by an independent third part? Say what you do Do What you say Prove it

  3. STAIR - CASE FUNCTION FOR STANDARD FORMATION Be The BestThrough ProcessImprovement A B L E L E A D E R S H I P Establishment of ISO Standard Refinement & Improvement 75% Voting Required of Member Bodies Draft International Standard (DIS) ISO Technical Committee (TS) Committee Draft (CD) Working Draft (WD) New Proposals (NP)

  4. DEVELOPMENT OF QUALITY MANAGEMENT STANDARDS Be The BestThrough ProcessImprovement 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

  5. BENEFITS OF ISO 9000 Be The BestThrough ProcessImprovement • 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 • 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

  6. COMMON MISUNDERSTANDINGS Be The BestThrough ProcessImprovement • 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

  7. THE 20 ELEMENTS OF THE ISO 9000 MODELS Be The BestThrough ProcessImprovement ELEMENTS NO ISO 9002 ISO 9003 ISO 9001 Management Responsibility 1. Quality System 2. Contract Review 3. Design Control 4. Document and Date Control 5. Purchasing 6. Control of customer-supplied product 7. Product identification and traceability 8. Process Control 9. Inspection and testing 10. Control of inspection, measuring and test equipment 11. Inspection and test status 12. Control of nonconforming product 13. Corrective and preventive action 14. Handling, storage, packaging, preservation and delivery 15. Control of quality records 16. Internal Quality Audits 17. Training 18. Servicing 19. Statistical Techniques 20. • Element present but less stringent Element NOT Present • Element present

  8. A SIMPLE EXAMPLE OF PROCESS ANALYSIS Be The BestThrough ProcessImprovement Level 1 Defines Approach and Responsibility Quality Manual Level 2 Defines who, What, When Procedures Level 3 Answers How Work Instructions (functional, departmental) Level 4 Results: Shows that the system is operating Other documentation (forms & records, process sheets, visual aids, posted instructions, test & inspection sheets)

  9. THE STEPS TOWARDS ISO 9000 ACTION Be The BestThrough ProcessImprovement Decide to go for ISO 9000 Select ISO 9001 or ISO 9002 Appoint Quality Manager Set up an ISO 9000 group OUTPUTS Quality Policy Write Policy Get staff commitment Define Responsibilities Job description Organization chart Describe Processes Involve staff Write procedures Procedures Manual Get staff to adopt new procedures Implement quality system Audit reports Train auditors Audit the system Maintain the system ISO 9000 Certification Get registered Publicizes your success

  10. AUDIT PROCESS FLOW SHEET Be The BestThrough ProcessImprovement Plan Audit DO Audit Production Service Problem Found Determine Cause Issue Report Issue Nonconformance Report Take Corrective Action

  11. TYPES OF CERTIFICATION Be The BestThrough ProcessImprovement Customer Certification (Second) Accredited Certification (Registration) Level of Quality Self Certification (First) Independent Certification (Third) Cost

  12. The Process of Certification and Surveillance Contact several certification bodies Complete questionnaire; get quotations Be The BestThrough ProcessImprovement Select certification bodies Apply for certification Certification body checks your manual Make Changes FAIL PASS Agree date for assessment Certification body checks your system Make Changes FAIL PASS Get ISO 9000 certification Regular surveillance visits for 3 years Make Changes FAIL

  13. Flow Chart of Customer Complaint Form ISSUANCE OF CCF Be The BestThrough ProcessImprovement MR Receipt of Customer Complaint from the Planning Q.C Mark to Concerned Deptt. Investigation Prepare the Investigation Reports Discussed with PM (CL) NO Is the Investigation satisfactory YES Sent to MR Discussed in Cust. Complaint meeting Minutes of Meeting Circulated + Cars Feed back to Customer by Sales

  14. PROCESS APPROACH Be The BestThrough ProcessImprovement • 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

  15. INTEGRATION OF ISO 9000 SERIES INTO FOURPRIMARY STANDARDS Be The BestThrough ProcessImprovement ISO 9000: Quality Management System-Concepts and vocabulary ISO 9001: Quality Management System: Requirements ISO 9000 : REV 2000 ISO 9004: Quality Management System: Guidelines ISO 10011: Guidelines for Auditing Quality System

  16. 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement General requirements Management Commitment Provision of resources Planning General Customer related processes Monitoring & measurement Documentation Requirements Customer focus Human resources Quality policy Control of NCP Infrastructures Design & development Planning Analysis of data Work environment Purchasing Responsibility, authority & communication Improvements Production & service provision Management Reviews System Requirements / Structure of the Standard 4 Quality Management System

  17. Application of the Elements in Departments COMPANY – WIDE 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 Department Department 5.2; 7.1; 7.2 Sales 7.4 Design 7.4 Purchase 7.1; 7.5 Production 7.6; 8.1; 8.2 8.3; 8.4 Testing 7.5 Stores 5.5 Administration 7.2 Service

  18. EIGHT POINT AGENDA OF REV 2000 Be The BestThrough ProcessImprovement Customer Focus Process Approach Leadership System Approach to Management Involvement of People QM Principles Factual Approach to decision Making Continual Improvement Mutually beneficial supplier Relationship

  19. SEVEN STEPS ACTION PLAN FORTRANSFORMATION TO ISO 9001:2000 Be The BestThrough ProcessImprovement Create Awareness Conduct Gap Analysis Do Process Mapping Increase Human Skills Review Quality Policy + Objectives Revise Documentation Conduct Mgt Review + Internal Audit

  20. ACTION STEPS FOR CONTINUAL IMPROVEMENT Be The BestThrough ProcessImprovement • 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.

  21. Customer Needs Tree Needs Be The BestThrough ProcessImprovement Current Future Visible Hidden Visible Hidden High Runability Availability Match between supplier & customer Consistent Supplier Defect Free Delivery Response VMI CPI Zero Inspection Quick Correct Agreed Delivery BEST Emergency Delivery Supply chain Analysis Supply Availability Maintainability Reliability

  22. KANO MODEL Be The BestThrough ProcessImprovement Customer’s Satisfaction Must be (one dimensional) Attractive Quality Expected Quality (one dimensional) Quality Basic Quality (Must be) Customer’s Dissatisfaction

  23. Competence Needs Be The BestThrough ProcessImprovement Existing Needs Competence of People Present Needs of Organization Govt. Policies Emerging Markets Strategic & operational future needs of organization Regulation & Statutory Req. Changing Standards

  24. Legal Requirements Be The BestThrough ProcessImprovement Processes Products Activities (Boiler Heating Area) Labour laws Pension Fund (Water Consumption) (Chemical flow) OAEB (Old Age Employee) (Gases Emission) Social Security (Air/ / Noise Pollution) Ethical Issues (Dumping of explosive materials) Compensatory leave Gazette Holiday (Safety Equip. / for Clean Area) Work Hours Promotion of ethical • Benefits to interested parties • Role of organization in the protection of community interest • Promotion of ethical interpretation.

  25. Work Environment Be The BestThrough ProcessImprovement Motivation, Employee Satisfaction, High performance of People Physical Factors Human Factors Creative work methodology Noise Light Safety rules Humidity Protective Equipment Hygiene Ergonomics Pollution (Air / Paper) Opportunities for greater involvement Air Flow Greater earning opportunities Vibration Special facilities (Night allowance, Conveyance allowance, TAPA, Heat allowance Compensatory leave, overtime Cleanliness Heat

  26. COMMUNICATION TOOLS Be The BestThrough ProcessImprovement • 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

  27. INFORMATION Be The BestThrough ProcessImprovement Needs for security + + Need forConfidentiality Innovation +ve + + Information Knowledge Base Innovation +ve Factual Decisions

  28. Training Be The BestThrough ProcessImprovement Awareness Competence Education Training Human Resource Skill Experience Core Core Core

  29. TRAINING CYCLE Be The BestThrough ProcessImprovement 1. Define Training Needs 4. Evaluate training outcomes 2. Design and plan training MONITOR 3. Provide for Training

  30. Be The BestThrough ProcessImprovement Needs Confidentiality Appropriate Security Internal source of Information External source of information Information Strategic Development Helps in Factual Decisions Effective Communication Explore potential improvement

  31. LEADERSHIP HEXAGON Be The BestThrough ProcessImprovement Unity of Purpose (vision) Direction (Path) Career Path Role Model Culture Motivate Policies Turnover Internal Environment (co-herence) System Behaviour Hanging Objectives Linked

  32. FUNDAMENTAL APPROACHES FOR IMPROVEMENT Be The BestThrough ProcessImprovement • 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

  33. CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000 Be The BestThrough ProcessImprovement DESCRIPTION DESCRIPTION 0 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 Scope 1 a) and b) parts 1.1 General 1.2 Application 2 Normative Reference 2 Normative references 2 3 Definitions 3 Terms and definitions 3 3.1 Product 3.2 Tender 3.2 Contract 4 Quality management system requirements 4 Quality system requirements 4.1 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

  34. CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000 Be The BestThrough ProcessImprovement DESCRIPTION DESCRIPTION 4.2.4 Control of records 4.1 Management responsibility 5 Management responsibility 4.1.1 Quality policy 5.1 Management commitment 5.1+5.3+5.4.1 4.1.2 Organization Only 5.2 Customer focus Responsibility and authority 4.1.2 5.5.1 5.3 Quality Policy Resources 4.1.2.2 6.1+6.2.1 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) 4.1.3 5.6.1+8.5.1 Quality system 4.2 Only 5.5 Responsibility, authority and communication 4.1.2 General 5.5.1 Responsibility and authority 4.1+4.2.22 4.2.2 Quality system procedures 5.5.2 Management representative 4.2.1 4.2.3 Quality Planning 5.5.3 Internal communication (Part of 4.1.2) 5.4.2+7.1 4.3 Contract review 5.6 Management Review Only 5.6.1 General 4.3.1 General 5.2+7.2.1+7.2.2+7.2.3 5.6.3 Review input 4.3.2 Review 7.2.2 4.3.3 Amendment to a contract 5.6.3 Review output 7.2.2 4.3.4 Records 4.4 Design control Only 6 Resources management (Part of 4.1.2.2) 4.4.1 General 4.4.2 7.3.1 6.1 Provision of resources (Part of 4.1.2.2) Design and development planning

  35. CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000 Be The BestThrough ProcessImprovement DESCRIPTION DESCRIPTION Organization and technical interfaces 6.2 Human resources (Part of 4.1.2.2) 4.4.3 7.3.1 7.2.1+7.3.2 4.4.4 Design input 6.2.1 General (Part of 4.1.2.1) 4.4.5 Design output 6.2.2 Competence, awareness and training (Part of 5.18) 7.3.3 4.4.6 Design review 7.3.4 6.3 Infrastructure Design verification 4.4.7 7.3.5 6.4 Work environment Design validation 4.4.8 7.3.6 4.4.9 Design changes 7 Product realization 7.3.7 Document Control and data control 7.1 Planning of Product realization (Part of 4.9) 4.5 Only General 4.5.1 4.2.3 7.2 Customer-related processes 4.5.2 Document and data approval and issue 7.2.1 Determination of requirements related to the product 4.2.3 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 7.2.3 Customer communication (Note 9 Part of 4.3.4) Only 4.6.1 General 7.3 Design and development 7.3.1 Design and development planning 7.4.1 4.6.2 Evaluation of subcontractors 7.4.2 7.3.2 Design and development inputs 4.6.3 Purchasing data 7.4.3 4.6.4 Verification of purchased product 7.3.3 Design and development outputs 7.3.4 4.6.4.1 Design and development review Supplier verification subcontractors premises 4.6.4.2 Design and development verification 7.3.5 Customer verification of subcontracted product 7.3.6 Design and development validation 7.5.4 4.7 Control of customer supplied product 4.8 Product identification and control 7.5.3 7.3.7 Control of design and development changes

  36. CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000 Be The BestThrough ProcessImprovement DESCRIPTION DESCRIPTION Process control 7.4 Purchasing 4.9 6.3+6.4+7.5.1+7.5.2 Only 4.10 Inspection and testing 7.4.1 Purchasing Process (General) 4.10.1 General 7.4.2 Purchasing information 7.1+8.1 4.10.2 Receiving inspection and testing 7.4.3+8.2.4 7.4.3 Verification of purchased product 4.10.2.1 7.5 Production and service operations 4.10.2.2 7.5.1 Control of production and service provision 4.10.2.3 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability In-process inspection and testing 4.10.3 8.2.4 7.5.4 Customer property 4.10.4 Final inspection and testing 7.5.5 Preservation of product 8.2.4 4.10.5 Inspection and test records 7.6 Control of measuring and monitoring devices 7.5.3+8.2.4 4.11 Control of inspection, measuring and Only test equipment 8 Measurement, analysis and improvement 7.6 4.11.1 General 7.6 8.1 General 4.11.2 Control procedures 7.5.3 4.12 Inspection and test status 8.2 Monitoring and measurement 8.2.1 4.13 Control of nonconforming product Only Customer satisfaction 4.13.1 General 8.3 Internal audits 8.2.2 8.2.3 Monitoring and measurement Customer satisfaction 8.3 4.13.2 Review and disposition of Nonconforming product

  37. CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000 Be The BestThrough ProcessImprovement DESCRIPTION DESCRIPTION Corrective and preventive action 8.2.4 Monitoring and measurement of Product 4.14 Only 8.5.2+8.5.3 4.14.1 General 4.14.2 Corrective action 8.3 Control of nonconforming product 8.5.2 4.14.3 Preventive action 8.5.3 Handling, storage, packaging, Only 4.15 preservation and delivery General 4.15.1 8.4 Analysis of data 7.5.5 4.15.2 8.5 Improvement Handling Storage 4.15.3 7.5.5 8.5.1 Continual improvement 4.15.4 Packaging 8.5.2 Corrective action 7.5.5 4.15.5 Preservation 8.5.3 7.5.5 4.15.6 Delivery 7.5.1 Control of quality records 4.16 4.2.4 8.2.2+8.2.3 4.17 Internal quality audits 6.2.2 4.18 Training 7.5.1 4.19 Servicing 4.20 Statistical techniques Only 4.20.1 Identification of need 8.1+8.2.3+8.2.4+8.4 8.1+8.2.3+8.2.3+8.4 4.20.2 Procedures

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