ISO 9001:2000

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 Process

OUT PUT

IN PU T

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 Inputs.
Raw Material Out Puts
Production Plan Product.
Machinery Production Production.
Men Quality.
Process Wastes.
Procedure
Specifications Byproducts.
Infra structure
Quality Plan

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 The Basics of ISO

Say What You Do

This means document your systems so you
will consistently do the job the same way
every time. We must make sure we have
appropriate documentation.
Do What You Say
This is what the auditors want to see. Objective
evidence that what you say you are doing in your
documentation is what you are doing in practice.

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ISO is a network of the national standards institutes of
156 countries, on the basis of one member per country,
with a Central Secretariat in Geneva, Switzerland, that
coordinates the system.

ISO is a non-governmental organization: its members are not,

as is the case in the United Nations system, delegations of
national governments. Nevertheless, ISO occupies a
special position between the public and private
sectors. This is because, on the one hand, many of its
member institutes are part of the governmental
structure of their countries, or are mandated by their
government. On the other hand, other members have
their roots uniquely in the private sector, having been
set up by national partnerships of industry
associations.

Therefore, ISO is able to act as a bridging organization

in which a consensus can be reached on solutions that 6
ISO standards are developed by national delegations of
experts from business, government and other relevant
organizations. They are chosen by the ISO members - the
national standards institutes participating in the technical
committee concerned - and are required to present a
national consensus position based on the views of
stakeholders in their country.

ISO's national members pay subscriptions that meet the

operational cost of ISO's Central Secretariat. The subscription paid
by each member is in proportion to the country's Gross National
Income and trade figures. Another source of revenue is the sale of
standards the operations of ISO Central Secretariat represent only
about one fifth of the cost of the system's operation. The main
costs are borne by the member bodies which manage the specific
standards' development projects and the business organizations
which provide experts to participate in the technical work. These
organizations are, in effect, subsidizing the technical work by
paying the travel costs of the experts and allowing them time to
work on their ISO assignments
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 ISO 9000 Standards
• The success in war was attributed to the
systems adopted and they were maintained
as Military secrets.
• In 1976, British Standard 5750 was
introduced.
• In 1987, ISO 9000 standards were adopted
by 92 countries
• First amendment was taken place in 1994
• In Dec 2000, the system was completely
reviewed and new standards ISO
9000:2000 series was released.

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 ISO 9000:1987 vs. ISO 9000:2000

• ISO 9000:1987 • ISO 9000:2000

• There were 3 • All have to go for
ISO 9001 only, and
standards Viz.
can get exemption
ISO 9001, ISO for any clause from
9002 and ISO Clause No 7,
9003. provided it is not
• There were 4 affecting the ability
main clauses and to meet customer
20 sub clauses in and regulatory
requirements.
Clause No 4
• There are 8 clauses
in ISO 9001:2000.
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 Objective

Introduce the concept of new ISO 9001 Standard

Highlight important areas and changes of the new standard

Briefly introduce the system requirements of the new standard

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 What is ISO 9001: 2000

2nd revision of Quality Management System Requirement Standard

from International Organization for Standards

Replacement for previous ISO 9001 / 9002 and 9003 standards of

1994

Introduced considerable conceptual changes

Applicable to all types of Organizations with possible

permissible omissions of certain requirements

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 New ISO 9001

Management
Responsibility

General Measurement, General

Resource
analysis &
requirements management QMS improvements
requirements

Product
Realization

Continual Improvement cycle

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 ISO 9001:2000 – Model
Continual Improvement of
the Quality Management System

5.Management
Responsibility

CUSTOMERS
CUSTOMERS

Quality Management

Satisfaction
6. Resource 8. Measurement
Analysis and
Management Improvement

System

7. Product
Requirements Product Consumption
Realization
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 Principles of new standard

Customer p
focus Leadershi

Mutual
beneficial nt
supplier Involveme
ip d o n eight of people
relationsh B a se
quality
ent
managem
Factual principles
to
approach
decision Process
making approach
System
to
Continual approach
en
improvem
ent Managem
t

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 Principles of new standard
Customer focus
•Organization depends customers
•Understand current & future customer needs.
•Meet / exceed customer expectations

Leadership
•Leaders establish purpose & direction of the organization
•Should create & maintain environment to achieve
organization’s objectives

Involvement of People
•People of all levels are essence of an organization
•Their full involvement for organization’s benefit

Process approach
Desired results are achieved more efficiently when activities and
resources are managed as process

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 Principles of new standard
System approach to Management
Identifying, understanding and managing interrelated process as a
system contributes to the organization’s effectiveness & efficiency

Continual improvements
Continual improvement of the organization’s overall performance
should be a permanent objective of the organization

Factual approach to decision making

Effective decisions are based on the analysis of data and information

Mutually beneficial supplier relationships

•An organization & its suppliers are interdependent
•Mutually beneficial relationship enhances the ability of both to
create value
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 QMS PRINCIPLES
1. Customer focus
• To identify and understand customer needs
• To satisfy customer requirements
• To meet customer expectations

2. Leadership
• Leaders establish unity of purpose,
direction
• and internal environment of the organization
• Leaders establish the context in which staff
• becomes involved

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 QMS PRINCIPLES
Contd..
3. Involvement of staff
• Full involvement of staff at all levels
• for the benefit of the organization

4. Process approach
• Managing resources and activities
processes
• to achieve desired results

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 QMS PRINCIPLES
Contd..
5. System approach management
• Understanding and managing a system of
• interrelated processes
• as a contribution to the organization’s
• effectiveness and efficiency

6. Continual improvement
• Must become the organization’s permanent
objective

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 QMS PRINCIPLES
Contd..
7. Factual and documented approach to decision
making:
• Effective decisions are based on the analysis
of data, information and indicators

8. Mutually beneficial relationships with suppliers

• Allows both organizations to create value

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 Expectations of the new Standard

Avoid the application of systems that are separate from the

organization’s business process

Enable the development of a Quality system that is fully integrated

into the normal operations of organization’s business

Enable Continual improvements of the system for enhanced

customer satisfaction

Enable compliance to statutory & regulatory requirements

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 Important changes

Criteria Previous version New Version

Main focus Products Customer satisfaction

Approach 20 quality elements Value adding processes

Product requirements Requirements specified by + Statutory & regulatory

customer / organization requirements

Involvement of people What to do, When, Whom & How + Why it is to be done
to do

Improvements Maintain the system Continual improvements

requirements should be achieved

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 Process approach

Process definition
Set of interrelated or interacting activities which transforms
inputs into outputs

Identify the
Identify Identify Establish Ensure
Interactions
the the Inputs measurin continual
to other
processes & outputs g criteria improvements
processes

Do it for all value adding processes

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 Process approach –
Continual improvements of Process

Understandings &
meeting requirements
PLAN

Continual improvements
Processes in terms
of Processes based on
Of Added Value PDCA Cycle
objective measurements
DO
ACTION

Measure results of process

Performance and effectiveness
- Objective Measurements
CHECK

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 E.g. - Purchasing Process

Inputs Purchasing Outputs

• Required item Procedure • Receipt of
/ quantity / Material on
date right condition
• Applicable • Right Quality
specs Right Quantity
Interactions to
• Supplier •Storage • Right Time
source •Inspection and
• Suppliers Testing
capability to •Manufacturing
meet our •Finance
requirements
Performance Measurements
•Delivery status – On-time, On
spec, NCP etc
•Supplier evaluation
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 System Requirements / Structure of the
Standard

4 Quality 5 Management 6 Resource 7 Product 8

Management Responsibility Management Realization Measurement
System Analysis &
improvement

Management
General Commitment Provision of Planning General
requirements resources

Customer focus Customer Monitoring &

Documentation Human related measurement
Requirements resources processes
Quality policy
Control of NCP
Infrastructures Design &
development
Planning Analysis of data
Work
environment Purchasing
Responsibility, Improvements
authority & Production &
communication service
provision
Management
Reviews

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 4 - Quality management system

Identification
Continual of processes
improvements required

4.1 General
requirements Criteria and

Monitoring and methods to ensure

Measuring of Operation & control

processes
Availability of
information &
resources for
operation & control

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 4 - Quality management system
4.2 Document requirements

Quality Policy

Quality Objectives

Quality Manual

Procedures required by the Standard

Procedures required for planning, operation & control of Organization activities

Records

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 5 - Management Responsibility

5.1 5.2 5.3 5.4 5.6 5.7

Management Customer Quality Planning Responsibility Management
commitment focus policy authority & Review
communicate

Quality Responsibility General

objectives & authority
Review
QMS Management inputs
planning representative
Review
Internal outputs
communication

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 5 - Management Responsibility
Development, implementation and
continually improvement of QMS

Establishment of
•Quality Policy
•Quality Objectives
Top
Management’s
Identification of Customer requirements
commitment

Communication of importance of
•Appointment of Management •Regulatory & statutory requirements
Representative
•Meeting customer requirements
•Conducting Management •Quality Policy & Quality objectives
Reviews •Responsibilities & authorities
•Providing required resources

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 5 - Management Responsibility

Evidence must be provided to show that the Management is committed

to the above requirements

Auditors could speak to and audit Top Management (E.g. MD /

Directors) to establish their commitment to the management system

New
Development

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 6 - Resource Management

6.1 6.2 6.3 6.4

Infrastructures
Provision of Human Work
resources Resources Environment

General

Competence,
awareness &
training

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 6 - Resource Management

Resources required to
Implementing, monitoring & continual
improvements
Enhance Customer satisfaction by meeting
customer requirements

Human Resources
Resource
Managemen
t Infrastructures
Infrastructures needed to achieve product
conformity

Work environment
Work environment needed to achieve product
conformity

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Enhanced
6 - Human Resources

Competent on the basis of appropriate

education, skill and experience

Define competencies for people performing

work affecting product quality

6.2
Human Provide training or actions
Resources

Evaluate effectiveness of the training / actions

Employees should aware importance of the

activity being performed

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 7 - Product Realization

7.1 7.2 7.3 7.4 7.5 7.6

Planning Customer Design and Purchasing Production Control of

related development & service monitoring
of product
processes provision measuring
realization devices

Identification of Design planning Purchasing Control

customer process
requirement
Design inputs Validation of
Purchasing processes
Review of Design outputs information
customer Identification &
requirement traceability
Design review Verification of
purchased
products
Customer Design Customer
communication verification property

Design validation Preservation of

product

Design Changes

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 7 - Product Realization

Quality objectives of Products – Specs

Processes, procedures to realize

product
7.1
Planning of Product
realization Verification, validation, monitoring,
inspection and testing of product

Record to demonstrate conformance

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 7 - Product Realization
Identification of Customer / Market
requirements
•Specified by customer
•Requirements taken for granted
•Statutory / Regulatory requirements
7.2
Customer related
processes – (Sales) Review of requirements related
product prior to acceptance /
commitment to customers - ability to
meet customer requirements

Effective communication with customer in relation to

•Product information
•Sales order handling
•Customer feedback
•Customer complaints

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 7 - Product Realization

Planning
•Effective & efficient
•Expectations of interested parties
•EHS

7.3
Design and
Development –
(Product) Design inputs and outputs

Review and verification, validation and control of changes

•Accuracy
•Potential hazards & faults
•Corrections
•Evaluations against lessons learned

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 7 - Product Realization

Degree of control depends on effects of

subsequent processes and effect on final
product
7.4
Purchasing
Purchasing is done
in controlled manner Supplier evaluation
to ensure that
purchased products
conforms to specific
requirements

Verification of purchased product –

Inspection and testing

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 7 - Product Realization
Product characteristics
(Specs) Procedures and work instructions

Suitable equipments to manufacture.

7.5 Monitoring and inspection & testing
Production and
service provision
Product release, delivery and post delivery
Manufacturing /
service provision
under controlled Process validation
condition to ensure
conformity of product

Identification and traceability

Customers property
Material supplied by customers – e.g.. 3rd party blending
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 7 - Product Realization

7.6 Control of monitoring and measuring devices

Control and Calibration of equipments used for monitoring, inspection and
testing

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 8 - Measurement, analysis
and improvement

8.1 8.2 8.3 8.4 8.5

Control of
General Monitoring & non Analysis of Improvement
measurements conforming data
product

Customer Continual
satisfaction improvements

Internal audits Corrective

action

Measurement of
processes Preventive
action
Measurement of
product

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 8 - Measurement, analysis
and improvement
To demonstrate
8.1 - To demonstrate
•Conformity of the product
•Conformity to QMS requirements
•Continually improvements and the effectiveness of the system

8.2 - Monitoring and Measurements

•Customer satisfaction / perception
•Internal audits - conformity planned arrangements of QMS and ISO9001
•Monitoring and measurements of processes – to determine / demonstrate ability of
processes to achieve required results
•Monitoring and measurements of product – Conformity to product requirements

8.3 - Control of NCP (Non Conforming Products)

•To assure that NCP products are identified and controlled to prevent
unintended use / delivery

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 8 - Measurement, analysis
and improvement
8.4 - Analysis of data
Collection and analysis of data generated through QMS
activities to verify suitability, effectiveness and continual
improvement of the system

Analysis shall provide information related to

•Customer satisfaction / perception

•Conformity to specs, requirements
•Trends of processes and products
• Opportunities for preventive actions
•Suppliers

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 8 - Measurement, analysis
and improvement
8.5 - Improvements
Continual Improvements
•QMS needed to be continually improved

Corrective action
•Actions to prevent recurrence of NCP, NCR etc
•Includes reviews, determination of causes, need of action,
implementation of action, review of action and maintenance of
relevant records

Preventive action
•Actions against potential non conformities to avoid their
occurrence
•Includes identification of potential non conformities, cause, need
for action, implementation of action, review of action and
maintenance of records

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 Criteria for measurements
–Satisfaction surveys for customers and other interested
parties
•Feedback on products
•Customer & market requirements

–Financial measurements
•Prevention cost
System •Non conforming / failure cost
performanc •Lifecycle cost
e
Self assessment

–Internal audits
•Effectiveness & efficiency of processes
•Opportunities for improvements
•Use of data / information
•Effective & efficient use of resources
•Adequacy, accuracy and performance of measurements
•Relationships with customers/ suppliers/ other interested parties
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 Criteria for measurements

–Process capability / process validation

–Reaction time
Processes
–Cycle time / throughput (Capacity)
–Utilization of technology
–Waste reduction
–Cost reduction

Products

–Inspection and testing of incoming, in process and final product

–Product verification
–Product validation

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Pros and Cons

More business oriented. Less procedure oriented

Company wide involvement

Mutual benefit to all interested parties

Customer focus than product focus

Continual improvements

Less emphasis on documentation

Demanding more resources ??

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Challenges in implementing new standard

Management Support

Encouragement

New ISO

Communication

Other employee Support

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 ISO 9001:2000
Transition Process

1st visit 2nd visit 3rd visit 4th visit

Review of Review of Review of Review of

QMS & Measurement, Management Resource
Product analysis & responsibilit management
realization improvements y

2 years

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Mission Purpose for which we are working?

What we would like to be? Vision

Policy Which path we need to adopt?

What we should achieve? Objectives

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 Five golden
questions.
• 1. A re we havi ng a pr ocedure?

• 2. H ow do we ensure it as the
best?

• 3. H ow it is i mplem ented?

• 4. W hether we got the resul ts as

anti ci pated?

• 5. H ow do we com pare wi th our

competi tors?
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Reasons for implementing ISO
9000

• To operate efficiently
• To achieve customer satisfaction
• To improve financial results
• To satisfy stakeholders, employees and
• partners
• To secure sustainability
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 ISO 9000 implementation hints
An 8 step approach An 8 step approach

1. Determination of customer needs and

expectations
2. Establishment of the organization's quality
policy and objectives
3. Determination of processes and
responsibilities to achieve the quality
objectives
4. Determination and provision of resources
to achieve the quality objectives

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 ISO 9000 implementation hints
An 8 step approach An 8 step approach (contd..)

1. Definition of methods for measuring process

effectiveness and efficiency

6. Implementation of measurement methods

7. Determination of means for dealing with

complaints and non conformities

8. Establishment and implementation of a

process for the continual improvement of the
Quality Management System QMS

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 ISO 9000 implementation hints
Role of top management Role of top
management

• Establish and maintain policy and set objectives

• Promote the quality policy in the organization
• Ensure focus on customer requirements
• Ensure the implementation of appropriate processes
to enable achievement of objectives and customer
requirements
• Ensure the availability of the needed resources
• Review the QMS periodically
• Decide on improvement actions

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 ISO 9000 Reminders

• Does NOT define quality

• Is NOT a one-time process
• Is NOT easy
• Requires commitment
• Requires resources

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 Standards and guidelines
ISO 9000:2000, Quality management systems - Fundamentals and
vocabulary
ISO 9001:2000, Quality management systems - Requirements
ISO 9004:2000, Quality management systems - Guidelines for performance
improvements
ISO 19011, Guidelines on Quality and/or Environmental Management
Systems Auditing (currently under development)
ISO 10005:1995, Quality management - Guidelines for quality plans
ISO 10006:1997, Quality management - Guidelines to quality in project
management
ISO 10007:1995, Quality management - Guidelines for configuration
management
ISO/DIS 10012, Quality assurance requirements for measuring equipment -
Part 1: Metrological confirmation system for measuring equipment
ISO 10012-2:1997, Quality assurance for measuring equipment - Part 2:
Guidelines for control of measurement of processes
ISO 10013:1995, Guidelines for developing quality manuals
ISO/TR 10014:1998, Guidelines for managing the economics of quality
ISO 10015:1999, Quality management - Guidelines for training
ISO/TS 16949:1999, Quality systems - Automotive suppliers - Particular
requirements for the application of ISO 9001:1994
Purpose
Establishes a starting point for understanding the standards and defines the
fundamental terms and definitions used in the ISO 9000 family which you need
to avoid misunderstandings in their use.
This is the requirement standard you use to assess your ability to meet
customer and applicable regulatory requirements and thereby address customer
satisfaction. It is now the only standard in the ISO 9000 family against which
third-party certification can be carried.
This guideline standard provides guidance for continual improvement of your
quality management system to benefit all parties through sustained customer
satisfaction.
Provides you with guidelines for verifying the system's ability to achieve
defined quality objectives. You can use this standard internally or for auditing
your suppliers.
Provides guidelines to assist in the preparation, review, acceptance and
revision of quality plans.
Guidelines to help you ensure the quality of both the project processes and the
project products.
Gives you guidelines to ensure that a complex product continues to function
when components are changed individually.
Give you guidelines on the main features of a calibration system to ensure that
measurements are made with the intended accuracy.
Provides supplementary guidance on the application of statistical process
control when this is appropriate for achieving the objectives of Part 1.
Provides guidelines for the development, and maintenance of quality manuals,
tailored to your specific needs.
Provides guidance on how to achieve economic benefits from the application
of quality management.
Provides guidance on the development, implementation, maintenance and
improvement of strategies and systems for training that affects the quality of
products.
Sector specific guidance to the application of ISO 9001 in the automotive
industry.
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