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ISO 9001:2008 QUALITY MANAGEMENT SYSTEM

ISO 9001:2008 QUALITY MANAGEMENT SYSTEM. William Seethaler, Area Manager Northern California & Northwestern States IMSM Ltd. Malmesbury, England. Seminar Outline. History of ISO Current Status Types of Companies Utilizing 9001:2008 ISO System Components Registration Procedures

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ISO 9001:2008 QUALITY MANAGEMENT SYSTEM

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  1. ISO 9001:2008 QUALITY MANAGEMENT SYSTEM William Seethaler, Area ManagerNorthern California & Northwestern StatesIMSM Ltd.Malmesbury, England

  2. Seminar Outline • History of ISO • Current Status • Types of Companies Utilizing 9001:2008 • ISO System Components • Registration Procedures • Time line - Zero to Registration • System Benefits & Cost  • Power of the Pyramid

  3. History of ISO • 1776 • UK World War II Munition Plants • Post World War II (NATO) • European Union (EU) – 1958 • International Organization for Standardization (IOS) - Geneva, Switzerland • ISO derived from Greek word “Isos” meaning "equal“

  4. History of ISO (cont.) • Over 17,000 Different ISO Standards • ISO 9000 Initial Release – 1987 • Ist Major Update – 1994 • 9001 - Design/Development/Production/ Installation/Servicing • 9002 - Same as 9001 except Design/Development not included • 9003 - Quality System in Final Inspection & Testing • 2nd Major Update - December 2000 • 9001:2000....One standard for all types and sizes of companies…..December 2008 - minor revisions releasedunder 9001:2008

  5. Current Status • Recognized as the World's #1 Quality Management System in over 150 Countries • Reviewed & Revised Every 5-7 Years by Industry Experts Worldwide • Year 2001 Change......Process Approach - the Way Most Businesses Operate • New Streamlined Version Applicable to Both Fortune 500 and Small Companies • Special Emphasis on Customer Satisfaction, Vendor Performance, & Employee Training • Major Change Expected 2015 - Combined with ISO 14001 (Environmental)

  6. Types Of Companies Utilizing 9001:2008Contract Mfg EngineeringMachine Shops Microwave ComponentsScrew Machine Products FabricatorsCable & Wire Metal & Die CuttingWelding SoftwarePCB Assemblies CastingsPlating & Coatings TelecommunicationsPlastics CeramicsEquipment Manufacturers ComputersDistributors Die CastingInstrumentation Electronics … and many, many more

  7. System Components • Quality Manual – by IMSM • Procedure Manual – by IMSM • Forms – by Client/IMSM • Work Instructions– by Client

  8. Registration Procedures • Assessor Compares Company Operations to 9001:2008 Requirements • Assessor Prepares Gap Analysis • Company Begins Implementation of Agreed Upon ISO Procedures • Assessor Drafts Custom Quality & Procedure Manuals • Company Reviews and Approves Manuals • Assessor Trains Internal Auditors -------Assessment Phase-----

  9. Registration Procedures (Cont.) • Auditor Seeks Documented Evidence of ISO System Implementation • Implementation Verified • Issuance of the ISO Registration Certificate • Mandatory Annual Renewals ----audit Phase--

  10. Milestone Time Line - Zero to Registration Assessment & Implementation Generate Documented Evidence Audit & Registration May June July August September October November

  11. System Benefits & Cost Benefits - Streamlines Company Operations - Reduces All Operating Costs - Ease of Training New Employees in Dept. Procedures - Improves Customer Service & Increases Repeat Orders - Presents New Marketing Opportunities - Higher Company Value – Management Succession or Sale - Improves Financial Performance and Profits Study of 750 companies, after 3 yrs – - Sales up 7-12% - Study: 99% degree of certainty - Profits up 12-55% - Cost of sales down 2-5% Cost of ISO … Based on type & size of company

  12. Power of the Pyramid Quality Manual ------------------ 1 Procedure Manual -------------- 2 Forms ---------------------------- 3 Work Instructions -------------- 4

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