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ISO 9000 Overview

ISO 9000 Overview. The Purpose of this Overview. “What is ISO 9000?” What will it require from YOU , as a (Company) Employee?. Things You Should Know. Corporate Objective How do you know how to do your job? What do you do if you find a defect? Are there written instructions for your job?.

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ISO 9000 Overview

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  1. ISO 9000 Overview

  2. The Purpose of this Overview • “What is ISO 9000?” • What will it require from YOU, as a (Company) Employee?

  3. Things You Should Know • Corporate Objective • How do you know how to do your job? • What do you do if you find a defect? • Are there written instructions for your job?

  4. What is ISO? • International Organization for Standardization

  5. Development of Quality Standards • Prior to WWII, Quality Standards were driven by the Military • Britain used the ‘BS’ Standards • United States used the ‘MIL’ Standards

  6. Development of Quality Standards • Europe- Government Driven BS-5750, EN 29000 • USA- Quality Driven Ford’s Q1 GM’s Targets for Excellence

  7. ISO 9000 Quality Management Standard • Adopted 1987; current version is 1994 • Practical collection of well recognized and universal business practices • Applies to any type of facility • Emphasizes the system a facility uses to assure quality

  8. ISO 9000 Quality Management Standard • ISO 9000 • ISO 9001 • ISO 9002 • ISO 9003 • ISO 9004

  9. Elements of ISO 9002 • 4.1 Management Responsibility • 4.2 Quality System • 4.3 Contract Review • 4.4 Design Control • 4.5 Document and Data Control • 4.6 Purchasing • 4.7 Control of Customer Supplied Product

  10. Elements of ISO 9002 • 4.8 Product Identification and Traceability • 4.9 Process Control • 4.10 Inspection and Testing • 4.11 Control of Inspection,Measuring, and Test Equipment • 4.12 Inspection and Test Status • 4.13 Control of Nonconforming Product

  11. Elements of ISO 9002 • 4.14 Corrective and Preventive Action • 4.15 Handling, Storage, Packaging, Preservation, and Delivery • 4.16 Control of Quality Records • 4.17 Internal Quality Audits • 4.18 Training • 4.19 Servicing • 4.20 Statistical Techniques

  12. 3 Major Requirements for ISO 9000 Certification • A standard system for documenting quality practices (i.e. a Quality Manual) • A system to track that the quality practices are in place and effective (Audits) • A third party (Registrar), whose function is to audit, certify and maintain certifications of organizations

  13. Types of ISO 9000 Audits • Gap Analysis • Self Certification Audit • Registration Audit

  14. Self Certification Audit • Perform Gap Analysis • Action Plan Developed from Gap Analysis • Action Plan Implemented • Perform Internal Audit • Corrective Action • Perform Self Certification Audit

  15. Registration Audit • Select Registrar • Registrar performs Gap Analysis • Action Plan developed from Gap Analysis • Action Plan implemented • Perform Internal Audit • Corrective Action • Registrar performs Registration Audit • Registration complete or corrective action

  16. Audit Results • Observation: Statement of fact made during a quality audit and substantiated through objective evidence • Conforming: Meets the intent of the standard • Nonconforming: Non-fulfillment of a specified requirement

  17. Types of Nonconformities • Major Nonconformity: Absence of a required procedure or the total breakdown of a procedure • Minor Nonconformity: Single observed lapse in a procedure

  18. Registration Cycle • Registration is valid for three years • Surveillance Audits (Maintenance Audits) * Mini Audit; covers only a portion of the Registration Audit * Required to be conducted at a minimum, annually

  19. Your Role During the Audit • Know the Quality Policy- “To produce the highestquality widget sold in North America” • When asked “Who is responsible for Quality?” the answer is- “Everyone” • If asked “How do you know how to do yourjob?” the answer is- “Through Training”

  20. Know the Plant’s Management Representative(s)! • They are the key contact for the ISO 9000 program; they are responsible for your plant’s Quality Manual; they will notify your Area Manager of upcoming audits.

  21. Management Representatives • Typically, each major area will have a representative

  22. ISO 9000Documentation Structure

  23. ISO 9000 is not ISO 14000 • Both standards written by the same organization * ISO 9000: Quality Management Standard * ISO 14000: Environmental Management Standard

  24. ISO 9000 Quick Definition Document what you do (Quality Manual) Do what you Document (Audits) Prove it! (Records)

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