ISO 9000 Overview
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Transcript of ISO 9000 Overview
![Page 1: ISO 9000 Overview](https://reader033.fdocuments.us/reader033/viewer/2022061503/568136f1550346895d9e864f/html5/thumbnails/1.jpg)
ISO 9000 OverviewISO 9000 Overview
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The Purpose of this OverviewThe Purpose of this Overview
“What is ISO 9000?” What will it require from YOU, as a (Company)
Employee?
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Things You Should KnowThings 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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What is ISO?What is ISO?
International Organization for Standardization
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Development of Quality Development of Quality StandardsStandards
Prior to WWII, Quality Standards were driven by the Military
Britain used the ‘BS’ Standards United States used the ‘MIL’ Standards
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Development of Quality Development of Quality StandardsStandards
Europe- Government Driven BS-5750, EN 29000
USA- Quality DrivenFord’s Q1GM’s Targets for Excellence
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ISO 9000 Quality Management ISO 9000 Quality Management StandardStandard
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
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ISO 9000 Quality Management ISO 9000 Quality Management StandardStandard ISO 9000 ISO 9001 ISO 9002 ISO 9003 ISO 9004
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Elements of ISO 9002Elements 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
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Elements of ISO 9002Elements 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
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Elements of ISO 9002Elements 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
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3 Major Requirements for ISO 3 Major Requirements for ISO 9000 Certification9000 Certification
A standard system for documenting qualitypractices (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
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Types of ISO 9000 AuditsTypes of ISO 9000 Audits
Gap Analysis Self Certification Audit Registration Audit
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Self Certification AuditSelf Certification Audit
Perform Gap Analysis Action Plan Developed from Gap Analysis Action Plan Implemented Perform Internal Audit Corrective Action Perform Self Certification Audit
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Registration AuditRegistration 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
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Audit ResultsAudit 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
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Types of NonconformitiesTypes of Nonconformities
Major Nonconformity: Absence of a requiredprocedure or the total breakdown of a
procedure
Minor Nonconformity: Single observed lapse in a procedure
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Registration CycleRegistration 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
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Your Role During the AuditYour Role During the Audit
Know the Quality Policy- “To produce the highest quality 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 your job?” the answer is- “Through Training”
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Know the Plant’s Management Know the Plant’s Management Representative(s)!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.
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Management RepresentativesManagement Representatives
Typically, each major area will have a representative
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ISO 9000ISO 9000Documentation StructureDocumentation Structure
L ev e l 4Q u a li ty D o cu m en ts - F orm s,
R e po r ts ( ILU s)
L ev e l 3W o rk In stru ctio ns
L ev e l 2Q u a li ty S ys tem P ro ce d ures
L ev e l 1Q ua li ty M a nu a l
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ISO 9000 is not ISO 14000ISO 9000 is not ISO 14000
Both standards written by the same organization* ISO 9000: Quality Management
Standard* ISO 14000:
Environmental Management Standard
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ISO 9000 Quick DefinitionISO 9000 Quick Definition
Document what you do
(Quality Manual)
Do what you Document (Audits)
Prove it!
(Records)