ISO 9001 : 2000

Anura Senarathna
 Objective

Introduce the concept of new ISO 9001:2000 Standard

Highlight important areas and changes of the new standard

Briefly introduce the system requirements of the new standard

Important issues in implementations

 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

Single standard (9001) for certification of all types of Organizations

with possible permissible omissions of certain requirements

Introduced considerable conceptual changes

From product centric to customer / business centric approach
 New ISO 9001 Model

Management
Responsibility

Measurement,
Resource
analysis &
management QMS improvements

Product
Realization

Continual Improvement cycle

 New ISO 9001 Model
Continual Improvement of the QMS

S
Information Management
Management a
Responsibility
Responsibility t
C i C
R
s
U e f U
S q Measurement,
Measurement, a S
Resource
Resource
u QMS Analysis
analysis & Info c
T management
Management improvements
T
i Improvements t
O r i O
M e o M
E m n E
R e Product
Product R
n Input Realization Product
Realization
t
s
 Principles of the New Standard

Customer
focus
Leadership
Mutual
beneficial
supplier
relationship Based and
Involvement
developed on
of people
eight quality
Factual management
approach to principles
decision
making
Process
approach
Continual System
improvement approach to
Managemen
t
Principles of the 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
Principles of the 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
 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 business operations of the organization

Enable continual improvements of the system for enhanced

customer satisfaction

Enable compliance to statutory & regulatory requirements

 Important Changes

 Criteria  Previous versions  9001:2000

 Main focus  Products  Customer satisfaction

 Approach  20 quality elements  Value adding processes

 Product  Requirements specified by  + Statutory & regulatory

requirements customer / organization requirements

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

people How to do

 Improvements  Maintain the system  Continual improvements

requirements should be achieved
 Process Approach

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

Identify
Identify Identify the Establish Ensure
the the Inputs Interaction measuring continual
processes & outputs s to other criteria improvements
processes

Do it for all value adding processes

 Process Approach
E.g.: Manufacturing
Process control
•Process parameters
•Inspection & testing
•Calibration and
maintenance of
equipments

Inputs
• Raw material
Output
• Manufacturing Manufacturing Finished product
formulations / Specs
• Equipments
Process
Manufacture /Testing
• Labour

Interactions to Performance Measurement

Inspection & testing
Warehousing •Final testing
Supply / Purchasing •Conformance rate
Sales
Training •Achieving of KPIs
Organizational processes are not in isolation
Linked and interacting with other processes

Manufacturing
Process

Purchasing
Sales Process
Process

Warehousing Management
QA process
process review process

Product development Training & Development

process process

Maintenance
process

Out put of one process will be an input to another process

Process approach: - Continual improvement

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
 ISO 9001:2000 model

Management
Responsibility
(ACTION)

Resource Measure, analysis

General General
Management improvements
requirements (PLAN)
QMS (CHECK)
requirements

Product
Realization
(DO)

Continual Improvement cycle

 ISO 9001:2000
System requirements
 System Requirements

4 5 6 7 8
Quality Measurement,
Management Resource Product
Management Analysis &
System Responsibility Management Realization
improvement

General Management Provision of Planning General

requirements Commitment resources

Customer Monitoring &

Documentation Customer focus Human related measurement
Requirements resources processes

Quality policy Control of NCP

Infrastructures Design &
development
Planning Analysis of data
Work
environment Purchasing
Responsibility, Improvements
authority &
communication Production &
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 – Company objectives & Departmental objectives

Quality Manual

Procedures required by the Standard – (6 procedures)

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 Responsibilit Management
commitment focus policy y authority & Review
communicate

Quality Responsibility & General

objectives authority
Review inputs
QMS planning Management
representative
Review
Internal outputs
communication
 5 – Management responsibility
Development, implementation and
continually improvement of QMS

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

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

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 of Customer Design and Purchasing Production Control of

related development & service monitoring
product measuring
realization processes provision
devices

Identification of Design planning Purchasing Control

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

Design validation Preservation

of product

Design Changes
 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

 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
 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
 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 to Supplier evaluation
ensure that
purchased products
conforms to specific
requirements

Verification of purchased product – Inspection

and testing
 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 condition to
Process validation
ensure conformity of
product

Identification and traceability

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

7.6 Control of monitoring and measuring devices

Control and Calibration of equipments used for monitoring, inspection and
testing
8 – Measurements, analysis & improvements

8.1 8.2 8.3 Control of 8.4 8.5

non
General Monitoring & Analysis of Improvement
conforming
measurements data
product

Customer Continual
satisfaction improvements

Internal audits Corrective

action

Measurement of
processes Preventive
action
Measurement of
product
8 – Measurements, analysis & improvements

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
8 – Measurements, analysis & improvements

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
8 – Measurements, analysis & improvements

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

System performance requirements

Process performance requirementrs

Product performance requirements

 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
Processe –Cycle time / throughput (Capacity)
s –Utilization of technology
–Waste reduction
–Cost reduction
–Conformance rate
–On time delivery

Products

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

–Product verification
–Product validation
Pros & 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

More resource demanding ??

 Challenges in implementation

Management Support

Encouragement / commitment

Resources
QA System

Communication

Other employee Support

 Summing up

Introduce the concept of new ISO 9001:2000 Standard

Highlight important areas and changes of the new standard

ISO 9001:2000 system requirements in brief

Important issues in implementations

Thank You