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Copyright: Quality Institute of America 1 QUALITY INSTITUTE OF AMERICA, Inc. PROFESSIONAL SERVICES IN ISO 9000 and QS 9000 QUALITY MANAGEMENT TRAINING.

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Presentation on theme: "Copyright: Quality Institute of America 1 QUALITY INSTITUTE OF AMERICA, Inc. PROFESSIONAL SERVICES IN ISO 9000 and QS 9000 QUALITY MANAGEMENT TRAINING."— Presentation transcript:

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2 Copyright: Quality Institute of America 1 QUALITY INSTITUTE OF AMERICA, Inc. PROFESSIONAL SERVICES IN ISO 9000 and QS 9000 QUALITY MANAGEMENT TRAINING CONSULTING AUDITING

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

4 Copyright: Quality Institute of America 3 OFFICES PARTNERING OFFICE TETRAHEDRON, INC KEY HIGHWAY SUITE c BALTIMORE, MD (USA) PARTNERING OFFICE CM, INC JOHN STREET SUITE 19 MARKHAM, ONTARIO (CANADA) BRANCH OFFICE 18A, ROAD 18 BANANI, DHAKA (BANGLADESH) CORPORATE OFFICE 8951 Ruthby St. SUITE 12 HOUSTON, TX (USA)

5 Copyright: Quality Institute of America(SOURCE :McGraw Hill) 4 GROWTH OF ISO9000 IN NORTH AMERICA

6 Copyright: Quality Institute of America(SOURCE: McGraw Hill) 5 SAVINGS TO COSTS RATIOS

7 Copyright: Quality Institute of America (SOURCE: McGraw Hill) 6 SYSTEM GOODNESS & SAVINGS-TO-COSTS RATIO

8 Copyright: Quality Institute of America 7 WHAT IS ISO 9000? THE STORY OF SMITHY-- THE VILLAGE BLACKSMITH E- MAIL E- MAIL US FOR THE STORY. SEE HOW SUPERIOR BUSINESSES WORLD WIDE HAVE USED THE PRINNCIPLES OF ISO 9000 THROUGHOUT HISTORY.

9 Copyright: Quality Institute of America 8 Resource Management Measurement, analysis, improvement Product Realization Management Responsibility CONTINUAL IMPROVEMENTOF THE QUALITY MANAGEMENT SYSTEM INPUT Product Model of the process approach Customers (and other Interested Parties) Requirements OUTPUT Customers (and other Interested Parties) Satisfaction Value-adding activities Information flow

10 Copyright: Quality Institute of America 9 EXPLODE THE MYTH! SAY WHAT YOU DO DO WHAT YOU SAY This catchy slogan can cause a lot of headaches. us, we will tell how not to fall into traps that this very popular slogan can spring on you.

11 Copyright: Quality Institute of America 10 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. ESSENCE OF AN ISO 9000 SYSTEM Act Plan Do Check

12 Copyright: Quality Institute of America 11 PDCA Cycle Plan Do Check Act Possible Changes Improvement

13 Copyright: Quality Institute of America 12 HOW TO ACHIEVE QUALITY 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. CLASSICAL APPROACH---- INSPECT IT IN, BY REMOVING DEFECTS.

14 Copyright: Quality Institute of America 13 Increased productivity Quality Conformance to requirements Meets customer expectations Exceeds customer expectations Superiority to competitors Reduced rework/repair Reduced costs Avoids customer dissatisfaction Reduced returns, complaints, warranty Customer satisfaction Reputation Increased market Premium prices Increased profit Theoretical framework relating quality and performance

15 Copyright: Quality Institute of America 14 Lost Opportunity Scrap Rework Inspection Warranty Rejects Lost sales Late delivery Engineering change orders Long cycle times Expediting costs Excess inventory The Cost of Poor Quality (COPQ) Iceberg Traditional Quality Costs Additional Costs of Poor Quality (intangible) (tangible) 4-8% 25-35% (Easily Identified) (Difficult or impossible to measure) Lost Customer Loyalty More Setups

16 Copyright: Quality Institute of America 15 EVOLUTION OF ISO 9000 INDUSTRIAL REVOLUTION--VOLUME PRODUCTION-- NEED FOR CONFORMITY--SORT GOOD FROM BAD WORLD WAR-- NEED FOR INTERCHANGEABILITY-- INSPECTION INADEQUATE MIL-I MIL-Q-9858

17 Copyright: Quality Institute of America 16 EVOLUTION OF ISO 9000 ADOPTED BY NATO AS AQAP-1 (1968) UK DEFENSE STANDARDS ( ) UK BS EVAL OF QA SYST UK BS TC 176: ISO ISO , UPDATED 1994 ISO 9000, December 2000

18 Copyright: Quality Institute of America 17 THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ANSI: American National Standards Institute. Approximately 90 members in good standing. USA Bangladesh ANSI BSTI CanadaCSA PakistanPSI UKBSI

19 Copyright: Quality Institute of America 18 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.

20 Copyright: Quality Institute of America 19 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)

21 Copyright: Quality Institute of America 20 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

22 Copyright: Quality Institute of America 21 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

23 Copyright: Quality Institute of America 22 ISO 9000: DEFINITIONS QUALITY SYSTEM MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY WHAT WHO HOW WHERE WHEN

24 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

25 Copyright: Quality Institute of America 24 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.

26 Copyright: Quality Institute of America 25 ISO MAJOR CHANGES §Family of standards: l ISO 9000: Normative reference, provides fundamentals and terminology. l ISO 9001: Requirements, provides ability to demonstrate capability for quality. l ISO 9004: Guidelines for system, continual improvement- consistent pair l ISO 19011: Guidance on quality and environmental audits

27 Copyright: Quality Institute of America 26 ISO MAJOR CHANGES §Eliminated 9002, §Only 9001 with permissible exclusions in clause 7. §Eight clauses (No- not lesser total requirements) §Essentially five groups of requirements: l Quality System l Management Responsibility l Resources l Product Realization l Measurement, analysis, improvement

28 Copyright: Quality Institute of America 27 ISO 9000: Changes: No big deal, Registered companies had one year Changes: Big deal. Got 3 years. Should take time to do it right, do all the right things.

29 Copyright: Quality Institute of America 28 EIGHT MANAGEMENT PRINCIPLES Principle 1- Customer-Focused Organization Principle 2- Leadership Principle 3- Involvement of People Principle 4- Process Approach

30 Copyright: Quality Institute of America 29 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

31 Copyright: Quality Institute of America 30 FOUR MAIN GROUPS 1. Management Responsibility. 2. Resource Management. 3. Management of Process. 4. Measurement, Analysis and Improvement.

32 Copyright: Quality Institute of America 31 HIERARCHY OF DOCUMENTS POLICY PROCEDURES INSTRUCTIONS RECORDS/ FORMS

33 Copyright: Quality Institute of America 32 POLICY WHAT THE COMPANY WANTS EMPLOYEES TO DO TOP LEVEL : COMPANY WANTS EVERYONE TO FOLLOW ISO 9001

34 Copyright: Quality Institute of America 33 PROCEDURES HOW DOES THE COMPANY WANT TO ACHIEVE ITS POLICY TO FULFILL THE VARIOUS REQUIREMENTS OF ISO 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 SEVERAL PROCEDURES MAY BE NECESSARY TO COMPLY WITH A PARTICULAR CLAUSE OF THE STANDARD.

35 Copyright: Quality Institute of America 34 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

36 Copyright: Quality Institute of America 35 ISO 9000: IMPLEMENTATION ORGANIZATIONAL CHECKPOINTS: Executive Steering Committee Executive Champion Project Team Project Leader Task Teams Consultants

37 Copyright: Quality Institute of America 36 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

38 Copyright: Quality Institute of America 37 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


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