QUALITY INSTITUTE OF AMERICA, Inc. PROFESSIONAL SERVICES IN ISO 9000 and QS 9000 QUALITY MANAGEMENT TRAINING CONSULTING AUDITING Copyright: Quality Institute of America

ISO 9000- 2008: Executive Briefing AGENDA: Why ISO 9000? Value of Quality Need for Quality Management System (QMS) Historical evolution Requirements of ISO 9k-2k Documenting and Implementing a QMS Using professional assistance Copyright: Quality Institute of America

Copyright: Quality Institute of America OFFICES PARTNERING OFFICE TETRAHEDRON, INC. 1414 KEY HIGHWAY SUITE c BALTIMORE, MD 21230 (USA) CM, INC. 2800 JOHN STREET SUITE 19 MARKHAM, ONTARIO (CANADA) BRANCH OFFICE 18A, ROAD 18 BANANI, DHAKA (BANGLADESH) CORPORATE OFFICE 8951 Ruthby St. SUITE 12 HOUSTON, TX 77061 Copyright: Quality Institute of America

GROWTH OF ISO9000 IN NORTH AMERICA Copyright: Quality Institute of America(SOURCE :McGraw Hill)

SAVINGS TO COSTS RATIOS Copyright: Quality Institute of America(SOURCE: McGraw Hill)

SYSTEM GOODNESS & SAVINGS-TO-COSTS RATIO Copyright: Quality Institute of America (SOURCE: McGraw Hill)

WHAT IS ISO 9000? THE STORY OF SMITHY-- THE VILLAGE BLACKSMITH E- MAIL US FOR THE STORY. SEE HOW SUPERIOR BUSINESSES WORLD WIDE HAVE USED THE PRINNCIPLES OF ISO 9000 THROUGHOUT HISTORY. Copyright: Quality Institute of America

CONTINUAL IMPROVEMENTOF THE QUALITY MANAGEMENT SYSTEM Customers (and other Interested Parties) Customers (and other Interested Parties) Management Responsibility Measurement, analysis, improvement Satisfaction Resource Management Requirements Product Realization OUTPUT INPUT Product Value-adding activities Model of the process approach Information flow Copyright: Quality Institute of America

Copyright: Quality Institute of America EXPLODE THE MYTH! SAY WHAT YOU DO DO WHAT YOU SAY This catchy slogan can cause a lot of headaches. E-mail us, we will tell how not to fall into traps that this very popular slogan can spring on you. Copyright: Quality Institute of America

Copyright: Quality Institute of America ESSENCE OF AN ISO 9000 SYSTEM The PDCA cycle is a trial and learning event that emphasizes learning by sequentially testing changes on a small scale. This is the essence of ISO 9001:2008. Act Plan Check Do Copyright: Quality Institute of America

Copyright: Quality Institute of America PDCA Cycle Improvement Act Plan Check Do Possible Changes Copyright: Quality Institute of America

Copyright: Quality Institute of America HOW TO ACHIEVE QUALITY CLASSICAL APPROACH---- INSPECT IT IN, BY REMOVING DEFECTS. TODAY'S APPROACH--- BUILD IT IN THE PROCESS(ES) THAT CREATE PRODUCT AND SERVICES---DEFECT PREVENTION AND CONTINUOUS PROCESS IMPROVEMENT: “VARIABILITY REDUCTION” CLASSICAL APPROACH---- INSPECT IT IN, BY REMOVING DEFECTS. Copyright: Quality Institute of America

Copyright: Quality Institute of America Theoretical framework relating quality and performance Quality Conformance to requirements Meets customer expectations Exceeds customer expectations Superiority to competitors Avoids customer dissatisfaction Reduced rework/repair Reputation Reduced returns, complaints, warranty Increased productivity Customer satisfaction Reduced costs Increased market Premium prices Increased profit Copyright: Quality Institute of America

Copyright: Quality Institute of America The Cost of Poor Quality (COPQ) “Iceberg” Traditional Quality Costs Inspection (Easily Identified) 4-8% Scrap Warranty Rework Rejects (tangible) Engineering change orders Lost sales Additional Costs of Poor Quality 25-35% (Difficult or impossible to measure) Long cycle times Late delivery (intangible) More Setups Lost Customer Loyalty Lost Opportunity Expediting costs Excess inventory Copyright: Quality Institute of America

Copyright: Quality Institute of America EVOLUTION OF ISO 9000 INDUSTRIAL REVOLUTION--VOLUME PRODUCTION-- NEED FOR CONFORMITY--SORT GOOD FROM BAD WORLD WAR-- NEED FOR INTERCHANGEABILITY-- INSPECTION INADEQUATE MIL-I-45208---MIL-Q-9858 Copyright: Quality Institute of America

Copyright: Quality Institute of America EVOLUTION OF ISO 9000 ADOPTED BY NATO AS AQAP-1 (1968) UK DEFENSE STANDARDS (1970-73) UK BS 5179 1974--EVAL OF QA SYST UK BS 5750--1979 TC 176: ISO--1983 ISO 9000---1987, UPDATED 1994 ISO 9000, December 2000 Copyright: Quality Institute of America

THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ANSI: American National Standards Institute. Approximately 90 members in good standing. USA ANSI Bangladesh BSTI PSI Pakistan BSI UK Canada CSA Copyright: Quality Institute of America

ISO STANDARDS GENERATION PROCESS Working Group Draft (WD) sent to Relevant Subcommittee Elevated to Committee Draft Sent for Balloting to member countries: approved as is, Disapproved (Reasons required), Approved with comments. Typically, series of improving versions are balloted until CD is accepted. Copyright: Quality Institute of America

ISO STANDARDS GENERATION PROCESS Draft International Standard once subcommittee satisfied w/ CD elevated to DIS status. sent to all national standards bodies more improvements may be necessary if positive ballots do not exceed 67% or negative ballots exceed 25%. Release as an international standard usually accepted as a national standard and published as such. (example: Q9001) Copyright: Quality Institute of America

ISO 9000: DEFINITIONS QUALITY DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS FITNESS FOR PURPOSE MEET REQUIREMENTS DELIGHTING CUSTOMERS RIGHT FIRST TIME ALL THE TIME Copyright: Quality Institute of America

ISO 9000: DEFINITIONS QUALITY MANAGEMENT COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY STRATEGIC PLANNING POLICY /MISSION DEFINITION EXECUTION OF POLICY IMPLEMENTATION Copyright: Quality Institute of America

ISO 9000: DEFINITIONS QUALITY SYSTEM MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY WHAT WHO HOW WHERE WHEN Copyright: Quality Institute of America

ISO 9000: AN OVERVIEW THE 1994 STANDARDS ISO 9001: “Quality Systems- Model for QA in Design, Development, Production, Installation, and Servicing” ISO 9002: “ --Model for QA in Production, Installation, and Servicing” ISO 9003: “--in Final Inspection and Test”

Copyright: Quality Institute of America ISO 9001: DEFINITIONS PRODUCT: Result of activities or processes-- may include service, hardware, software, processed materials or a combination thereof-- intended product offering only, not to unintended by-products. TENDER: Offer made by a supplier in response to an invitation to satisfy a contract award to provide a product. CONTRACT: Agreed requirements between a supplier and customer transmitted by any means. Copyright: Quality Institute of America

Copyright: Quality Institute of America ISO 9000-2000 MAJOR CHANGES Family of standards: ISO 9000: Normative reference, provides fundamentals and terminology. ISO 9001: Requirements, provides ability to demonstrate capability for quality. ISO 9004: Guidelines for system, continual improvement- ‘consistent pair’ ISO 19011: Guidance on quality and environmental audits Copyright: Quality Institute of America

Copyright: Quality Institute of America ISO 9000-2000 MAJOR CHANGES Eliminated 9002, 9003. Only 9001 with permissible exclusions in clause 7. Eight clauses (No- not lesser total requirements) Essentially five groups of requirements: Quality System Management Responsibility Resources Product Realization Measurement, analysis, improvement Copyright: Quality Institute of America

Copyright: Quality Institute of America ISO 9000: 2000 1994 Changes: No big deal, Registered companies had one year. 2000 Changes: Big deal. Got 3 years. Should take time to do it right, do all the right things. Copyright: Quality Institute of America

Copyright: Quality Institute of America EIGHT MANAGEMENT PRINCIPLES Principle 1- Customer-Focused Organization Principle 2- Leadership Principle 3- Involvement of People Principle 4- Process Approach Copyright: Quality Institute of America

EIGHT MANAGEMENT PRINCIPLES (contd.) Principle 5- System Approach to Management Principle 6- Continual Improvement Principle 7- Factual approach to decision making Principle 8- Mutually beneficial supplier relationships Copyright: Quality Institute of America

Copyright: Quality Institute of America FOUR MAIN GROUPS 1. Management Responsibility. 2. Resource Management. 3. Management of Process. 4. Measurement, Analysis and Improvement. Copyright: Quality Institute of America

Copyright: Quality Institute of America HIERARCHY OF DOCUMENTS POLICY PROCEDURES INSTRUCTIONS RECORDS/ FORMS Copyright: Quality Institute of America

Copyright: Quality Institute of America POLICY WHAT THE COMPANY WANTS EMPLOYEES TO DO TOP LEVEL : COMPANY WANTS EVERYONE TO FOLLOW ISO 9001 Copyright: Quality Institute of America

Copyright: Quality Institute of America PROCEDURES HOW DOES THE COMPANY WANT TO ACHIEVE ITS POLICY TO FULFILL THE VARIOUS REQUIREMENTS OF ISO 9001. PROCEDURES ARE MANDATORY. A WRITTEN STATEMENT OF RESPONSIBILITIES AND THE ORGANIZED SEQUENCE OF ACTIONS WHICH COLLECTIVELY FULFILL A PARTICULAR FUNCTION, AND FULFILL THE REQUIREMENTS OF A PARTICULAR CLAUSE OF ISO 9001. SEVERAL PROCEDURES MAY BE NECESSARY TO COMPLY WITH A PARTICULAR CLAUSE OF THE STANDARD. Copyright: Quality Institute of America

Copyright: Quality Institute of America WORK INSTRUCTION A WRITTEN STATEMENT OF HOW AN ACTIVITY IS TO BE PERFORMED (USUALLY) BY A PERSON AN INSTRUCTION SUPPORTS A PROCEDURE: SEVERAL INSTRUCTIONS MAY BE NECESSARY TO SUPPORT A PROCEDURE AN INSTRUCTION IS NECESSARY WHERE THE ABSENCE OF THE INSTRUCTION WOULD ADVERSELY AFFECT THE OBJECTIVE OF THE PROCEDURE THAT THE INSTRUCTION SUPPORTS Copyright: Quality Institute of America

Copyright: Quality Institute of America ISO 9000: IMPLEMENTATION ORGANIZATIONAL CHECKPOINTS: Executive Steering Committee Executive Champion Project Team Project Leader Task Teams Consultants Copyright: Quality Institute of America

Copyright: Quality Institute of America ISO 9000: IMPLEMENTATION IMPLEMENTATION CHECKPOINTS: Design Structure of System Design Document Control System Identify Procedures and Instructions Create Procedures and Instructions Implement Procedures and Instructions Training in Internal Audits Copyright: Quality Institute of America

Copyright: Quality Institute of America ISO 9000: IMPLEMENTATION IMPLEMENTATION CHECKPOINTS Use Internal Audits in detecting system inadequacies Take Corrective Actions Select Registrar Pre- assessment (optional, by registrar-- somewhat discouraged by RAB) Registration Audit Celebrate Surveillance (by Registrar) Triennial Recertification Copyright: Quality Institute of America