UNDERSTANDING ‐‐ ISO 9000 

UNDERSTANDING ISO 9000

Q
QUALITY MANAGEMENT SYSTEM

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 WHAT IS ISO ?
WHAT IS ISO ?
• IInternational Organisation
t ti lO i ti for Standardisation
f St d di ti
• Established in 1946 @Geneva, Switzerland
• It is an association of National Standard Bodies of 
more than 150 countries
• Primary objective is coordination & unification of 
Pi bj i i di i & ifi i f
international standards.
• It employs system of technical committees, sub 
It l t ft h i l itt b
committees & working groups to develop 
international standards
international standards.

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 Why ISO ?
Why ISO ?
• It controls quality. 
• It saves money.
It saves money. 
• Customers expect it. 
• And competitors use it.

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 Benefits from (ISO‐9001) Quality 
Management System
• It is a passport for entry in international market.
i f i i i l k
• It increases the professional image of your 
organization.
• It increased customer confidence.
• It improves quality cut in costs reducing to 
rejection control.
rejection control.
• It shows clarity of responsibility and authority.
• It increases consistent quality.
It increases consistent quality
• According to this better and defined system.

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 Documents to be Prepared
Documents to be Prepared
• Quality Policy Manual
• Quality System Procedures (QSPs)
Quality System Procedures (QSPs)
• Work Instructions (WIs)
• Records / Formats / Forms

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ISO Document Levels
ISO Document Levels

LEVEL 1 – defines approach & 
Quality 
responsibility
Manual

Procedures LEVEL 2 – defines Who, What 

& When 

Work Instructions LEVEL 3 – Answers how

LEVEL 4 – Promotes 
Other Documentation Records 
Evidences

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 QUALITY POLICY MANUAL
QUALITY POLICY MANUAL
• First level documentation, defines “ what will 
be done and why” y
• The manual communicates the quality policy 
and objectives of an organisation
and objectives of an organisation
• It is a living document because it reflects the 
current system being followed in the 
organisation.

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 Quality System Procedures (QSPs)
Quality System Procedures (QSPs)
• Second level documentation defines who
dl ld i d fi h
should perform specific tasks, when the task 
should be done and where the documentation 
will be made.
• It collectively defines the organisation’s
p g q y
operations from receiving an enquiry to 
delivering a completed product / service.
• These are confidential documents and need 
These are confidential documents and need
not be revealed to outsiders.

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 Work Instructions (WIs)
Work Instructions (WIs)
• 3rd Level Documentation defines how individual 
work processes (Ex: machining, welding..etc) are 
carried out within a company.
p y
• It also specifies how the work should be done; 
who should undertake the work and what records
who should undertake the work and what records 
are to be maintained.
• It may be in the form of drawings, routing sheet, 
It may be in the form of drawings routing sheet
photographs..etc
• It is advisable that it should be written by the 
It is advisable that it should be written by the
employee who performs the task.

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 Records / Formats / Forms
Records / Formats / Forms
• These are the evidence of activity having been 
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performed in compliance with quality system 
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procedure.
• These are used to provide traceability of 
These are used to provide traceability of
actions on specific product or batch of 
products.
• “IN
IN GOD WE TRUST FROM ALL OTHERS WE 
GOD WE TRUST FROM ALL OTHERS WE
REQUIRE OBJECTIVE EVIDENCE”

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 1.Scope
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1.1.  General
The Standard  specifies requirements for QMS 
where an organisation needs to demonstrate its
where an organisation needs to demonstrate its 
ability to consistently provide product that meets 
customer and applicable regulatory requirements
customer and applicable regulatory requirements.
1.2  Application
All requriements of this standard are generic and 
ll f h d d d
are intended to be applicable to all organisations 
regardless of type, size and product provided.
dl f d d d d

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2.Normative Reference

ISO 9000:2000 
ISO 9000:2000 – Quality 
Quality
Management Systems –
Fundamentals & Vocabulary
Fundamentals & Vocabulary 

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 3 Terms and Definitions
3.Terms and Definitions

The term “Organisation” replaces the 
term supplier used in ISO 9001:1994 
and refers to the unit to which the 
i
international standard applies.
i l d d li

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 4 Quality management system
4.Quality management system.
4.1General Requirements
4 1General Requirements
The organisation shall 
a) Identify the processes needed for QMS and their application.
b) Determine the sequence & interaction of these processes
c) Determine criteria & methods needed to ensure the operation 
&
& control of these processes are effective.
t l f th ff ti
d) Ensure availability of resources & information necessary to 
support the operation and monitoring processes.
e) Monitor, measure & analyse these processes.
f) Implement actions necessary to achieve planned results and 
continual improvement of these processes
continual improvement of these processes.
4.2 Documentation Requirements.
All four level documents as explained earlier.
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 5 Management Responsibility
5.Management Responsibility
5.1Management Commitment
Top Management shall provide evidence of its commitment to the 
development & implementation of the QMS and continually improving its 
effectiveness by Establishing the Quality policy and Quality Objectives
effectiveness by  Establishing the Quality policy and Quality Objectives.
5.2Customer Focus
Top Management shall ensure that the customer requirements are 
determined and are met with the aim of enhancing customer satisfaction.
5.3Quality Policy
Top Management shall establish communicate review the continuing
Top Management shall establish, communicate, review the continuing 
suitability of the  Quality Policy 
5.4Planning
Top Management shall ensure that Quality objectives including those 
needed to meet the requirement of the products are established and the 
same shall be measurable & consistent with the Quality Policy
same shall be measurable & consistent with the Quality Policy.

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 5 Management Responsibility
5.Management Responsibility
5.5 Responsibility, Authority & Communication
Top Management shall ensure that responsibilites and authorities are defined
Top Management shall ensure that responsibilites and authorities are defined 
and communicated within the organisation. 
Top Management shall appoint a member of management who irrespective of 
other responsibilites shall have responsibility and authority that includes
other responsibilites shall have responsibility and authority that includes
a) Ensuring that processes needed for QMS are established, implemented & 
maintained.
b) Reporting to top management on the performance of the QMS and any
b) Reporting to top management on the performance of the QMS and any 
need for improvement
c) Ensuring the promotion of awareness of customer requirements throughout 
the organisation
the organisation
5.6 Management Review
Top Management shall review the organisation’s QMS at planned intervals to 
ensure its continuing suitability adequacy and effectiveness
ensure its continuing suitability, adequacy and effectiveness.

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 6.Resource Management 
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6.1  Provision of resources
The organisation shall determine and provide the 
resources needed to implement & maintain the QMS and 
contin all impro e its effecti eness
continually improve its effectiveness.
6.2 Human resources
P
Personnel performing work affecting product quality shall 
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be competent on the basis of appropirate education, training, 
skill and experience
skill and experience
6.3 Infrastructure – Buildings, transport, communication 
devices ..etc
6.4 Work Environment – work space, ventilation ..etc

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 7 Management Responsibility
7.Management Responsibility
7.1  Planning of Product Realisation
A document specifying the processes of QMS and the 
resources to be applied to a specific product referred as quality plan
resources to be applied to a specific product referred as quality plan
7.2 Customer– related Process
Requirements specified by the customer for delivery and post
Requirements specified by the customer for delivery and post 
delivery activities / requirements not stated by the customer but 
necessary for specified or intended use
7.3 Design & Development
7.4 Purchasing
7.5 Production & service provision
d &
7.6 Control of monitoring and measuring devices

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 8.Measurement, Analysis & 
Improvement
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8.1  Generall
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The organisation shall plan & Implement the 
applicable methods, including statistical techniques 
li bl h d i l di i i l h i
and continually improve the effectiveness of the 
QMS.
QMS
8.2 Monitoring & Measurement
821C
8.2.1 Customer Satisfaction
S if i
8.2.2 Internal Audit
8.2.3 Monitoring & measurement of Processes
8.2.4 Monitoring & measurement of Product
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 8.Measurement, Analysis & 
Improvement
8.3 Control of nonconforming product
(a) by taking action to eliminate the detected nonconformity
(b) by authorising its use, release or acceptance under 
concession by relevant authority and where applicable by the 
customer.
customer
8.4 Analysis of data – with data from customer satisfaction, 
conformity of product requirement suppliers etc
conformity of product requirement, suppliers..etc
8.5 Improvement – The Organisation shall continually 
improve the effectiveness of the QMS through the use of the
improve the effectiveness of the QMS through the use of the 
quality policy, objectives, audit results, analysis of data, 
corrective and preventive actions

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 ISO 9000 family a review
ISO 9000 family a review
ISO 9001 – for QA in design, development, 
production, installation and servicing (Module H 
in ISO 9001 : 2000)
ISO 9002 – for QA in Production and installation 
(
(Module D in ISO 9001: 2000) )
ISO 9003 – for QA in final inspection & test (Module 
E in ISO 9001:2000)
E in ISO 9001:2000)
ISO 9004 – for Quality Management and system 
elements guidelines (Converted as QMS in ISO
elements guidelines (Converted as QMS in ISO 
9001:2000) 

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 Benefits on implementing QMS as per 
ISO standards
“Users” experience clearly indicates the several significant 
“U ” i l l i di h l i ifi
improvements in the following areas :
• Improved employee involvement (Avg gain 100%)
Improved employee involvement (Avg gain 100%)
• Improved House Keeping (Avg.gain 140%)
• Improved Decision making based on facts & data (Avg.gain
Improved Decision making based on facts & data (Avg.gain 
95%)
• Improved Customer Satisfaction (Gain 55%)
• Improved safe working area (Gain 45%)
• Reduced Customer Complaints (about 40%)
• Reduced inspection efforts (about 45%)
• Reduced Quality Cost (about 50%)

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 List of Changes in ISO 9001: 2008 & 
likely impact on QMS
• Refer the text matter attached 3 pages 

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ALL THE BEST

THANK U
THANK U

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