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ISO 9001:2008 TRANSITION
COURSE

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COURSE INTRODUCTION

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 COURSE TIMINGS

Day 1 08:00 - 15:00

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Coffee breaks: Mid Morning
Mid Afternoon

Lunch & Prayers: 12:00 – 12:30

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 HOUSE RULES

Facilities

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Safety rules & evacuation routes
Courtesy (mobile phones, pagers)
Local arrangements

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 COURSE STRUCTURE

Tutor lead sessions

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Discussions
Exercises
Auditing

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ISO 9001:2008
FUNDAMENTALS

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 PUBLICATIONS
FIRST TIME PUBLISHED IN 1987
FIRST REVISION IN 1994.
SECOND REVISION IN 2000.

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THIRD VERSION IN NOVEMBER 2008
REVIEWED AFTER EVERY 05 YEARS.
OWNED AND PUBLISHED BY INTERNATIONAL
ORGANIZATION FOR STANDARDIZATION.
HEAD OFFICE IN GENEVA.

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 SCOPE
 TO ACHIEVE CUSTOMER SATISFACTION.
 TO CONFORM PRODUCT/SERVICE
REQUIREMENTS.

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 TO DEMONSTARTE YOUR ABILITY TO
SATIFY CUSTOMER NEED AND
EXPECTATION.

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 WHY ISO 9001:2008
 CUSTOMER REQUIREMENT.
 THIS IS BASIC PRE-QUALIFICATION
CRITERION.

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 BECAUSE OF BUSINESS SURVIVAL.
 FOR INTERNAL IMPROVEMENT.
 FOR REJECTION/REWORK/BREAK DOWN
CONTROL.

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 “Process” Approach
Resources

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Input Process Output

Controls Monitoring &

Measurement

A desired result is achieved more

efficiently when activities and related
10
resources are managed as a process

Is this process independent of other process?

 “Process” Approach

O I Process B
I
Process A
Process C

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C
Process D
Process E
Process E

Process F

11 If one process is not independent of other

processes, do not forget to understand, identify
and document the sequences and interrelation of
all the processes
 “Process” Approach

Which Clause of ISO 9001:2008 describes

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the Process Approach?

Clause 4.1
12
 What is required by
Clause 4.1
• Determine the processes needed for the quality
management system and their application

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throughout the organization
• Determine the sequence and interaction of these
processes
• Determine criteria and methods needed to ensure
that both operations and control of these
processes are effective
• Ensure availability of resources and information
necessary to support operation and monitoring
of these processes
13 • Monitor, measure and analyze these processes
• Implement actions necessary to achieve planned
results and continual improvement of these
processes
 “Process” Approach

In the presence of process approach (Clause

4.2.1) why do we need other clauses of ISO
9001 standard?

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Other clauses of ISO 9001 standard provides
the minimum requirements, so at the time of
applying process approach do not forget the
minimum requirements of ISO 9001 standard!

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 MAIN CLAUSES
1 SCOPE
2 NORMATIVE REFERENCES

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3 TERMS AND DEFINITIONS.
4 GENERAL REQUIREMENTS.
5 MANAGEMENT RESPONSIBILITY.
6 RESOURCE MANAGEMENT.
7 PRODUCT REALIZATION.
8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT.
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REVIEW OF CHANGES

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Change No. 01 Affect: ?

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Forward Para 2 D+A

Amended Text

17
Change No. 02 Affect: ?

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Para 3,
Forward A
Sentence 1

Amended Text

The main task of technical committees is to prepare

International Standards

18
Change No. 03 Affect: ?

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Para 4,
Forward D+A
Sentence 1

Amended Text

19
Change No. 04 Affect: ?

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Forward Para6 D+A

Amended Text

20
Change No. 05 Affect: ?

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Forward Para7 D

Amended Text

21
Change No. 06 Affect: ?

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Forward Para 8 D

Amended Text

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Change No. 07 Affect: ?

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Forward New Para 7 A

Amended Text

Detail of the changes between the third edition

and this fourth edition are given in Annex B.

23
Change No. 08 Affect: ?

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Para 1, Sentence
0.1 2 & Sentence 3 D+A

Amended Text

24
Change No. 08 Affect: ?

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0.1 Para 4 A

Amended Text

This international standard can be used by

internal and external parties, including
certification bodies, to assess the organization
ability to meet customer, statutory and
regulatory requirements applicable to the
product,
25 and the organization’s own
requirements.
 Change No. 09 Affect: ?

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0.2 Para 2 D+A
determine
Amended Text

26
Change No. 10 Affect: ?

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0.2 Para 3 A

Amended Text

The application of a system of processes within

an organization, together with the
identification and interactions of these
processes, and their management to produce
the desired outcome, can be referred as the
“process
27 approach”.
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0.3 Para 1 D

Amended Text

28
Change No. 12 Affect: ?

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0.3 Para 3 D+A

Amended Text

At the time of publication of this international Standard, ISO 9004 is under revision. The
revised edition of ISO 9004 will provide guidance to management for achieving sustain
success for any organization in a complex, demanding, and over changing, environment,
ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the
needs and expectations of all interested parties and their satisfaction, by the systematic
and continual improvement of the organization’s performance. However, it is not intended
for certification, regulatory or contractual use.
Change No. 13 Affect: ?

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0.4 Para 1 D+A

Amended Text
Change No. 14 Affect: ?

Bullet a), Bullet

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1.1 b), Note & New A +D
Note 2

Amended Text
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1.2 Para 3 A

Amended Text
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2 Para 1 D+A

Amended Text
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3 Para 1 D+A

Amended Text
Change No. 18 Affect: ?

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3 Para 2, 3 D

Amended Text
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4.1 Bullet a) D+A

Amended Text
Change No. 20 Affect: ?

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4.1 Bullet e) A

Amended Text

e) monitor, measure where applicable and

analysis these processes, and
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4.1 Para 4 D +A

Amended Text
Change No. 22 Affect: ?

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4.1 Note 1 D +A

Amended Text
Change No. 23 Affect: ?

New Notes 2 &

4.1 A

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3

Amended Text
NOTE 2 An “outsourced process” is a process that the organization
needs for its quality management system and which the
organization chooses to have performed by an external party.

NOTE 3 Ensuring control over outsourced processes does not

absolve the organization of responsibility of conformity to all
customer, statutory and regulatory requirements. The type of
extent of control to be applied to the outsourced process can be
influenced factors such as
a)the potential impact of the outsourced process on the
organization’s capability to provide product the conforms to
requirements.
b)the degree to which the control for the process is shared.
c)The capability of achieving the necessary control through the
application of 7.4.
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4.2.1 Bullet c) A

Amended Text

c) documented procedures and records required by

this International Standard, and
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4.2.1 Bullet d) A+D

Amended Text
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4.2.1 Bullet e) D

Amended Text
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4.2.1 Note 1 A

Amended Text

Note 1 where the term “documented procedure”

appears within the International Standard, this
means that the procedure is established,
documented, implemented and maintained. A
single document may address requirements for
one or more procedures. A requirement for a
documented procedure may be covered by more
than one document.
Change No. 28 Affect: ?

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4.2.3 Bullet f) A

Amended Text

f) to ensure that documents of external origin

determined by the organization to be necessary
for the planning and operation of the quality
management system are identified and their
distribution controlled, and
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4.2.4 Para 1 D +A

Amended Text
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5.5.2 Para 1 A

Amended Text

Top management shall appoint a member of the

organization’s management who, irrespective of
other responsibilities, shall have responsibility and
authority that includes.
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Para 1 & New
6.2.1 A+D
Note

Amended Text
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6.2.2 Clause title A+D

Amended Text
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6.2.2 Bullet a) & b) A+D

Amended Text
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6.3 Bullet c) A

Amended Text

c) Supporting services (such as transport,

communication or information system).
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6.4 New Note A

Amended Text

NOTE The term “work environment” relates to

those conditions under which work is performed
including physical environmental and other factors
(such as noise, temperature, humidity, lighting or
weather).
Change No. 36 Affect: ?

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7.1 Bullet b) A

Amended Text

b) the need to establish processes and

documents, and to provide resources specific
to the product;
Change No. 37 Affect: ?

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7.1 Bullet c) A

Amended Text

c) required verification, validation,

monitoring, measurement, inspection and test
activities specific to the product and the
criteria for product acceptance;
Change No. 38 Affect: ?

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Bullet c), d)
7.2.1 D+A
& New Note

Amended Text
Change No. 39 Affect: ?

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7.3.1 New Note A

Amended Text

NOTE Design and development review,

verification and validation have distinct
purpose.
They can be conducted and recorded
separately or
in any combination, as suitable or the product
and
the organization.
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7.3.2 Para 2 D +A

Amended Text
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7.3.3 Para 1 D +A

Amended Text
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7.3.3 Bullet b) D

Amended Text
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7.3.3 New Note A

Amended Text

NOTE Information for production and service

provision can include details for the
preservation of product.
Change No. 44 Affect: ?

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No text change.
7.3.7 Para 1 & 2 Paras now
merged
Amended Text

Design and development changes shall be identified and

records maintained. The changes shall be reviewed,
verified and validated, as appropriate and approved before
implementation. The review of design and development
changes shall include evaluation of the effect of the
changes an constituent parts and product already
delivered. Records of the result of the review of the
changes and any necessary actions shall be maintained
(see 4.2.4)
Change No. 45 Affect: ?

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7.5.1 Bullet d) D+A

Amended Text
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7.5.1 Bullet f) A

Amended Text

f) the implementation of product release,

delivery and post-delivery activities.
Change No. 47 Affect: ?

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7.5.2 Para 1 D+A

Amended Text
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7.5.3 Para 2 A

Amended Text

The organization shall identify the product

status with respect to monitoring and
measurement requirements throughout
product realization.
Change No. 49 Affect: ?

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7.5.3 Para 3 D+A

Amended Text
Change No. 50 Affect: ?

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Para 1, Sentence
7.5.4 3 & Note
D+A

Amended Text
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7.5.5 Para 1 D+A

Amended Text
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7.6 Title D+A

Amended Text
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7.6 Para 1 D+A

Amended Text
Change No. 54 Affect: ?

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7.6 Bullet a) A

Amended Text

a) be calibrated or verified, or both, at specific

intervals, or prior to use, against measure
standards traceable to international or national
measure standards; where no such standard
exist, the basis used for calibration or
verification shall be recorded (see 4.2.4).
Change No. 55 Affect: ?

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7.6 Bullet c) D+A

Amended Text
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Para 4, Sentence Now new para 5
7.6 3 with out change

Amended Text

Records of the results of calibration and

verification shall be maintained (see 4.2.4).
Change No. 57 Affect: ?

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7.6 NOTE D+A

Amended Text
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8.1 Bullet a) D+A

Amended Text
Change No. 59 Affect: ?

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8.2.1 New Note A

Amended Text

NOTE Monitoring customer perception can

include obtaining input from source such as
customer satisfaction surveys, customer data
on delivered product quality, user opinion
surveys, lost business analysis, complements,
warranty claims and dealer reports.
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Para 2
8.2.2 A
Sentence 3
Amended Text

The selection of auditors and conduct of audits

shall ensure objectivity and impartially of the
audit process.
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8.2.2 New Para 3 A

Amended Text

A documented procedure shall be established to

define the responsibilities and requirements for
planning and conducting audits, establishing
records and reporting results.
Change No. 62 Affect: ?

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Now para 4
8.2.2 Para 3 D +A

Amended Text
Change No. 63 Affect: ?

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Para 4 Now para 5
8.2.2
Sentence 1 A

Amended Text

The management responsible for the area being

audited shall ensure that any necessary corrections
and corrective actions are taken without undue
delay to eliminate detected nonconformities and
their causes.
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8.2.2 Note D + A

Amended Text
Change No. 65 Affect: ?

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Para 1
8.2.3 D
Sentence 3
Amended Text
Change No. 66 Affect: ?

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8.2.3 New Note A

Amended Text

NOTE When determining suitable methods, it

is advisable that the organization consider the
type and extent of monitoring or measurement
appropriate to each of its processes in relation
to their impact on the conformity to product
requirements and on the effectiveness of the
quality management system .
Change No. 67 Affect: ?

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8.2.4 Para 1, 2 A+D

Amended Text
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8.2.4 Para 3 D + A

Amended Text
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Para 1,
8.3 D + A
Sentence 2
Amended Text
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8.3 Para 2 A

Amended Text

Where applicable the organization shall deal

with nonconforming product by one or more of
the following ways.
Change No. 71 Affect: ?

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New bullet d) A & Moved to
8.3
& Para 3 be Para 4

Amended Text
Change No. 72 Affect: ?

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Moved to be
8.3 Para 4 Para 3

Amended Text

When nonconforming product is corrected it shall be

subject to re-verification to demonstrate conformity
to the requirements.
Records of the nature of nonconformities and any
subsequent actions taken, including concessions
obtained, shall be maintained (see 4.2.4)
Change No. 73 Affect: ?

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Now new bullet
8.3 Para 5 d)

Amended Text
Change No. 74 Affect: ?

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Bullet b), Bullet
8.4 D+A
c) & Bullet d)

Amended Text
Change No. 75 Affect: ?

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8.5.2 Para 1 D+A

Amended Text
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8.5.2 Bullet f) A

Amended Text

f) reviewing the effectiveness of the corrective

action taken.
Change No. 77 Affect: ?

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8.5.3 Bullet e) A

Amended Text

e) reviewing the effectiveness of the

preventive action taken.