1. 1/25 S tandardization & Quality Assurance Policy Management Cross- Functional Management Daily Management Suggestio n System Quality Control Circle 5S5S STANDARDIZATION & QUALITY ASSURANCE

2. 2/25 STANDARD STANDARD Definition Is the best way easiest way safest way in particular time

3. 3/25 STANDARDIZATION OBJECTIVE(1) Gather and “preserve “ know-how As standard to measure performance Prevent the occurrence of the same mistake As a basis for improvement

4. 4/25 STANDARDIZATION OBJECTIVES (2) Assure stability As basis for Training Ease the job delegation and its monitoring As basis for audit Increase efficiency Lower cost

5. 5/25 STANDARD TYPES Company (In-House) Standard Association Standard National Standard International Standard

6. 6/25 TYPES OF WRITTEN STANDARDS Regulations Norms Specifications Engineering / Technical Standards Work/ Process Standards Manuals Circular Notices Memos

7. 7/25 QUALITY ASSURANCE Provide product/service the customer want at the time required and at reasonable price Formal quality system Prevention not Detection –getting it right at the first time, every time

8. 8/25 FORMAL QUALITY SYSTEM Method defined to manage whole necessities that affect quality

9. 9/25 WHAT IS ISO 9000 ?  ISO, is a non-government organisation  ISO means “same” used as name for standards made by International Organization for Standardization  International Organization for Standardization based in Geneva, Swiss  ISO 9000 is Quality system standard not product standard

10. 10/25 THE HISTORY OF ISO 9000 SERI  EXPERIENCE FROM WORLD WAR II  Europe : NATO - AQAP (1945)  UK: MINDEF, DEF STANS 05-21 SERIES (1960)  UK: BS 4891, A GUIDE TO QUALITY ASSURANCE (1972)  UK: BS 5179, PART 1,2 AND 3 (1975)  UK: BS 5750, PART 1,2 AND 3 (1979)  INTERNATIONAL: ISO 9000 SERIES  EUROPE: EN 29000 SERIES

11. 11/25 ISO 9000 QUALITY STANDARD SYSTEM Structure of ISO 9000 Seri ISO 9000 Selection of Model Non Contractual Contractual ISO 9001 ISO 9002 ISO 9003 ISO 9004 Model Quality system Reference

12. 12/25 ISO 9000 QUALITY SYSTEM STANDARD ISO 9000 –Quality Management and Quality Assurance Standard - Guidelines for Selection and Use ISO 9001 –Quality Systems- Model for Quality Assurance in Design/Development, Production, Installation, and Servicing ISO 9002 –Quality Systems- Model for Quality Assurance in Production and Installation ISO 9003 –Quality systems- Model for Quality Assurance ISO 9004 –Quality Management and Quality System Element- Guidellines ISO 8402 –Quality - Vocabulary

13. 13/25 CROSS REFERENCE OF QUALITY SYSTEM ELEMENT N/A = Not Applicable

14. 14/25 EVOLUTION OF QUALITY SYSTEM ELEMENTS improvement TOTAL QUALITY MANAGEMENT Design QUALITY ASSURANCE Processing QUALITY CONTROL INSPECTION Sorting ISO 9001 ISO 9002 ISO 9003 20 clauses external contractual 19 clauses external contractual 16 clauses external contractual

15. 15/25 ISO 9001 QUALITY SYSTEM CONTROL THE OPERATING PROCESS SUPPORT ACTIVITIES 4.1. Management Responsibility 4.2. Quality System 4.5. Document Control 4.14. Corrective Action 4.17. Internal Quality Audits 4.3. Contract Review 4.4. Design Control 4.9. Process Control 4.10. Inspection & Testing 4.7. Purchaser Supplied Product 4.12. Inspection & Test Status 4.13. Control of Non-Conforming Products 4.15. Handling, Storage, Packaging & Delivery 4.19. Servicing 4.6. Purchasing 4.11. Inspection, Measuring & Test Equipment 4.18. Training 4.8. Product Identification & Traceability 4.16. Quality Records 4.20. Statistical Techniques SALES & MARKETING SALES & MARKETING DESIGN SHOPFLOOR SHOPFLOOR DISTRIBUTION DISTRIBUTION AFTER SALES AFTER SALES QUALITY RESOURCES QUALITY DATA Source: BS 5750-THE STANDARD FOR QUALITY SYSTEM

16. 16/25 STRUCTURE OF QUALITY SYSTEM DOCUMENTATION What How, what, who, where when, why How, what with QUALITY MANUAL QUALITY SYSTEM PROCEDURE WORK INSTRUCTION

17. 17/25 QUALITY MANUAL  Company profile (brief history, scope of business, domicile, quality system had and currently applied)  Quality policy  Quality objectives  Management representative  Company organization description  Job description  Job qualification  Outline of quality system currently applied

18. 18/25 QUALITY SYSTEM PROCEDURE  Procedure objective  Scope of procedure  Term of definition  Cross reference with other relevant document  Procedure description  Form attachment, checklist, or label used

19. 19/25 QUALITY PLAN  Process of production affecting quality  Handling tools  Machine / production tool  Number and Qualification of employee needed  Inspection and Test point for each job  Inspection and test method  Acceptance criteria at each inspection and test point  Measuring tool, inspection and test used  production, inspection and test record

20. 20/25 WORK INSTRUCTION  Can be in form of simple flowchart diagram  Step by step guidelines for conducting job  Filling forms  Production process  Operating machine/ tool  Conducting inspection and test  Handling / storage of product  Calibration tools  Work Instruction consist :  Tools/ Material/Operator qualification  Work step (includes description of acceptance criteria “workmanship” or with product sample/ prototype/ mock- up/ show unit.)

21. 21/25 IMPLEMENTATION PROCESS  SURVEY AND SYSTEM EVALUATION  DEVELOPING IMPLEMENTATION ORGANIZATION  PROJECT PLANNING  BRIEFING FOR TOP MANAGEMENT  COACHING DOCUMENTATION TECHNIQUE  DESIGN, REVIEW, IMPLEMENTATION, DOKUMENTATION AND SYSTEM IMPROVEMENT  AWARENESS TRAINING  INTERNAL QUALITY AUDIT  CERTIFICATION

22. 22/25 CERTIFICATION PROCESS  APPLICATION  QUESTIONER  QUESTIONER EVALUATION + QUALITY MANUAL  AUDIT AT PLACE  IMPROVEMENT STEPS (If any)  RECOMMENDATION FOR CERTIFICATION  CERTIFICATION  SURVEILLANCE AUDIT  CERTIFICATION RENEWAL (Every three year)

23. 23/25 WHY ISO 9000 IS ESSENTIAL ? Company benefit(1)  Assure quality consistence of the product/service  minimize rework - and save cost  build good foundation to enable fast evolvement ( to facilitate training and Human resources development)  Customize company to act based on data  Equip management with tool to make a tight observation of quality achievement possible  Increase the clarity of responsibility and authority in every function

24. 24/25  Standardize and distribute good practices  Eliminate quality dependency on one / few personnel  A program where commitment and employee motivation are realized (example: targeted time for certification drives every action to achieve same goal)  Quality system documented will improve communication inter department  Quality system documented will contribute the training  Quality system documented will become a ground for continuous improvement WHY ISO 9000 IS ESSENTIAL? Company Benefit (2)

25. 25/25  Improve company “Quality Image”  Open up the access to large market requiring ISO 9000 certificate  Increase Customer confidence of company quality  A prerequisite for applying other certificate, such as CE mark MENGAPA ISO 9000 PENTING ? Marketing benefit