Slide 1IntroductionISO RegistrationInternal Reasons for Becoming ISO RegisteredNegativesISO 9000Sector-specific StandardsAS9100ISO/TS 16949TL9000TL 9000 continued-ISO 9001 REQUIREMENTSSlide 132. Normative Reference: Fundamentals and vocabularySlide 15Slide 16Slide 17Slide 18Slide 19IMPLEMENTATIONDOCUMENTATIONPOLICY:PROCEDURE:WORK INSTRUCTIONS:RECORDS:DOCUMENT DEVELOPMENT:WRITING THE DOCUMENTSINTERNAL AUDITSAUDITOR:TECHNIQUES:Examination of Documents:PROCEDURE:REGISTRATIONSELECTING A REGISTRARREGISTRATION PROCESSCLOSING COMMENTSQuality Management SystemsChapter 10Introduction•ISO- International Organization for Standardization•Founded in 1946, in Geneva, Switzerland •Main function is to promote the development of standardization of goods and services, to better accommodate a world wide market.•ANSI- American National Standards Institute•ANSI represents U.S. in the ISOISO Registration•Companies can become registered as an ISO company•This involves the registrar giving an assessment of the operations a company, and then making periodic surveillance audits•Primary Reason: To give your customer the comfort of knowing that you have a quality plan in place, and it is being monitored by an objective third partyInternal Reasons for Becoming ISO Registered•100 Italian manufacturing firms were surveyed to find out what improved after certification.–Internal quality: less scrap, rework, nonconformities–Production reliability: less breakdowns, less time with emergencies, downtime–Time performance: time to market, punctual deliveriesExternally: less nonconformitiesNegatives•Prevention and appraisal costs increased–Only one negative shown in 100 surveys.–Positives outweigh negatives–Takes time to implement, but worth it in the long runISO 9000•The ISO 9000 series of standards is generic•It is designed to adapt to fit any industry type•Three standards of the 9000 series:–ISO 9000:2000- Fundamentals and vocabulary–ISO 9001:2000- Requirements–ISO 9004:2000- Guidelines for performance improvementsSector-specific Standards•Some industries require special set of ISO rules; not operated the same as most•Three other quality systems:–AS9100-–ISO/TS 16949–TL9000AS9100•This standard is specifically for the aerospace industry•Attempt at unifying the requirements of NASA, DOD, and FAA•At the same time satisfying the industry’s needsISO/TS 16949•Standard specifically for automotive suppliers•Merges supplier quality requirements of U.S. with German, French, and Italian automakers•Goal- provide continuous improvement, defect prevention, reduce variation and waste•Is assumed that this standard will show 85% improvement rate in first 5 yearsTL9000•Telecommunications Industry•Consolidate various quality systems requirements•Defines design, development, production, delivery, installation and maintenance of telecommunications•Customers receive benefits , worldwide competition, benchmarks, improvement initiativesTL 9000 continued-•This standard focused on:–Hardware Specific Requirements and Measures–Software Specific Requirements and Measures–Services Specific Requirements and MeasuresISO 9001 REQUIREMENTS•The standard has 8 clauses1) Scope2) Normative Reference3) Terms and Definitions4) Quality Management Systems5) Management Responsibility6) Resource Management7) Product Realization8) Measurement Analysis and Improvement1. Scope To provide a product that meetsa) Customer Requirementb) Regulatory Requirementsc) Customers Satisfaction2. Normative Reference: Fundamentals and vocabulary3. Terms and Definitions: Supplier Organization Customers4. Quality Management System: a) General Requirements b) Documentation * General Documentation * Quality Manual * Control of Documents * Control of Records5) Management Responsibility: a) Management commitment b) Customer Focus c) Quality policy d)Planning * Quality Objectives * Quality Management System Planning e) Responsibility, Authority, And Communication * Responsibility and Authority * Management Representative * Internal Communication f) Management Review * General Management * Review Input * Review Output6) Resource Management : a) Provision of Resources b) Human Resources * General * Competence, Awareness and Training c) Infrastructure d) Work Environment7) Product Realization a) Planning of product Realization b) Customer Related Processes * Determination Of Requirement Related to the Product * Review Of Requirement Related to the Product *Customer Communication c) Design And Development * Design And Development Planning * Design And Development Inputs * Design And Development Outputs * Design And Development Review * Design And Development Verification * Design And Development Validation * Control of Design And Development Changesd) Purchasing * Purchasing Process * Purchasing Information * Verification Of Purchased Product e)Production And service Provision * Control Of Production And service Provision * Validation Of Processes For Production And service Provision *Identification And Traceability * Customer Property * Preservation of Productf) Control Of Monitoring And Measuring Devices8) Measurement , Analysis, And Improvement a) General b) Monitoring And Measurement * Customer Satisfaction * Internal Audit * Monitoring And Measurement Of Processes * Monitoring And Measurement of Product and Service c) Control Of Nonconforming Product d) Analysis Of Data e) Improvement * continual improvement * corrective Action * preventive ActionIMPLEMENTATION1) Top Management Commitment2) Appoint the Management Representative3) Awareness4) Appoint an Implementation Team5) Training6) Time Schedule7) Select Element Owners8) Review the Present System9) Write the Documents10) Install the New System11) Internal Audit12) Management Review13) Preassessment14) RegistrationDOCUMENTATIONpolicyproceduresWork instructions or practicesRecords or proofStates Policy and Objectives for each ofthe pertinent ISO elementsDepartmental Procedures & responsibilitiesForms, Work Instructions & Equipment InstructionsBusiness supporting
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