Copyright: Quality Institute of America 1 QUALITY INSTITUTE OF AMERICA, Inc. PROFESSIONAL SERVICES...

Copyright: Quality Institute of America

QUALITY INSTITUTE OF QUALITY INSTITUTE OF AMERICA, Inc.AMERICA, Inc.

PROFESSIONAL SERVICES IN ISO 9000 and QS 9000

QUALITY MANAGEMENT

•TRAINING•CONSULTING

•AUDITING

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

OFFICES

PARTNERING OFFICETETRAHEDRON, INC.1414 KEY HIGHWAY

SUITE cBALTIMORE, MD 21230

PARTNERING OFFICECM, INC.

2800 JOHN STREETSUITE 19

MARKHAM, ONTARIO(CANADA)

BRANCH OFFICE

18A, ROAD 18BANANI, DHAKA

(BANGLADESH)

CORPORATE OFFICE8951 Ruthby St.

SUITE 12HOUSTON, TX 77061

Copyright: Quality Institute of America(SOURCE :McGraw Hill)

GROWTH OF ISO9000 IN NORTH AMERICA

92 93 94 95 96 97 98 99 00 01

Growth Of ISO 9000 in North America

# of Registration

Copyright: Quality Institute of America(SOURCE: McGraw Hill)

SAVINGS TO COSTS RATIOS

020406080

100120

93 96 99

Saving to Costs Ratio

Total saving Total cost

Copyright: Quality Institute of America (SOURCE: McGraw Hill)

SYSTEM GOODNESS & SAVINGS-TO-COSTS RATIO

Poor Good VeryGood

System Goodness & Saving-to-costs Ratio

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.

Resource Management

Measurement,analysis,

improvement

ProductRealization

ManagementResponsibility

CONTINUAL IMPROVEMENTOF THEQUALITY MANAGEMENT SYSTEM

INPUTProduct

Model of the process approach

Customers(and other Interested Parties)

RequirementsOUTPUT

Customers(and other Interested Parties)

Satisfaction

Value-adding activities

Information flow

EXPLODE THE MYTH!

SAY WHAT YOU DODO 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.

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

DoCheck

PDCA Cycle

Possible Changes

Improvement

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.

Increasedproductivity

Quality

Conformanceto

requirements

Meets customer

expectations

Exceedscustomer

expectations

Superiorityto

competitors

Reducedrework/repair

Reducedcosts

Avoidscustomer

dissatisfaction

Reduced returns,

complaints,warranty

Customersatisfaction

Reputation

Increasedmarket

Premiumprices

Increasedprofit

Theoretical framework relating quality and performance

Lost Opportunity

Rework

Inspection

WarrantyRejects

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)

25-35%

(Easily Identified)

(Difficult or impossible to measure)

Lost Customer LoyaltyMore Setups

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

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

THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

ANSI: American National Standards Institute.Approximately 90 members in good standing.

Bangladesh

Canada CSA

PakistanPSI

ISO STANDARDS GENERATION PROCESS

Working Group Draft (WD) sent toRelevant SubcommitteeElevated to Committee DraftSent 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.

ISO STANDARDS GENERATION PROCESS

Draft International Standardonce subcommittee satisfied w/ CDelevated to DIS status.sent to all national standards bodiesmore improvements may be necessary if positive ballots do not exceed 67% or negative ballots exceed 25%.

Release as an international standardusually accepted as a national standard and published as such. (example: Q9001)

ISO 9000: DEFINITIONSQUALITY

DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS

FITNESS FOR PURPOSEMEET REQUIREMENTSDELIGHTING CUSTOMERSRIGHT FIRST TIME ALL THE TIME

ISO 9000: DEFINITIONSQUALITY MANAGEMENT

COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY

STRATEGIC PLANNINGPOLICY /MISSION DEFINITIONEXECUTION OF POLICYIMPLEMENTATION

ISO 9000: DEFINITIONSQUALITY SYSTEM

MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY

WHAT WHOHOWWHEREWHEN

03-00 Copyright: Quality Institute of America

ISO 9000: AN OVERVIEWTHE 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”

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.

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

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

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.

EIGHT MANAGEMENT PRINCIPLES

Principle 1- Customer-Focused Organization

Principle 2- Leadership

Principle 3- Involvement of People

Principle 4- Process Approach

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

FOUR MAIN GROUPS

1. Management Responsibility.

2. Resource Management.

3. Management of Process.

4. Measurement, Analysis and Improvement.

HIERARCHY OF DOCUMENTS

POLICY

PROCEDURES

INSTRUCTIONS

RECORDS/ FORMS

POLICY

WHAT THE COMPANY WANTS EMPLOYEES TO DOTOP LEVEL : COMPANY WANTS EVERYONE TO FOLLOW ISO 9001

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.

WORK INSTRUCTION

A WRITTEN STATEMENT OF HOW AN ACTIVITY IS TO BE PERFORMED (USUALLY) BY A PERSONAN INSTRUCTION SUPPORTS A PROCEDURE: SEVERAL INSTRUCTIONS MAY BE NECESSARY TO SUPPORT A PROCEDUREAN INSTRUCTION IS NECESSARY WHERE THE ABSENCE OF THE INSTRUCTION WOULD ADVERSELY AFFECT THE OBJECTIVE OF THE PROCEDURE THAT THE INSTRUCTION SUPPORTS

ISO 9000: IMPLEMENTATION

ORGANIZATIONAL CHECKPOINTS:

Executive Steering CommitteeExecutive ChampionProject TeamProject LeaderTask TeamsConsultants

IMPLEMENTATION CHECKPOINTS:Design Structure of SystemDesign Document Control SystemIdentify Procedures and InstructionsCreate Procedures and InstructionsImplement Procedures and InstructionsTraining in Internal Audits

IMPLEMENTATION CHECKPOINTSUse Internal Audits in detecting system inadequaciesTake Corrective ActionsSelect RegistrarPre- assessment (optional, by registrar-- somewhat discouraged by RAB)

Registration AuditCelebrateSurveillance (by Registrar)Triennial Recertification

Copyright: Quality Institute of America 1 QUALITY INSTITUTE OF AMERICA, Inc. PROFESSIONAL SERVICES...

Documents

ISO 9000 series QFD: Quality Function Deployment

024 ISO 9000 Quality Systems - hrodc.com

17831742 Understanding Iso 9000 Quality Management System

Supplier Quality Assurance Requirements 9000

Chapter Three ISO 9000:2000 Quality Management System

TACKLING ISO 9000 DOCUMENTATION - OCSTCocstc.org/ana_conf/pdf/pc3_a.pdfISO 9000 SERIES OF STANDARDS Additional Guidelines – ISO 9004-2 - Quality Management and Quality System Elements

Perceptions About The ISO 9000 (2000) Quality System

UNDERSTANDING - ISO 9000 QUALITY MANAGEMENT SYSTEM

IS/ISO 9000 (2005): Quality Management systems - Fundamentals

BQ-9000 Quality Management System Laboratory Requirements

Quality Management in Reference with ISO 9000 in

Questions and answers on quality, the ISO 9000 standard

The ISO 9000 Standards for Quality Management Systems

Internal quality mgmt system audit checklist (iso 9000 2000)

AG 9000: Quality Management System for Grain Production

ECONOMIC COMMISSION FOR LATIN AMERICA AND THE … · services and cost reductions. An example of these quality management techniques is the ISO 9000 standards on quality management

ISO 9000 AND TOTAL QUALITY MANAGEMENT: THE RELATIONSHIP

Project Quality Management. Quality Certification (PMP is an ISO 9000 certified credential) ISO 9000: 2005 Quality Principles: Quality Principles:

BQ-9000 Quality Management System Laboratory Requirementsbq-9000.org/documents/Lab Req Rev B Final.pdf · BQ-9000 Quality Management System Laboratory Requirements Revision B Effective

Accepting Supplier ISO 9000 Quality Programs