Bahir Dar Institute of Technology

Faculty of Mechanical and Industrial Engineering

Quality Management System

Target group:-5th IED (Quality Stream)

Prepared by Zelalem B.
2014
1
 CHAPTER ONE
1.1 Introduction to quality
1.2 Overview of quality management system
1.3 Quality management concepts
1.4 Principle of quality management system
1.5 ISO 9000 family and background
1.6 Review of ISO 9001:2008 requirements
1.7 ISO 9001:2008 VS ISO 9001:2015 Requirements
1.8 Implementation of Quality Management System
1.9 Benefits and Challenges of Implementing QMS

2
 1.1 INTRODUCTION TO QUALITY
Different scholars define quality differently i.e. according to
Joseph Juran, quality means
 “Fitness for use” and
 “Zero defects,
 "Quality is Free." His position was that where there are zero
defects, there are no costs associated with issues of poor quality.

According to Philip Crosby, it means “conformance to

requirements”. (Diaz, 2014) Quality planning involves
developing the products, systems, and processes needed to meet
or exceed customer expectations. (Nanda, 2005)
3
DEFINITION OF KEY TERMS

4
DEFINITION OF KEY TERMS Cont..

5
Cont.…

6
 1.2 Overview of Quality Management System

The world is changing and accordingly, the expectations of

human beings are also changing. People want assurance of the
quality and safety of the materials they procure. They need true
quality which means that the product and services should not
only meet the expectations of the customers but should also be
safe and produced by ethical means. (Purushothama, 2015) A
view on quality is changing, from the period before the year
1980 to today and Quality management is changing, too.

7
 Cont…
According to Osman (2016), many organizations are using different Models
for Quality Improvement that cover product, process and/or people-based
improvement, such as:
 ISO:(International Organization of Standardizations) Guidance on use
for process improvement and process capability determination
 QFD: Quality Function Deployment, also known as the House of Quality
approach, that focuses on customer wants or needs in the (re)design of a
product or service
 Kaizen: Japanese for change for the better; the common English term is
continual improvement
 Zero Defect Program: created by NEC Corporation of Japan (Nippon
Electric Company), based upon statistical process control and one of the
inputs for the inventors of Six Sigma
.
8
 Cont…
 Six Sigma: combines established methods such as statistical process control, the
design of experiments and failure mode and effects analysis in framework
 PDCA: Shewhart /Deming's plan, do, check, act cycle for quality control
purposes. Six Sigma's DMAIC method (Define, Measure, Analyze, Improve and
Control) may be viewed as a derivation of this.
 Taguchi Methods: statistical oriented methods including quality robustness,
quality loss function, and target specifications
 Toyota Production System: reworked in the west into “Lean manufacturing”
 TQM: Total Quality Management is a strategy aimed at embedding awareness of
quality in all organizational processes.
 BPR: Business Process Reengineering, a management approach aiming at 'clean
slate' improvements and evolved as principle quality systems since they address
the whole business and thus are more widely used.
9
 Cont…
Quality management system is defined as a management system to direct
and control an organization with regard to quality. Quality is a dynamic state
associated with products, services, people, processes, and environments that
meets or exceeds expectations and helps produce superior value.
The purpose of a quality management system is to establish a framework of
reference points to ensure that every time a process is performed the same
information, methods, skills, and controls are used and applied in a consistent
manner.
In this way, it helps to define clear requirements, communicate policies and
procedures, monitor how work is performed and improve teamwork.

10
 Cont…
Quality management comprises all activities that are required to plan for quality in
an organization and all activities that are required to satisfy quality objectives.
Specifically, quality management comprises four elements i.e.
 Quality Planning,

 Quality Control

 Quality Assurance, and Quality Improvement.

Quality management system should define and cover all facets of an organization's
operation, from identifying and meeting the needs and requirements of customers to
design, planning, purchasing, manufacturing, packaging, storage, delivery,
installation, and service, together with all relevant activities carried out within these
functions (DALE, 2003).

A quality management system consists of the organizational structure, procedures,

processes, and resources needed to implement quality management (Nanda, 2005).
11
 Cont…
Juran recommends the following ten-step quality improvement process to achieve
continuous quality improvements: (Nanda, 2005). Part of the challenges for
implementation will also emanate from those steps.
 Build awareness of the need and opportunity for improvement.

 Set goals for improvement.

 Organize to meet the goals that have been set.

 Provide training throughout the organization.

 Carry out projects to solve problems.

 Report progress.

 Give recognition.

 Communicate results.

 Keep score.
 Maintain momentum by building improvement into the company’s
regular systems.
12
 1.3 Quality Management Concepts

In supplying products or services there are three fundamental parameters that

determine their salability
 Price,
 Quality

 Delivery

Customers require products and services of a given quality to be delivered by a

given time and to be a price that reflects value for money. These are the
requirements of customers.

An organization will survive only if it creates and retains satisfied customers and this
will only be achieved if it offers products or services that respond to customers and
upon understanding the needs and expectations of its customers, and upon managing
the organization in a manner that deals to continued satisfaction of them.

13
 Cont…
The management system is
 The way the organization operates
 The way it carries out its business, and
 The way things are done.

Its purpose is to enable the organization to accomplish its mission, its

purpose and its goals.
All organizations possess a management system, some are formal and some
are in formal. Therefore managing a system is crucial part of every
organization to deliver the required output

14
 Cont…
A quality managements system is not a random collection of procedures, tasks or
documents. It is that art of the organizations management system that focus on the
achievement of outputs in relations to the quality objectives.

It is unlikely that any organization will be able to produce and sustain the required
quality unless it organized to do so.

Quality does not happen by chance. It has to be managed. No organization has ever
been successful with out having been planned, organized and controlled in some
way.

One of the popular and internationally accepted management systems that help to
manage quality and bring effectiveness is ISO 9000 QMS.

15
 1.4 Principle of Quality Management System
Managing an organization encompasses quality management amongst other
management disciplines. Eight management principles have been identified that can
be used by top management in order to lead the organization towards improved
performances.

Principle 1: Customer focus

 To understand customer needs ( Present & future)

 To satisfy customer requirements

 To exceed customer expectations

Principle 2: Leadership
 Leadership establish unity of purpose, directions and internal environment of
the organization
 Leadership establishes the context in which people involved

16
 Cont…
Principle 3: Involvement of people
 Full involvement of people at all levels for the benefits
of the organization
Principle 4: Process Approach
 Managing resources and activities as a process helps in
the achievement of desired results

Principle 5: System approach management

 Understanding and managing a system of interrelated
processes. This will contribute to the organization
effectiveness and efficiency

17
 Cont..
Principle 6: Continual improvement
 Must become the organizational permanent objective

Principle 7: Factual approach to decision making

 Effective decisions are based on the analysis of data
and information

Principle 8:Mutually beneficial supplier relation ships

 Allow both organizations to create value

18
 1.5 ISO 9000 Family and Background
Background
It was in 1987 that the International Organization for Standardization (ISO) developed
and published ISO 9001, 9002 and 9003 and other related guidelines on international
standards. This gave birth to the currently popular ‘The main purpose of ISO 9000 is
essentially to define the terminology that exists throughout the rest of the standards.

The first revision of the ISO 9001, 9002 and 9003 standards took place in 1994
without much alteration in their structure.

The second major revision was done in 2000, when ISO 9001, 9002 and 9003 were
replaced by a single standard − ‘ISO 9001:2000 Quality Management Systems −
Requirements’. This was revised again in 2008 as ISO 9001:2008. Both then ISO
9001: 2015.

ISO standards and requirements revision take place from five to ten years

19
 Cont.
ISO 9000 Family
The ISO 9000 family of standards represents an international consensus on
good quality management practices. It consists of standards and guidelines
related to quality management systems (QMS) and supporting standards.

The adoption of all standards published by ISO, including standards in the

ISO 9000 family, is voluntary in nature not mandatory.

The main purpose of ISO 9000 is essentially to define the terminology that
exists throughout the rest of the standards.

20
 Cont.
ISO 9000 Family

21
 Cont.
ISO 9000
 An entire family of standards
 ISO 9000 is also an individual standard
 Outlines vocabulary/definitions for entire QMS series
 Main purpose - definition

ISO 9000 can be defined in two separate ways, because it is technically two separate
things. The first definition of ISO 9000 is an entire family of standards.
To be more specific, ISO 9000 holds a series of individual standards underneath it,
which includes ISO 9001.However, the ISO 9000 family also includes an individual
standard called ISO 9000.

22
 Cont.
ISO 9000 as Single Standard

This gives general background information to quality management, and

lists definitions and terms used in quality management.
It is a guidance document only and will not be used by assessment
bodies for surveillance or certification purposes. However, it is called up
as a Normative reference in ISO 9001 and could be used by auditors to
support their interpretation of ISO 9001 requirements.

23
 1.6 Review of ISO 9001:2008 Requirements
ISO 9001 is applicable to all sectors of industry, including manufacturing and service,
and to organizations of all sizes. It is not a product standard but a management system
standard to demonstrate an organization’s ability consistently to provide products or
services that meet customer and regulatory requirements.

ISO 9001 specifies ‘what’ is required to be done by an organization but does not
indicate ‘how’ it should be done, thus giving you great flexibility in running your
business.

Furthermore, ISO 9001 does not set any particular level of quality. You and your
customers do that. The standard will only help you to achieve the level you want.

For example, if you set an objective that 99% of the time you will meet your delivery
commitments, the system will help you to achieve that.

24
 1.6 Review of ISO 9001:2008 Requirements

ISO 9001
 An individual standard within ISO 9000 family

 Includes specific requirements for a company

 Gap analysis and internal audits are required

 Main purpose – actions analysis and internal audits

ISO 9001 is an individual standard within the larger category of the ISO 9000 family,
but it is different than the ISO 9000 standard itself.

This is due to the fact that ISO 9001 is consistent of specific requirements for a
company.

This is what the personnel of a business will use to stay within the lines of the quality
management system.
25
 1.6 Review of ISO 9001:2008 Requirements

ISO 9001
 This will replace the current series of ISO
9001/9002/9003
 There are some significant changes to the current
requirements, and this guide highlights some of these
changes.
 This is the standard which assessment bodies will use
for surveillance or certification purposes

26
1.6 Review of ISO 9001:2008 Requirements

27
1.6 Review of ISO 9001:2008 Requirements

28
Cont.

29
Cont.

30
Cont.

31
Cont.

32
Cont.

33
Cont.

34
Cont.

35
Cont.

36
Cont.

37
Cont.

38
Cont.

39
Cont.

40
Cont.

41
Cont.

42
 Cont.
Clause 4: Quality Management System

Clause 4 state the general requirements for a Quality

Management System. Clause 4 is divided into two main
Subclauses:

 4.1 General Requirements

 4.2 Documentation Requirement

43
 Cont.

This contains the basic requirements for establishing a management system rather than
any particular component of the system. In this section it is stated that ways in which a
management system must be defined and documented.

The standard required to establish, document, implement and maintain a quality

management system and continually improve its effectiveness. The standard explains
how to do this. Identify and manage processes necessary for the QMS, throughout the
organization.

44
 Cont.

Special attention is given to the demand to control processes that affect product
conformity that the organization preferred to outsource.

The QMS general requirements include.

 Determine the QMS processes

 Determine their sequence and interactions

 Determine the methods of operations and control

 Provide resource to ensure effective operations ( Clause 6)

 Monitor, measure and analyze processes ( Clause 8.2 to 8.4)

 Improve the effectiveness of the process( Clause 8.5)

45
Cont.

46
Cont.

47
 Clause 4:2.A Quality Policy Cont.

Top management establishes the organization rules and principles. Their vision and
mission is part of the quality policy and has to be appropriate to the company. The
policy statement has to provide a frame work for determining, controlling and
meeting requirements.

It should express the commitment to continual improvement of the QMS. It

should be understood by all levels in the organization. This section embraces the
standard view on the role of the QMS in the company, in a PDCA cycle.

The policy has to be periodically reviewed for establishing its suitability.

48
Quality Policy Cont.

49
Clause 4:2.B Manual

50
Clause 4:2.C Quality Objectives

51
 Clause 4:2.D Control of Documents

Documented procedures are required to control documents

needed for the effective running of the QMS ( from internal or
external sources, other than records).
Documents have to be formally approved for fitness, prior to
release. They must be reviewed and updated when ever
necessary. Changes need re-approval. There is a need of formal
method to identify the revision level of controlled.
The necessary document must be available at point of use and
remain legible. The distribution of relevant external document
must be controlled .Obsolete documents may be retained if so
required by users, however they should be clearly identified to
prevent misuse.

52
 Clause 4:2.D Control of Documents

As noted in the standard, “documented information” can be required:

 When information needs to be disseminated or shared.
 To prove (and retain that proof) that a quality process has been completed and what the
results were.
 To retain organizational knowledge including:
Processes
Specifications and revisions
Goals and expectations
Monitoring and measuring
Analysis, reviews, evaluations, and validation
Terminology
Decisions made
Negotiations
Notifications
Authorizations
Actions taken
Assets, inventories and property management
Position descriptions and qualifications

53
 Clause 4:2.D Control of Records

A documented procedure for managing all required records, by

the QMS, customers legally and by the standard, must be
established.
• Those are records that demonstrate the conformity of
products to requirements as well as the effectiveness of the
QMS
• The procedure shall help identifying, storing, protection,
retention time and describe disposal of these records.
• Process owners must identify, classify and maintain all
process records in good and secure conditions throughout
retention period
• Records shall remain legible, readily identifiable and
retrievable

54
 Clause 4:2.D Control of Records

Organizations must establish a documented procedure to:

o Approve documents for adequacy prior to issue
o Review, update as necessary, and re-approve documents
o Identify the changes and current document revision status
o Make relevant documents available at points of use
o Ensure the documents remain legible and readily
identifiable
o Identify external documents and control their distribution
o Prevent obsolete documents from unintended use
o Apply suitable identification if obsolete documents are
retained

55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
 1.7 ISO 9001:2008 VS ISO 9001:2015

A new version of the standard, ISO 9001:2015, has just been

launched, replacing the previous version (ISO 9001:2008).
 The changes include more clauses and use a new concept
and approach.
 If ISO 9001:2008 emphasizes on continual improvement
and customer satisfaction,
 ISO 9001:2015 puts more focus on risk-based thinking.
 Risk-based thinking, as the concept and approach added in
the new version, requires organizations to identify and
analyze potential risks that could arise both from inside
and outside of the organizations.

70
 1.7 ISO 9001:2008 VS ISO 9001:2015

 Thus, organizations can formulate strategies to prevent

any impact of the risks and they can be expectantly more
resilient and sustainable by accommodating the risks.
 Other changes in the new version are the consideration of
the organizational stakeholders’ needs, the importance of
knowledge management and less emphasis on
documentation.
 The new version of ISO 9001 has 10 clauses and a brief
comparison of clauses between both versions is presented
in Table 1.

71
72
73
74
 1.8 Implementation of Quality Management System
Sequential steps of implementation, based on the requirements of ISO 9001:
2015:
Step 1 - Recognition of the Initial Situation
 The first phase is to analyze what the organization does and how it
does, identifying their critical processes and sub-processes
 The second phase the organization should conduct an audit of diagnosis
regarding the quality aspects related to its processes, suppliers,
products or services
 The third phase identifying the regulatory requirements related and
verifying the degree of compliance

75
 Cont.
Step 2 - Sensitization Management
 In this step the results of initial diagnosis has been presented to top
management to sensitize directions to the advantages of implementing
a quality management system
 The Organization should begin to give proper training to its directors
and middle managers
 In addition to training is essential to promote awareness-raising for the
largest possible number of employees in order to achieve the accession
of all and the good cooperation of each to the project

76
 Cont.

Step 3 - Quality Policy Definition

 At this stage the Organization defines its quality policy

 The quality policy should take into account the result of the initial
diagnosis
 It is through the quality policy that the top management formalizes
Organization's commitment to ensure that quality is a top priority,
combined with the vision and strategy of the company
 The Organization shall establish its view, based on "Where we want to
go?” and "How do we get there?"

77
 Cont.
Step 4 - Definition of Project Team
 At this stage the organization analyses the work that has to be done and who can
do it
 After assessing the skills you have, the Organization decides on the need to hire
outside help

Step 5 - Definition of Implementation Plan

 At this stage the Organization defines the implementation plan

 The Organization establishes the objectives of the project,

 Defines its schedule, skills and individual responsibilities of each member of the
project team,
 The Organization defines the form of monitoring of project progress and
frequency of follow-up meetings with the representative of the top management
78
 Cont.
Step 6 - Project Team Training in QMS
 At this stage, the Organization providence specialized training in order to
provide the project team with the skills needed to develop the project (Quality
management processes, document management, systems management, etc.)
Step 7 - Planning
 At this stage we proceed to the project planning
 By analyzing the requirements of the standard, usually, the Organization
finds that a significant part of the requirements already a common practice.
 It is time to compile the existing internal documentation.
 However, it is necessary to make the framework in accordance with the
requirements in the standard

79
 Cont.
Step 8 - Implementation and Operation
 At this stage we proceed of project implementation.

 For the system to work, it is essential to involve all employees

 It is important to stress that any employee can propose changes to the system,
but that all changes have to be properly approved
 The requirements that are not part of the Organization's daily practices have to
be analyzed and adapted to the organization
 In order to encourage all employees and the top management it is advisable
that the project team prepare monthly a newsletter giving news of the project
advances

80
 Cont.
Step 9 - Checking and corrective action
 At this stage makes up a critical analysis of the system as to achieve its
objectives and create the mechanisms for the systematic and continuous
monitoring in order to act proactively on the system
 Develop and implement to the control procedures of
 Documents and records,
 Non-conformities,
 Corrective and preventive actions and audits
 With internal audits seek to be objective evidence to confirm the effectiveness
and compliance of what is being done or identify deviations so that in time we
can act on them correcting them
81
 Cont.
Step 10 - Certification of QMS

This step is required an external audit of the certification body

For a company require a certification audit must make an application package to send to

the certification body

This file is essentially made up of the following documents:

 Certification request to the certification entity (entities have their own draft for its

formalization);

 Organization Chart of the Organization

 Simplified premises layout, in the case of industrial entities

 Map or road layout with the location of the Organization;

 List of measuring and monitoring equipment

82
Cont.

83
Cont.

84
Cont.

85
Cont.

86
Cont.

87
1.9 Benefits and Challenges of Implementing QMS

88
 Challenges of QMS Implementation Cont.
Barriers to implementation of QMS are classified into
1. External barriers include
 Impact of government on the implementation of ISO 9000 standards in the country's
organizations
 Impact of the government represented in issues such as legislation, financial
support.
 The effect of the certification process fees such as consultancies and certification
body fees and cost of training programs
2. Organizational barriers Include
 Lack of understanding the benefits of ISO 9000 certification, awareness of
ISO 9000 standards,
 Lack of top management commitment, leadership and involvement
 Lack of human resource management
 Lack of employees' involvement and empowerment

89
 Challenges of QMS Implementation Cont.
3. The organizational culture barriers.
 Employee's resistance to change,
 Wrong people in wrong positions
 Promotion of directors, managers and head of departments not based on
qualifications
 Employee absenteeism
4. The technical barriers
 Ineffective communication
 Lack of information
 The difficulty of access to test laboratories
 Lack of understanding the requirements and implementing them

90
91