Chapter 5

Quality Systems and

Quality Systems Auditing
Dr. Ayham Jaaron

Objectives
list and discuss the elements of a quality management system
understand the basic elements of the major quality management
systems
understand the basics of the ISO 9001 standard
understand the basics of the MBNQA process
list and discuss the objectives of quality audits
list and discuss the types of quality audits
discuss the quality system audit process
discuss the scope and objectives of quality information systems
discuss the importance of ensuring data accuracy and integrity
discuss quality documentation systems
understand the basics of a quality information system, document
control, and information flows

Quality Systems & Quality

Systems Auditing
A system is any set of
interdependent parts that perform a
function or set of functions.
Quality Management Systems
include:
Plans
Activities
Events

Quality Systems & Quality

Systems Auditing
Quality Audits
Are a part of the evaluation and
assessment process
Should be systematic and independent
to identify the activities and results
Are a form of performance audit
Need the desired state documented

Quality Management Systems

Planning

Elements of a
Quality
Management
System

Performance
Measurement
Improvement

Quality Systems

Qu

The best evidence for the

existence of a quality system
is the quality manual.

M ali
an ty
ua
l

A quality system is the collective plans, activities and events

that are provided to ensure that a product, process, or service
will satisfy given needs.

Qu
alit
yM

anu
al

Quality Manual

a process has been

defined

Qu

M ali
an t y
ua
l

The quality manual provides

evidence that:

Qu
alit
yM

anu
al

the procedures are

approved
the procedures are
under control

Quality Manual

Qu

M ali
an t y
ua
l

The quality manual provides

NO evidence that:

Qu
alit
yM

the system has

been implemented

anu
al

Implementation is verified through

quality audit

Formal Guidelines
(Approaches) to Quality Control

ISO 9001

ISO/TS 16949

MBNQA

QS-9000

ISO 9001
ISO 9000is a series of standards, developed
and
published
by
the
InternationalOrganizationforStandardization
(ISO), that define, establish, and maintain an
effective quality assurance system for
manufacturingandserviceindustries

ISO/TS 16949
Aims
to
the
development
of
a
qualitymanagementsystemthat provides for
continual
improvement,
emphasizingdefect
prevention and the reduction of variation and
waste in thesupplychain. It is based on the
ISO9001and the first edition was published in
March2002asISO/TS16949:2002.

QS-9000
QS9000isaqualitystandarddevelopedbyajoint
effortofthe"BigThree"automakers,
GeneralMotors,ChryslerandFord.Itwas
introducedtotheindustryin1994.Ithasbeen
adoptedbyseveralheavytruckmanufacturersin
theU.S.aswell.Essentiallyallsupplierstothe
domesticautomakersneedtoimplementa
QS9000system.

Quality Management System

Each approach has the goal of
providing a framework through which
a quality control program can be:

Identified
Designed
Developed
Implemented
Enhanced

Quality Management
Systems

ISO 9000

ISO 9000 Family

There are many standards in the ISO 9000 family, including:
ISO 9000:2005 - covers the basic concepts and language
of how to build a quality system.
ISO 9001:2008 - sets out the requirements of a quality
management system
ISO 9002: same as 9001 but it does not cover product
realization requirements (now obsolete).
ISO 9004:2009 - focuses on how to make a quality
management system for long term success. Not meant
for certification rather how to build strategy of quality.
ISO 19011:2011 - sets out guidance on internal and
external audits of quality management systems.

Popular Standards

ISO
ISO
ISO
ISO
ISO
ISO
ISO
ISO

14000Environmental management
3166Country codes
26000Social responsibility
50001Energy management
31000Risk management
22000Food safety management
27001Information security management
20121Sustainable events

Quality Management Systems

Eight Management Principles that
are the basis for ISO 9000 standards:

Customer focus
Leadership
Involvement of people
Process approach
Systems approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

ISO 9000 Process approach

Quality Management Systems

Eight Steps for ISO 9000
Determine the needs and expectations of customers and
other constituents
Establish quality policy and quality objectives for the
organization
Determine the processes and responsibilities necessary to
attain the quality objectives
Determination and provision of the resources necessary
to attain the quality objectives

ISO Audit Checklist

Quality Management Systems

Eight Steps for ISO 9000 continued
Establish measures for the effectiveness and efficiency
of each process
Application of these measures to determine the
effectiveness and efficiency of each process
Determination of means of preventing nonconformities
and eliminating their causes
Establishment and application of a process for continual
improvement of the quality management system

Quality Management Systems

Self-Assessment and Improvement
Path for ISO 9000
Comprehensive self-assessment to review actual
processes and result of the quality policies and
objectives
Identification of areas for improvement based on the
results of the internal audit

Quality Management Systems

Self-Assessment and Improvement
Path for ISO 9000
Establishment of objectives for the improvement efforts
Development of improvement plans
Implementation of the improvement plan
Re-audit to assure the improvement plans achieved the
desired results

Self-Assessmenttool

Quality Management Systems

QS-9000
QS-9000-specialized standard for U.S.
Automotive suppliers.

ISO/TS 16949:2000(E)
An international quality management
system specification for the supply
chain.

Quality Management Systems

Malcolm Baldrige National Quality
Award (MBNQA)
Created in 1987
Highest recognition a U.S. organization
can receive

Quality Management Systems

MBNQA continued
Six categories

Manufacturing
Service
Small business
Education
Health care
Nonprofit

Quality Management Systems

SevenCategoriesofCriteriaforMBNQA
Category
Number

Business

Education

Health Care

1
2
3

Leadership
StrategicPlanning
CustomerandMarket
Focus

Measurement,Analysis,
andKnowledge
Management

Measurement,Analysis,
andKnowledge
Management

Measurement,Analysis,
andKnowledge
Management

5
6
7

HumanResourceFocus
ProcessManagement
BusinessResults

FacultyandStaffFocus
ProcessManagement
Organizational
PerformanceResults

StaffFocus
ProcessManagement
Organizational
PerformanceResults

Leadership
Leadership
StrategicPlanning
StrategicPlanning
Student,Stakeholder,and FocusonPatients,other
MarketFocus
Customers,andMarkets

Quality Auditing
Aqualityauditcompareswhat isavailabletowhat is supposed to be.
Thereforeaqualityauditcannotbeperformedunlesswhat
issupposedtobeisproperlydocumented.Itisimpossible
todeterminethedegreeofcompliancewithanundefined
state.Foraqualitysystemaudit,thequalitymanualis
thedefinitionofwhatissupposedtobe.
QualityAuditcanbeinternalorexternal

Specific Types of Quality

Audits
Tunners Generic Types (1990)
PolicyAudit
compareswrittenpoliciesandprocedures
withstandardsandspecifications
PracticeAudit
comparesactualpracticeswithestablished
procedures.
ProductAudit
comparesperformanceofaproductwith
itsspecifications.

SOP

y
Polic

SOP

Specific Types of Quality

Audits..cont.
Four Dimensions of Audits (Mills,
1989)

The purpose of the audit-why?

The object of the audit-what?
The nature of the audit-who? int. vs. ext.
The method of the audit-how? On
site/report

Audit Types
Arters Classification
First-PartyAudit
Qualityauditorinyourorganization
auditsyourqualitysystem.
Second-PartyAudit

Third-PartyAudit

Qualityauditorinyourorganization
auditsyour suppliersqualitysystem.
MBNQAauditteamauditsyour
organizationsqualitysystem.

Performing a Quality Audit

(ANSI/ASQC Q1-1986)
The above systems list the
responsibilities of:
Audit Client Responsibilities: the organization
who request the audit (such as government,
ISO, MBNQA organisation).
Auditee Responsibilities
Auditor Responsibilities

Class task
Discusswithyourgroupmembersthe
expectedresponsibilitiesfor:theAuditclient,
Auditee,Auditor?

Audit Client Responsibilities

Initiate audit
Define reference standards
Receive audit report
Abstain from any undue interference with
audit activities
Determine follow up activities

Auditee Responsibilities

Appoint someone to accompany auditor

Provide access to facilities and evidential materials
Provide adequate working facilities
Cooperate with the auditors
Attend meetings
Review findings
Take corrective action
Abstain from any undue interference with the audit

Auditor Responsibilities
Comply with applicable audit standards
Clarify and articulate the audit objectives
Effectively and efficiently plan and implement the
audit
Report the audit results
Audit results of corrective actions
Retain and safeguard audit working papers
Maintain independence from organization being
audited

Quality Information Systems

Information Systems are designed to:
Collect
Process
Store
And
Transmit data & information

Quality Information Systems

Quality Information Systems (QIS)
can be:
Entirely electronic
Entirely manual
A combination of electronic and manual

Quality Information Systems

3 key components
Data
Data Flows
Processing Logic

Problem Identification, Analysis,

Reporting, & Corrective Action
System
Information
Flows

Quality Information System

Data Accuracy and Security
Check and verify on a regular basis
Improve accuracy by using automatic
data entry approaches such as:
Barcodes
RFID
Automated measurement systems

Quality Information System

(QIS)
An information system designed to meet the needs of the
quality system. Data accuracy and integrity are musts.
QIS

IN

OUT

Summary
Examined:

Quality
Quality
Quality
Quality

Systems
Management Systems
Audits
Information Systems