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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

ISO 9001:2008 QUALITY MANAGEMENT SYSTEM

William Seethaler, Area ManagerNorthern California & Northwestern StatesIMSM Ltd.Malmesbury, England

seminar outline
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
history of iso
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“
history of iso cont
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
current status
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)
slide6

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

system components
System Components
  • Quality Manual – by IMSM
  • Procedure Manual – by IMSM
  • Forms – by Client/IMSM
  • Work Instructions– by Client
registration procedures
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-----

registration procedures cont
Registration Procedures (Cont.)
  • Auditor Seeks Documented Evidence of ISO System Implementation
  • Implementation Verified
  • Issuance of the ISO Registration Certificate
  • Mandatory Annual Renewals

----audit Phase--

time line zero to registration

Milestone

Time Line - Zero to Registration

Assessment & Implementation

Generate Documented Evidence

Audit & Registration

May

June

July

August

September

October

November

system benefits cost
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

power of the pyramid
Power of the Pyramid

Quality Manual ------------------ 1

Procedure Manual -------------- 2

Forms ---------------------------- 3

Work Instructions -------------- 4