Understanding - Iso 9000 Quality Management System

UNDERSTANDING - ISO
9000 QUALITY
MANAGEMENT SYSTEM
WHAT IS ISO ?
• International Organisation for
Standardisation
• Established in 1946 @Geneva,
Switzerland
• It is an association of National Standard
Bodies of more than 150 countries
• Primary objective is coordination &
unification of international standards.
• It employs system of technical
committees, sub committees & working
groups to develop international
standards.
Why ISO ?
• It controls quality.
• It saves money.
• Customers expect it.
• And competitors use it.
Benefits from (ISO-9001)
Quality Management
System
• It is a passport for entry in international
market.
• It increases the professional image of
your organization.
• It increased customer confidence.
• It improves quality cut in costs reducing
to rejection control.
• It shows clarity of responsibility and
authority.
• It increases consistent quality.
• According to this better and defined
Documents to be Prepared
• Quality Policy Manual
• Quality System Procedures (QSPs)
• Work Instructions (WIs)
• Records / Formats / Forms
ISO Document Levels
LEVEL 1 – defines
Quality
approach &
Manual
responsibility
Procedures LEVEL 2 – defines Who,

What & When
Work LEVEL 3 – Answers how

Instructions
LEVEL 4 –
Other Documentation
Promotes
Records
Evidences
QUALITY POLICY MANUAL
• First level documentation, defines “
what will be done and why”
• The manual communicates the
quality policy and objectives of an
organisation
• It is a living document because it
reflects the current system being
followed in the organisation.
Quality System Procedures
(QSPs)
• Second level documentation defines
who should perform specific tasks,
when the task should be done and
where the documentation will be
made.
• It collectively defines the
organisation’s operations from
receiving an enquiry to delivering a
completed product / service.
• These are confidential documents
and need not be revealed to
Work Instructions (WIs)
• 3rd Level Documentation defines how
individual work processes (Ex:
machining, welding..etc) are carried out
within a company.
• It also specifies how the work should be
done; who should undertake the work
and what records are to be maintained.
• It may be in the form of drawings,
routing sheet, photographs..etc
• It is advisable that it should be written
by the employee who performs the
task.
Records / Formats / Forms
• These are the evidence of activity
having been performed in
compliance with quality system
procedure.
• These are used to provide
traceability of actions on specific
product or batch of products.
• “IN GOD WE TRUST FROM ALL
OTHERS WE REQUIRE OBJECTIVE
EVIDENCE”
1.Scope
1.1. General
The Standard specifies requirements
for QMS where an organisation needs to
demonstrate its ability to consistently
provide product that meets customer and
applicable regulatory requirements.
1.2 Application
All requriements of this standard are
generic and are intended to be applicable
to all organisations regardless of type, size
and product provided.
2.Normative Reference
ISO 9000:2000 – Quality

Management Systems –
Fundamentals & Vocabulary
3.Terms and Definitions
The term “Organisation”

replaces the term supplier used
in ISO 9001:1994 and refers to
the unit to which the
international standard applies.
4.Quality management
system.
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.
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.
4.2 Documentation Requirements.
5.Management
5.1
Responsibility
Management 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.
5.2 Customer Focus
Top Management shall ensure that the customer
requirements are determined and are met with the aim of
enhancing customer satisfaction.
5.3 Quality Policy
Top Management shall establish, communicate, review the
continuing suitability of the Quality Policy
5.4 Planning
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
5.Management
5.5 Responsibility
Responsibility, Authority & Communication
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
a) Ensuring that processes needed for QMS are established,
implemented & maintained.
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
5.6 Management Review
Top Management shall review the organisation’s QMS at
planned intervals to ensure its continuing suitability, adequacy
and effectiveness.
6.Resource Management
6.1 Provision of resources
The organisation shall determine and provide
the resources needed to implement & maintain
the QMS and continually improve its
effectiveness.
6.2 Human resources
Personnel performing work affecting product
quality shall be competent on the basis of
appropirate education, training, skill and
experience
6.3 Infrastructure – Buildings, transport,
communication devices ..etc
6.4 Work Environment – work space, ventilation
..etc
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
7.2 Customer– related Process
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
7.6 Control of monitoring and measuring devices
8.Measurement, Analysis &
Improvement
8.1 General
The organisation shall plan &
Implement the applicable methods,
including statistical techniques and
continually improve the effectiveness of
the QMS.
8.2 Monitoring & Measurement
8.2.1 Customer Satisfaction
8.2.2Internal Audit
8.2.3 Monitoring & measurement of
Processes
8.2.4 Monitoring & measurement of Product
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.
8.4 Analysis of data – with data from customer
satisfaction, conformity of product requirement,
suppliers..etc
8.5 Improvement – The Organisation shall
continually improve the effectiveness of the QMS
through the use of the quality policy, objectives,
audit results, analysis of data, corrective and
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)
ISO 9004 – for Quality Management and
system elements guidelines (Converted
as QMS in ISO 9001:2000)
Benefits on implementing QMS
as per ISO standards
“Users” experience clearly indicates the several
significant improvements in the following areas :
• Improved employee involvement (Avg gain 100%)
• Improved House Keeping (Avg.gain 140%)
• 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%)
List of Changes in ISO 9001:
2008 & likely impact on QMS
• Refer the text matter attached 3
pages
ALL THE BEST
THANK U

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UNDERSTANDING - ISO

Procedures LEVEL 2 – defines Who,

Work LEVEL 3 – Answers how

ISO 9000:2000 – Quality

The term “Organisation”

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