QUALITY

STANDARDS

PROF. J. MUMBA, PhD

ESAMI
 QUALITY MANAGEMENT SYSTEMS

• Evolution of Quality Management Standards

• ISO - the Organization
• ISO Family of Standards
• Benefits of implementing ISO 9001 standard
 INTRODUCTION
• ISO 9000 is a specific standard, but is also the
general term for what has become the ISO
9000 phenomenon, meaning not just the
single standard but the infrastructure that has
grown around ISO 9001 certification.
• There are 18 standards in the ISO 9000 family
(i.e. Generic Quality Management and
Quality Assurance Standards), and a detailed
knowledge of all of them is not essential.
 THE ISO 9000 SERIES

• The ISO 9000 Series is a subset of the ISO 9000 family of

standards.
• The ISO 9000 Series consists of 4 standards referenced in
Clause 0.1 of ISO 9000:2005 (Quality Management
Systems- Fundamentals and Vocabulary).
• The 4 standards together they form a coherent
set of Quality Management System Standards,
that facilitate mutual understanding in national
and international trade.
Relationship Between the ISO
9000 Series
1. ISO 9000: Defines the principles and
fundamental concepts and terms used in the
ISO 9000 family.
2. ISO 90001: Defines the requirements of a
quality management system, the purpose of
which is to enable organization to continually
satisfy their customers.
3. ISO 9004: Describes how organizations can
achieve sustained success by application of
the quality management principles.
4. ISO 19011: Provides guidance on the
principles of auditing, managing audit
programmes, conducting management
system audits and guidance on the
competence of management system
auditors.
 VOCABULARY OF THE STANDARDS
(ISO 9000: 2005)
• QUALITY: Degree to which a set of
inherent characteristics fulfils
requirements. The term “quality” can be
used with adjectives such as poor, good or
excellent. “Inherent”, as opposed to
“assigned”, means existing in something,
especially as a permanent characteristic.
• CUSTOMER: Organization or person that
receives a product. E.g. Consumer, client, end-
user, retailer, beneficiary and purchaser. A
customer can be internal or external to the
organization.
• PRODUCT: Result of a process. There are four
generic product categories, as follows: —
services (e.g. transport); — software (e.g.
computer program, dictionary); — hardware
(e.g. engine mechanical part); — processed
materials (e.g. lubricant).
• PROCESS: is defined as “set of interrelated or
interacting activities which transforms inputs
into outputs”.
• Requirement: A need or expectation that is
stated, generally implied or obligatory.
• Customer satisfaction: Customer's
perception of the degree to which the
customer's requirements have been fulfilled.
Customer complaints are a common indicator
of low customer satisfaction but their absence
does not necessarily imply high customer
satisfaction.
QMS STANDARDS

Evolution of QMS standards

Establishment of quality management standard started in the

second half of 20th century. - in the late 1950s.
Most of these early quality management standards had their
origin in the army.

Some of the standards developed were established focusing on

some specific industries or sectors such as:
• Medical
• Manufacturing
• Nuclear
QMS STANDARDS

Evolution of QMS standards

1959
Mil-Q-9858
Quality Program Requirements – United States Department of Defence

1968
AQAP 1
NATO Quality Control Requirements For Industry – NATO

1972
BS 4891
A Guide to Quality Assurance – British Standards Institute (BSI)
QMS STANDARDS

Evolution of QMS standards

1973
DEF STAN 05-21
Quality Control Requirements For Industry – UK Ministry of Defence

1974
BSI 5179
Guide to the Operation and Evaluation of Quality Assurance - BSI

1979
BS 5750
Quality Systems standard – British Standards Institute (BSI)
QMS STANDARDS

Evolution of QMS standards

1987
ISO 9000
Quality Management Systems standards – First Edition

1994
ISO 9000
Quality Management Systems standards – Second Edition

2000
ISO 9000
Quality Management Systems standards – Third Edition
QMS STANDARDS

Evolution of QMS standards

2008
ISO 9000
Quality Management Systems standards – Fourth Edition

Note
The ISO 9000 is a family of Quality Management Systems standards.

From year 2000, ISO has been revising standards in this family separately
therefore the revision years for standards in this family are now different.
 ISO

The standards organization - ISO

ISO : International Organization for Standardization

• Founded on 23rd February 1947, adopting the common name

ISO (not an acronym! Believed to come from the Greek word
isos) due to the many languages of the founding members.

• ISO is the largest developer of voluntary international

standards in the world

• ISO has already published more than 22,383 standards as of

November, 2018.
• ISO was born from the union of two
organizations. One was the ISA
(International Federation Of The National
Standardizing Associations), established in
New York In 1926, and administered from
Switzerland. The other was the UNCC
(United Nations Standards Coordinating
Committee), established in 1944, and
administered in London.
 ISO

How is ISO constituted ?

• 162 national standards bodies from around the world are the
members that constitute ISO.
Example:
Tanzania : Tanzania Bureau of Standards (TBS)
Kenya : Kenya Bureau of Standards (KEBS)
Zambia : Zambia Bureau of Standards (ZABS)
Zimbabwe : Standards Association of Zimbabwe (SAZ)
Malawi : Malawi Bureau of Standards (MBS)
 ISO

How does ISO develop standards ?

ISO standards are need based

• ISO develops standards in response to requests from the
industry, through the ISO member bodies.

Therefore:
• ISO standards are market driven
• Based on opinions of experts worldwide
• Include inputs from various stakeholders
• Based on consensus
 ISO

Standards development process

• Proposal submission stage

• Preparation stage (Technical committee)
• Committee stage - Draft
• Enquiry stage - voting by members
• Approval stage - final draft
• Publication
 ISO STANDARDS

Some of ISO’s popular standards

1. ISO 9000 : Quality Management Systems

2. ISO 14000 : Environmental Management

3. ISO 22000 : Food Safety Management

4. ISO 26000 : Social Responsibility

5. ISO 3001 : Risk Management

6. ISO 5001 : Energy Management

 ISO 9000 SERIES

ISO 9000 family of standards

Published for the first time in 1987, the ISO 9000 family of
standards had the following key standards:

ISO 9001 : 1987

Quality Systems – Model for quality assurance in design/development,
production, installation and servicing.

ISO 9002 : 1987

Quality Systems – Model for quality assurance in production and installation

ISO 9003 : 1987

Quality Systems – Model for quality assurance in final inspection and testing
 ISO 9000 SERIES

1994 Revision
The 1987 standards were revised in 1994, but maintained the
same structure:

• ISO 9001 : 1994

• ISO 9002 : 1994

• ISO 9003 : 1994

 ISO 9000 SERIES

Year 2000 major restructuring

The revision in year 2000 came with some major restructuring of
the ISO 9000 family of standards.

The three standards that organizations could be certified to were

all merged into one standard.

• ISO 9001 : 1994

ISO 9001 : 2000
• ISO 9002 : 1994

• ISO 9003 : 1994

For the first time – all organizations could be certified to the same standard.
 ISO 9000 SERIES

Year 2008 review & Year 2015 review

The ISO 9001 standard was once again reviewed in 2008.

The new standard ISO 9001:2015 has significant changes which

include incorporating a Risk-Based Approach, and emphasizing
the role of Leadership.

Note
ISO 9001: 2015 started operating in September 2018, when ISO 9001:2008
expired.
 ISO 9000 SERIES

Current ISO 9000 family

Therefore the current standards in the ISO 9000 series of standards
are:
1. ISO 9001: 2015
Quality Management Systems – Requirements

2. ISO 9000: 2005

Quality Management Systems – Fundamentals and Vocabulary
3. ISO 9004: 2009
Managing for the sustained success of an organization – A Quality
Management Approach
4. ISO 19011:2018
Guidelines for Auditing Management Systems
Benefits of implementing the ISO 9001 standard
Some of the benefits of implementing the standard include:

• Improvement and consistency in processes

• Improved productivity and reduction of waste

• Improved quality on products and other services

• Improved record generation and information gathering

• Enhanced status, motivation and morale for employees

• Improvement on competitive advantage

END