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Quality Management Systems

(QMS)
ISO
• International Organization for standardization
(ISO)was founded in 1946 in Geneva,
Switzerland.
• To promote and facilitate exchange of goods
and services worldwide.
• Composed of more than 70 countries.
• ISO Technical Committee (TC) 176 developed a
series of international standards for quality
systems.
• The standards ISO 9000, 9001, 9004 intended
to be advisory for two party contractual
situations and internal auditing.
• European community also adopted the same.
• The fourth edition of ISO 9001 released in
2008, it replaced third edition.
• Most countries adopted ISO 9000 series as
their national standards.
• National standards published in USA by
American National Standards Institute.
• In India Bureau of Indian Standards (BIS)
adopts ISO certification standards under the
dual numbering system.
• In TWO party system supplier of product or
service develop quality systems that
conformed to standards.
• Customer may audit system for acceptability.
• Now third-party registration is replaced prior
one.
• Third party who is registrar assesses and do
periodic surveillance and issues certificates.
Benefits of ISO Registration:
• Compliance to quality system (product /
service).
• To improve the processes and systems for
global deployment of products and services.
• Subcontractors and suppliers need to be
registered for ISO.
• To increase the market share.
• To develop well documented quality system.
A study at Italy proved:
• Internal quality is measured by the percent of
scrap, rework, nonconformities.
• Production reliability measured by breakdowns
by month, time dedicated for emergencies,
percentage of downtime.
• External quality measured by product accepted
by customers without inspection and claims.
• On time delivery, time to market.
ISO 9000 Series of Standards:
• ISO 9000 Series Of Standards is generic in
scope.
• Can be tailored to fit small or big
organizations, manufacturer or service
organization.
• Can be applied to construction, engineering,
health care, legal and other services.
• It explains what company is doing to ensure
quality, do what it says, documentation.
The Three standards of Series are:
• ISO 9000:2005 – QMS – Fundamentals and
Vocabulary.
• ISO 9001:2008 – QMS – Requirements ( in
conformance to standards).
• ISO 9004:2000 – QMS – Guidelines for
performance improvements.
Sector Specific Standards:
• ISO 9000 System is generic.
• ISO 9001 is basic framework to modify to their
needs.
• Currently there are three other quality
systems: AS9100, ISO/TS 16949, TL9000.
• Registration Accreditation Board (RAB) points
out sector specific standards, created need of
auditors and training courses.
AS 9100
• This is Aerospace industry quality system.
• Released by Society of Automotive Engineers in
May 1997.
• Attempt to unify requirements of NASA, DOD,
FDA.
• In March 2001, the International Aerospace
Quality Group (IAQG) aligned AS9100 with ISO
9001:2000.
• Aerospace organizations in Europe, Japan and U.S
certifies Registrars and Auditors.
ISO/TS 16949
• Quality Systems Automotive Suppliers –
application of ISO 9001.
• Harmonizes Supplier Quality Requirements of
U.S.
• French, German and Italian automakers provided
QS 9000.
• Standard has been approved by Asian
automakers.
• Goal is to defect prevention, reduction of
variation and waste.
ISO/TS 16949 contains three levels:
1) ISO 9001.
2) Sector Specific Requirements.
3) Company specific requirements.
TL 9000
• The Quality Excellence for Suppliers of
Telecommunications Forum (QuEST) wrote TL
9000 to consolidate Quality Systems
Requirements.
• Based on ISO 9001.
• Defines Design, Development, Production,
Delivery, installation and maintenance of
telecommunication products and services.
• The University of Texas – Dallas administer the
QSM.
Structure of TL 9000 Requirements:
ISO 9001 Requirements
Common TL 9000 Requirements (QSR) – Book 1
Hardware specific Software specific Services specific
requirements requirements requirements
Common TL 9000 Measurements (QSM) – Book 2
Hardware specific Software Specific Services Specific
Measurements Measurements Measurements.
TL 9000
• More than 200 forum members are available.
• Each organization can benchmark its
performance against industry standard.
• Can determine which processes needs
improvement.
ISO 9001 Requirements:
The standard has 08 clauses:
1. Scope,
2. Normative references,
3. Definitions,
4. Quality Management Systems,
5. Management responsibility,
6. Resource Management,
7. Product and / or Service Realization,
8. Measurement, Analysis and Improvement.
Model of a Process-Based QMS
Management
responsibility

QMS Measurement,
Resource Customer
Continual Analysis and
Management Satisfactio
Improvement Improvement n

Input Product
Realization Output
Require
Product
ments
Scope:
• The purpose of the standard is to provide
product / service that meets Customer and
Regulatory requirements to enhance customer
satisfaction.
• This can be achieved by evaluating and
continual improvement in systems.
• It is applicable to all types of organizations.
Normative Reference:
• ISO 9000:2005 QMS- Fundamentals and
Vocabulary are a normative reference.
Terms and Definitions:
• The terms and definitions are given in ISO
9000:2000.
• Product means Service also.
QMS
• The organization shall establish, document,
implement, and maintain a QMS and
Continually improve its effectiveness.
• Determine the process needed, sequence and
interaction, criteria & methods, availability of
resources and information, monitor measure
analyze, implement actions for continual
improvement.
QMS steps:
• Documentation:
Shall include:
1. Statement of Quality Policy and Objectives,
2. Quality Manual,
3. Required documented procedures and records,
4. Needed documents to ensure effective planning,
operation, control of processes and records.
Quality manual: includes-
• Scope of QMS,
• Documented procedures or references,
• Description of the interaction among the QMS
Processes.
Control of Documents: contains
a) Approve documents prior to use,
b) Review, update and re-approve as necessary,
c) Identify current revision status,
d) Ensure current versions are available to use,
e) Ensure documents are legible, readily
identified,
f) Identify and distribute documents of external
origin,
g) Prompt removal of obsolete documents.
Control of Records:
Procedure shall be established to define the
controls needed for the identification, storage,
protection, retrieval, retention and dispositionof
records.
Management Responsibility:
• Management commitment,
• Customer Focus,
• Quality Policy,
• Planning,
i) Quality Objectives,
ii) Quality Management System Planning.
• Responsibility, authority and Communication.
• Management Review : top management review for
suitability, adequacy and effectiveness. Review input
(results of audit, conformance, preventive
performance, effectiveness of process.
6. Resource Management:
• Provision of Resources (people, infrastructure,
work environment, information, suppliers,
natural resources, financial resources).
• Personnel performance.
• Competence, Training and Awareness.
• Infrastructure: buildings, equipment's,
supporting services.
• Work environment: employee motivation,
satisfaction and performance.
7. Product / service Realization:
i) Planning of Product realization: quality
objectives and requirements, establishing
processes and providing resources,
verification validation monitoring
measurement inspection, records to provide
evidence.
ii) Customer Related Processes:
Determination of requirements related to
the product, Review of requirements related to
the Product, Customer communication.
iii) Design and Development Planning,
Design and Ddevelopment Inputs,
Design and Development Outputs.
Design and Development Review,
Design and Development Verification,
Design and Development Validation,
Control of Design and Development Changes.
iv) Purchasing:
Purchasing process, Purchasing information,
verification of Purchased Product.
v) Production and Service Provision:
Control of Production and Service Provision,
Validation of Production and Service Provision,
Identification and Traceability,
Customer Property,
Preservation of Product (handling, packing,
storage).
vi) Control of Monitoring and Measuring Equipment:
Evidence of conformity (calibrated or verified).
8. Measurement, Analysis and
Improvement:
• Demonstrate conformity to product
requirements,
• Ensure conformity to QMS,
• Continually improve the effectiveness of QMS.
Monitoring and Measurement:
Customer satisfaction.
Internal Audit.
Monitoring and measurement of Processes.
Monitoring and Measurement of Product and
Service.
• Controlling of Nonconforming Product.
• Analysis of Data.
• Improvement: Continual improvement,
Corrective Action, Preventive Action.
Module 2
• Leadership: definition, characteristics of
quality leaders, leadership concept,
characteristics of effective people, ethics, the
Deming Philosophy, role of TQM leaders,
implementation, core values, concepts and
framework, strategic planning,
communication, decision making.
Leadership definition:
James MacGregor Burns says – leaders and
followers raise one another to higher levels of
motivation and morality, leadership becomes
moral in that it raises the level of human
conduct and ethical aspiration of both the
leader and the led, and thus has a transforming
effect on both.
• According to Daimler Chrysler’s CEO Bob Eaton
leader is - someone who can take a group of
people to a place they don’t think they can go.
• According to Narayana Murthy – a great leader Is
one who is not only good in creating vision,
creating the big picture, but also ensuring that he
goes into the nitty-gritty, into the details of
making sure that his vision is actually translated
into reality through excellence of execution. In
other words, great leaders have great vision,
great imagination, great ideas but they also
implement these ideas through hard work,
commitment and flawless execution. In doing so
they motivate thousands of people.
Characteristics of Quality Leaders:
• They give priority attention to external and
internal customers and their needs.
• They empower rather than control,
subordinates. Provide resources, training and
environment.
• They emphasize improvement rather than
maintenance.
• They emphasize prevention.
• They encourage collaboration rather than
competition (among departments).
• They train and coach, rather than direct and
supervise.
• They learn from problems.
• They continually try to improve communications
(two way).
• They continually demonstrate their commitment
to quality. Leaders Walk their Talk.
• They choose suppliers on the basis of quality.
• They establish organizational systems to support
the quality effort.
• They encourage and recognize team effort
(rewards).
Leadership Concepts:
• In order to become successful, Leadership
requires an intuitive understanding of human
nature – the basic needs, wants, and abilities
of people. To be effective, a leader
understands that:
i) People, paradoxically, need security and
independence at the same time.
ii) People are sensitive to external rewards
and punishments and yet are also strongly self-
motivated.
iii) People like to hear a kind word of praise.
Catch people doing something right, so you can
pat them on the back.
iv) People can process only a few facts at a
time, thus, a leader needs to keep things simple.
v) People trust their gut reaction more than
statistical data.
vi) People distrust a leader’s rhetoric if the
words are inconsistent with the leader’s action.