Session Plan
Course Title – ISO 9001 : 2008 Auditor / Lead Auditor Training
Session Title – Purpose, Content &
Interrelationship of ISO 9001 &
Session No.-02
Duration – 510 min
ISO 9004
Purpose of Session
 To introduce the development process & overview of ISO 9000:2008 series, difference
between auditable standards & guidance documents & to understand ISO 9001 form an
auditing perspective.
Learning Objectives
 By the end of the session successful students will be able to explain the purpose,
content & interrelationship of ISO 9000, ISO 9001 & ISO 9004
Tutor Notes – Training Activities and Methods
Introduction
 Introduce the learning objectives of the session
 Explain that the learning objective would be achieved
through activities by participants, reflection, conclusion &
identification of the next steps along with some formal
presentation of the tutors.
Duration and Tutor
Aids
Tutor Aids : Slide
projector / Screen, flip
charts; Standards ISO
9000, ISO 9001, ISO 9004;
Quiz 2 Model Answers;
Case Study workbook
Contents of the Session:
 This session consists of session 2a, 2b 2c and 2 d
 Session 2a
o Purpose of ISO 9000 series :
o Family of standards
o Evaluation & continuing development of the standards
o Revision of the standards
o Difference between auditable standard & guidance
documents
o Difference between legal compliance & conformance
with ISO standards
 Session 2b
o Selected definitions of quality terminology from ISO
9000:2005
o ISO structure
 Session 2c
o Intent & requirements of ISO clauses & linkage to ISO
9004
o Scope of audit & Scope of ISO 9001
o Basis for permissible exclusions & justifications
o
o
Apr 2010
90 mins.
30 mins / Act, Feed, Ppt
15 mins/ Ppt
40 mins. / Act, Ppt
5 mins Ppt
60 mins Ppt, Act
30 mins./Act, Ppt. Rev
270 mins.
30 mins. / Ppt
Exercise on Understanding ISO 9001 and ISO 9004
90 mins./Act, Ppt. Rev
requirements (EO1)
90 mins./ Ppt.
ISO 9001 Clause Details
Tutor Notes
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o
Linkage between QMPs & clauses
 Session 2d
o Documentation requirements
o Activity on Documentation
o
o
o
60 mins. Act, Rev
60 mins
25mins Act, Ppt.
10 mins
Structure of documentation
Typical contents of documents
Benefits & approaches for documentation
 QUIZ 2 (conducted on day 2 during Session 2)
25 mins PPT
15 mins
Corresponding Practical Activity, if any:
Refer to Continuous Assessment Plan : Session 2
Points to be highlighted/Questions to be raised during Sum-up:
 Session 2a
o Purpose of ISO 9000 series in an organizational
context
o Usefulness of guidance documents (ISO 9004)
 Session 2b
o Importance of ISO 9000 for Understanding ISO
terminology & interpreting the standard
o ISO structure: Process Model
 Session 2c
o Permissible exclusions and justification
o Linkage of ISO 9001 clauses with QMPs
o Value of QMS documentation
 Session 2d
o Documentation requirements of ISO 9001
o Structure, typical contents of documents
Delegate Assessment:
 Refer to continues assessment Plan : Session 2 & Session plan
for E01
Please refer to Session Plan for Activities when conducting the activities given in this session
Please refer to Session Plan for Recapitulation for the Recap session on Days 2,3 4 and 5
Apr 2010
Tutor Notes
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Continuous Assessment Plan: Session 2
Name
Course Details
Learning Objectives
Tasks / Outputs
Achieved
Successful students will be
able to explain the purpose,
content & interrelationship
of ISO 9000, ISO 9001 &
ISO 9004
2a
Individual scoring
on quiz responses
(Min 60 %)*
1.
2.
Activity & review an exploring the purpose
of ISO 9000 series
Activity & review on identification of
auditable and guiding standards & rationale
behind it
2b
3.
Activity & review on matching definitions
with the appropriate terminology
4.
Activity & review to interpret requirements
of ISO 9001: 2008, & justifying permissible
exclusions : Refer to detail session plan of
E01
Activity & review on establishing linkage
between ISO 9001 clauses & QMPs
2c
5.
2d
6.
Activity & review on identifying factors
that decide form and type of documentation
Quiz on Session 2 for individual assessment
*In case a student does not achieve 60 % in the questionnaire evaluation, the tutor shall provide
additional guidance /inputs to ensure that the student incorporates the correct / appropriate answer
before moving on to the next learning objective. This shall be recorded by the tutors.
Apr 2010
Tutor Notes
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SESSION PLAN FOR ENABLING OBJECTIVE : KNOWLEDGE & SKILLS
Course Title : ISO 9001 : 2008 QMS Auditor / Lead Auditor
Session Title : Interpreting Requirements of ISO 9001 / 2008
Session No.: E01
Duration : 90 Min
Purpose of the Session : To provide delegates with the practical experience in interpreting requirements of ISO 9001 / 2008
in the context of the audit & understanding the broader intent of ISO 9004:2009.
Learning Objectives :
 Relate incidents to appropriate clause or clauses.
 Validate the above relation with reasons.
 Identify the activities or processes which organizations may be permitted to exclude from the scope.
 Understanding broader intent of ISO 9004:2009.
Tutor Notes : Training Activities and Methods
Introduction :
 Explain that the exercise is designed to understand the ISO
9001: 2008
 Opportunity to understand the requirements in the context of the
audit situation.
 Explain that delegates will be formally assessed during this
session
Introduce exercise: Provide the exercise brief highlighting the following
points:
Task :
 To analyse the incidents, relate to the appropriate clauses and to
understand justifications for permissible exclusion.
 Appropriate reasonings from clauses to be provided for a
particular co-relation.
 Need not decide whether they are NCRs or not.
 Justify permissible exclusions.
 Identify incidents which are outside the Scope of ISO 9001.
Process :
 Syndicate group exercise
 If delegates require help on how to approach this exercise
highlight steps that they might follow in order to accomplish the
task.
Output :
 The output is to be presented in the proforma provided in the
Work Book and Case Studies.
Note :
 The output of the exercise is part of the formal continuous
assessment and will therefore be marked.
Run exercise : Individual Work 30 Min
Group Work 30 Min
 Tutors to monitor time keeping and provide clarification as
required.
Apr 2010
Tutor Notes
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Materials and Equipment
Work Book, Flip Charts
Refer to instruction on EO1 in Work Book and
Case Studies.
Syndicate exercise
Proforma sheets provided in Case Studies and
presented onFlip Charts
Feedback from exercise : 30 Min
 Delegates to present their group exercise outputs on Flip Charts
 Tutors to facilitate discussions leading to understanding of the
intent of the clauses of ISO 9001:2008 as appropriate and any
other relevant points as necessary.
 Clarify any doubt arises out of Entry Level Exam
As per marking scheme of E01
Apr 2010
Tutor Notes
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MARKING SCHEME
Exercise No
:
E 01
Session No
:
2c
Exercise Name
:
Interpreting the ISO 9001:2008 Clauses
Exercise Type *
:
1
Learning Objective
:
Interpret requirements of ISO 9001 in the context of an
audit
Enabling Objectives
:
a.
Explain the intent and requirements of each clause of ISO 9001
b.
Interpret and apply ISO 9001 appropriately in an audit situation
c.
Identify activities and / or processes which organisations may be permitted to exclude
from the scope
Criteria
A
B
Marks
Appropriate clause nos./sub clause nos. are given
3
Appropriate reasoning is given
3
Identified where the situation is outside the scope of ISO 9001
1
Permissible exclusions/scope assessed
3
Individual Participation Level
1 - 10
Marks Obtained = (A + B) / 2 by an individual participant
Note :
a)
For exercise Type : 2
Maximum 10 marks. Delegates must score a minimum of 6 marks to one
successfully complete the exercise. Delegates achieving less than this
invited to resubmit.
b)
a) For exercise Type : 1, 3
Maximum 10 marks. Delegates must score a minimum of 6 marks to successfully
complete the exercise.
___________________________________________
*
1.
Group exercise and presentation
2.
Group exercise – output is to be submitted for Tutor Assesssment
3.
Role play
Apr 2010
Tutor Notes
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1 – Low
10 – High
MODEL ANSWERS TO EXERCISE E-01
Sl.No.
Whether covered
Clause / Sub Clause of ISO 9001:
in Scope of ISO
2008
Reasons
9001:2008
1.
YES
1.2 & 4.2.2 a
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
YES
NO
YES
YES
NO
YES
YES
YES
YES
YES
NO
4.1 (a, b, c, d, e, f )
1.2, 4.1 a, 7.3.2
4.1 (last para), Notes 2 and 3
6.4
1.2, 4.2.2ª
8.2.1 & Note
6.2.2 (a, b & c)
1.2, 4.2.2a
Clarify the exclusions using the content of course slides no 03-4 & 03-5 fitted “JUSTIFICATION OF
EXCLUSIONS” & “MOST LIKELY EXCLUSIONS” respectively
Apr 2010
Tutor Notes
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