ISO 9001 Upgrading

SECTION A:
ISO 9000 BACKGROUND
SECTION B:
MODELS OF ISO 9000 & ITS

CERTIFICATION
SECTION C:
ISO 9000 QUALITY

MANAGEMENT SYSTEM
SECTION D:
ISO 9001 ELEMENT

DESCRIPTION
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ISO
The International Organization
To promote the development of

standardization and related activities in the
world with a view to facilitating the
international exchange of goods services.
To develop cooperation in the spheres of

intellectual, scientific, technological and
economic activity.
For Standardization
Headquarter- Located in Geneva,
Switzerland
Word derived from Greek ISOS

Meaning EQUAL
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ISO
MEMBER OF ISO
Is a worldwide federation of national
standard bodies from more than 157
countries, one from each country.
Representative from Malaysia Department of Standards Malaysia
(Standards Malaysia).
Since 1969, Malaysia became the member
of ISO.
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ISO TECHNICAL COMMITTEE

Involving
Qualified
Representatives
Industry
Research Institutes
Government authorities
Consumer bodies
Note: ISO 9000 QMS is designed by ISO/ TC/ 176
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REVISION OF
ISO 9001 STANDARDS
ISO 9001 International Standards are revised at least every 5 years
ISO/ TC 176 established in 1976
ISO 9001:1987
ISO 9001:1994
ISO 9001: 2000
ISO 9001:2008
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ISO 9000 SERIES

ISO 9000:2005
Quality Management System
Fundamental and Vocabulary
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IMPLEMENTATION OF
ISO STANDARD
Say / write what you do:
ISO 9000:
QUALITY
MANAGEMENT
SYSTEM
ISO 9001:2008
Requirements
ISO 9004:2009
Guidelines for Performance
Improvements
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(Mission, responsibilities, goals, process steps, processes or work

descriptions, etc.)
Do what you say / wrote:
(Perform to the point to obtain desired results, document and
implement processes and record the results.)
Prove it, show evidences & records:
(Show the documented processes and recorded results.)
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ACCREDITATION BODY &

CERTIFICATION BODY
International
Accreditation
Forum (IAF)
ISO/IEC 17011:2004
Responsibility for accrediting Certification Bodies to perform assessments

and award certifications against the International Standard.
ISO/IEC Guide 61
Accreditation
Body
ISO/IEC 17021:2006
e.g. Pacific Accreditation Cooperation(PAC),

Europe Accreditation Cooperation(EA),
Inter-American Accreditation Cooperation
(IAAC)
United Kingdom Accreditation Service (UKAS)

Department of Standards Malaysia (DSM)
Joint Accreditation System of Australia and New Zealand
(JAS-ANZ)
National Institute of Metrology, Standardization & Industrial Quality,
Brazil (INMETRO)
Standards Council of Canada (SCC)
Hong Kong Laboratory Accreditation Scheme (HOKLAS)
The Japan Accreditation Board for Conformity Assessment (JAB)
e.g. Standards Malaysia (Msia), UKAS,

RAB, JAB, DAR, SCC...
EN 45012 or
ISO/IEC Guide 62
Certification
Body
ISO 9001:2008
Companies
e.g. BM TRADA(MALAYSIA) S/B [UK],

SIRIM QAS S/B [MSIA],
TUV NORD [GERMAN],
BSI [UK],
LLOYDS [UK],
PSB [SPORE]...
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An impartial body, government or non-government, processing the necessary

competence and reliability to operate a certification system and in which those
with an interest in the process of certification are represented without any single
interest predominating.
LOCAL Certification Body:
Sirim QAS Sdn Bhd
NON-LOCAL Certification Body Operate in Msia:
BM TRADA
BVQI
MOODY INTERNATIONAL
DNV
LLOYDS
SGS YARSLEY
RWTUV
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QUALITY IS 22
Conformance to customer specification
Meeting customer expectations
Trouble-free
No problems
Zero defects
No complaints from customer
No disappointments
Keeping to promises
Good service
Etc
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ISO DEFINITION ON QUALITY

degree to which a set of inherent
characteristics fulfills requirements
- ISO 9000: 2005
Quality Management Systems Fundamentals
and Vocabulary
part of quality management focused

on fulfilling quality requirements
QUALITY
ISO 9000: 2005

Quality Management Systems Fundamentals and
Vocabulary
QUALITY
CONTROL
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part of quality management focused

on providing confidence that quality
requirements will be fulfilled.
management system to direct and

control an organization with regard
to quality
- ISO 9000: 2005
and Vocabulary
ISO 9000: 2005

and Vocabulary
QMS
QUALITY
ASSURANCE
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QUALITY MANAGEMENT
PRINCIPLES
Comprehensive & fundamental rule or

belief,
for leading & operating an organization,
aimed at continually improving
performance over the long term
PRINCIPLE 1: Customer-Focused
Organization
PRINCIPLE 2: Leadership
PRINCIPLE 3: Involvement of
People
PRINCIPLE 4: Process Approach
PRINCIPLE 5: System Approach

to Management
PRINCIPLE 6: Continual
Improvement
by focusing on customer
PRINCIPLE 7: Factual Approach
to Decision Making
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PRINCIPLE 8: Mutually Beneficial

Supplier Relationship
QUALITY MANAGEMENT
PRINCIPLES
QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 1 - CUSTOMERCUSTOMER-FOCUSED
ORGANIZATION
PRINCIPLE 2 LEADERSHIP
Leaders establish unity of purpose and direction
of the organization.
Organizations depend on their customers and

therefore should understand current and future
customer need, meet customer requirement and
strive to exceed customer expectations.
They should create and maintain the internal

environment in which people can become fully
involved in achieving the
organizations objectives..
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QUALITY MANAGEMENT
PRINCIPLES
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QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 3 - INVOLVEMENT OF PEOPLE
PRINCIPLE 4 PROCESS APPROACH

A desire result is achieved more
efficiently when related resource
and activities are managed as a
process.
People at all levels are the essence of an

organization and their full involvement
enables their abilities to be used for the
organizations benefit.
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QUALITY MANAGEMENT
PRINCIPLES
What is a process?
Activity that transforms input into output
6 process characteristics
INPUT
ACTIVITY
OUTPUT
Has an owner
Is defined
Is documented
Linkages are established
Resources:
Results:
Qualified People
Quality Products
Right Facilities
Quality Services
Is monitored
Proven Method
Customer satisfaction
Records maintained
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QUALITY MANAGEMENT
PRINCIPLES
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QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 6 - CONTINUAL IMPROVEMENT
PRINCIPLE 5 SYSTEM APPROACH TO

MANAGEMENT
Continual improvement should be a permanent objective of the

organization.
Identifying, understanding and managing a

system of interrelated processes for a given
objective improve the organizations
effectiveness and efficiency..
PRINCIPLE 7 - FACTUAL APPROACH TO

DECISION MAKING
Effective decisions are based on the
analysis of data and information.
(system = a set of processes)

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QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 8 MUTUALLY BENEFICIAL
SUPPLIER RELATIONSHIP
An organization and its supplier are interdependent,

and a mutually beneficial relationship enhance the
ability of both to create value..
Improve management resources.
Improve overall performance & product quality.
Consistency in process flow
Assist & reduce multiple 2nd party

assessment.
Enhance company image with International

recognition.
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QUALITY MANAGEMENT
PROCESS MODEL
QUALITY MANAGEMENT CONTINUAL IMPROVEMENT
C
U
S
T
O
M
E
R
R
e
q
ui
r
e
m
e
n
t
Management
Responsibility
Resource
Management
Input
Measurement, Analysis,
Improvement
Product
(and / or service)
realization
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Output
Product /
Service
S
a
ti
s
f
a
c
ti
o
n
C
U
S
T
O
M
E
R
ISO 9001
ISO 9001
5 Management Responsibility
4 Quality Management System
5.1 Management commitment
4.1 General requirements
5.2 Customer focus
4.2 Documentation requirement
5.3 Quality policy

5.4 Planning
4.2.1 General
5.4.1 Quality objectives
4.2.2 Quality manual
5.4.2 Quality management system planning
4.2.3 Control of documents
5.5 Responsibility, authority & communication
(procedure)
5.5.1 Responsibility & authority

5.5.2 Management representative
4.2.4 Control of records
5.5.3 Internal communication
(procedure)
5.6 Management review

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ISO 9001
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ISO 9001
7 Product Realization
6 Resource Management
7.1 Planning of product realization (records)
6.1 Provision of resources
7.2 Customer-related processes

7.2.1 Determination of requirements related to the product
6.2 Human resources
7.2.2 Review of requirement related to the product (records)
6.2.1 General
7.2.3 Customer communication

7.3 Design and development
6.2.2 Competence, training
7.3.1 Design and development planning
and awareness (records)
7.3.2 Design and development inputs (records)
6.3 Infrastructure
7.3.3 Design and development outputs
6.4 Work environment
7.3.4 Design and development review (records)

7.3.5 Design and development verification
(records)
7.3.6 Design and development validation (records)

7.3.7 Control of design and development changes (records)
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ISO 9001
ISO 9001
7 Product Realization
8 Measurement, analysis and improvement
7.4 Purchasing
8.1 General
7.4.1 Purchasing process (records)
8.2 Monitoring and measurement
7.4.2 Purchasing information
8.2.1 Customer satisfaction
7.4.3 Verification of purchased product
8.2.2 Internal audit (procedure & records)
7.5 Production and service provision
8.2.3 Monitoring and measurement of processes
7.5.1 Control of production and service provision
8.2.4 Monitoring and measurement of product (records)
7.5.2 Validation of processes for production and service provision

(records)
7.5.3 Identification and traceability (records)
8.3 Control of nonconforming product (procedure & records)

8.4 Analysis of data
8.5 Improvement
7.5.4 Customer property (records)
8.5.1 Continual improvement
7.5.5 Preservation of product
8.5.2 Corrective action (procedure & records)
7.6 Control of monitoring and measuring devices (records)
8.5.3 Preventive action (procedure & records)

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8.5.3 Preventive Action
8.5.2 Corrective Action

Prevent Recurrence.
Prevent occurrence.
Reviewing non-conformities (including

complaints)
Identify potential non-conformities &

causes.
Determine causes.
Evaluate action needed.
Evaluate action needs.
Implement action.
Implement action.
Verify effectiveness of action.
Verify effectiveness of action.
Records maintained.
Records maintained.
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Changes on ISO 9001:2008

ISO 9001: 2008 require 6 documented procedures:
4.2.3 Control
of Documents
8.2.2 Internal Audit
8.5.2 Corrective
Action
4.2.4 Control
of Records
Introduces NO New requirements

Is rather an amendment than revision
Introduces clarifications to the existing
requirements of ISO 9001:2000
8.3 Control
of Non-Conforming
Product
Introduces changes intended to improve

consistency with ISO14001:2004
8.5.3 Preventive
Action
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Changes on ISO 9001: 2008
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Outsourced Processes
Documentation
clarifies that specific controls are to be defined and

applied, not just identified
4.2 QMS documentation has expanded all QMS process

record which not only required by the standard but also
the records that the organization needs to have in order
to be able to plan, operate, and control its QMS
processes.
add new Notes to explain what is considered an

outsourced process and the factors influencing the
control of outsourced process.
4.2.3 (f) clarifies that External Documents which are

necessary for the planning & operation are required
to be controlled.
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Competence
Management Representative
6.2.1 Personnel performing task affecting Conformity

to Product Requirements shall be competent
5.5.2 management representative must be a member

of the organizations own management
6.2.2 Title change from Competence, Awareness and

Training to Competence, Training and
Awareness
6.2.2 (b) add Where applicable, to provide training or take
other actions to achieve the necessary competence.
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Infrastructure
Customer Processes
6.3 (c) Add Information System as an example of

Supporting services
7.2.1 clarifies that Post Delivery activities include warranty

service, maintenance services, recycling or final disposal.
Work Environment
6.4 add note to explain work environment is related to
physical environment, such as noise, temperature,
humidity, lighting or weather.
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Design and Development Planning
Identification and Traceability
7.3.1 clarifies that review, verification and validation can be

conducted and recorded separately or in combination.
7.5.3 the product monitoring and measurement status

applies throughout product realization
Customer Property
Design and Development Outputs
7.5.4 customer property has expanded to include

personal data
7.3.3 new notes added to indicate design output should

consider product preservation, e.g. product
packaging
Monitoring & Measuring Equipment

7.6
The word "devices" has been changed to

"equipment".
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Customer Satisfaction
8.2.1 explans that there are many ways to monitor
customer satisfaction. Example, surveys, delivery,
lost business analysis, compliments, warranty claims,
dealer reports.
Process Monitoring & Measurement

8.2.3 Add note to explain on the Suitable Method to
consider the impact of the process on conformity to
product requirements and system effectiveness
Internal Audit Record

Conformity to Product Requirements
8.2.2 emphasizes that records of audits and their results

shall be maintained
In several places the term "product quality" has been

replaced with "conformity to product requirements",
putting the emphasis on conformity.
8.2.2 expanded the action to necessary correction and

corrective actions to be taken when detecting NC
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Impact On Certification
New or Re-Certification
Corrective and Preventive Actions

8.5.2 (f) and 8.5.3 (e)
One year after publication of ISO 9001:2008 all

accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008.
reviewing effectiveness of corrective/ preventive action

taken. Add the word - effectiveness
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Impact On Certification
SUMMARY
All certifications
Two years after publication of ISO 9001:2008,

any existing certification issued to ISO 9001:2000
shall not be valid.
The main core team must be committed right

to the end.
The successful of ISO 9001 certification is only

the start of a long journey. The system must
be monitored and serviced regularly.
Existing Certification
The entire company must appreciate the

benefits that can be derived and transferred
into any level of quality processes. It is not just
a Piece of Paper- Certificate only.
Upgrade anytime or during

Surveillance Audit / Re-certification audit
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ISO 9001 Upgrading

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SECTION A:

ISO 9000 BACKGROUND

MODELS OF ISO 9000 & ITS

ISO 9000 QUALITY

ISO 9001 ELEMENT

To promote the development of

To develop cooperation in the spheres of

Word derived from Greek ISOS

ISO TECHNICAL COMMITTEE

Note: ISO 9000 QMS is designed by ISO/ TC/ 176

ISO 9001: 2000

ISO 9000 SERIES

(Mission, responsibilities, goals, process steps, processes or work

ACCREDITATION BODY &

Responsibility for accrediting Certification Bodies to perform assessments

e.g. Pacific Accreditation Cooperation(PAC),

United Kingdom Accreditation Service (UKAS)

e.g. Standards Malaysia (Msia), UKAS,

e.g. BM TRADA(MALAYSIA) S/B [UK],

An impartial body, government or non-government, processing the necessary

Conformance to customer specification

Meeting customer expectations

No complaints from customer

ISO DEFINITION ON QUALITY

part of quality management focused

ISO 9000: 2005

part of quality management focused

management system to direct and

ISO 9000: 2005

Comprehensive & fundamental rule or

PRINCIPLE 4: Process Approach

PRINCIPLE 5: System Approach

PRINCIPLE 8: Mutually Beneficial

Organizations depend on their customers and

They should create and maintain the internal

PRINCIPLE 3 - INVOLVEMENT OF PEOPLE

PRINCIPLE 4 PROCESS APPROACH

People at all levels are the essence of an

Linkages are established

PRINCIPLE 5 SYSTEM APPROACH TO

Continual improvement should be a permanent objective of the

Identifying, understanding and managing a

PRINCIPLE 7 - FACTUAL APPROACH TO

(system = a set of processes)

An organization and its supplier are interdependent,

Improve management resources.

Improve overall performance & product quality.

Consistency in process flow

Assist & reduce multiple 2nd party

Enhance company image with International

4 Quality Management System

5.1 Management commitment

4.1 General requirements

5.2 Customer focus

4.2 Documentation requirement

5.3 Quality policy

5.4.1 Quality objectives

4.2.2 Quality manual

5.4.2 Quality management system planning

4.2.3 Control of documents

5.5 Responsibility, authority & communication

5.5.1 Responsibility & authority

4.2.4 Control of records

5.5.3 Internal communication