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maintained, updated or withdrawn.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…
