QUALITY INSTITUTE OF 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
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OFFICES
CORPORATE OFFICE 8951 Ruthby St. SUITE 12 HOUSTON, TX 77061 (USA)

BRANCH OFFICE 18A, ROAD 18 BANANI, DHAKA (BANGLADESH) PARTNERING OFFICE CM, INC. 2800 JOHN STREET SUITE 19 MARKHAM, ONTARIO (CANADA)

PARTNERING OFFICE TETRAHEDRON, INC. 1414 KEY HIGHWAY SUITE c BALTIMORE, MD 21230 (USA)

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GROWTH OF ISO9000 IN NORTH AMERICA

Grow th Of ISO 9000 in North Am erica 60000

50000

40000

30000

# of Registration

20000

10000

0 92 93 94 95 96 97 98 99 00 01

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

SAVINGS TO COSTS RATIOS

Saving to Costs Ratio
120 100 80 60 40 20 0 93 96 Year Total saving Total cost 99

Ratios

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

SYSTEM GOODNESS & SAVINGS-TO-COSTS RATIO

System Goodness & Saving-to-costs Ratio

3
Ratios

2 1 0 Poor Good Very Good

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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)

Management Responsibility Measurement, analysis, improvement Product Realization OUTPUT Product

Customers (and other Interested Parties)

Resource Management Requirements

Satisfaction

INPUT
Value-adding activities

Information flow

Model of the process approach

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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.
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ESSENCE OF AN ISO 9000 SYSTEM

Act Plan

The PDCA cycle is a trial and learning event that emphasizes learning by sequentially testing changes on a small scale.

Check
Do

This is the essence of ISO 9001:2008.

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PDCA Cycle
Improvement

Act

Plan
Check Do

Possible Changes
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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.

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Theoretical framework relating quality and performance

Quality

Conformance to requirements

Meets customer expectations

Exceeds customer expectations

Superiority to competitors

Reduced rework/repair Reduced returns, complaints, warranty

Avoids customer dissatisfaction

Reputation

Increased productivity

Customer satisfaction

Reduced costs

Increased market

Premium prices

Increased profit 13

The Cost of Poor Quality (COPQ) Iceberg

Traditional Quality Costs

4-8%
Rejects

Inspection Warranty

(Easily Identified)
Scrap Rework

(tangible)
Engineering change orders Lost sales

Additional Costs of Poor Quality

(Difficult or impossible to measure)
Long cycle times More Setups Expediting costs

25-35%

(intangible)

Late delivery Lost Customer Loyalty

Lost Opportunity

Excess inventory

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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

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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

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THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

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

PSI

Pakistan

Bangladesh

BSTI

BSI

UK

Canada

CSA

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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.

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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)

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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

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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

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ISO 9000: DEFINITIONS QUALITY SYSTEM

MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY WHAT WHO HOW WHERE WHEN

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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

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

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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
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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
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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

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EIGHT MANAGEMENT PRINCIPLES

Principle 1- Customer-Focused Organization
Principle 2- Leadership Principle 3- Involvement of People Principle 4- Process Approach

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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

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FOUR MAIN GROUPS

1. Management Responsibility. 2. Resource Management. 3. Management of Process. 4. Measurement, Analysis and Improvement.
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HIERARCHY OF DOCUMENTS

POLICY

PROCEDURES
INSTRUCTIONS

RECORDS/ FORMS
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POLICY
WHAT THE COMPANY WANTS EMPLOYEES TO DO TOP LEVEL : COMPANY WANTS EVERYONE TO FOLLOW ISO 9001

Copyright: Quality Institute of America

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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

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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

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ISO 9000: IMPLEMENTATION

ORGANIZATIONAL CHECKPOINTS: Executive Steering Committee Executive Champion Project Team Project Leader Task Teams Consultants

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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

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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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