This document provides an overview of quality management systems and ISO 9001:2008 standards. It defines key terms like quality, management system, quality management, quality assurance, and quality control. It describes the basic principles of a quality management system like customer focus, leadership, engagement of people, and continual improvement. It explains the PDCA cycle and process approach used in quality management. The aims and benefits of implementing a certified quality management system are also summarized.

1. QMS-ISO9001:2008
QUALITY MANAGEMENT SYSTEM
Dr Kalpesh Parikh, Director

2. QMS-ISO9001:2008
System is for the organisation, and not
organisation for the system.
AIM
Enhancing
Customer
Satisfaction
Same Result
irrespective of
Person Performing it.

3. QMS-ISO9001:2008
What is Quality?
“DEGREE TO WHICH A SET OF INHERENT
CHARACTERISTICS FULFILS REQUIREMENTS”
Quality of a product is denoted by its
• Market Acceptance
• Appearance
• Usage
• Consistency
• Lasting Value

4. QMS-ISO9001:2008
H/W
S/W
Humanware
MS
IT Solution
Infrastructure
System
What is Management System?
“set of interrelated or interacting elements to establish
policy and objectives and to achieve those objectives”

5. QMS-ISO9001:2008
Quality definitions
 Deming: A predictable degree of uniformity and
dependability at low cost and suited to the market.
 Crosby: Conformance to the requirements.
 ISO 8402: A totality of features and characteristics of a
product or service that bear on its ability to satisfy stated
or implied needs.
Source:
www.intellisenseit.com

6. QMS-ISO9001:2008
Quality Management System
Quality Assurance :
“Part of Quality Management System,
focused on providing confidence
that quality requirements
will be fulfilled”
Quality Management
Coordinated activities to direct
and control organization
Wrt Quality
Quality Control :
“Part of Quality Management,
focused on fulfilling
quality requirements”
QMS requirements are complementary to technical requirements for
product

7. QMS-ISO9001:2008
• System Approach
• Continual Improvement
• Factual Approach to Decision
Process
• Mutually beneficial Supplier
Relationship
• Process Approach
• Factual Approach
• Organization and Personal
Learning (Knowledge)
• Agility (To react Change)
• Creating Customer Value
• Focus on Social Value
• Visionary Leadership
• Understanding Core Competence
(profound knowledge of business)
• Involvement of People
• Collaboration with partners
• Total optimization of system
• Autonomy (Empowerment)
Quality Management Principles

8. QMS-ISO9001:2008
Introduction to ISO 9000
ISO : International Organization for Standardization
ISO 9000 : International Quality Management System Standard
: Applies to Quality Management System and
not to the Products
: They are generic and not specific to any Industry
• These are developed to effectively document the quality elements
to be implemented in order to maintain an efficient quality system in
company.
• Do not specify the technology to be used for implementing quality
system elements.
• They tell what you ought to consider doing when you manage your
organization, not how precisely you should do.

9. QMS-ISO9001:2008
What is Standard ?
A Written document detailing minimum features, specifications and
requirement of product. These are required to
(a) Prescribe the minimum requirements for Quality
(b) Ensure safety of operations both for workmen and users
(c ) Promote interchangeability of the product.
(d) Achieve variation reduction
ISO 9000
QMS Manual
PROCEDURE
FORMS RECORDS
WORK INSTRUCTION
ISO Requirements

10. QMS-ISO9001:2008
C
U
S
T
O
M
E
R
C
U
S
T
O
M
E
R
Management
responsibility
Resource
management
Measurement, analysis,
improvement
ProductProduct
realisation
Quality Management System
Continual Improvement
R
e
q
u
i
r
e
m
e
n
t
s
S
a
t
i
s
f
a
c
t
i
o
n
Input
Output
The QMS Model

11. QMS-ISO9001:2008
Plan: establish the objectives
and processes necessary to
deliver results in accordance
with customer requirements and
the organization's policies
Do: implement the processes
Check: monitor and measure
processes and product against
policies, objectives and
requirements for the product
and report the results
Act: take actions to continually
improve process performance;"
PDCA Cycle
The Deming Cycle

12. QMS-ISO9001:2008
Process
ProcessProcess
ActivitiesActivities
++
ResourcesResources
InputInput OutputOutput
ControlsControls
(e.g.procedure)(e.g.procedure)
An activity using resources and managed in order to
enable the transformation of input into outputs can be
considered as process.
ISO 9000:2000 clause 3.4.1 defines a "Process" as:
"Set of interrelated or interacting activities which transforms
inputs into outputs”

13. QMS-ISO9001:2008
Process Approach
The application of a system of processes within organization, together with the
identification and interactions of these processes and their management can be referred to
as the “Process Approach”
Processes - understand interactions
ProcessProcess
AA
ProcessProcess
DD
ProcessProcess
BB
ProcessProcess
CC
InputInput
OutputOutput
ControlsControls

14. QMS-ISO9001:2008
Why Process Approach
If processes are right Product/Service is supposed
to be ‘right’
A desired result is achieved more efficiently when
activities and related resources are managed as a
process.
Knowledge is input to
Process and not output
From Process
Person Dependent
to
Process Driven Organization

15. QMS-ISO9001:2008
Process
Integration
Process Dimensions
Proof of Process
Performed
Process
Verification
Process
Validation
Process
Monitoring
Process
Owner
Process
Measurement

16. QMS-ISO9001:2008
Process Performance
•Skill and Knowledge to Perform the Process
•What is to be done (Procedure)
•How it is to be done (Work Instruction)
This is irrespective of Technology and Technicality of
process, irrespective of infrastructure used, tools used.
•Effectiveness of Process
•Efficiency of Process
Institutionalization of Processes
Person is incidental to Organization
Tools & Technology also should be incidental to Organization

17. QMS-ISO9001:2008
Effectiveness
“producing or capable of producing desired effect”
“extent to which planned activities are realized and planned
results are achieved”
Efficiency
“Acting or Producing effectively with a minimum of waste,
expense, or unnecessary effort”
“Exhibiting high ratio of output to input”
“relationship between the result achieved and the resources
used”
Effectiveness and Efficiency

18. QMS-ISO9001:2008
Better Product Quality
• Cost Effectiveness
• Transparency in
operations
• System dependent rather
than person dependent
Advantages to Employees
• Simple Standard Instruction
• Less blaming & finger pointing
• Pride
• Training to newcomers
becomes easy
• Enhance confidence of
customer
• Demonstrates company is
committed to Quality
•Less stress at work
•Better work environment
Advantages to Company

19. QMS-ISO9001:2008
QMS Plan-Do-Check-Act Implementation Model

20. QMS-ISO9001:2008
•Apex Manual
• Policy and Objectives
•Mandatory Process Documentation
•Business Process Documentation (What is to done)
•Procedure Documentation (How it is to be Done)
•Record Formats / Templates (Proof of Process Performed)
•Training – Awareness, Internal Audit and MR
•Implementation
•Internal Audit
•Management Review
•Invite Certification Body for Initial Audit
•Surveillance Audit
•Re-Certification Audit
QMS Certification Process

21. QMS-ISO9001:2008
SHANTIKRUPA
ESTATES PVT LTD
Icons Who Trusted us
Hashmukh
Shah
Group
Government Agencies
UGC-AICTE-INFLIBNET-AMC
Government Corporations
GSFC-GIIC-GAIC-GIDC
GHB
Gujarat
Housing
Board

22. QMS-ISO9001:2008
Think Techknowlogically
MSWH-new Generation ERP
Technology
KnowledgeLogic ownership
SolutionTechnique
Techknowlogical
Quality Seekers are
Too BUSY
to be SAD
Too POSITIVE
to be DOUBTFUL
Too OPTIMISTIC
to be FEARFUL
Too DETERMINED to be DEFEATED