JAY ISO 9000

ISO 9000

Quality Management Systems

Jay shah2

Before

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EXPECTED QUALITY

by the Customer

PLANNED QUALITY

by the Company

PRODUCED QUALITY

by the Company

PERCEIVEDQUALITY

by the Customer

Measurement of the Performance of the Company

Measurement of theClient’s satisfaction

TQM CONCEPT

• Customer focus• Leadership• Empowerment• Process approach• Systemic approach• Continuous improvement• Decisions based on facts• Relationship with suppliers mutually

beneficiary

The 8 principles of TQM …

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Quality Control Quality Management

Past FutureDetect faults Prevent errorsLook for guilty persons Look for defaults in the processesAccuse Help, Moderate, FacilitatePunish MotivateMicro-management Systematic and systemic management

Transition towards TQM

Deming’s wheel (P.D.C.A.)

PLAN DO

ACT CHECK

Continuous

Improvement

Continuous improvement

Quality Improvement …

Up to what extent???

Confusion

ISO 9000 – A WAY TO TQM !!!

Destination ……

In The Early Days..

The quality movement can trace its roots back to middle Europe, where craftsmen began organizing into unions called guilds in the late 13th century.

This model was followed until the early 19th century when factories came to be and there was more emphasis on product inspection.

In the early 20th century manufacturers began to include quality processes in quality practices.

The Beginning….

In 1946, delegates from 25 countries met in ““GENEVAGENEVA”(Switzerland) ”(Switzerland) and decided to create a new international organization, of which the object would be "to facilitate the international coordination and unification of industrial standards".

The new organization, ISO, officially began operations on 23 February 1947.

I S OI S O International Standard Organization International Standard Organization

In Greek ISO means “In Greek ISO means “EQUALEQUAL” & is called as” & is called as

““International Organization of StandardInternational Organization of Standard””

WHAT IS ISO 9000?

They provide a framework for quality system development in all types of industries including service organizations.

It is just purely a management system that will help to run business in a more organized and systematic manner which will lead organisation to a more consistent in quality of the service that it deliver to customers.

1) 1) 14 Industrialized Countries from EUROPE,

2) The US (ANSI),

3) British Common Wealth.

180 technical committees (TCs)620 active sub committees (SCs)

The actual standards preparation is done by ISO

Technical committees (ISO/TCs). TCs are assisted by member country Technical Action

Group (TAG).

There are 158 National members out of the 195 total countries in the World :

ISO has three membership category, they are:

1) Member bodies

2) Correspondent Member

3) Subscribers Member

██ ██ member bodiesmember bodies████ correspondent memberscorrespondent members████ subscriber memberssubscriber members██ ██ other places with an ISO 3166-1other places with an ISO 3166-1 code who aren't members of ISOcode who aren't members of ISO

ISO 9000

Quality ManagementQuality System

Elements

Quality Assurance

Models

ISO 9001 ISO 9002 ISO 9003ISO 9004-1.-2,-3

ISO 9000 : SERIES OF STANDARDS

The Structure Of ISO 9000 StandardsAdvanced Industrial Pharmacy

ISO 9000-1 : Guidelines for selection and use ISO 9000-2 : Generic guideline for the application of

ISO 9001, ISO 9002, ISO 9003 ISO 9000-3 : Guideline for the application of ISO

9001 to development, supply, and maintenance of software

ISO 9000-4 : Guide to dependability program management

ISO 9001 - Quality Assurance in design/ development,

production, installation and servicingISO 9002 - Quality Assurance in production and

installationISO 9003 - Quality Assurance in final inspection and

testISO 9004 - Quality management and quality system

elements

List of Quality System Requirements

Quality system Requirements Management Responsibility Quality System Contract Review Design Control Document and Data Control Purchasing Control of Customer Supplied Product Product identification and Traceability Process Control Inspection and Testing Control Inspection, Measuring, and Test Equipment Inspection and Test Status Control of Non Conforming Product Corrective and Preventive Action Handling, Storage, Packaging, Preservative, and Delivery Control of Quality Record Internal Quality Audits Training Servicing Statistical Techniques

World wide equivalents of ISO 9000 StandardsCOUNTRY ISO 9000 Standard Nomenclature

Australia AS 3900

Brazil NB 9000

Canada Z 299

Denmark DS/ISO 9000

France NF EN 29000

Germany DIN ISO 9000

India IS 14000

Japan JIS Z 9900

Mexico NOM – CC 2

United State Q 9000

IS:14000:1990 (ISO 9000:1994) IS:14001:1990 (ISO 9001:1994) IS:14002:1990 (ISO 9002:1994) IS:14003:1990 (ISO 9003:1994) IS:14004:1990 (ISO 9004:1994)

ISO 9001 : 1994

ISO 9001 : 2000

Principles of ISO 9000 Standard

Based on eight quality

management

principles

Leadership

Process approach

Involvement of people

System approach to

ManagementContinual

improvement

Factual approach to

decision making

Mutual beneficial supplier

relationship

Customer focus

A) Principle : 1 Customer focusA) Principle : 1 Customer focus

1) Organization depends 1) Organization depends

on their customers.on their customers.

2) Should understand the 2) Should understand the

customerscustomers need, need,

requirement, requirement,

expectation.expectation.

Benefits :

1) Increased revenue & market share.

2) Improve customer satisfaction.

Application:

1) Research work.

2) Understanding the customers

needs, expectation, satisfaction..

B) Principle : 2 LeadershipB) Principle : 2 Leadership

1) Leaders establish unity of purpose & direction of Organization.

2) Should create & maintained the internal environment.

BenefitsBenefits : : 1) People will motivated towards Organization’s goals.

2) Activities are evaluated.

ApplicationApplication::

1) Clear vision of the Organization’s Future.

2) Setting challenging goals & targets.

People at all levels are the essence of an Organization & their abilities are used for the Organization’s benefit.

C) Principle : 3 Involvement of peopleC) Principle : 3 Involvement of people

BenefitsBenefits : :

1) Motivated, committed, Involved People within the Organization.) Motivated, committed, Involved People within the Organization.

2) Innovation & creativity. 2) Innovation & creativity.

Application:

1) People accepting the ownership of problems.

2) People freely sharing knowledge & experience.

D) Principle:4 Process approachD) Principle:4 Process approach

Benefits :

1) Lower cost & shorter cycle Times.

2) Improved, consistent, & predictable results.Application:

1) Systematically defining the activities.

2) Identifying the interfaces of key activities.

Identification, understanding,

managing interrelated

process as a system

contributes to the

Organization’s effectiveness

& efficiency in achieving its

objectives.

E) Principle : 5 System approach to managementE) Principle : 5 System approach to management

11) Structuring a system to achieve the Organization’s objectives.

2) Continually improving the system through measurement & evaluation.

Benefits :

1) Ability to focus the effort on the key processes.

2) Providing confidence to interested parties as consistency,

effectiveness & efficiency of the Organization.

F) Principle :6 Continual improvementF) Principle :6 Continual improvement

Overall performance should be a permanent objective of the Organization .

Benefits :

1) Increase the performance due to the improvement of the Organizational capabilities.

2) Flexibility to react quickly to the opportunities.

Application:

1) Providing training to the people for the continual Improvement.

2) Establishing the Goals for continual Improvement.

3) Recognizing & acknowledging improvement.

G) Principle :7 Factual approach to decision makingG) Principle :7 Factual approach to decision making

Effective decisions are based on the analysis of data & information.

BenefitsBenefits : :

1) Informed decisions. 1) Informed decisions.

2) Increased ability to demonstrate the effectiveness of the past decisions. 2) Increased ability to demonstrate the effectiveness of the past decisions.

3) Increased ability to review.3) Increased ability to review.

1) Analyzing data & information using valid method.1) Analyzing data & information using valid method.

2) Making decision & action based on analysis. 2) Making decision & action based on analysis.

Mutually beneficial relationship between the Organization & supplier enhances the ability of both to create value.

Benefits :

1) Optimizing of cost & resources.

2) Flexibility & speed will increase in the market.

Application:

1) Identifying & selecting key suppliers.

2) Clear & open communication.

3) Sharing information & future plans.

Application

SurveillanceAudit

Documentation Review

Pre - Assessment

Registration Audit

Registration Decision

DOCUMENTATION REQUIREMENTSDOCUMENTATION REQUIREMENTS

Quality Management System DocumentationQuality Management System Documentation

Quality Manual Quality

System Procedures Work

InstructionsForms

1) Quality Manual

Quality Policy Objectives Overview Responsibilities Requirements Policy/Responsibility

2) Quality System Procedures

A set of procedures which detail how the requirements of the quality manual are to be implemented

Detailed procedures which define how the processes are to be performed and controlled

Specifying who is responsible for what

3) Work Instructions

Detailed instructions for the performance of specific tasks

Such instructions may cover

-Materials

-Processes

-Verification

4) Forms

Records that provide proof that specified activities were carried out

Quality Management System

StandardISO 9000

Quality Manual

Quality System Procedures

Work Instructions

LEVEL 1

LEVEL 2

LEVEL 3

LEVEL 4

Policy Statement, Commitment, Organization, Responsibilities

Company Practices, Interfaces

Written Instructions to Control Tasks

Quality Records

Sales Design Purchasing Manufacturing Accounts Personnel After SalesAdvanced Industrial Pharmacy 51

ISO CertificateISO Certificate

1) Continuous improvement

2) Marketing strategy

3) To meet Customer requirement

11) Improved system documentation

2) Fewer customers audits

3) Improve customers relationship

4) Improved quality awareness

Example Very Near To You !!!!!

BAPUJI MBA COLLEGEBAPUJI MBA COLLEGE

56Advanced Industrial Pharmacy

After Registration..

Life is not like this because….

Advanced Industrial Pharmacy

Naroola G. Conell RM. How to achieve ISO 9000 Registration

Economically and Effectively. New York 1996. Marcel Dekker, Inc.

Stamatis DH. Understanding ISO 9000 and implementing the

basics to quality. New York 1995. Marcel Dekker, Inc.

Rastogi PN.Total quality management theory & practice. AICTE Continuing Education Program .March 1989;Code No : 298.

Krishnan NS. Total quality management 1.AICTE Continuing Education Program .December 1996 ; Code No

: 623.

Bali PL. Total quality management . AICTE Continuing Education Program .June 1997 ; Code No : 541.

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JAY ISO 9000

Documents

Transcript of JAY ISO 9000

Iso 9000 2015

Presentacion Iso 9000

certificacion ISO 9000

Conferencia iso 9000

Iso 9000 2000_GET

Bibliografia ISO 9000

Iso 9000 - 14000

Nc iso 9000-

1 Iso 9000

ISO 9000 vs. QS-9000 (pdf)

ISO 9000-2008

Norma iso-9000

Iso 9000 Compras

ISO 9000 2000

Glosario de Términos. ISO 9000. La ISO 9000 es una familia ...

Normas Iso 9000

ISO-9000 2005

ISO 9000 cls

Iso 9000 2005_fr

Presentación iso 9000