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PRESENTED TO: SIR ALI ZUQARNAIN

PRESENTED BY:
SHEHR BANO YAWAR ALI (10585)
MUHAMMAD SAAD AWAN (10302)
QAMROSH ZAHEER (10443)
SYED MUHAMMAD FAHAD (8165)
What Is Quality?
Degree to which a set of inherent characteristics
fulfils requirements
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Identify, understand and agree customer requirements
Plan to achieve them
Measure, monitor & control processes/activities
Requires A System
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Meeting Our Customers Requirements

Doing Things Right the First Time; Freedom from Failure
(Defects)

Consistency (Reduction in Variation)

Continuous Improvement

Quality in Everything We Do
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A belief in the employees ability
to solve problems


A belief that people doing the
work are best able to improve it


A belief that everyone is
responsible for quality
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MANAGEMENT SYSTEM
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Management Support
Mission Statement
Proper Planning
Customer and Bottom Line Focus
Measurement
Empowerment
Teamwork/Effective Meetings
Continuous Process Improvement
Dedicated Resources
ELEMENTS FOR
What Is A Quality Management System?
People
Processes
Materials
Equipment
Resources
Planned
Individually
System
Best Practice
Implemented
Collectively
Documented
System
Describes how
this happens
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Quality Techniques & QMS Standards
Quality
Control
Quality
Assurance
Quality
Management
(Detection) (Prevention) (Direction)
BS 5750
1979-1987
ISO
9001/2/3
1987-2000
ISO 9001
2000
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Why Document in
Quality Management
Communication Tool
Manage Change
Aids consistency
Record of Best Practice
Enables Effective Audit
ISO 9001 Pre-requisite
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Documented Q.M.S.
POLICY
QUALITY
MANUAL
PROCEDURES
LOCAL/WORK INSTRUCTIONS
RECORDS / FORMS
INTENT
WHAT?
PROOF
HOW?
WHY?
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ISO 9001 - Q.M.S. Requirements


ISO 9004 - Q.M.S. Guidelines on Performance Improvement



ISO 9000 - Q.M.S. Fundamentals & Vocabulary
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The Structure of Quality Standards
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
ISO 9001:2000
Based on the 8 Quality Management Principles:
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Continual improvement of
the quality management system

Requirements


Satisfaction

Customers
Customers
Resource
management
Measurement,
analysis and
improvement
Product
Realisation
Management
Responsibility
Input Output
Product
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ISO9001 defines what the organization does to
ensure that its products or services satisfy the
customer's quality requirements and comply
with any regulations applicable to those
products or services.
ISO 14000 is primarily concerned with
"environmental management". In plain
language, this means what the organization
does to minimize harmful effects on the
environment caused by its activities.

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ISO 14001 is an internationally recognised standard for environmental
management system which can be applied by any organisation.

It has much in common with ISO 9001, in particular the PLAN - DO -
CHECK- ACT concept.

As a minimum, ISO 14001 requires a commitment to legal compliance,
continual improvement and pollution prevention.

It involves the identification and assessment of all environmental aspects
and impacts in order to determine which are significant.

These must then be managed so as to minimise harm to the environment.
ISO14001 - Environmental management system model
for the international standard
Environmental Policy
Planning
Environmental aspects
Legal and other requirements
Objectives and targets
Environmental management
programmes
Implementation and Operation
Structure and responsibility
Training, awareness and competence
Communication
EMS documentation
Document control
Operational control
Emergency preparedness and response
Checking and Corrective Action
Monitoring and measurement
Non-conformance and corrective
and preventative action
Records
EMS audits
Continual
improvement
Management Review
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ISO 14001
Fundamental requirements



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From

Motivation through fear and loyalty

To

Motivation through shared vision

Attitude: Its their problem Ownership of every problem affecting
the customer

Attitude: the way weve always done it

Continuous improvement
Decisions based on assumptions/ judgment
calls
Decisions based on data and facts


Everything begins and ends with
management


Everything begins and ends with
customers
Crisis management and recovery Doing it right the first time

Choosing participative OR scientific
management

Choosing scientific AND participative
management

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Control
&
Improvement
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Process set-up?
Risks?
Objectives of the process?
Which contributes to the goals of the
organization?
Resources and
conditions?
Results of the process?
Measurement and steering?
?
1
2 3
4
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The ISO 9000:2000 series consists of 3 Primary
standards
ISO 9000: QMS concepts and vocabulary
ISO 9001: QMS requirements
ISO 9004: QMS guidelines
This is supported by an additional standard
ISO 10011: QMS auditing guidelines
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ISO 9001 specifies the requirements for a
quality management system that may be
used for internal application by
organizations, certification, or contractual
purposes.
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ISO 9004 gives guidance on a wider
range of objectives of a quality
management system to improve the
organisations overall performance.

It is not a guideline for implementing
ISO 9001 and is not intended for
certification or contractual use.
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ISO 9001:2008 is divided into 8 sections:
the first 3 are introductory

The requirements begin at section 4 and have the
following headings:
Quality management system
Management responsibility
Resource management
Product realisation
Measurement, analysis and improvement
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QUALITY MANAGEMENT
PRINCIPLES
Quality Management System
The organisational structure, responsibilities,
procedures, processes and resources
for implementing quality management.
ISO 9001:2000 Process model
Customer
satisfaction
Customer
Customer
?
Delivery of
Services
Management
Resources Measurement
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1. SCOPE
Includes the design and construction of clean room, ventilation
and air conditioning system, metal finishing system,
environmental control system for automotive and other
industrial or commercial applications. Exclusion Design and
development validation.

2. Normative References :
- ISO 9000:2005
- ISO 9001: 2008 QMS
- ISO 9001:2000 QMS
- ISO 9002:1994
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3. Terms and Definition
Definitions Terms used by an organization; Processes, interaction,
improvement The focus is on looking at: What we do. Who we are
doing it for. Improving how we provide service.

4. General requirements
Documentation requirements Control of document Documents must
show a control number, adoption and revision dates, in order to
ensure use of the most recent information. Control of records Each
record must be controlled in order to ensure uniform quality.

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4. General requirements
- General Documents
- Quality Manual
- Control of Documents
- Control of Records

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5. Management Responsibility
- Commitment
- Focus
- Policy
- Objectives
- Planning
These correspond to the following
principles: Customer focus
Leadership
6. Resource Management
- Provide quality resources
- Provide quality personnel
- Provide quality infrastructure
- Provide quality environment
This corresponds to the following principle: Involvement of People

7. Product Realization
Control of the following process realization, planning, customer, communication,
product development, purchasing, function, operation, monitoring

These correspond to: Get the facts before you decide Focus on customers Use a
process approach Work with your suppliers
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8. Measurement, Analysis and Improvement
- Perform remedial processes Monitor and measure quality Control
- nonconforming products
- Analyze quality information
- Make quality improvements

This corresponds to: Get the facts before you decide Encourage continual
improvement
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International, expert consensus on state-of-the-art
practices for quality and environnemental management.
Common language for dealing with customers and
suppliers worldwide in B2B.
Increase efficiency and effectiveness.
Model for continual improvement.
Model for satisfying customers and other stakeholders.
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Build quality into products and services from design
onwards.
Address environmental concerns of customers and
public, and comply with government regulations.
Integrate with global economy.
Sustainable business
Unifying base for industry sectors
Qualify suppliers for global
supply chains
Technical support for regulations

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Documented procedures required by this standard and
those needed by the organisation to control its
processes.

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Establish & maintain a manual including:
scope of QMS with details/justification for any exclusions
procedures or reference to them
description of sequence and interaction of processes
included in QMS
The quality manual shall be controlled
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Quality Manual
ISO 9001 IS SIMPLY
A SYSTEM FOR
CREATING
PAPERWORK!!!
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The extent of the QMS documentation depends on the
following:
a) size and type of the organisation
b) complexity and interaction of the processes
c) competence of personnel

Note: The documented procedures may be in any
form or type of medium.
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QMS documents shall be controlled.
A documented procedure shall be
established:
to approve documents prior to use
to review/update & re-approve as
necessary
to identify changes and current revision
status
to ensure relevant versions are available
to ensure legibility and identification
to control documents of external origin
to control obsolete documents


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QMS records shall be maintained to provide evidence of
conformance to requirements and effective QMS
operation.
A documented procedure shall be established for :
Identification,
storage
retrieval
protection
retention time and
disposition of records.
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Determine team, set budget
Internal auditor(s) training if using in-house resources
Hire consulting firm if applicable
Gap Assessment
Implement requirements of standard to meet your business
needs against the gap assessment
Go-Live
Hold Management Review Meeting
Conduct Internal Audit
Refine documentation
Employee involvement training
System adjustment
Registration audit Stage 1
System adjustment
Registration audit Stage 2

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Submit application to registrar

Stage 1: Assessment of readiness

Stage 2: Assessment for registration audit

Registration/certification awarded for 3 years

Surveillance audits (at least annually)

Recertification audit at the end of 3
rd
year

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