Iso9000 2000

ISO 9001:2000
April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 1

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

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

New ISO 9001
Management
Responsibility
General Measurement, General

Resource
analysis &
requirements management QMS improvements
requirements
Product
Realization
Continual Improvement cycle

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
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

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

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
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

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

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

Process approach –
Continual improvements of Process
Understandings &
meeting requirements
PLAN
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

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
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

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

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

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

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

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

6 - Resource Management
6.1 6.2 6.3 6.4

Infrastructures
Provision of Human Work
resources Resources Environment
General
Competence,
awareness &
training

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

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

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

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

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

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

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

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
7.6 Control of monitoring and measuring devices

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

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

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

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

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

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

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
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

Pros and Cons
More business oriented. Less procedure oriented
Company wide involvement
Mutual benefit to all interested parties
Customer focus than product focus
Less emphasis on documentation
Demanding more resources ??

Challenges in implementing new standard
Management Support
Encouragement
New ISO
Communication
Other employee Support

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

Thank You

Iso9000 2000

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ISO 9001:2000

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 1

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

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 2

2nd revision of Quality Management System Requirement Standard

Replacement for previous ISO 9001 / 9002 and 9003 standards of

Introduced considerable conceptual changes

Applicable to all types of Organizations with possible

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 3

General Measurement, General

Continual Improvement cycle

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 6

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 7

Factual approach to decision making

Mutually beneficial supplier relationships

Avoid the application of systems that are separate from the

Enable the development of a Quality system that is fully integrated

Enable Continual improvements of the system for enhanced

Enable compliance to statutory & regulatory requirements

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 9

Criteria Previous version New Version

Approach 20 quality elements Value adding processes

Product requirements Requirements specified by + Statutory & regulatory

Improvements Maintain the system Continual improvements

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 10

Do it for all value adding processes

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 11

Measure results of process

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 12

Inputs Purchasing Outputs

4 Quality 5 Management 6 Resource 7 Product 8

Customer focus Customer Monitoring &

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 14

Monitoring and methods to ensure

Measuring of Operation & control

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 15

Procedures required by the Standard

Procedures required for planning, operation & control of Organization activities

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 16

5.1 5.2 5.3 5.4 5.6 5.7

Quality Responsibility General

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 17

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 18

Evidence must be provided to show that the Management is committed

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

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 19

6.1 6.2 6.3 6.4

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 20

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 21

Competent on the basis of appropriate

Define competencies for people performing

Evaluate effectiveness of the training / actions

Employees should aware importance of the

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 22

7.1 7.2 7.3 7.4 7.5 7.6

Planning Customer Design and Purchasing Production Control of

Identification of Design planning Purchasing Control

Design validation Preservation of

April 24, 2007 Ikhwandy properties/Introduction to ISO 9001:2000 23

Quality objectives of Products – Specs

Processes, procedures to realize