The ISO 9000 Quality Management System: A Definition

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ISO 9000 and Total Quality: The
Relationship
Eng. Basel F. Qandeel
ISO 9000:2008
Introduction

There are many companies in the world have already
adopted to ISO 9000,Why?
Because it controls quality. It saves money. Customers expect
it. And competitors use it.

ISO 9000 applies to all types of organizations. It doesn't
matter what size they are or what they do. It can help
both product and service oriented organizations achieve
standards of quality that are recognized and
respected throughout the world.
Introduction
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All organizations have an established way or
system of doing things
These systems may be effective, but are often
informal, inconsistent, & not documented
The purpose of quality management is to identify
those systems & processes that can help an
organization meet its customers’ expectations
ISO 9001:2008 is helpful because it defines basic
quality processes that have proven to be effective in
successful organizations over the past 50 years
What is ISO

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ISO is the International
Organization for
Standardization
Established in 1947 and
located in Switzerland
Its members come from
over 120 national standards
bodies
What is ISO 9000:2008
ISO 9000 refers to a set of quality management standards
 Present guidelines
 Establishes a start point for understanding
the standards
 Defines the fundamental terms and definition used in the
ISO 9000 family

What is ISO 9000:2008

The ISO 9000:2008 Standards apply to all kinds
of organizations in all kinds of areas.
E.g. computing , financial services , accounting , banking ,
telecommunications , education
Objectives of ISO 9000:2008
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Enable integration of management system
Reach stakeholders’ requirements
Enable implementation of continuous improvement
Simple to use and easy to interpret
ISO's purpose is to facilitate international trade by providing
a single set of standards that people
everywhere would recognize and respect.
Benefits of ISO 9000:2008
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Improved customer satisfaction
Reduced costs of quality
Improved productivity and quality
Improved internal communication
Improved working efficiency
Increase the competitive power
Transparency of process
Motivate the staff of the companies
Increase the credibility of the customer
Reduce the probability of error in the working process
8 principles of ISO 9000:2008
Customer focus
System approach
Leadership
Continuous
Improvement
Involvement of people
Factual
Improvement
Process approach
Supplier
Relationship
Principle 6 : Continuous Improvement
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Continual improvement should be a permanent objectives
of the organization.
Continually improving the efficiency of all process
Increase competitive power
Principle 6 : Continuous Improvement
Management
Responsibility(5)
Customer
requirements
Resource
Measurement, analysis
management(6) and improvement(8)
input
Product
Realization(7)
product
output
Model of ISO 9000:2008
Satisfaction
customer
Use of ISO 9000 as Continuous
Improvement
Act
Plan
•How to improve
next time?
•What to do?
•How to do it?
Deming’s wheel (P.D.C.A)
Check
Do
• Did things happen
according to plan?
•Do what was
planned
The ISO 9000 Quality Management
System: A Definition

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To secure registration, organizations must develop and use
quality management systems conforming to the requirements
of ISO 9001.
As stated in ISO 9000, a QMS is a management system to
direct and control an organization with regard to quality.

The quality management system will include this
documentation:
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A quality policy. This statement describes how the organization
approaches quality.
The quality manual. This must address each clause of the ISO 9001
standard. It will also typically include an organization chart, or some
such device, illustrating management responsibility for operating the
quality system. Quality procedures may be part of this manual, or they
may be referenced.
Total Quality Management
14
The ISO 9000 Quality Management
System: A Definition
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Quality objectives. These are the goals related to quality and must be in
harmony with the quality policy. Quality objectives are assigned to the
relevant organizational functions and levels and are tracked by top
management.
Quality procedures. These describe step by step what the company does
to meet the quality policy. As a minimum, there will be a procedure for
each of the ISO 9001 clauses outlining requirements. There may also be
procedures for any processes that can impact quality.
Forms, records, and so on. These provide proof of activities for the firm
and for the auditors.
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15
Certification Process
1. Develop a quality manual & procedures addressing ISO
9001:2008 requirements
2. Train personnel and implement processes based on the
quality manual & procedures
3. Carry out & document internal audits to verify that
processes are carried out according to defined processes
4. Contact 2 or 3 registrars
5. The lead auditor will evaluate your quality manual &
procedures about 2 months before the certification audit
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