DDCL Implementers @2014.Quality management system

qms implementors standard

1. Dual Dimension Consulting Limited
DUAL DIMENSION CONSULTING LIMITED
RUPRANI HOUSE, 2
nd
FLOOR
MUKTAR DADDAH STREET,
P.O BOX 8983 – 00100
NAIROBI.

Wireless: [phone] / 4
Mobile: [phone]
E-mail: - [email protected]
Website: www.ddcl.org
© 2014

2. Dual Dimension Consulting Limited
SEMINAR ON IMPLEMENTATION OF
A QUALITY MANAGEMENT SYSTEM
ACCORDING TO ISO 9001

3. Dual Dimension Consulting Limited
Seminar Objectives
1.Introduce Participants to the basic concepts of quality, ISO 9000
Quality Management System standards and the principles of QMS
2.Participants to understand requirements of ISO 9001:2008
standard and how to implement them in their organizations
3.Participants to be able to develop the ISO 9000 QMS
documentation
4.Introduce participants to the concepts of internal quality audits
5.Give an overview of steps to certification

4. Dual Dimension Consulting Limited
Basic Concepts of Quality and
Evolution of Quality Management

5. Dual Dimension Consulting Limited
Session Outline
Definition of Quality
Quality and customer satisfaction
Supplier quality
Dimensions of quality
Cost of quality
History of Quality management

6. Dual Dimension Consulting Limited
Quality
What is quality?

7. Dual Dimension Consulting Limited
What is Quality?
People often use attributes to describe quality:
Examples:
Beauty, Goodness, Freshness,
Expensiveness etc
Different people perceive these attributes differently,
making the use of attributes to describe quality
IMPRECISE
Quality, therefore needs to be defined

8. Dual Dimension Consulting Limited
Definition of Quality
Quality is the degree to which a set of inherent
characteristics fulfils requirements.
Inherent - Inherent means existing in
something, especially as a permanent
characteristic.
Characteristic - Distinguishing feature; inherent
or assigned which can either be qualitative or
quantitative. There are various classes of
characteristics including; physical, behavioral,
functional e.t.c.
Requirement - A need or expectation that is
stated, generally implied or obligatory.

9. Dual Dimension Consulting Limited
Who defines Quality – The Q Lens
Lens of an organization

Products/Services
Processes
People


Results
Outcomes
Benefits
Lens of the customer

10. Dual Dimension Consulting Limited
Quality and Customer Satisfaction
Organizations of all types and sizes have come to
realize that their main focus must be to satisfy
their customers.
Two important questions arise:
1. Who are the customers?
2. What does it take to satisfy them?

11. Dual Dimension Consulting Limited
Dimensions of Product quality
Dimension 1: Performance
Does the product do what it is supposed to do,
within its defined tolerances?
Dimension 2: Features
Does the product possess all of the “extra” features
specified?

12. Dual Dimension Consulting Limited
Dimensions of Product quality
Dimension 3: Reliability
Will the product consistently perform within
specifications?
Reliability may be closely related to performance.
Dimension 4: Conformance
Does the product conform to the specification?
If it’s developed based on a performance
specification, does it perform as specified?

13. Dual Dimension Consulting Limited
Dimensions of Product quality
Dimension 5: Durability
How long will the product perform or last before
replacement?
Dimension 6: Serviceability
Is the product relatively easy to maintain and
repair?
Dimension 7: Aesthetics
How does the product look, feel, sound, smell or
taste like?

14. Dual Dimension Consulting Limited
Dimensions of Product Quality
Dimension 8: Perceived quality
How does the customer or public view the product?
Dimension 9: After-sales Service
Is there customer support following the purchase
of a product?
Dimension 10: Safety
Is the user free from harm or injury while using
the product?

15. Dual Dimension Consulting Limited
Dimensions of Service Quality
Dimension 1: Time and timeliness
What is the customers’ waiting time?
Did the service meet this time commitment?
Dimension 2: Completeness
Did the customer get all they asked for?
Dimension 3: Courtesy
Was the customer treated with respect by the
employees?
Dimension 4: Consistency
Are services delivered in the same manner to all
customers regardless of prevailing conditions?

16. Dual Dimension Consulting Limited
Dimensions of Service Quality
Dimension 5: Accessibility and Convenience
Was the service easy to obtain?
Dimension 6: Responsiveness
Were unexpected situations handled appropriately?
Dimension 7: Accuracy
Was the service right every time?
Dimension 8: Communicating milestones
Are key milestones on service delivery
communicated to the customer?

17. Dual Dimension Consulting Limited
Cost of Quality
Quality costs are the total of the cost incurred by:
a)Investing in the prevention of
nonconformance to requirements.
b)Appraising a product or service for
conformance to requirements.
c)Failing to meet requirements.
Quality, good or bad has a cost.

18. Dual Dimension Consulting Limited
Cost of Quality
1. Cost of good quality
Prevention
Appraisal
2.Cost of poor quality
External Failure Costs
Internal Failure Costs

19. Dual Dimension Consulting Limited
History of Quality Management
The Quality movement can trace its roots back to
medieval Europe, where craftsmen began
organizing themselves into unions called guilds in
the late 13th century.
Eventually, the factory system with its emphasis on
product inspection, started in Great Britain in the
mid-1750s and grew into the Industrial Revolution
in the early 1800s.
In the early 20th century, manufacturers began to
include quality processes in production.

20. Dual Dimension Consulting Limited
Evolution of Quality Management
The development of Quality management can be
clustered in 4 stages:
1.Quality Inspection (1920s)
2.Quality Control (1950s)
3.Quality Assurance (1970s)
4.Total Quality Management (1980s)

21. Dual Dimension Consulting Limited
Quality Inspection (1920s)
Inspection involves measuring, examining, and
testing products, process and services against
specified requirements to determine conformity.
Involved inspection of already manufactured
products which led to the following problems:
a.Technical problems occurred, requiring
specialized skills
b.Lack of trained inspectors
c.Inspectors were ordered to accept defective
goods to increase output
d.Skilled workers were promoted into other
roles, - less skilled performed the operational
jobs

22. Dual Dimension Consulting Limited
Quality Control (1950s)
This stage presented a fundamental shift from
inspection stage
It detected and fixed problems along the
production line to prevent the production of faulty
products

23. Dual Dimension Consulting Limited
Quality Assurance (1970s)
Quality Assurance, refers to planned and
systematic production processes that provide
confidence in a product's suitability for its
intended purpose.
The principles of Quality Assurance are:
a."Fit for purpose"- the product / service should
be suitable for the intended purpose.
b."Right first time"- mistakes should be
eliminated.

24. Dual Dimension Consulting Limited
Total Quality Management(1980s)
In the 1980s to the 1990s, a new phase of quality
control and management began. This became
known as Total Quality Management (TQM).
TQM is a business management strategy aimed at
embedding awareness of Quality in all
organizational processes
It is the process of individual & organizational
development the purpose of which is to increase
the level of satisfaction of all the stakeholders

25. Dual Dimension Consulting Limited
Quality!!
Question: How much effort should an organization
devote to QUALITY?
Reply: What fraction of your work do you want
done without QUALITY?

26. Dual Dimension Consulting Limited
Thank You!

27. Dual Dimension Consulting Limited
Introduction to ISO System and
Quality Management System
Concept

28. Dual Dimension Consulting Limited
Session Outline
Definition of ISO
How ISO started
What ISO has done
ISO Membership
Structure and features of ISO 9000 QMS standards
Benefits of implementation of ISO 9000 QMS
Management System Concept

29. Dual Dimension Consulting Limited
Who is ISO?
ISO is an International Agency that develops
International Standards to foster increased trade of
products and services
ISO consists of 163 member countries.
A country becomes a member of ISO through its
national standards body e.g. Kenya is a member
through Kenya Bureau of standards

30. Dual Dimension Consulting Limited
ISO Membership
Currently ISO is made up of 164 members who
are divided into three categories:
1. Member Bodies
2. Correspondent Bodies
3. Subscriber Bodies

31. Dual Dimension Consulting Limited
Member Bodies
A member body of ISO is a country’s standards
organization "mostly representative of
standardization in its country".
Only one such body for each country is accepted
for membership of ISO.
Member bodies are entitled to participate and
exercise full voting rights on any issue in policy
and other matters.

32. Dual Dimension Consulting Limited
Correspondent Bodies
 A correspondent member is usually an organization
in a country which does not yet have a fully-
developed national standards activity.
Correspondent members do not take an active part
in the technical and policy development work, but
are entitled to be kept fully informed about the work
of interest to them.

33. Dual Dimension Consulting Limited
Subscriber Members
Subscriber Membership has been established for
countries with very small economies.
Subscriber Members pay reduced membership fees
that nevertheless allow them to maintain contact
with international standardization.

34. Dual Dimension Consulting Limited
History of ISO
ISO was born from the union of two organizations -
the International Federation of the National
Standardizing Associations, (ISA) established in
New York in 1926, and the United Nations
Standards Coordinating Committee, (UNSCC)
established in 1944.
 In a meeting in London, ISA and UNSCC merged
to form ISO in October 1946 to facilitate the
international coordination and unification of
industrial standards.
ISO officially began operations on 23
rd
February
1947.

35. Dual Dimension Consulting Limited
History of ISO
ISO’S NAME
"International Organization for Standardization“
has different acronyms in different languages, its
founders therefore decided to give it “ISO” a
short, all-purpose name.
They chose "ISO", derived from the Greek isos,
meaning "equal".
Whatever the country, whatever the language,
the short form of the organization's name is
always ISO.

36. Dual Dimension Consulting Limited
History of ISO
WHAT ISO HAS DONE
Between 1947 and the present day, ISO has
published more than 19500 International
Standards, ranging from standards on agriculture
and construction, through mechanical engineering,
to medical devices, to the newest information
technology developments i.e. across all sectors of
the economy

37. Dual Dimension Consulting Limited
History of ISO
HOW ISO WORKS
The work of preparing international standards is
normally carried by ISO through ISO technical
committees.
Each member body interested in a subject for
which a technical committee has been established
has the right to be represented in that committee.
International organizations, both governmental
and non governmental, in liaison with ISO, also
take part in the work.

38. Dual Dimension Consulting Limited
Standards Identification
Standards are identified through indexing e.g.
KS – denotes “Kenya Standard”
BS – denotes “British Standard”
ISO – denotes “International Standard”
These are followed by a number e.g.
ISO 9000 the number “9000” is allocated by the
international standardization agency
BS 5750 the number “5750” is allocated by the
British standards institute
KS 1515 the number “1515” is allocated by the
Kenya Bureau of standards
The last number is the year the standard was
published e.g. ISO 9001:2008

39. Dual Dimension Consulting Limited
History and Evolution of ISO 9000
During World War II, there were quality issues in
many European industries e.g. those of
ammunitions, where bombs were exploding in
factories.
The solution adopted to address these quality
problems
 required factories to document their
procedures and to prove by record-keeping that
the procedures were being followed according to
the Allied Quality Assurance Programme (AQAP).

After the war, the British government adopted
this solution as BS 5750 in 1973.

40. Dual Dimension Consulting Limited
History and Evolution of ISO 9000
The base document to ISO 9000 was BS 5750, and
it was known as a management standard because
it specified not what to manufacture , but how
the manufacturing process was to be managed.
In 1987, the International Organization for
Standardization (ISO) 
adopted BS 5750 as an
international standard.
The international standard was named ISO 9000.

41. Dual Dimension Consulting Limited
The ISO 9000 Family
Four Primary standards
ISO 9000:2005, QMS – Fundamentals and
Vocabulary
ISO 9001:2008 , QMS – Requirements
ISO 9004:2009, Managing for the sustained
success of an organization -A quality
management approach
ISO 19011:2011, Guidelines on management
systems auditing

42. Dual Dimension Consulting Limited
Features of ISO 9000 Standards
Based on Eight Quality Management principles as
the philosophy
Consistent in terminology
Emphasis on processes
Employs QMS process model
Embraces the spirit of Continual Improvement
Focuses on customer satisfaction

43. Dual Dimension Consulting Limited
Quality Management Process Model
Value-adding activities
Information flow
KeyKey
OutputOutputInputInput
Continual improvement of
the quality management system
Customers and
Interested Parties
Satisfaction
Customers and
Interested Parties
Requirements
Resource
management
Clause 6
Measurement, analysis
and improvement
Clause 8
Management
responsibility
Clause 5
Product
Product
realization
Clause 7

44. Dual Dimension Consulting Limited
Spirit of Continual Improvement
Moving target
QMS:
Sustaining
the gains
C
ontinual
Im
provem
ent
Plan
What to do?
How to do?
Do
Do what was
planned
Check
Did things happen
according to plan?
Act
How to improve
next time?
Goal: Attaining
Higher levels

45. Dual Dimension Consulting Limited
The Management System Concept
For an organization to effectively plan, develop and
maintain any management system, it needs to
consider all the elements of the management
system

46. Dual Dimension Consulting Limited
The Management System Concept-Elements
Analysis
Strategy
+
Objectives+
Action Plan
+
Responsibilities
Skills
Methods
Communication
+
Review
+
+Detection of non-conformities
Performance measurement
Audits
Its Elements

47. Dual Dimension Consulting Limited
Common « Pitfalls » (1)
Analysis
-
-
Objectives
Action plan
Responsibilities
Skills
Methods
Communication
Review
?
Dispersion
Detection of non-conformances
Performance measurement
Audits

48. Dual Dimension Consulting Limited
Common « Pitfalls » (2)
Analysis
Objectives
?
Responsibilities
Skills
Methods
Communication
Review
Confusion
Detection of non-conformances
Performance measurement
Audits
Strategy

49. Dual Dimension Consulting Limited
Common « Pitfalls » (3)
Analysis
Strategy
Objectives
Action plan
Review ?
Chaos
Detection of non-conformances
Performance measurement
Audits

50. Dual Dimension Consulting Limited
Common « Pitfalls » (4)
Analysis
Strategy
Objectives
Action plan
Responsibilities
Skills
Communication
Methods
Review
?
Slow (no) change

51. Dual Dimension Consulting Limited
Common « Pitfalls » (5)
Analysis
Strategy
Objectives
Action plan
Responsibilities
Skills
Communication
Methods
Lack of consistency
(coherence)
Detection of non-
conformances
Performance measurement
Audits
?

52. Dual Dimension Consulting Limited
<<One Mould>>
Analysis
Strategy
Objectives
Action plan
Responsibilities
Skills
Communication
Methods
Controlled System
Detection of non-
conformances
Performance measurement
Audits
Review

53. Dual Dimension Consulting Limited
Benefits of Implementation
Operational efficiency
Enhanced customer satisfaction
Improved financial returns
Satisfaction of other stakeholders
Sustainability
Continual improvement
International recognition

54. Dual Dimension Consulting Limited
Thank You!

55. Dual Dimension Consulting Limited
The 8 Management Principles

56. Dual Dimension Consulting Limited
Session Outline
Introduce the Quality Management Principles
Integration of the Management Principles in an
organization

57. Dual Dimension Consulting Limited
Introduction
The revised ISO 9000 series of standards are
based on 8 quality management principles
The principles are derived from the collective
experiences of members of the ISO/TC/176

58. Dual Dimension Consulting Limited
Introduction cont…
Recommended that the principles be used by
management to guide organizations to improve
performance
The principles should be seen as a consistent set
and should not be applied individually

59. Dual Dimension Consulting Limited
The Principles
1.Customer focus
2.Leadership
3.Involvement of people
4.Process approach
5.Systems approach
6.Continual improvement
7.Factual approach to decision making
8.Mutually beneficial supplier relationships

60. Dual Dimension Consulting Limited
Integration of the Principles in an
Organization
Successful integration of the management
principles relies on the application of the process
approach and the Plan-Do-Check-Act (PDCA)
methodology.
This approach enables top management to assess
requirements, plan activities, allocate appropriate
resources, implement continual improvement
actions and measure results in order to determine
effectiveness.

61. Dual Dimension Consulting Limited
Integration of the Principles in an
organisation – PDCA
PLAN DO CHECK ACT
OUTPUT
Continual Improvement Cycle
Self-assessment steps to achieve the input:
Prioritization of improvement opportunities
Realization of financial and
economic benefits

Results of self- assessment
INPUT

62. Dual Dimension Consulting Limited
Principle 1: Customer Focus
Organizations depend on their customers and
therefore should understand current and future
customer needs, should meet customer
requirements and strive to exceed customer
expectations
Implication
Customer focus means putting your energy into
satisfying customers and understanding that
profitability comes from satisfying customers

63. Dual Dimension Consulting Limited
Integration of the Principle in an
Organization
Do
Product
realization
PLAN
Market Appraisal
Customer
requirement
identification
Achievable benefit
a)Improved revenues
b)Increases competitiveness
c)Improved customer retention and loyalty
d)Improved supply chain performance
e)Reduced time to market
f)Enhanced organizational performance, credibility and
sustainability.
Check
Assessment
Act
Improvement

Results of self assessment
Customer feedback
measurement
Output
Input
Continual improvement cycle

64. Dual Dimension Consulting Limited
Principle 2: Leadership
Leaders establish unity of purpose and direction of
the organization. They should create and maintain
the internal environment in which people can
become fully involved in achieving the organization’s
objectives
Implication
Leadership is providing role model behavior
consistent with the values of the organization.
Behavior that will deliver the organization objectives.
Internal environment includes the culture and
climate, management style, shared trust, motivation
and support

65. Dual Dimension Consulting Limited
Integration of the Principle in an
organization
Do
Values, policies
and objectives
Internal and
external
communication
Acquisition and
resource
management
PLAN
Strategic planning
Definitions of
responsibilities and
authority
Achievable benefit
a) Improved budgetary performance
b) Increases competitiveness
c) Improved customer retention and loyalty
d) Improved effectiveness of decision making
e) Optimized use of available resources
f) Heightened employee accountability
g) Improved intellectual capital
h) Optimized effective and efficient processes
i) Improved supply chain performance
j) Enhanced organizational performance, credibility and sustainability.
Check
Assessment
Act
Improvement

Results of self assessment
Output
Input
Continual improvement cycle

66. Dual Dimension Consulting Limited
Principle 3: Involvement of People
People at all levels are the essence of an
organization and their involvement enables their
abilities to be used for the organizations benefit.
Implication
Involving people means sharing knowledge,
encouraging and recognizing their contribution,
utilizing their experience and operating with
integrity.

67. Dual Dimension Consulting Limited
Integration of the Principle in an
organization
Do
Recruit training and
development
Competence
enhancement
communication
PLAN
Human Resource
planning
Check
Assessment
Act
Improvement

Results of self assessment
Output
Input
Continual improvement cycle
Achievable benefit
a) Reduced cost
b) Improved customer retention and loyalty
c) Heightened employee accountability
d) Improved intellectual capital
e) Optimized effective and efficient processes
f) Improved supply chain performance
g) Enhanced organizational performance, credibility and
sustainability.

68. Dual Dimension Consulting Limited
Principle 4: Process Approach
A desired result is achieved more efficiently when
activities and their related resources are managed
as a process
(Processes are systematically designed and
managed)
Implication
Processes within an organization should be
structured in order to achieve a certain objective in
the most efficient and effective manner

69. Dual Dimension Consulting Limited
Integration of the Principle in an
organization
Do
Allocation of
resources
Monitoring of
performance
indicators
PLAN
Identification of
processes
Determination of
sequence and
interaction activities
Check
Assessment
Act
Improvement

Results of self assessment
Output
Continual improvement cycle
Achievable benefit
a)Reduced cost
b)Increased competitiveness
c)Optimized use of available resources
d)Heightened employee accountability
e)Optimized effective and efficient processes
f)Improved supply chain performance
g)Reduced time to market
h)Enhanced organizational performance, credibility and
sustainability.
Input

70. Dual Dimension Consulting Limited
Principle 5: System Approach to
Management
Identifying, understanding and managing
interrelated processes as a system contributes to
the organization’s effectiveness and efficiency in
achieving it’s objectives
Implication
Systems are constructed by connecting interrelated
processes together to deliver the overall
organizational objectives

71. Dual Dimension Consulting Limited
Integration of the principle in an
organization
Do
System development
Process integration
and implementation
PLAN
Strategic planning
Check
Assessment
Act
Improvement

Results of self assessment
Output
Continual improvement cycle
Achievable benefit
a)Optimized use of available resources
b)Optimized effective and efficient processes
c)Reduced time to market
d)Enhanced organizational performance,
credibility and sustainability.
Input

72. Dual Dimension Consulting Limited
Principle 6: Continual Improvement
Continual improvement of the organization’s
overall performance should be a permanent
objective of the organization
Implication
Continual improvement is the progressive
improvement in overall organizational efficiency
and effectiveness

73. Dual Dimension Consulting Limited
Integration of the Principle in an
organization
•Audit Results
•Bench mark output
•Brain storm outputs
•Customer feed back
•External factors
•Financial performance
•Human Resources
•Problem solving
•Recommendations for Improvement
•Results of failure mode and effect analysis
•Results of business excellence Model
•Results of balanced score card
•Results of management Review
•Results of statistical process control
•Self assessment results
•Value of goods and services
•Yield
Sources of opportunities
for improvement plans
Process steps Review for action
Input
Budget allocations
•Capital expenditure
•Cash flow
•Cost reduction targets
•Performance target levels
•Projected sales
•Strategic plan
Output
Achievable benefit
a)Improved profitability
b)Increased revenues
c)Improved budgetary performance
d)Reduced cost
e)Improved cash flow
f)Improved return on investment
•Action plan development
•Allocation of resources
•Application of all principles and
selected tools
•Data analysis
•Identification of action terms
•Prioritization
•Recon ducting self assessment
and evaluation
•Results evaluation
•Self assessments
•Set and cascade objectives
•Trend identification

74. Dual Dimension Consulting Limited
Principle 7: Factual Approach to
Decision Making
Effective decisions are based on the analysis of
data and information
Implication
Facts are obtained from observations performed by
qualified people using qualified means of
measurement i.e. the integrity of the information is
known.

75. Dual Dimension Consulting Limited
Do
Data monitoring and
measurement
Record retention
PLAN
Data collection
planning
Authorization and
empowerment
Check
Data analysis and
evaluation
Act
Improvement

Results of self assessment
Output
Continual improvement cycle
Achievable benefit
a)Improved cash flow
b)Improved return on investment
c)Improved effectiveness of decision making
d)Optimized use of available resources
e)Optimized effective and efficient resources
f)Enhanced organizational performance, credibility and
sustainability.
Integration of the Principle in an
Organization
Input

76. Dual Dimension Consulting Limited
Principle 8: Mutually Beneficial Supplier
Relationships
An organization and it’s suppliers are
interdependent and a mutually beneficial
relationship enhances the ability for both to create
value
Implication
Beneficial relationships are those in which both
parties share knowledge, vision, values, and
understanding.
Suppliers are not treated as adversaries

77. Dual Dimension Consulting Limited
Integration of the Principle in an
Organization

Results of self assessment
Do
Supplier selection
Information sharing
and acceptance
criteria
Purchasing
PLAN
Supplier capabilities
evaluation
Joint strategic planning
and key suppliers
Check
Review and measure
Act
Improvement
Output
Achievable benefit
a)Reduced cost
b)Optimized use of available resources
c)Improved supply chain performance
d)Reduced time to market
e)Enhanced organizational performance, credibility and
sustainability.
Continual improvement cycle
Input

78. Dual Dimension Consulting Limited
Thank You!

79. Dual Dimension Consulting Limited
Summary of the ISO 9001:2008
Standard

80. Dual Dimension Consulting Limited
Session Outline
Text analysis of the clauses of ISO 9001 standard
Interpret the requirements as set out in the
clauses

81. Dual Dimension Consulting Limited
Clause 1: Scope
Talks about the standard and how it applies to
organizations
ISO 9001:2008 is intended to be generic and
applicable to all organizations, regardless of type,
size and product category.
 It is recognized,
however, that not all the requirements of this
standard will necessarily be relevant to all
organizations.
Under certain circumstances, an organization may
consider the exclusion of the application of some
requirements of ISO 9001:2008 from its QMS.

82. Dual Dimension Consulting Limited
Justification for Exclusion
 The appropriateness of the exclusion depends on
considerations of items such as:
Who is the customer ?
What is the product ?
What are the requirements (stated, implied
and legal) related to the product ?

83. Dual Dimension Consulting Limited
Clause 2: Normative Reference
References another document that should be used
along with the standard, ISO 9000:2005 , Quality
Management Systems-Fundamentals and
Vocabulary

84. Dual Dimension Consulting Limited
Clause 3: Terms and Definitions
Refers to ISO 9000:2005 for terms and definitions
used in the standard.

85. Dual Dimension Consulting Limited
Clause 4: General Requirements
This Clause gives the requirements for the
foundation or establishment of the Quality
Management System (QMS): -
QMS General requirements
Documentation requirements: -
Quality Manual
Control of Documents
Control of Records

86. Dual Dimension Consulting Limited
Clause 5: Management Responsibility
Gives requirements for Management and their role in
the Quality Management System: -
Management Commitment
Customer focus
Quality Policy
Planning
Quality Objectives
QMS planning
Responsibility, authority and communication
Management Representative
Management Review

87. Dual Dimension Consulting Limited
Clause 6: Resource Management
Gives requirements for resources including
personnel, training, the facility and work
environment: -
Provision of Resource
Human Resources
Infrastructure
Work Environment

88. Dual Dimension Consulting Limited
Clause 7: Product Realization
Gives requirements for the production of the product
or service, including activities like planning,
customer related processes, design, purchasing and
process control: -
Planning of Product Realization
Customer-related processes
Design and Development
Purchasing
Production and service provision
Control of monitoring and measuring
equipment

89. Dual Dimension Consulting Limited
Clause 8: Measurement, Analysis and
Improvement
Provides requirements on monitoring and
improving products and established processes: -
General requirements of measurement,
analysis and improvement
Monitoring and measurement
Control of nonconforming product
Analysis of data
Improvement

90. Dual Dimension Consulting Limited
Thank You!

91. Dual Dimension Consulting Limited
Defining Quality Management
System through Documentation

92. Dual Dimension Consulting Limited
Session Outline
Definitions
QMS Documentation requirements
Hierarchy of Documents
Procedures
Benefits of Documentation

93. Dual Dimension Consulting Limited
Definitions
Document: information and its supporting medium.
(ISO 9000:2005 cl. 3.7.2)
A document may specify requirements (e.g. a
drawing or technical specification); provide direction
(e.g. quality plan); or show results or evidence of
activities performed (e.g. records).
Record: a document stating results achieved or
providing evidence of activities performed. (ISO
9000:2005 cl. 3.7.6)
Note: records are historical

94. Dual Dimension Consulting Limited
Definitions
Procedure: specified way to carry out an activity
or process. (ISO 9000:2005 cl. 3.4.5)
A written procedure is referred to as a documented
procedure.
Work Instruction: detailed descriptions of how to
perform and record tasks (ISO/TR 10013:2001 cl
3.1)
e.g. detailed written descriptions, flowcharts,
templates, etc

95. Dual Dimension Consulting Limited
Definitions
Quality Manual: document specifying the quality
management system of an organization. (ISO
9000:2005 cl. 3.7.4)
Quality Plan: document specifying which
procedures and associated resources shall be
applied by whom and when to a specific project,
product, process or contract. (ISO 9000:2005 cl.
3.7.5)
Form: document used to record data required by
the QMS ISO/TR 10013:2001 cl 3.2
Note: a form becomes a record when data is
entered

96. Dual Dimension Consulting Limited
QMS Documentation Requirements
The ISO 9001:2008 clause 4.2.1 requires the
following documents within a QMS: -
a)Documented statement of quality policy and
quality objectives
b)Quality manual
c)Documented procedures and records
required by this international standard
d)Documents, including records determined by
the organization to be necessary to ensure
the effective planning, operation and control
of its processes.

97. Dual Dimension Consulting Limited
Hierarchy of Documents
Level 1: QP Defining the Organization QMS
QM Structure
Level 2: MP Standard Operating
OP Procedures
Level 3: WI Work Instructions
4.2.4 Records to demonstrate
effectiveness

98. Dual Dimension Consulting Limited
Quality Policy
It defines commitment to quality by the top
management
It is based on the quality management principles
Usually simple and straight to the point
Requirements for the quality policy are defined in
clause 5.3 of ISO 9001:2008

99. Dual Dimension Consulting Limited
Quality Policy: Example 1
Sample Quality Policy Statement
XYZ is committed to providing high quality and sustainable
services in an equitable manner to improve the living
standards of her residents.
In accomplishing this commitment, XYZ shall comply with all
applicable customer and legal requirements and continually
improve on her effectiveness by implementing a QMS based
on ISO 9001:2008.
XYZ’s top management shall review established quality
objectives and this policy on annual basis for continuing
suitability.
Signed:
CEO

100. Dual Dimension Consulting Limited
Quality Objectives
Quality objectives are a practical outline of the
Quality Policy
Established at relevant functions and levels within
the organization
They must be SMART
Must be consistent with the quality policy (clause
5.4.1 of ISO 9001:2008)

101. Dual Dimension Consulting Limited
Quality Objective: Examples
To enhance staff competence by conducting 3
refresher trainings in year 2011/2012
To improve production efficiency by automating
the production department by June 2012
To improve the yield per acre from 30% to 60%
within the next 5 years
Reduce the production costs by 5% by June 2012
Release at least 2 new products by June 2012

102. Dual Dimension Consulting Limited
Quality Manual
A quality manual (QM) is a special type of
document that describes an overall organization’s
QMS.
It provides information on organizational
background and capabilities.
It defines the scope of an organizations QMS,
explain exclusions in the scope, justify all
exclusions (reductions in scope) and describes how
the QMS processes interact
Clause 4.2.2 of ISO 9001:2008 specifies the
minimum content for a quality manual

103. Dual Dimension Consulting Limited
Procedures
A procedure is a sequence for undertaking various
activities.
A documented procedure shall detail;
Who shall do it
What shall be done
How it shall be done
When it shall be done
Where it shall be done
Which (materials, documents etc) shall be used
What if (decision making points-existence of
options)

104. Dual Dimension Consulting Limited
Procedure Format
ORGANIZATION NAME: ( ABC CO. LTD) DOCUMENT IDENTIFICATION NO.
SECTION: HUMAN RESOURCE REV. ………..
TITLE: PROCEDURE FOR TRAINING DATE OF ISSUE ………
ISSUED BY……….. ……
AUTHORIZED BY………
1.Purpose
2.Scope
3.References
4.Terms definitions
5.Principal Responsibility
6.Steps
7.Appendices

105. Dual Dimension Consulting Limited
Process Mapping
Processes are sequences of actions designed to
transform inputs into outputs.
A “process map” visually describes the flow of
activities of a process.
Process mapping is a tool that is used to
understand, analyze and document processes and
activities in an organization
Process mapping should be the first step in
documenting a procedure.

106. Dual Dimension Consulting Limited
Common Process Mapping Symbols
Start/Stop Used to signify the start and finish points
of a process

Process – this icon/shape
represents a step or
activity in the process. i.e. What
happens? Who does it? How long
does it take? How much
inventory is at this step?
Start/Stop
Process

107. Dual Dimension Consulting Limited
Common Process Mapping Symbols
Decision – this represents where a
decision is made e.g. Yes or No – usually
subsequent steps are shown in the
process map for each decision that could
have been made.
Connector –An arrow is basically a line
that joins one step of a process to another –
arrows are useful as they show the direction
the process is following.
Data- this represents input and output.
Decision
Connector
Data

108. Dual Dimension Consulting Limited
Example on Process Mapping
OFFICER HOD ADMINISTRATION ACCOUNTANT
Raise requisition
Communication
from HOD
STOP
Verify
Requisition
Communication
of the
outcome
Approval
Facilitate
Requisition
Filing the
requisition
Filling the
requisition
yesyes
No
No

109. Dual Dimension Consulting Limited
Thank You!

110. Dual Dimension Consulting Limited
Introduction to Auditing

111. Dual Dimension Consulting Limited
Session Outline
Definition and Purpose of a Quality Audit
Types of audit
Qualifications of Quality auditors
The Audit process
Auditor guidelines

112. Dual Dimension Consulting Limited
Definition of Quality Audit
It is the process of systematic examination of a
quality system carried out by an internal or
external quality auditor or an audit team.
ISO 9000:2005 defines a quality audit as a
systematic, independent and documented
process for obtaining audit evidence and
evaluating it objectively to determine the extent
to which agreed criteria are fulfilled.

113. Dual Dimension Consulting Limited
Definition cont…
Systematic meaning that an audit should be orderly i.e.
know what is following what
Independent meaning that the auditee should not direct
the auditor but allow him/her to make a decision that is not
influenced
Documented meaning that an auditor needs to provide
evidence that the audit was carried out.
Objective – the evaluation should be guided by facts and
not feelings
Audit criteria are a set of policies, procedures or
requirements. This also means the basis on which an audit is
carried out.

114. Dual Dimension Consulting Limited
Importance of Quality Audits
To determine whether the quality management
system conforms to specified requirements.
To determine the effectiveness of the implemented
system by establishing whether objectives are
being achieved.
To initiate improvements in the system by
implementing and monitoring the effectiveness of
corrective actions.
To compare practice with procedure
To provide objective evidence for certification

115. Dual Dimension Consulting Limited
Types of Audits by Focus
There are 3 types of audits namely:-
a)System Audit
b)Process Audit
c)Product Audit

116. Dual Dimension Consulting Limited
Types of Audits by Purpose
1.First party (internal) audits – they are
performed by the organization
2.Second party (supplier) audits are usually
performed by the customer on its suppliers (or
potential suppliers) to ascertain whether or not the
supplier can meet existing or proposed contractual
requirements.
3.Third party audits – These are done by an
external independent body for the purpose of
certification.

117. Dual Dimension Consulting Limited
Qualification of Auditors
ISO 19011:2002 requires an auditor to possess the
following qualifications:-
Education – minimum requirements is
secondary education
Training – Should be trained as an auditor
Experience – the auditor should have general
and specific knowledge about the field being
audited.
Personal attributes

118. Dual Dimension Consulting Limited
Personal Attributes
An auditor should also possess the following
personal attributes
A – Analytical
U – Unassuming and unbiased
D – Diplomatic
I – Inquisitive and independent
T – Thorough and tenacious
O – Objective and Observant
R – Reliable

119. Dual Dimension Consulting Limited
The Audit Process
The audit process can be divided into the
following phases:-
Planning and preparation for the audit
Execution of the audit
Reporting the findings
Follow-up activities

120. Dual Dimension Consulting Limited
Planning and Preparation
Notification - Prior to the beginning of an audit,
appropriate administrators are notified of the
pending audit and appraised of the audit
objectives.
Planning - During this phase of the audit,
background information on the area to be
audited is obtained.
a)Applicable policies and procedures
b)applicable laws and regulations
c)Prior audits of the area
d)Interviewing of employees
e)An audit plan is prepared.

121. Dual Dimension Consulting Limited
Execution of the Audit
Opening meeting - Confirm guide and his role
Not an arbitrator
May sign for observations
Not to interfere
Confirm resources availability (tools, office)
Confidentiality if need be
Confirm time of closing
NB: Keep meeting professional
Team leader chairs the meeting
Don't allow auditee to take over the control of the
meeting

122. Dual Dimension Consulting Limited
Audit Lozenge
Record
Check
Observe
Ask

123. Dual Dimension Consulting Limited
Auditors’ Meeting
Auditors undertake the following:-
Compilation of findings and observations
Recording of non-conformities
Preparation of summary report
Formation of opinion to be presented at closing
meeting

124. Dual Dimension Consulting Limited
Closing Meeting Agenda
Attendance register
Thank the auditee
Mention the principles of sampling followed
during the audit
Summarize audit observations
Give non-conformities in detail
Present overall summary and conclusions
Allow for discussion
Request corrective action dates
Agree on follow-up date
Close meeting

125. Dual Dimension Consulting Limited
What should an Audit Report contain?
Cover Sheet
Executive Summary,
Background Information
Audit Scope & Purpose,
Summary & Conclusions,
Detailed Findings, recommendations will be
included in the final report), and
Any attachments or appendices as appropriate

126. Dual Dimension Consulting Limited
Corrective Action Follow-Up
During the follow-up audit, it is important for
auditors to verify completion and effectiveness of
corrective action 

127. Dual Dimension Consulting Limited
Auditor’s Guidelines
During the audit an auditor should:-
Keep calm and relaxed
Look at the other person-eye contact
Keep the right distance from the person
Keep discussion factual and involve all
participants
Ask one question at a time & let the other
person finish talking
Do not lecture
Be friendly without being too familiar
Use the right gestures/expressions
Keep personal opinions to yourself

128. Dual Dimension Consulting Limited
Auditors Sins
An auditor should never:-
Compare the auditee with others
Argue, criticize or be sarcastic.
Be side tracked
Discuss personalities or company policy
Discuss religion or politics
Drink alcohol before an audit
Be late

129. Dual Dimension Consulting Limited
Thank You!

130. Dual Dimension Consulting Limited
STEPS TO CERTIFICATION

131. Dual Dimension Consulting Limited
Steps to Certification
1.Educate Top Management
2.Appoint management representative
3.Appoint project team
4.Train Middle Management
5.Undertake a gap analysis of the QMS
6.Awareness training for all employees
7.Document the QMS – Define the System
8.Implement the QMS - Improve Results

132. Dual Dimension Consulting Limited
9.Improve the QMS and system documentation
10.Train internal quality auditors
11.Undertake internal quality audits
12.Improve the QMS and documentation
13.Undertake a management review
14.Application for certification
15.Stage 1 audit
16.Certification/stage 2 audit
17.Certification/registration
Steps to Certification

133. Dual Dimension Consulting Limited
The Main Phases of ISO 9000 QMS
Phase 1: QMS planning
Phase 2: Awareness creation
Phase 3: Development/documentation of the
QMS
Phase 4: Implementation of the designed
QMS
Phase 5: Certification
Phase 6: Post certification phase

134. Dual Dimension Consulting Limited
The Certification Contract
 A certification contract lasts three years
 During the contract period the following audits are done:-
1. an initial certification audit
2. semi-annual surveillance audits
At end of the contract year a re-certification audit is carried
out and a new contract signed

135. Dual Dimension Consulting Limited
Potential Internal 

Barriers
Resources
Internal costs
Lack of management/employee time
Multitasked employees
Rapid turnover of employees
Lack of skills/training

136. Dual Dimension Consulting Limited
Potential Internal 

Barriers
Attitude
Resistance to change
Inconsistent management support
Discrepancy between perceived benefits and costs
involved
Insufficient “empowerment” of the people in charge of the
QMS (too low in the hierarchy)
Bad experience with other systems

137. Dual Dimension Consulting Limited
Potential External 

Barriers
High certification costs
Changing economic context (QMS not a priority of the
company)
No advantage on the market place
Lack of experience of the consultants

138. Dual Dimension Consulting Limited
The end!