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MG1401 Total Quality Management

Prepared by

N.Shanmuga Sundaram, AP/ECE.

K.K.Senthil Kumar, Lect./ECE.

MAHENDRA ENGINEERING COLLEGE, Namakkal Dt.

Unit V: QUALITY SYSTEMS (#1)

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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

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History of Quality

Before Industrial revolution, the quality was heavily reliedon craftsman & workmanship.

After Industrial revolution, the concept of mass production,inspection and standards were set.

Later, the concept of Quality Control (QC) came intoexistence, 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 vitalfor the survival of an organization.

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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 162countries, with a Central Secretariat in Geneva, Switzerland,that coordinates the system.

ISO is a non-governmental organization that forms a bridgebetween the public and private sectors.

ISO standards are voluntary.

ISO itselfdoes not regulate or legislate.

ISO standards are based on international consensus amongthe experts in the field, by making a periodic review of its standardsat least every five years to decide whether they should bemaintained, updated or withdrawn.

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What is ISO 9000?

ISO Technical committee developed a series ofinternational standards for Quality Systems in 1987 andinterim revision was carried out in the year 1994, 2000 and2008.

ISO 9000 is a series of Quality Assurance methods,designed and intended to apply to any product orservices made by an organization.

ISO ensures Continual improvement and satisfaction toall stake holders in an organization.

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ISO 9000 series of standards

Medical devices (includes ISO 9001)FDA-CGMP

Establishes QS requirements for worldwide telecom.Networks (based on ISO 9001)TS 9000

Encompasses ISO 9000QS 9000

Guidelines for services.ISO 9004 -2

Generic guidance for QM and systemsISO 9004

Model for QA in final inspection & TestISO 9003

Model for QA in Prod / InstallationISO 9002

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

Quality management & QA Standards guidanceISO 9000

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Major elements in ISO 9000:2000

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Principles of Quality Management

Customer Focus

Leadership

Involvement of People

Process approach

Continual improvement

Factual approach to decision making

Mutually beneficial supplier relationships

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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 arenot suitable to any organization can be excluded.

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ISO 9001:2000 QMS Requirements (contd..)

1. Scope

2. Normative reference

3. Terms and Definitions

4.

Quality ManagementSystem

5. Management responsibility

6. Resource management

7. Product realization

8. Measurement, Analysis andImprovement

The standardscontain 8 clauses,

of which firstthree give

information about theorganization

and remainingfive clauses are therequirements that the

company has to meet.

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

2. Normative reference: The required concepts and relateddefinitions can be obtained from ISO 9000:2000 standards.

3. Terms and Definitions: Terms and Definitions given in ISO9000:2000 can be applied.

4. Quality Management System:

* General requirements

The organization has to identify the customer requirements andaccordingly has to establish, document, implement and maintainQMS.

* Documentation

Quality statements, Quality manuals, Quality system procedures,work instructions, etc in standard format.

ISO 9001:2000 QMS Requirements (contd..)

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5. Management Responsibility:

a) Management commitment

b) Customer focus

c) Quality policy

d) Planning

e) Responsibility, Authority and Communicationf) Management Review

6. Resource Management:

a) Processing of resources

b) Human resources

c) Infrastructure

d) Work environment

ISO 9001:2000 QMS Requirements (contd..)

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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 productd) Analysis of Data

e) Improvement

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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

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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 manualfor review

Registration / agency certification audit.(Duration of audit will take 1 ~ 3 days).

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Drawbacks in Successful implementation

Using a Generic document / copying documents from otherorganization.

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

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ISO Documentation

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ISO Auditing

Purpose:

The auditing is done to check whether the System (QMS) is followedand 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.

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ISO Auditing (contd..)

Auditor:

A Qualified person who looks for objective evidence throughverification of records, files, etc., and finds out the strengths andweakness 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 andSuggestions for Corrective actions will be discussed.

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Remaining part of the

Quality systems (ISO 14000)

will be continued in the

next presentation