ISO 9001-2008 - New

1
ROOTS-ISO-TRN-9001 /12
Your participation is KEY to
success…..
If any doubt, stop & clarify

any time….
Share your thoughts any
time….
Get involved….
2
• Introduction
05 Min
• Definition – Quality
05 Min
• Quality
y Assurance
• Quality Control
10 Min
• Quality Management System
• Function of Eight
g QMS
Q Principles
p
10 Min
• Brief about ISO 9001:2008

25 Min
• Questions – If Any
05 Min
3
Concepts of Quality and Historic Evolution?
What is Quality ?
Fitness for the Purpose
p
Conformance to Requirements
Customer Satisfaction /Delight
How does the ISO standard define “Quality”?

Quality ?
Degree to which a set of characteristics fulfills requirements
4
Quality Management System
Quality Assurance:
“All
All the Planned and Systematic activities implemented within the
Quality Management System and Demonstrated as needed to
provide adequate confidence for an entity to fulfill requirements
for Quality ”
Two aspects
p of Q
Quality
y Assurance are:
1. External - Quality Assurance provides Confidence to Customers.
2. Internall - Quality
l d Confidence
Assurance provides fd h
to the
management to understand the customer’s needs at lowest
possible cost & time, thus making profit.
5
Quality Control:
“ Operational Techniques and Activities

that are used to fulfill requirements for
Q lit ”
Quality
Quality Control is Reactive in nature

nature.
Quality Assurance is Pro-
Pro-active in
nature..
nature
6
Quality Management System:
“All activities of overall Management function that

determine Quality Policy, Objectives &
Responsibility, & Implement them by means of
Q li Planning,
Quality Pl i Q li Control,
Quality C l Quality
Q li Assurance
A
& Quality Improvement”
Improvement”..
7
8 Quality Management Principles
Eight Principles:
Customer Focus
Leadership
Involvement
o e e to of People
eop e
Process Approach
System Approach
Continual Improvement
Factual Approach to decision making
M
Mutually
t ll B Beneficial
fi i l S
Supplier
li R Relationship
l ti hi
ISO 9001:2008 is developed based on 8 Quality

Management Principles
8
ISO 9001:2008
What is ISO?
ISO (International Organization for Standardization) is a worldwide

group of national standards bodies from approximately 150
countries (1 from each);
ISO is a non-
non-governmental organization established in 1947;
ISO’s name – came from the Greek word “ isos ” means “equal ”.
ISO 9000: 1987 – FIRST Edition

ISO 9000: 1994 – Second Edition
ISO 9001: 2000 – Third Edition
ISO 9001: 2008 – Fourth Edition
ISO 9001; 2015 – Fifth Edition Upcoming
9
ISO
ISO 9001 is the most successful standard in ISO

history and is accepted world wide.
Nearly 1,000,000
1 000 000 registrations world
world-
-wide with
registrants in over 157 countries
Being applied in a wide variety of organizations
Over 40 “sectors” or industry classifications
Led by: electrical/optical equipment

equipment, metal products
products, Chemicals
Chemicals,
construction,, machinery, wholesale/retail trade
construction
but growing in acceptance by many others, including:
engineering, information technology, health/social work,

engineering,
utilities,, transportation, public administration, education, other
utilities
services..
services
10
ISO 9001 Standard
ISO 9001:2008
11
ISO 9001-
9001- Flow Diagram
CUSTOMERS 8.2 Monitoring Customer
Satisfaction
8.2 Internal Audits

Shipping & Covering the entire QMS is:
Delivery 8.3 Control of 4.2.3 DOCUMENT
Nonconforming Product CONTROL AND
4.2.4 RECORDS
8.4 Analysis of Data CONTROL
(Suppliers, Process,
Product, Customer) 8.5 CONTINUAL
IMPROVEMENT
7.6 Monitoring & 8 5 Corrective &
8.5
Measuring Devices Preventive Action
RESPONS
5.0 MANA
7.5 Production Control 8.0 MEASUREMENT, 5.6 Management Review
ATION
ANALYSIS AND
DUCT
7.4 Purchasing & IMPROVEMENT 5.4 Quality Objectives

REALIZA
7.0 PROD
AGEMENT
R i i
Receiving
SIBILITY
5.3 Quality Policy
7.3 Design 5.1 Management

Commitment
6.0 RESOURCE
7.1 Planning MANAGEMENT
6.2 Human Resources

(Training)
6.3 Infrastructure
64W
6.4 Workk Environment
E i
Bids, Quotations,
Orders, and Contracts CUSTOMERS
12
QMS Pyramid
Pyramid-- Documentation Structure
Quality Policy ------------------- 0
Quality Manual ----------------- 1
Procedures---------------------- 2
Procedures
Work Instructions-------------- 3
Forms & Lists------------------- 4
Records------------------------- 5
13
ISO 9001 Standard
• Needs to demonstrate its ability and

1.Scope enhance customer satisfaction
• Any Exclusion – only from Clause 7
2.Normative • Referenced documents are input for

Reference the application of this document
3.Terms
3 Terms & • Supplier – Organization – Customer
Definitions • “ Product’’ means “ service’’ also.
also.
ROOTS-ISO-TRN-9001 /12 14
ISO 9001 Standard
4.2.1
General
4.1
General Requirements
4.2.2
422
4. Quality Management Quality manual
System
4.2 4.2.3
Document Information Control of documents
4.2.4
Control of records
ISO 9001 Standard
4 . Quality management system

4 1 General requirements
4.1
The organization shall
Determine the processes
p
Sequence and interaction of these processes,
Ensure the availability of resources
monitor, measure and analyze these processes where applicable
16
ISO 9001 Standard
4.2 Documentation requirements

4.2.1 General
a) Quality policy and quality objective
objective;;
b) Quality manual
manual;;
c) Documented procedures and records required by QMS

QMS..
4.2.2 Quality manual

The organization shall establish and maintain,
a) The scope & and justification for any exclusions;
b) d
procedures
procedures, f
, or reference h ; and
to them
them; d
c) interaction between the processes.

processes.
17
ISO 9001 Standard
4.2.3 Control of 4.2.4 Control of Document /Records shall

documents records remain legible, readily
identifiable and
•Created ,Reviewed & •Evidence of conformity retrievable & retention
Approved . to requirements time and disposition to
•Distribution Controlled be maintained.
ISO 9001 Standard
5.1 5.4.1 Quality

management objectives
commitment
5.4.2 QMS
5.2 Customer
p g
planning
Focus
5.5.1 Rasp&
5.3 Quality
Authority
policy
5. Management 5.5.2 MR
5.4 Planning
responsibility
5.5.3 Internal
5.5
5 5RResp, Communication
C
Authority &
communication
5.6.1 General
Management
Review
5.6.2 Review
Input
5.6.3
5 6 3 Review
Output
ISO 9001 Standard
5 . Management responsibility
5.1
5 1 Management commitment
a) Communicating to the org the importance of meeting customer as

well as statutory and regulatory requirements;
b) establish the quality policy

policy;;
c)) ensure that

h quality
l objectives
b are established
established;
bl h d;
d) conduct management reviews;

reviews; and
e) ensure the availability of resources

resources..
20
ISO 9001 Standard
5.2 Customer Focus

Top management shall ensure
a) Customer requirement are determined ;and
b) Are met with the aim of enhancing customer satisfaction
5.3 Quality policy

a) Appropriate
Appropriate;;
b) commitment to comply and continually improve

improve;;
c) provides a framework for establishing and reviewing quality

objectives;;
objectives
d) communicated and understood

understood;; and
e)) Reviewed
R i
Reviewed.
d.
21
ISO 9001 Standard
5.4 Planning
5.4.1 Qua
5 Quality
ty object
objectives
es
a) Establish quality objectives at relevant function & levels; and
b) these
h shall
h ll be
b measurable
bl and
d consistent
i with
i h the
h quality
li policy.
li
5.4.2 Quality
y management
g system
y p
planning
g
Planning of the QMS is carried out in order to meet the
requirements as well as the quality objectives

objectives..
22
ISO 9001 Standard
5.5 Responsibility, authority & communication

5.5.1
5 5 1 Responsibility and authority
a) Define
Define;; and
b) communicate.
5.5.2 Management representative
a) Ensure QMS is established, implemented & maintained;
b)) report
p to top
p management
g on the performance
p & need for
improvement; and
c) promote awareness of customer requirement.

requirement.
23
ISO 9001 Standard
5.5.3 Internal communication
a) Top management shall ensure that appropriate

communication processes are established; and
b) that communication takes place regarding the

effectiveness of the QMS.
QMS
24
ISO 9001 Standard
5.6 Management review

5.6.1
5 6 1 General
1. Top management shall review QMS, at planned intervals, to ensure

its continuing suitability,
bl adequacy
d and
d effectiveness
effectiveness.
ff .
2. Maintain records.
records.
25
ISO 9001 Standard
5.6.2 Review input
a) Customer feedback;
b) process performance
f and
d product
d t conformity;
f it
c) status of preventive and corrective actions;
d) follow
follow-
-up actions from previous management reviews;
e)) recommendation
d i for
f improvements;
i and d
f) results of audit.
5.6.3 Review output
The output from the management review shall include any
decisions and actions related to:
a) Improvement of the effectiveness of the QMS and its processes;

processes;
b) improvement of product related to customer requirements;
requirements; and
c)) resource needs
needs.
d .
26
ISO 9001 Standard
6.1 .
Provision of resources
6.2.1
General
6.2 .
Human resources
6.2.2
6 . Resource
Competence, training
management
and awareness
6.3 .
Infrastructure
6.4 .
Work environment
ISO 9001 Standard
6 . Resource management
6.1 Provision of resources
The
h organization shall
h ll provide
d the
h resources needed
d d to
to implement
l and
d maintain
the QMS and continually improve its effectiveness and customer Satisfaction.
6 2 Human resources
6.2
6.2.1 General
6.2.2 Competence, training and awareness

a) Personnel performing work affecting conformity to product requirements
shall be competent on the basis of appropriate education
education, training
training, skills
and experience.
b) maintain appropriate records of education, training, skills and experience.
ISO 9001 Standard
6.3 Infrastructure
a) Buildings
Buildings,, workspace and associated utilities;
b) process equipment (both hardware and software);
c)) supporting
pp g services ((such as transport
p or communication or
information system).
6.4
6 4 Work environment
The organization shall determine and manage the work environment
needed to achieve conformity to product requirements
requirements..
NOTE The term "work environment" relates to conditions under which
work is performed including physical, environmental and other factors
(such as noise, temperature, humidity, lighting, or weather).
29
ISO 9001 Standard
7.1
Planning of product
realization
72
7.2
Customer-related
Customer-
processes
7.3
73
Design and
development
7. Product realization
(Service)
74
7.4
Purchasing
7.5
Production & Service
Provision
7.6
Control of Monitoring &
Measuring Equipment.
ISO 9001 Standard
7 . Product realization (Service)

7 1 Pl
7.1 Planning
i off product
d realization
li i
1. Project quality
a) The need to establish processes, documents, plans
and provide resources to the product; 2. Organization
Quality Plan
b) required verification, validation, monitoring, (QCS 2014)
3 Process flow
3.
measurement, inspection & test activities & the
diagrams
criteria for acceptance; and 4. Method
statements
c) records needed to provide evidence that the
realization processes and resulting product
q
meet requirements (see 4.2.4).
31
ISO 9001 Standard
7.2.1
Determination of
requirement related to the
product
7.2 7.2.2
Customer-related Review of requirements
processes l t d tto th
related d t
the product.
7.2.3
Customer Communication
ISO 9001 Standard
7.2 Customer
Customer--related
processes
7.2.1 Determination of requirements
related to the product
a)) R
Requirements
i t specified
ifi d b
by th
the
customer;
b) requirements not stated by the

customer but necessary for specified or
intended use, where known;
c) statutory and regulatory requirements;
33
ISO 9001 Standard
7.2.2
7 2 2 Review of requirements related to the product
a) Product requirements are defined

defined;;
b) the organization has the ability to meet the defined requirements

requirements..
c) maintain records of review.
d) if product requirements are changed, ensure that relevant

documents are amended and that relevant personnel are made
aware
aware.
34
ISO 9001 Standard
7.2.3 Customer communication
The organization shall determine and implement

effective arrangements for communicating with
customers in relation to
a) Product information;
b) enquiries,
i i contracts or order
d h handling,
dli
including amendments; and
c) customer
custo e feedback,
eedbac , including
c ud g customer
custo e
complaints.
ISO 9001 Standard
7.3.1
D & D planning
7.3.2
D & D inputs
7.3.3
D & D outputs
7.3 Design and 7.3.4

development
D & D review
7.3.5
D & D verification
7.3.6
D & D validation
7.3.7
Control of D&D
changes
ISO 9001 Standard
7 3 Design and development

7.3
7.3.1 Design and development planning
a) The design and development stages
stages;;
b) the review, verification & validation that

are appropriate to each design &
development stage
stage;; and
c) responsibilities & authorities for design &

develop..
develop
37
ISO 9001 Standard
7 3 2 Design and development inputs

7.3.2
Inputs relating to product requirements
requirements::
a)) Functional and performance
p
requirement;;
requirement
b) applicable statutory and regulatory

requirements;;
requirements
c) where applicable, information derived

ffrom previous similar
l d designs
designs;;
ISO 9001 Standard
7.3.3 Design and development outputs

Design and development outputs shall:
a) Meet the input requirements for design

and
d development
d
development;
l ;
b) provide appropriate information for

purchasing production and for service
purchasing,
provision;;
provision
c) specify the characteristics of the product

that are essential for its safe and proper
use..
use
39
ISO 9001 Standard
7.3.4 Design and development review
a) To evaluate the ability of the results of design and

development to meet requirements; and
b) to identify any problems and propose necessary

actions..
actions
c) Records shall be maintained

maintained..
7.3.5 Design and development verification

a) Planned arrangements
arrangements;;
b) have met the design and development input

input;; and
c)) records shall be maintained

maintained..
40
ISO 9001 Standard
7.3.6 Design and development validation

a) Planned arrangements
arrangements;;
b) product is capable of meeting the requirements

for the specified application / intended use
use;;
c) validate prior to the delivery / implementation

implementation;;
and
d) records shall be maintained

maintained..
7.3.7 Control of design and development

changes
a) Identified and records maintained
maintained;; and
b) reviewed, verified and validated, as appropriate,

and
d approved
d before
b f i
implementation.
implementation
l t ti .
41
ISO 9001 Standard
7.4.1
Purchasing
P h i process
7.4 Purchasing 7.4.2

Purchasing information
743
7.4.3
Verification of purchased
product.
ISO 9001 Standard
7.4 Purchasing
7.4.1 Purchasing
g process
p
Ensure purchased product conforms to

specified requirements
requirements;; and
evaluate and select suppliers based on

their ability;
ability;
criteria for selection, evaluation and re

re-
-
evaluation shall be established
established;; and
maintain records.
records.
43
ISO 9001 Standard
7.4.2 Purchasing information

a) Requirements for approval of product.
product.
procedures, processes and equipment
equipment;;
b) Requirement for qualification and QMS

i f
information.
information
i .
7.4.3 Verification of purchased

p
product
a) Establish and implement the

inspection or other activities necessary
for ensuring;
ensuring; and
b) verification at the supplier premises.
44
ISO 9001 Standard
751
7.5.1
Control of
production and
service provision
7.5.2
Validation of
processes for
production and
service provision
7.5 Production &
service provision 7.5.3
Identification and
traceability
7.5.4
Customer
property
7.5.5
Preservation of
product
ISO 9001 Standard
7.5 Production & service provision

7.5.1 Control of production and service provision
Plan and carry out production and service provision under controlled
conditions
co
conditions.
d t o s.
a) The availability of work instructions, as necessary

necessary;;
b) the
th use off suitable
it bl equipment
equipment;
i t;
c) the availability and use of monitoring and measuring equipment;

equipment;
d) the implementation of monitoring & measurement

measurement;;
46
ISO 9001 Standard
7.5.2 Validation of processes for production and service provision

Validation shall demonstrate the ability of these processes to achieve
planned
l d results
results.
lt .
a) Defined criteria for review and approval
approval;;
b) approval of equipment and personnel

personnel;;
c) use of specific methods and procedures

procedures;;
d)) requirements
q for records;
records;
7.5.3 Identification and traceability
Where appropriate, shall identify & trace the product by suitable means
and maintain records

records..
47
ISO 9001 Standard
7.5.4 Customer property
Exercise care with customer property while it is under the organization’s
control or being used by the organization.

organization.
Identify;
dentify;
verify;;
verify
protect;; and
protect
Safeguard
maintain
i i records.
records
d .
48
ISO 9001 Standard
7.5.5 Preservation of product
Identification;
dentification;
handling;;
handling
packaging;;
packaging
delivery;;
delivery
storage;; and
storage
protection..
protection
49
ISO 9001 Standard
7.6 Control of monitoring and measuring equipment
Determine monitoring and measuring devices needed

needed;; and
Establish processes to ensure that monitoring and measurement

are consistent with requirements.
requirements.
Be calibrated or verified or both at specified intervals, or prior to

use;;
use
Be identified to enable the calibration status to be determined

determined::
50
ISO 9001 Standard
8.2.1
8 21
8.1 Customer
General Satisfaction
8.2.2
8.2 Internal Audit
Monitoring &
Measurement
8.2.3
8.3 M & M Of Process.
8 .Measurement , Control of
Analysis and nonconformity
product 8.2.4
Improvement
M & M Of Product.
8.4 8.5.1
Analysis of Data Continual
Improvement
8.5.2
8.5 Corrective Action
Improvement
8.5.3
P
Preventive
i Action
A i
ISO 9001 Standard
8 . Measurement Analysis and Improvement

8.2 Monitoring and measurement
8.2.1
8 2 1 Customer satisfaction
Monitor information relating to customer perception as to whether

the organization has met customer requirements
requirements..
(customer satisfaction survey )
52
ISO 9001 Standard
8.2.2 Internal audit
To determine whether the QMS

QMS::
Conforms to the requirements of this standard and to
the QMS requirements established;
established; and
is effectively implemented and maintained

maintained..
An audit program shall be:

be:
planned - consider the status and importance
importance;;
criteria, scope, frequency & methods shall be defined

defined;;
and
auditors and conduct of audits shall ensure objectivity

p y of the audit p
and impartiality process..
process
53
ISO 9001 Standard
8.2.3 Monitoring & measurement

of processes
Methods for monitoring QMS
processes;
measurement of the QMS

processes ;
demonstrate the ability of the

processes to achieve planned
results;;
when planned results are not

achieved, correction and corrective
action shall be taken; and
maintain records.
54
ISO 9001 Standard
8.2.4 Monitoring & measurement of product
Methods for monitoring product

product;;
measurement of the product ;
Evidence of conformity with acceptance criteria shall be

maintained..
maintained
demonstrate the ability of the processes to achieve planned

results;;
results
when planned results are not achieved, correction and corrective

action shall be taken
taken;; and
maintain records.
records.
55
ISO 9001 Standard
8.3 Control of nonconforming

p
product
Identify and control to prevent its unintended

use or delivery
responsibilities and authorities for dealing with

nonconforming product shall be defined
56
ISO 9001 Standard
8.4 Analysis of data

Determine,, collect & analyze data – to demonstrate the suitability &
Determine
effectiveness of QMS. Collect data from monitoring & measurement of
processes.
This shall provide information relating to

to::
Customer satisfaction;
satisfaction;
Conformity to product requirement
requirement;;
Ch
Characteristics
t i ti and d trend
t d off processes
processes;; and
d
Suppliers..
Suppliers
57
ISO 9001 Standard
8.5.1 Continual Improvement
Organization shall continually improve the effectiveness of the QMS

through the use of Quality policy , Objectives ,Analysis
Analysis of Data,
Data CAPA
&Management Review.
852C
8.5.2 Corrective
ti action
ti
Take action to eliminate the causes of nonconformities in order to
prevent recurrence.
a) reviewing nonconformities
nonconformities;;
b) determining the cause of nonconformities
nonconformities;;
c) evaluating the need for action;
action;
d) determining and implementing action needed
needed;;
58
ISO 9001 Standard
8.5.3 Preventive action
Determine action to eliminate the causes of potential nonconformities in
order to prevent their occurrence.

occurrence.
Establish procedures to define requirements for

for::
a) evaluating the need for action to prevent occurrence of non-

non-
conformities;
b) records of results of action taken; and
c) reviewing the effectiveness of preventive action taken.
59
New ISO 9001:2015
Scope
Normative
Improvement
Reference
Performance Terms
Evaluation Definitions
ISO 9001:2015
Context of
Operation
Organization
Support Leadership
Planning
60
MARAMING SALAMAT PO
NANRI … NANRI
THANK YOU

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1

If any doubt, stop & clarify

• Brief about ISO 9001:2008

Customer Satisfaction /Delight

How does the ISO standard define “Quality”?

Degree to which a set of characteristics fulfills requirements

“ Operational Techniques and Activities

Quality Control is Reactive in nature

Quality Management System:

“All activities of overall Management function that

Factual Approach to decision making

ISO 9001:2008 is developed based on 8 Quality

ISO (International Organization for Standardization) is a worldwide

ISO 9000: 1987 – FIRST Edition

ISO 9001 is the most successful standard in ISO

Being applied in a wide variety of organizations

Over 40 “sectors” or industry classifications

Led by: electrical/optical equipment

but growing in acceptance by many others, including:

engineering, information technology, health/social work,

8.2 Internal Audits

7.4 Purchasing & IMPROVEMENT 5.4 Quality Objectives

7.3 Design 5.1 Management

6.2 Human Resources

Quality Policy ------------------- 0

Quality Manual ----------------- 1

Forms & Lists------------------- 4

• Needs to demonstrate its ability and

2.Normative • Referenced documents are input for

4 . Quality management system

4.2 Documentation requirements

c) Documented procedures and records required by QMS

4.2.2 Quality manual

a) The scope & and justification for any exclusions;

c) interaction between the processes.

4.2.3 Control of 4.2.4 Control of Document /Records shall

5.1 5.4.1 Quality

a) Communicating to the org the importance of meeting customer as

b) establish the quality policy

c)) ensure that

d) conduct management reviews;

e) ensure the availability of resources

5.2 Customer Focus

a) Customer requirement are determined ;and

b) Are met with the aim of enhancing customer satisfaction

5.3 Quality policy

b) commitment to comply and continually improve

c) provides a framework for establishing and reviewing quality

d) communicated and understood

a) Establish quality objectives at relevant function & levels; and

Planning of the QMS is carried out in order to meet the

requirements as well as the quality objectives

5.5 Responsibility, authority & communication

5.5.2 Management representative

a) Ensure QMS is established, implemented & maintained;

c) promote awareness of customer requirement.

5.5.3 Internal communication

a) Top management shall ensure that appropriate

b) that communication takes place regarding the

5.6 Management review

1. Top management shall review QMS, at planned intervals, to ensure

5.6.2 Review input

decisions and actions related to: