MG1401 – Total Quality Management

Unit – V: QUALITY SYSTEMS (#1)

Prepared by
N.Shanmuga Sundaram, AP/ECE.
K.K.Senthil Kumar, Lect./ECE.
MAHENDRA ENGINEERING COLLEGE, Namakkal Dt.
Contents

 History of Quality
 ISO – An introduction
 What is ISO 9000?
 ISO 9000 – Series of Standards
 Major Elements of ISO 9001:2000
 Principles of QMS
 ISO 9001:2000 Requirements
 ISO Implementation
 ISO Documentation
 ISO Auditing
History of Quality

 Before Industrial revolution, the quality was heavily relied

on craftsman & workmanship.
 After Industrial revolution, the concept of mass production,
inspection and standards were set.
 Later, the concept of Quality Control (QC) came into
existence, by using Statistical Process Control (SPC)
techniques.
 Then came the concept of Quality Assurance (QA).
 Quality improvement finally took a new dimension by
identifying and eliminating problems at source itself.
 Quality Management System (QMS) has now become vital
for the survival of an organization.
ISO – An Introduction

 ISO means International Organization for Standardization.

 It is the world's largest developer of International Standards.

 ISO is a network of the national standards institutes of 162

countries, with a Central Secretariat in Geneva, Switzerland,
that coordinates the system.

 ISO is a non-governmental organization that forms a bridge

between the public and private sectors.

 ISO standards are voluntary.

 ISO itself does not regulate or legislate.

 ISO standards are based on international consensus among

the experts in the field, by making a periodic review of its standards
at least every five years to decide whether they should be
maintained, updated or withdrawn.
What is ISO 9000?

 ISO Technical committee developed a series of

international standards for Quality Systems in 1987 and
interim revision was carried out in the year 1994, 2000 and
2008.

 ISO 9000 is a series of Quality Assurance methods,

designed and intended to apply to any product or
services made by an organization.

 ISO ensures Continual improvement and satisfaction to

all stake holders in an organization.
ISO 9000 series of standards

ISO 9000 Quality management & QA Standards guidance

ISO 9001 Model for QA in design / Dev. / Prod. / Install.

ISO 9002 Model for QA in Prod / Installation

ISO 9003 Model for QA in final inspection & Test

ISO 9004 Generic guidance for QM and systems

ISO 9004 -2 Guidelines for services.

QS 9000 Encompasses ISO 9000

Establishes QS requirements for worldwide telecom.

TS 9000
Networks (based on ISO 9001)

FDA-CGMP Medical devices (includes ISO 9001)

Major elements in ISO 9000:2000
Principles of Quality Management

 Customer Focus

 Leadership

 Involvement of People

 Process approach

 Continual improvement

 Factual approach to decision making

 Mutually beneficial supplier relationships

ISO 9001:2000 QMS Requirements

 ISO 9001:2000 is generic in nature and

concentrates on following three areas.

# Focus on customer

# Process oriented approach

# Continual improvement

 Since it is generic in nature, any clauses that are

not suitable to any organization can be excluded.
ISO 9001:2000 QMS Requirements (contd..)

1. Scope The standards

contain 8 clauses,
2. Normative reference

3. Terms and Definitions of which first

three give
4. Quality Management information about the
System organization
5. Management responsibility
and remaining
6. Resource management five clauses are the
requirements that the
7. Product realization company has to meet.
8. Measurement, Analysis and
Improvement
ISO 9001:2000 QMS Requirements (contd..)

 1. Scope: Requirement of the organization to develop QMS.

 2. Normative reference: The required concepts and related

definitions can be obtained from ISO 9000:2000 standards.

 3. Terms and Definitions: Terms and Definitions given in ISO

9000:2000 can be applied.

 4. Quality Management System:

* General requirements
The organization has to identify the customer requirements and
accordingly has to establish, document, implement and maintain
QMS.
* Documentation
Quality statements, Quality manuals, Quality system procedures,
work instructions, etc in standard format.
ISO 9001:2000 QMS Requirements (contd..)

 5. Management Responsibility:
a) Management commitment
b) Customer focus
c) Quality policy
d) Planning
e) Responsibility, Authority and Communication
f) Management Review

 6. Resource Management:
a) Processing of resources
b) Human resources
c) Infrastructure
d) Work environment
ISO 9001:2000 QMS Requirements (contd..)

 7. Product realization:
a) Planning for Product realization
b) Customer related processes
c) Design and Development
d) Purchasing
e) Production and Service provision
f) Control of monitoring and measuring devices

 6. Measurement, Analysis and Improvement:

a) General
b) Monitoring and Measurement
c) Control of Non-conforming product
d) Analysis of Data
e) Improvement
Implementation of ISO 9001:2000

 Top management commitment

 Appointment of Management Representative
 Awareness program
 Appointment of care team for implementation
 Training
 Time schedule
 Selection of Process owners
 Review of the Existing system
 Writing Documents
 Installation of New system
 Internal audit
 Management Review
 Pre-Assessment
 Registration
Registration of ISO 9001:2000

The registration process includes three parts, namely:

 Identifying a system / certifying agency

(by assessing the reputation of agency, cost and lead time)

 Submitting an Application along with Quality manual

for review

 Registration / agency certification audit.

(Duration of audit will take 1 ~ 3 days).
Drawbacks in Successful implementation

 Using a Generic document / copying documents from other

organization.

 Over documentation / complex in nature

 Using external agency / consultants (without involving employees)

 Continuing documentation to text (not using other media)

 Neglecting top management

 Developing a system that does not represent reality

ISO Documentation
ISO Auditing

 Purpose:
The auditing is done to check whether the System (QMS) is followed
and expected results are obtained.

 Frequency:
The audit is done once in every six months / at least once in a year.

 Objectives of Audit:
1) To apply corrective action to avoid repetition of mistakes.
2) To follow-up on Non-conformities from previous audits.
3) To determine whether organization follows documented QMS.
4) Steps for Continual improvement in QMS.
5) Provide opportunity to improve Quality system.
ISO Auditing (contd..)

 Auditor:
A Qualified person who looks for objective evidence through
verification of records, files, etc., and finds out the strengths and
weakness in implementing the QMS.

 Procedure for Audit:

1) Planning: Selection of auditors, dept., time duration, required
documents, etc.
2) Audit has 3 parts: Pre-audit meeting, audit and closing meeting.
3) Review of documents, questioning the members of audited dept.,
to find out the factual evidence. (3 types of questions are
asked. They are open, closed and clarifying questions).
4) Auditing is done with mutual trust existing between auditor and
auditee.
5) Non-conformity Report (NCR) is developed.
6) In closing meeting, Audited information, Details of NCR and
Suggestions for Corrective actions will be discussed.
Remaining part of the
Quality systems (ISO 14000)

will be continued in the

next presentation…