9kla21-24 April A M Rao Activities

9KLA 21-24 APR A M RAO ACTIVITY 1-3
!!Shree Swami Samarth!!
Activity 1: Terms & Definitions related to audit
Purpose: To understand the terms of audit as given in ISO 19011.

Duration: 15 minutes Work Individually
15 minutes classroom discussion
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10: excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment Sheet.
Directions:
Audit related terms are given below and the definitions as per ISO 19011 are provided. You have to
read the definition and place the term which it defines against it.
Terms Answer Definition

F Outcome of an audit, provided by the
1 Audit Criteria A audit team after consideration of the audit
objectives and all audit findings
I
2 Competence B Organization being audited
L
3 Audit Program C Extent and boundaries of an audit
C Person who provides specific knowledge or

4 Audit Scope D
expertise to the audit team
N
5 Audit Conclusion E Non-fulfilment of a requirement
G
6 Auditor F Set of policies, procedures, or requirements
K
7 Audit Client G Person with the competence to conduct an audit
H Systematic, independent and documented

process for obtaining audit evidence and
8 Audit H evaluating it objectively to determine the extent
to which the audit criteria are fulfilled
J Demonstrated personal attributes and
9 Audit Evidence I demonstrated ability to apply knowledge and
skills
M Results of the evaluation of the collected audit
10 Audit Team J
evidence against audit criteria
A
11 Audit Findings K Organization or person requesting an audit
B Set of one or more audits planned for a specific

12 Auditee L time frame and directed towards a specific
purpose
E One or more auditors conducting an audit,
13 Non-conformance M
supported if needed by technical
O Records, statement of fact or other

14 Audit Plan N information, which are relevant to the audit
criteria and verifiable
D Description of the activities and arrangements
15 Technical Expert O
for an audit
9KLA 21-24 APR A M RAO ACTIVITY 1-3
Activity-2 Difference between first party, second party and third party audits;
Purpose: Understand various types of the audits and differentiate between them into
1’st, 2’nd and 3’rd party Audits.
Duration: 15 minutes in group
15 Minutes, Feedback and Summary:
Direction: Based on your understanding of audit identify key differences in 1’st, 2’nd and 3’rd
party audit. You can write your answer on the flipchart/notepad.
1st Party - An internal audit that an organization performs on itself
2nd Party - An external audit that an organization performs on a supplier of goods or services
3rd Party - An external audit that is conducted by an independant organization upon another
organization.
9KLA21-24 APRIL A M RAO ACTIVITY 4-6
Activity-3 To understand the audit activities

Purpose: Understand sequence of activities related to audits.
15Minutes, Feedback and Summary:
Direction: Fastest Finger first……….Refer the activities mentioned below with respect to
typical audit, please try and arrange these activities in chronological order
AUDIT ACTIVITIES CHRONOLOGICAL ORDER Subgroup ( As per task-

B)
Distributing the audit report Establishing the initial contact with the Initiating audit
auditee
Assigning the work to the audit team Determining the feasibility of the audit
Conducting the opening meeting Preparing the audit plan
Establishing the initial contact with the auditee Assigning the work to the audit team
Collection and verification of information Conducting the opening meeting
Prepare work document Prepare work document
Conducting the audit follow up Roles responsibility of guides and observer Conducting audit
activities
Conducting the closing meeting Communication during the audit
Preparing the audit plan Document review
Audit findings Collection and verification of information
Roles responsibility of guides and observer Audit findings
Determining the feasibility of the audit Audit conclusions
Audit conclusions Conducting the closing meeting
Communication during the audit Preparing the audit report Conducting & distributing
the audit report
Document review Distributing the audit report
Preparing the audit report Conducting the audit follow up
Task-B …..Subgroup above activities into following categories
Initiating the audit; preparing the audit activities; conducting the audit activities; conducting &
distrusting the audit report
Activity-4: Difference in Methodology of 1’st Party, 2’nd Party & 3’rd party audits
Purpose: Understand key difference amongst three types of the audit w.r.t.
approach, time, methodology, and objectives
Direction: As per activity #2 you already know the difference between first party;
second party and third-party audits; now further classify them w.r.t. approach, time,
methodology, and objectives.
Approach Time Method Objectives
1st Party Audit Measure strengths and 1 to 2 days PDCA Verify compliances to
weaknesses on own Reporting – Informal internal or ISO 9001
standards Continuous
Internal audit Non conformities to improvement efforts
Auditee- SOP is identified Measurement of
returns on investments
2nd Party Audit Audit Vendor process Customer audit 2 Prior intimation Compliance to SOP,
Audit by customer days. Opng session QAP
Audit of Vendor Informal Ensure Supply of goods
premises – 1 day Checklist and services with safe
Check compliance to practices
checklist
3rd Party Audit Audit by Independent Agreed between Formal Audit Verify compliance to all
Organisation Auditor and Auditee QMS management specific regulations or
2-3 days system with certified standards of ISO 9001
Renewal / surveillance auditors
audit Confirmity and non
conformity is reported
Activity-5 Determine Audit Objectives, Scope and Criteria

Purpose: To Outline the Audit Objectives, Scope and Criteria for 1’st 2’nd and
3’rd party audits.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment
Sheet
Task-A: Refer the Activities 2 & 4. You have already understood the 1’st; 2’nd and 3’rd party
audits. Now identify the AUDIT OBJECTIVES, SCOPE AND CRITERIA laid down for each type of the
audit.
AUDIT OBJECTIVES SCOPE CRITERIA
1st Party Verify compliances to internal Specific dept or function or As given by the customer or
or ISO 9001. Continuous
improvement efforts. All processes reqd for mfg a ISO 9001 or Internal policy
Measurement of returns on specific item / organization and procesures
investments
2nd Party Ensure Supply of goods and Customer audit- As per Decided by customer –
services with safe practices Contract reqmt. Or specific Quality plan etc
reqmt by customer.
3rd Party Verify compliance to all Certification body will Set of policies and reqmts
specific regulations or decide the scope and as per ISO 9001
standards of ISO 9001 boundary
Activity-6: Responsibility and authority of the personnel associated with audit activities
Purpose: Determine the Responsibility and Authority of Team Leaders, Auditors,
Guides, Observers, and Auditee & Client.
Duration: 20 minutes in group;
tutor will distribute the 35 statements given below; amongst the group.
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10: excellent. Each
delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment Sheet
Task :Read the statement given below and place them under appropriate box/es; so as to acquire
the knowledge about the responsibility & authority of audit personnel. Reference 19011:2018
1. …deny observers from taking part in certain audit activities.- Auditor/ Team Leader
2. ….assist the audit team - Guide
3. ….assisting the auditors in identifying individuals to participate in interviews and confirming
timings;- Guide
4. ….ensuring that rules concerning location safety and security procedures are known and
respected by the audit team members and observers.- Guide
5. ….witnessing the audit on behalf of the auditee- Observer
6. ……..providing clarification or assisting in collecting information.- Guide
7. …….Establishing initial contact with the auditee- Team Leader
8. assign to each team member responsibility for auditing specific processes, activities, functions or
locations.- Team Leader
9. ……….collect and review the information relevant to their audit assignments and prepare work
documents,- Auditors
10. ………..communicate the progress of the audit and any concerns to the auditee and audit client,- Team
Leader
11. ……..Any concern about an issue outside the audit scope should be noted and reported to Client
12. ……Conducting the closing meeting – Team Leader
13. ….should agree on the time frame for an action plan to address audit findings.- Auditee/ Client
14. ….should advise the auditee of situations encountered during the audit that may decrease the
confidence that can be placed in the audit conclusion- Team Leader
15. …..report the audit results in accordance with the audit programme procedures- Team Leader
16. give permission and access to those parts of the audit site, to be visited in accordance with the audit
scope;- Client
17. ….avoid any unnecessary disturbance of the operational processes- Auditors
18. ……reach agreement on whether the audit should be interrupted, rescheduled or continued; Team Leader
19. ……..if taking photographs or video material, ask for authorization from management in advance and
consider security and confidentiality matters and avoid taking photographs of individual persons
without their permission; -Auditors/ Team leader
20. …..Selecting the audit team members – Team Leader
21. …..operate under the direction of an auditor, but should not act as auditors- Observer
22. …..if a conflict of interest or competence issue arises, it should be discussed with…..- Team Leader/ Programme
Manager
23. ……should develop, maintain and improve their competence through continual professional
development and regular participation in audits – Client/ Auditee
24. ….should exhibit professional behaviour during the performance of audit activities,- Auditors/ Team Leader
25. ….plan and organize the work effectively;- Team Leader
26.prioritize and focus on matters of significance understand and consider the experts’ opinions-- Auditors
27. …confirm the sufficiency and appropriateness of audit evidence to support audit findings
and conclusions- Team leader
28. …use work documents to record audit activities- Auditor
29. ….maintain the confidentiality and security of information, data, documents and records- Team Leader/
Auditors
30. ….preventing and resolving conflicts, as necessary;- Team leader
31. ….Those documents involving confidential or proprietary information should be suitably
safeguarded at all times by the……….- - Auditors and the team
32. …..sought confirmation to the agreement of all parties to the audit plan; Team leader
33. ….acknowledge the audit report…Client
34. …..accept the nonconformities as closed….Auditors/ Team leader
35. ….provide specific knowledge or expertise related to the organization, the process or activity
to be audited,or language or culture.- Guide
Team Leaders, Auditors, Guides Observers, Auditee Client.
IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 9

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Activity-7 Purpose: To understand different audit methods,

Sheet
TASK: Study the previous Activity-2 & 4 and identify what method were used by the various auditors…
also list down +ve and -ve points of these methods.
Audit
Meth On-site Remote
od
Conduct opening meeting Carry out long distance interviews.
Human Interaction
Carry out face-to-face interviews of various Complete checklists with auditee help.
employee of Auditee
Fill out questionnaires with auditee help.
Collect samples with auditee participation.
Review documents with auditee participation.
Review documents with auditee participation.
Checking consistency of documentation
Complete checklists with auditee assistance.
Flexibility Plan based on availability of auditees
Fill out questionnaires with auditee
assistance.
Closing meeting
Understand body language
Emotions, eye contact
Review documents without auditee help Feasibility of Audit

Non-human Interaction
Conduct onsite visits without auditee participation. Roles and responsibilities of Guide and observers
Complete checklists Review documents without auditee assistance.
Analyze information Analyze information without auditee assistance.
Collect samples Observe work without auditee assistance.
Observe work

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Activity-8 Purpose: To understand the audit plan requirements,

Sheet
TASK: Refer ISO19011 clause # 6.3.2; and prepare the structure for Audit Plan based on that these
requirements. Also identify the risk in achieving the Audit Objectives (With respect to Objective, Scope,
Criteria, locations etc.) refer clause 6.3.2.2 Audit planning details ISO19011
1. Audit objectives
2. Audit scope
3. Functional units, as well as processes to be audited
4. Audit criteria
5. Any reference documents
6. locations, dates, expected time and duration of audit activities to be conducted
7. Audit methods
8. Audit evidence
9. Roles and responsibilities of the audit team members, including guides & observers
10. Allocation of critical areas of the audit.
Activity-9: Purpose: Opening Meeting

Sheet
TASK: Refer ISO19011 clause 6.4.3 - Conducting the opening meeting, and prepare your points for the coverage
of opening meeting presentation.
The purpose of the opening meeting is to:
a) confirm the agreement of all participants (e.g. auditee, audit team) to the audit plan;
b) introduce the audit team and their roles;
c) ensure that all planned audit activities can be performed.
d)other participants, including observers and guides, interpreters and an outline of their roles;
e)the audit objectives, scope and criteria;
f)the audit plan and other relevant arrangements with the auditee, such as the date and time for the closing
meeting, any interim meetings between the audit team and the auditee’s management, and any change(s)
needed;
g) Complaint resolution process

h)formal communication channels between the audit team and the auditee;
i) the language to be used during the audit;
j)the auditee being kept informed of audit progress during the audit;
k)the availability of the resources and facilities needed by the audit team;
l)matters relating to confidentiality and information security;

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m) Circumstances under which Audit can be terminated
Activity-10: Purpose: Capturing & verifying Audit Evidences

Sheet
TASK: Refer ISO19011 clause 6.4.7 – methods of collecting information are INTERVIEW, OBSERVATION and REVIEW
OF DOCUMENTS & RECORDS… capture how to convert various methods of collecting the information into Audit
Evidence………
Methods of collecting
How to convert it into Audit evidence
information
verify conformity, evaluate effectiveness,
Evidence of Gaps
INTERVIEW
Monitor the management system and its processes
Management review and action evidences
Completely filled out records

Process parameters
OBSERVATION Dates in the records
Participants in meetings
Actual results.trends
Subsequent actions.
The review of records and documents , Log books ( Document No,

Date, Title of document, performance, Name, Period , ) provides audit
REVIEW OF DOCUMENTS and
RECORDS evidence Review of certain documents may provide audit evidence of
the existence of a review mechanism , compliance to customer
standards, Customer complaints anasysis and improvement etc., Vision
, Policy, etc- t.

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Activity-11: Purpose: Questioning Technique

Sheet
TASK: One team will ask questions to their auditee (selected from another
team) From the learning of various questioning technique now read following
paragraph and identify the questioning types.
Question: Do you measure customer satisfaction? – Close ended

Answer; Yes! We did
Question: Are your customer satisfaction? Close
ended - Yes! They are?
Question: How satisfied or dissatisfied are customers? Open ended
Answer: We send questionnaire to our customer every quarter, then we seek feedback from them.
Once feedback is received we analysis overall satisfaction and individual dissatisfaction level, if any.
Question: How many customers are satisfied? Probing
Answer: Out of 21 customers 3 had shown strong dissatisfaction, 18 are rated us
“excellent” Question: What Actions are the opportunities improve the dissatisfied
customers? Probing
Answer: We have very less presence in that segment of Refrigerated Vans. We are hiring a person you
has got expertise in this area in all functions. This was explained to customers and they gave time frame
of 3 months. Person already on board.
Question: Have you done risk analysis on newly added project “refrigerated Vans”? Close ended
Answers: Yes!
Question: what is risk of high priority”? Open ended
Answer: it was “competence” which I already explained.
Q; How many customer complaints lodged since last year? Probing
A; 3!
Q: How many them are repetitive? How many of them are related to single customer? How many are
them related to competence and how many of them are attributable to supplier? Probing
A: There was competence related area for which we hired a expert and that person has already on
the board.
Q: What are analysis of these complaints? Do you use any specific problem-solving technique to arrive
at the root cause after analysis? Probing
A: We use FISH-BONE diagram for root cause analysis.
Q. what is highest level concern from analysis Probing
A. it was competence and agility.
Q. What actions are initiated to tackle this issue? Probing
A. Trainer hired and he is on the task to align all training with respect to customers.
9KLA21-24 APRIL A.M.RAO ACTIVITY 13-15
Activity-12: Purpose: Follow up audit scenario

Sheet
TASK:
1. Recollect the leaning from today’s session
2. Who decides the follow up audit?

Lead Auditor / Team Leader
3. What could be the Objective, Scope, and duration of follow up audit?
Obj: Do audit and close NC
Scope : Dept,
Duration :1 day
4. Who will conduct this follow up audit?
Team leader / Auditor
5. Does it require audit plan?
Yes
6. Opening meeting required?
Yes
7. What will be the possible outcome from the follow-up audit?
a) All NC are addressed effectively by Auditee - recommendation for certification OR
b) If None of the NC s not addressed effectively- Conclude No Progress , Recommend for Stage 1 audit.

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Activity 13: Quality Management System Terms & Definitions
Purpose: Familiarization with terms and definition related to QMS ISO 9001:2015
Duration: 10 minutes Work Individually &

05 minutes feedback
Sheet
Directions: Individually, review he terms and definitions and determine which definition
belongs to which term, Enter the correct letter of the definition next to the
appropriate term in the table on the following page. Definition of terms used
in QMS ISO 9001:2015 has been provided.
Solution:
Terms Definition
E Set of interrelated or interacting elements of an organization to
1 Competence A establish policies and objectives and processes to achieve those
Continual L Person or group of people that has its own functions with
2 B
Improvement responsibilities, authorities and relationships to achieve its10
Corrective F Person or group of people who directs and controls an organization
3 C
Action at the highest level16
Documented K
4 D Results to be achieved13
Information
5 Process O E Ability to apply knowledge and skills to achieve intended results 1
Interested P Action to eliminate the cause of a nonconformity and to
6 F
Party prevent recurrence 3
7 Management A G Effect of uncertainty15
System
N Make an arrangement where an external organization performs
8 Measurement H
part of an organization’s function or process12
9 Monitoring M I Measurable result 8
10 Objective D J Need or expectation that is stated, generally implied or obligatory
B 14
Information required to be controlled and maintained by an
11 Organization K
organization and the medium on which it is contained 4
12 Outsource H L Recurring activity to enhance performance 2

I
13 Performance M Determining the status of a system, a process or an activity9
14 Requirement J N Process to determine a value

G Set of interrelated or interacting activities which transforms inputs
15 Risk O
into outputs5
Top C Person or organization that can affect, be affected by, or
16 P
Management perceive itself to be affected by a decision or activity 6

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Activity 14: Understanding EDIM (Establishment, Documentation,

Implementation & maintenance of QM S
Purpose: Establishment of QMS ISO 9001:2015
Duration: 20 minutes Work individually &

10 minutes feedback
Sheet
Directions: Fastest finger first….. Please arrange following statement in correct
chronological way
QMS objectives 7
Planning 5
External issues 1
Evaluation of Data 11
Interested parties 3
Management review 13
Risk assessment 6
Monitoring & measurement 10
Corrective action 14
Resource provision 8
Operations 9
Internal audit 12
Continual improvement 15
Internal issues 2
Strategic direction 4
Activity 15: Understanding audit trail
Purpose: How to generate audit trail while auditing ISO9001 2015 requirements
Duration: 45 minutes Work Individually &

15 minutes feedback
Sheet
Directions:
During audit of METAPHORA, you are auditing marketing function as an auditor. When you asked
about the customer complaints to marketing manager he says there are 6 customer complaints
reported in the current year. He further explains that 3 customer complaints are repetitive in nature
and related to only truck drivers. Customers are bit annoyed because of delayed caused by the track
drivers, as they are not providing correct information about the exact location and this delays the
incoming material and subsequently, production of customers, ……this have been the performance of
the drivers……., material was either reaching late, or in damaged conditions.
As an auditor how will you trace this matter further….what all you verify within marketing and all
other departments to ensure the effective implementation of QMS….list down the items you would
like to verify in the Orgnization and further; try to correlate it with ISO9001:2015 clauses by
mentioning the clause numbers against the items you want to verify….
Item Clause
Customer complaint communication, 8.2 ; 8.4
Communication due to changed requirement.
Competency of service provider, 7.2, 7.3, 7.4
awareness of implications of non compliance to QMS,
Communication with service provider
Infrastructure conformities, 7.1.3; 7.1.4; 7.1.5
Environment for operations- Physical and
psychological
Monitoring and measurement
Continuous improvement 10.3
Meeting product and service requirements; 9.1.2; 8.6
Customer satisfaction

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Activity 16: Understanding QMS documented information
Purpose: What are the documents and records required by ISO9001 2015
Duration: 30 minutes Work in group &

15 minutes feedback
Directions: Start from clause number 4 to clause number 10 of ISO9001:2015
requirements, search for the phrases “documented information to be maintained”
and “documented information to be retained.”. And list down these documents,
records and corresponding clause number
4.4. Quality Manual, Required Procedures, Required Forms, Records,
1 Control Documents; Control Forms
5.2. Quality Policy

1
Activity 17: Initiating the audit.
Purpose: To acquire skill for initiating the audit.

Duration: 20 minutes
10 Minutes, Class discussions
Directions:
You are working for a certification body as programme manager ….and received a request to plan
surveillance audit…..for the automotive client who has two manufacturing units one at Mumbai and
other at Chennai, head office is in Bangalore, this office gives support to both the manufacturing sites for
activities like Sales & marketing, Design Centre, Strategic Planning, Central purchase and corporate
Human Resource department,
Previous audit was certification audit and both manufacturing sites had received 4 NC s each and
Bangalore support function 2 NCs,
What information you will seek from the and Auditee Management, Audit Client, Design and
Development center….
Design&Developme
Auditee Management, Audit Client
nt
Products and services Performance data of Orgn Details of closure of NC
How many sites are there to audit Document review wrt ISO9001-2015
How the inter relation and
communication takes place between
Design centre and HO

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9KLA21-24 APRIL A M RAO ACTIVITY - 19
Audit plan for M/s Metafora
Name of the Client: METAFORA File No.:
HO New Delhi
Addr
ess:
Date:
Site
Kind Attn.:
Designation: Head – Unit Quality
E
Audit Criteria(s) [Standard(s)] ISO 9001:2015 ma
il

22
-
Da
24
te
th
Type of Audit: STAGE 2 of
Oc
Au
t
dit
20
20
Scope: Logistic services
Audit Objectives to verify: [Delete whichever Type of Audit is not

applicable]
§ Information and evidence about
conformity to all requirements of
Surveillance#1 the applicable management
system standard or other
normative document
§ Performance monitoring,
measuring, reporting and reviewing
against key performance
objectives and targets (consistent
with the expectations in the
applicable management system
standard or other normative
document)
§ The Organization's management
system and performance as
regards legal compliance
§ Operational control of the
Organization’s processes
§ Internal auditing and
management review
§ management responsibility for
the Organization's policies
§ Links between the normative
requirements, policy, performance
objectives and targets (consistent
with the expectations in the
applicable management system
standard or other normative
document), any applicable legal
requirements, responsibilities,
competence of personnel,
operations, procedures,
performance data and internal
audit findings and conclusions.
§ Enquiries from the IRQS to the
Organization on aspects of
certification
§ Review of actions taken on
nonconformities identified during
the previous audit,
§ Handling of

complaints,
§ the effectiveness of the
management system in its entirety
in the light of internal and external
changes and its continued
relevance and applicability to the
scope of certification;
2019 § To evaluate the suitability and
Document review
From Matafora
Clause Detail Docs Manual
4.4.2 Required procedures Transportation &
Logistics; Vehicle
Maint; Biz Plng; HRD
&Training
Control Documents Quality Manual - QR
01
Control Forms
5.2.2 Quality Policy Metform 0
6.2.1 Quality Objectives Metform 0
7.1.5.2
a Basis for Calibration
7.1.6a Knowledge shared
7.2 d Evidence of competence MT/MR/03
7.5.1a Documentation reqd for ISO 9001 Resources
7.5.1a Documented Info for effectiveness of QMS
8.1 Determining , maintaining and documenting Info necessary
8.2.3.2
a Retain info on results of the review In place
8.2.3.2
b Any new requirement of products and services
8.3.2j Docs to determine that design and dev reqmts have been met Metform 14
8.3.3 Retain docs on design & dev Metform 15
8.4.f Retain docs design & dev validation Metform 16
8.3..5 Retain design & dev outputs
8.3.6 Retain design & dev changes
Retain doc Evaluation , selection, monitoring of performance, re-evaluation o external
8.4.1 providers Metform 20
8.5.2 Retain documented info to enable traceability
8.5.6 Results of review of changes
8.7.2 Info on non confirmity, actions taken, concessions obtained Metform 21
9.1.1 Evidence of results on perf of QMS
9.2.2f Evidence reg implementation of audit & results Metform 22
9.3.3 Results of Management review Form
10.2.2 Nature of non confirmities, subsequent actions taken and corrective actions taken Metform 28,29,30
Activity 25: Nonconformity and closure
Purpose: TO test the skill required, as an auditor, to identify and grade the
nonconformity based on the its impact to system and customer.

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15 minutes sum-up the activity
Sheet
Directions: This is group activity.

Refer the scenarios allocated to you.
Each group has identified nonconformity/es during audit of their allocated
department from METAFORA case study.
Please write the nonconformity into 3 elements
1. Statement of Nonconformity.
2. Requirement of ISO9001:2015
3. Objective Evidences against the nonconformity.
Audit Objective: Stage-2 audit of METAFORA
Audit Criteria: ISO9001 2015 & Documented information of METAFORA Clause 10.2.1
Scope: Entire Metafora activities.
Direction: Audit evidences gathered during this shall be used for preparation of
audit report.
PLEASE REFER ACTIVITY # 28 in next pages
Activity 26: Closing meeting
Purpose: TO test the skill required, as an team leader to plan and conduct closing
meeting.
10 minutes, sum-up the activity
Sheet
Directions:
Please prepare for the closing meeting based on the requirements of ISO19011.
Tutor will select one delegate as team leader.
This closing meeting is for the stage-2 certification audit of METAFORA.
All other class member will have to prepare minimum one nonconformity based on their audit
finding and be ready to present it when your team leader will prompts you for the during the
closing meeting.

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Audit Objective: Stage-2 audit of METAFORA
Audit Criteria: ISO9001 2015 & Documented information of METAFORA Clause 10
Scope: Entire Metafora activities.
Activity 27: Audit Report
Purpose: TO test the skill required, to prepare audit report, based on the conclusions
and recommendation given in the closing meeting
Duration: 45 minutes.
15 minutes Class discussions
Sheet
Directions: Please prepare the audit summary report based on the Metafora’s audit.
Then hand it over to the tutor.
Please use A4/Note pad for the summary report.
Please refer ISO19011 requirements related to Audit Report.
Activity 28: Audit Follow-up

Purpose: TO test the skill required, to evaluate proposed corrective actions received
from the client Orgnization, as part of your recent audit on them.
To understand the various aspects of NC closure.
Duration: 70 minutes.
20 minutes Class discussions
Sheet
Directions:
You have conducted audit of METAFORA for stage-2 certification audit.
Refer the nonconformities ISSUED DURING STAGE-2 AUDIT along with the
METAFORA’s response in the form of Correction and corrective action.
Review it decide whether NC accepted or Not.
Corrective Action Plan
Stage-2 Audit NC by
STAGE-2 NC # :CB AD-01 Date: Sept-xx
a Certification Body
METAFORA
CLAUSE # Clause 7.1.5 Customer Complaint CC-
A] Problem Statement: Weighing Scale (Metafora/WS-04/May-xx ) used in the Logisitcs for calculating the
quantity of lubricant being shipped out to the customer was not calibrated. Quality In-charge stated that they
do not feel the necessity of calibration
Process Owner : Logisitcs Supplier representative:
B] Correction: Containment Action/s. (Immediate actions taken)
Weighing scale re-calibrated Not applicable.
C] Root Cause Analysis: (Attach separate sheet for problem solving technique used to arrive at Root cause (s).
Root Cause (s):
missed one of error, M.D.’s son manufactures this weighing scale
D] Proposed Corrective Action/(s) (PCA) E] Corrective Action implemented / Initiated:
Weighing scale re-calibrated Weighing scale re-calibrated
E] Changes made in the Documents / systems (kindly attach the proof)
Document Document
1 NIL 3
2 4
F] Effectiveness of corrective action to prevent recurrence of cause of NC.
NC Reviewed and Accepted by
Response : Non confirmance (NC) reviewed and not accepted

2019
Stage-2 Audit NC by
METAFORA
CLAUSE # Clause 7.2 Not applicable Customer Complaint CC- nil
A] Problem Statement: Effectivess of training of drivers and cleaners are not verified for the training on “Safe
driving of Tankers”. But this training was given by client of Metafora and they tested the skill of drivers and
cleaners and then only issued a “Driver-ID” to them. When asked question about the “safe Driving” driver Mr.
Sandy could not able to explain, HR personnel said that they are nervous because auditor was asking a
question to them. This service was started six months back and no incident or complaint raised by client. But
records of effectivess of training not available with HR department.
Process Owner : HR Supplier representative: Head Mkt.
Drivers ID issued by customer now retained as All other training records are available.
record of effectivess
Root Cause (s):
missed one of error,
D] Proposed Corrective Action/(s) (PCA) E] Corrective Action implemented / Initiated:
Record of Driver ID made available Record of Driver ID made available.
Document Document
1 NIL 3
2 4

.
Stage-2 Audit NC by
METAFORA
CLAUSE # 8.2.1 Customer Complaint CC- nil
A] Problem Statement: Customer “Cambridge Logistics” had given one of their trucks (Truck # UWE 5648- SD) to
operate for their shipment within the 100km area. As per contract this truck was suppose to be used only for
“Cambridge Logistics” cargo handling. In Aug-XX there were 2 occasions, that this truck was being used for
other customers. This was not at all informed to “Cambridge Logistics”. Logistics in-charge said that contract is
old and we have now owned this vehicle. But such contract termination or maturity documents were not
available.
Process Owner : HR Supplier representative: Head Mkt.
Inform to customer. Customer had proposed to buy this vehicle, we are buying it in Dec-xx
Root Cause (s):
There was no truck available to ship a cargo of “Northern Roadways”

Truck which was owned by “Cambridge Logistics” was available.
We decided to use it and it was duty of Marketing to inform to customer
Marketing in-charge failed to inform.
Lack of communication skill
D] Proposed Corrective Action/(s) (PCA) Training on E] Corrective Action implemented / Initiated:
Communication Skill. Training provided on Sept-xx and verified the
effectiveness by monitoring the person.
Document Document
1 NIL 3
2 4

Stage-2 Audit NC by
METAFORA STAGE-2 NC # :CB AD-04
Date: Sept-xx

A] Problem Statement: METAFORA had outsourced activities of cargo shipping “ ZEBRA Trans-lines” their
job was to ship the material from client premises and ship to their customers.
When quality objectives set for “Zebra” was being audited it was evident that since last three months
because of their service 9 customer complaints are reported.
Supplier selection process had one parameter of driver’s attribute testing through psychological mapping.
This test was not done by expert due to urgency. There were 8 complaints attributable to 2 drivers who
had behavioural issue.
Process Owner : PURCHASE Supplier representative: HEAD PURCHASE

Strict Warning to drivers, salary cut will be No Customer complaint because of behavioural issue in Sept-XX &
there for behavioural issue Oct- XX
Root Cause (s):

Before selection of “Zebra Trans-lines” , Metafora knew that they had shortage of drivers.
The drivers’ list approved by Metafora was not being used, because of heavy workload on the “Zebra Trans-lines”
So “Zebra Trans-lines” hired few new drivers on contract basis, which was not informed to us. Metafora
accepted the things because of urgency and big order in the pipeline.Violation of supplier selection process.
D] Proposed Corrective Action/(s) (PCA) Training on E] Corrective Action implemented / Initiated:
procedure for Supplier selection not adhered to. Re-trained all on Sept-XX. Understood the impact on
Express way of psychological mapping module to be business because of customer complaints.
design with expert- by Oct-XX Express psychological mapping model “MAP-Intelligence”
developed and results are useful. 12 drivers disqualified.
Document Document
1 Procedure for Supplier selection amended. 3
Express Express psychological mapping model
2 4
“MAP-Intelligence” is part of selection of drivers.
Response : Non confirmance (NC) reviewed and accepted

Stage-2 Audit NC by
METAFORA STAGE-2 NC # :CB AD-05
Date: Sep

A] Problem Statement: Orgnization has conducted the internal audit at the frequency of once in six mo
While going the through internal audit documents, third party auditor noticed that there are risk an
opportunities not audited. Further investigation reveals that internal auditor not trained on risk and
opportunities, although one of the customers had specific requirement of trained internal auditor on
risk and opportunity auditing. Third party auditor could able to identify many a potential risk and
opportunities. A management review record says risk and opportunities are effective..
Process Owner : INTERNAL AUDITS Supplier representative: HEAD SYST

Training to ALL internal auditors. NIL
Root Cause (s):

inadvertently missed the points during internal audit.
D] Proposed Corrective Action/(s) (PCA) : In the next E] Corrective Action implemented /

internal ( 8’th month of next calendar year) audit risk Initiated: Training planned in July-XY next
and opportunities will have to be covered by each year. Next internal audit – Next year Aug
internal auditor as there was nonconformity on this -XY
aspect in the third party audit conducted in the 9’th
month of the calendar year.
Document Document
1 3
2 4
CQIand IRCA Specimen exam paper QMS, September 2018. Amended for use on certified course XXXX operated
by ATP xxxx
Page 1 of 34
01) Name of the Client M/s METAFORA
02) Address of HO & Site(s) Building C, Property # 24;
North Block, Alfa Building,
Thomas Alva Road, New Delhi, India 110 11o

03) File Number ####
04) Name of “Head of Organization” / Unit Mr/ Ms. Managing Director
05) Name of Organization Representative Mr./ Ms. Auditee MR

coordinating with CB
Names of the management legally responsible Mr/ Ms. HR Head
for occupational health and safety, personnel
responsible for monitoring employees health and
employees representative(s) with responsibility
for occupational health and safety.(Applicable
for OHSMS)
06) Audit Criteria ISO 9001:2015 ISO 14001:2015 OHSAS 18001:2007 ISO 45001:201
(strike out the standard not under audit)  Applicable legal & other requirement.
 Organization’s procedures & documented information in line wi
the respective standards.
07) Date of Audit 24/4/2020
08) Type of Audit Stage II/Renewal/ Surveillance/ Scope extension / Scope reduction /
(strike out the standard not under audit) Follow-up / Transfer / Special Audit for a/b/c as referred under Audit
Objectives “9d”
Joint/ Combined / Integrated
09) Audit Objective
a) Stage 2 Audit :
Is to evaluate the implementation including the effectiveness of the organization’s implemented management syste
for the above criteria covering the following :
 Information and evidence about conformity to all requirements of the applicable management system standard
other normative documents
 Performance monitoring, measuring, reporting and reviewing against key performance objectives and targe
(consistent with the expectations in the applicable management system standard or other normative document)
 Organization’s management system ability and its performance regarding meeting of applicable statutor
regulatory and contractual requirements
 operational control of the organization’s processes
 Internal auditing and management review
 Management responsibility for the client’s policies.
10) Changes to the audit objectives, audit scope or audit criteria (e.g. physical location, organizational units, activities and
processes), if any: Please attach “Notice of Change”
NIL
Pre-audit information
by ATP xxxx
Page 2 of 34
12) Audit Team Details Name Role
(Team Leader, Team Member, Provisional Auditor,
A.M.Rao Team leader
Provisional Team Leader, Evaluator, Industry Expert Any
accompanying persons; e.g. Guides, Observers, Translator, R.Venkatesan Aditor
Facilitator etc)
13) Audit conducted at [Physical Functions/ Process(es)
location(s) as applicable] Address Date of Audit /Activities audited
at the Location/Site
Building C, Property # 24; North Block, Alfa
Head office Building,Thomas Alva Road, New Delhi, India
Permanent site(s)
Temporary site(s)
14) To comment:
Any deviation from audit plan and their reasons (if yes, please justify)
Upon any adverse conditions faced during the audit (e.g.; power outage, Fire, Flood, specifically related to th
condition of the sites affecting the auditing activities).
No
by ATP xxxx
Page 3 of 34
Audit Findings
SEC A : Comments on the Effectiveness for the Closure of Previous Audit Findings:
Findings Comments on the effectiveness for the closure
No. of Previous audit NCs: 0
No. of Areas of Concerns raised during Stage 1: 5 Partly closed
SEC B : Management System(s)
a) Scope of Certification: (If Multi-site audit, then scope as applicable at each site should be verified [for Stage 2 from Stage 1
Audit Report and for Subsequent audit against the issued Certificate] & reported)
Justification for the scope of certification [Brief description for scope verification highlighting on the process flow / activ
involved for the scope. Provide at least one example for scope of certification.
Metafora Head Office, Infra structure, Sites, Province offices, Commercial policies and strategies
Summary of Site Visit: Team containing 2 audited all Processes and its owners on Sampling basis .
b) Process of understanding & review of the needs and expectation of interested parties
Table 4.2 – Reviewed through MRM
c) Methodology of identification, access of compliance obligations
[i.e. applicable Legal (Statutory / Regulatory & Other) requirements]
Global logistic execution/customs and transport documentation generation
processes
d) Methodology of determination of risk & opportunities related to
 the context of organization,

 Interested Parties
 management system and its processes/activities
Give examples of determined risk & opportunities
All details mentioned in Metform 2 and Metform 3
e) A) Brief description of organization processes determined taking into account planning, Monitoring and control of
management processes, change control (management of change) needs to achieve the expected outcome.
B) Control over identified externally provided processes, products and services (Outsourced activities).
by ATP xxxx
Page 4 of 34
f) Process of establishment and monitoring objectives of management system (with few examples for respective managem
systems audited)
Quality management system created by Management – Metform 0
g) The availability of resources, environment necessary to support the operations & monitoring of management process.
Personnel Interviewed, including workers / contract workers (For OHSMS).
NAME DESIGNATION INTERVIEWED FOR CONCLUSION BASED ON INTERVIEW
Mr.Amod Head Transportation Transpor and Logistics While the processes were complying
and Logistics process ISO 9001 -2015 Quality system, dur
our Audit, the team has been able
identify certain Non compliances(NC)
Summary of Health Performance including health objectives: (For all ISO 45001 – OHSMS AUDITS).
h) Methodology of determination & maintenance of organization knowledge necessary for the operations of its processe
achieve conformity of product /service, environmental impact / prevention of injury for the respective management system
In place
I) Demonstration of Leadership and commitment towards management system
In place
j) Method / procedure for Corrections and Corrective actions, as applicable for respective scheme, with example
k) Effectiveness of Internal Audit & Management Review
l) Examples of improvement/s as a result of correction, corrective actions, break through changes, innovation and reorganiza
including continual improvement.
m) Comments on the process of Organization’s Management of Change
by ATP xxxx
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SEC C : Current Audit Non-conformity
a) Grading of
NC No. Clause No. Statement(s)
(Major/Min
1 6.1 Process Effectiveness of Planning and execution of the targets is Major

impacted as the Key result area (KRA)of the Head of Logistics ( with
6.2
Targets and timelines) and cascading of the same to his reportees is
not evident
2 8.1 Review process of deliverables of the Head Logistics is not effective as Major
the points are not minuted there by no clarity on the responsibility
and timelines which have been committed in the review meeting
3 7.4 The Improvement Project information with committed Timelines is Minor

not known to Logistics which is not complying to the Planning process
of logistics
4 4.1 The drivers and vehicles taken from outside are not complying to the Minor
requirements of products and services. This is not compliance to the
8.4
Vehicles/ service competency process
5 7.4 Effective communication from Logistics reg the GPS requirement to Minor
purchase section is impacting the future engagement of vehicles there
by raising effectiveness issue on Purchase process.
b) No. of Major NCs: 2
c) No. of Minor NCs: 3
SEC D (a) : Maturity Of The Management System
(i) Level of Integration in case of Integrated Management System:
a) Integrated Documentation Yes No
(Manual, policy and objectives, procedures, work instruction etc.)
b) An Integrated approach to Roles & Responsibilities Yes No
c) Conduct of Integrated / approach to Internal Audit Yes No
d) Conduct of Integrated Management Reviews considering the overall business strategy and Yes No
plan
e) An Integrated approach to systems processes Yes No
f) An Integrated approach to continual Improvement mechanisms Yes No
by ATP xxxx
Page 6 of 34
g) Organization’s personnel to respond to questions more than one management system Yes No
standards.
ii) Comment on the maturity of the management system i.e. about the management system is fully Yes.
established in the organization and the level of support that it has from senior and top
management. Committed
Management
SEC D (b) : Brief comments on Annexure to Questionnaire for Result of the review of the system (over
period of certification), (applicable during renewal audits)
SEC E : Comments on Usage of Marks / Logos (Accreditation / IRQS)
NABCB :
 The logo shall not be displayed on buildings and flags.

 The logo shall not be displayed on vehicles except in publicity material like part of a large
advertisement
 The logo shall not be used on the visiting cards
 Use of logo not permitted on laboratory test, calibration or inspection reports, as such reports are
deemed to be products in this context.
 Neither the IRQS’s Logo nor the NABCB’s Logo shall be used on the packaging of a product, labels,
publicity material, written announcements etc. that in any way suggests that the IRQS or NABCB have
certified or approved any product, process or services of the registered client
RvA
 On reports and certificates of certified calibration-, testing and medical laboratories and inspection
bodies;
 On business cards of the certified client’s personnel.
SEC F (a) : Any Unresolved Issues
SEC F (b) : Any Other comments / observations
NOTE:
1) Processes required for verification of applicability of the Scope of Certification shall be audited in each
visit.
2) Dominant applicable clauses for respective Department/ Functions / Processes to be verified [Refer SEC B:
Summary of Conformity.
3) Information required in this Audit Programme is to be updated during First Assessment of the auditee
organization in a given cycle i.e. Stage-1 / Transfer / Renewal Audits / Subsequent Audit if there is any
modification of Scope (reduction / extension) / Site(S) / Department/ Functions if not audited as planned.
(to be discussed)
4) Information provided shall remain for guidance purpose only for the Audit Team of subsequent audits in
the cycle & hence, shall not be binding w.r.t. additional functions to be audited and / or clauses to be
audited in each function to confirm compliance to the respective audit criteria
by ATP xxxx
Page 7 of 34
SEC H : Recommendation:
[Please mark ‘Tick - ’ as applicable]
a) the issuance “ Certificate of Approval” for ISO 9001:2015
02) Based on the audit findings, it is concluded that:
- the audit objectives as identified under 9a above .., the effectiveness of the management system
could not be evidenced for the noted non conformities, hence, recommend for :-
a) the issuance “Certificate of Approval” for ISO 9001:2015 , subject to satisfactory closure of
non-conformities on or before _23-10-2020
b)
the audit objectives as identified under…9 a above ., effectiveness of the management system could
not be evidenced for the noted Major / Minor non conformity(ies), hence recommends for the
a) follow-up visit for closure of major NC(s)/ minor NC(s) requiring closure based on the site visit,
before 23-10-2020____________.
b) follow-up of audit before 23-10-2020____________.
- the audit objectives as identified under 9a above ),effectiveness of the management system could
not be evidenced for the noted Major non conformity(ies) (indicating breakdown of management
system or major impact on environment or high potential of an incident which may result in
injury/illness).
by ATP xxxx
Page 8 of 34
Team Leader Name A M RAO Signature & Date 24-4-2020
Auditee Representative Name Mr. AMOD Signature & Date 24-4-2020
by ATP xxxx
Page 9 of 34
Annexure to Audit Report:
Annexure - A : Review of Present Certification Cycle w.r.t. following criteria:
(To be filled during last surveillance audit of the Certification Cycle)
01) NC's, Observations - Overall Effectiveness of

Corrective & Preventive actions
02) Weak / Strong areas
03) Scope covered
04) Locations, Multi-sites covered
05) Any significant change in Operations/ management/

locations envisaged in the next one year / six
months
06) Any customer complaints / Appeals
07) Results of Internal audit / management review
08) All elements of Standard are covered in the last

audit Cycle
09) Improvement (throughout the certification cycle)
10) Legal compliance / Any incidence of violation
11) Check the manpower of SA1, SA2, SA3 etc.. as

applicable. Mention the manpower per Surveillance
Audit.
12) Verify the above manpower vis-à-vis as mentioned

in the Questionnaire for Renewal.
Conclusion regarding overall effectiveness of Management System Certification for the existing cycle:
Team Leader Name Signature & Date
by ATP xxxx
Page 10 of
34
CONFIDENTIAL APPROVED
TRAINING PARTNERS
CQI and IRCA Specimen Examination Paper

for Quality Management Systems Auditor
Training Courses
(PR328 & PR345 ISO 9001)
Please write your name and the date in the space

below.
Name: AMRao
Date:
THESE SPACES ARE FOR OFFICIAL USE ONLY
Section Marker 1 Marker 2 Pass mark Maximum
1 5 10
2 10 20
3 15 30
4 15 30
Total 63 90
Name of Marker Confirmed

Result
This examination is closed book.
• A clean copy of ISO 9001 and a bilingual dictionary are the only items permitted
for reference.
• Electronic devices, including laptops and mobile phones, are not permitted
into the examination room. Exceptions may be granted to delegates with
special needs. Any such arrangement must be with the prior written
agreement of the Approved Training Partner and shall include a record of
appropriate precautions that will be taken to ensure the fairness and security
of the examination process and examination questions.
by ATP xxxx
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34
Information for delegates
The examination paper is in four sections. Attempt all sections and all questions.
The time allowed is two hours. There is no additional time allowed for reading the
examination paper.
90 marks are available. To pass you must achieve at least 63 marks (70%), and
you must achieve at least 50% in each of the four sections. The maximum marks
for each question, or part of a question, are shown in brackets.
Your answers must be written on the sheets supplied. Please avoid writing in the
margins; these are for the markers. Write on the reverse side of a page if
necessary. Additional loose sheets will not be accepted.
All references to ISO 9001 refer to the latest issue.
Examination technique
Time management is very important in the examination. For guidance, the

average time available is:
a) Reading the examination instructions – five minutes
b) Section one – fifteen minutes
c) Section two – twenty minutes
d) Section three – forty minutes
e) Section four – forty minutes
Total time available – two hours (120 minutes)
Allow enough time to read each question properly. Make sure you understand what
is being asked for before starting to write your answer.
Where appropriate, the action verb that indicates the depth of answer required by
the question – explain, list, describe – is printed in bold. You should ensure you
understand the meaning of these terms (see below). Full marks will not be
awarded for a list if an explanation is required. Conversely, it is a waste of time to
provide a detailed explanation if the question asks for a list.
Action verb Meaning describe

depict in words
explain give a clear account of
outline give the most important features of (less depth than explain
or describe)
briefly using few words or without giving a lot of details
give provide without explanation (used normally with the
instruction to ‘give an example (or examples) of ....’)
list provide a list without explanation (bullet points)
identify select and name
define provide a generally recognised or accepted definition
state a less demanding form of ‘define’ or where there is no
generally recognised definition
prepare make (something) ready for use or consideration
support strengthen, substantiate, back up, give weight to
Section one – Five questions worth two marks each – maximum 10 marks
1.1 ISO 9001:2015 requires that internal audits are objective and impartial.
Describe the difference between objectivity and impartiality in this context.
(2 marks)
Impartiality is about being neutral and fairly giving all sides an equal value without bias.
Objectivity is all about sticking to the observable facts without bias, judgement and
prejudice.
1.2 Explain, in the context of auditing, the difference between being

argumentative and being assertive.
(2 marks)
Being assertive is getting your wants fulfilled by other person by stating that he is
correct.
Being argumentative means to prove that the other person is totally wrong and possess
wrong opinion about any particular issue.

1.3 The organisation needs to monitor customer satisfaction. List two methods
an organisation can use to determine the degree of customer satisfaction.
(2 marks)
Customer satisfaction survey
Market share
1.4 Clause 8.3.4 of ISO 9001:2015 requires design and development

verification to be carried out. List two verification activities that may be
used by the design function of an organisation.
(2 marks)
Simulation through softwares
Actual functional checking of the prototype

() CQI @D IRCA
1.5 Identify two ways in which an auditor can verify that agreed corrective
actions have been effectively implemented.
(2 marks)
1)Obtain data, Procedures and check effectiveness
2) Go to the site , Observe and check effectiveness
by ATP xxxx
Page 6 of 34
Section two – four questions worth five marks each – maximum 20 marks
2.1 ISO 9000:2015 identifies ‘evidence-based decision making’ as one of the 7

Quality Management Principles that facilitate achievement of Quality
Objectives.
a) Explain your understanding of what is meant by ‘evidence-based

decision making’.
(2 marks)
Evidence Based Decision-Making is a process for making decisions about a program,
practice, or policy that is grounded in the best available research evidence and
informed by experiential evidence from the field and relevant contextual evidence.
b) Identify six ISO 9001:2015 clauses that support such an approach.

(3 marks)
9.1.1
9.1.2
9.1.3
9.2.1
9.2.2
9.3.
2.2 ISO 9001:2015 requires Top Management to demonstrate leadership
and commitment with respect to the QMS.
a) Describe briefly a method you could use to evaluate Top Management

leadership and commitment.
(2 marks)
Top management Leadership and commitment to QMS can be evaluated by their

degree of engagement in the following activities :
Taking accountability for the QMS
Promoting the use of the process approach and of risk-based thinking
Communicating the importance of the effective QMS and of conforming to the QMS
requirements
Engaging, directing and supporting persons to contribute to the effectiveness of the QMS
Promoting improvement
Supporting other management roles in demonstrating their leadership.
CQI and IRCA Specimen exam paper QMS, September 2018. Amended for use on certified course XXXX
operated by ATP xxxx
Page 8 of 34
() CQI @D IRCA
b) Give three examples of audit evidence you would gather as part of your
evaluation of Top Management leadership and commitment.
(3 marks)
Establish Vision , Mission
Establish Quality Policy
Strategic Objectives
Regular Management Reviews
by ATP xxxx
Page 9of 34
.n
( ) CQI •••• IRCA
••••
2.3 A
positive
auditor
professional
behaviour
is to be
diplomatic.
a)
S
t
a
t
e
t
h
e
m
e
a
n
i
n
g
o
f
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by ATP xxxx
Page 10 of 34
example to demonstrate how an auditor could
be diplomatic.
(3 marks)
Ability to avoid offending others or hurting their feelings,
especially in situations where this ability is important.
- Not personalising any issues

- Not making comments about management
- Not involving in company politics
- Not disclosing findings of one from audit with
anyone other than him or management
by ATP xxxx
Page 11 of 34
() CQI @D IRCA
b) Describe briefly the effect that not being diplomatic could have on an
audit.
(2 marks)
Not being diplomatic during ISO audits will antagonise, threaten the auditee
employee if their ability is challenged or dismissed and an be reluctant to offer any
information. This may bring risk to the Audit objectives
by ATP xxxx
Page 11of 34
2.4 At the opening meeting of an external audit, you are informed that a recent
internal audit has found many nonconformities relating to the in-house
purchasing department.
Corrective action has already been planned. It is therefore suggested that

to audit this department again would add no value and asks if you could
delete this department from the audit plan and spend more time in the
production area.
Outline five issues you would include in the response you would give to
this request.
(5 marks)
1) Audit plan was already agreed with the management and scope can
not be changed at this stage.
2) Such changes may reduce the meaning of stage 2 audit process.
3) The internal non compliance certificate and plan may be enclosed
along with audit findings
4) Audit can include review of already planned corrective actions .
5) Inclusion will help bring more value to the improvement of dept.
Section three – three questions worth ten marks each – maximum 30
marks
3.1 During a routine surveillance visit, the organisation you are auditing informs
you that they no longer carry out any design and development work. This
activity is now outsourced to an external provider (contractor).
Give four examples of audit evidence you would look for to determine the
conformance of the current system with ISO 9001:2015, given the
information you have just received.
AND
For each of your examples, identify the clause(s) of ISO 9001:2015 that
relate to this situation.
1. Evidence reg nature of control on the external process service provider-

Legal, Technical ( 4.1)
2. Assessment of Risks involved in engagement of external service provider
( 4.4.1)
3. Determine and apply criteria to evaluate , select and monitor
performance and Competence of external process service provider ,
Reevaluation and retain documentation ( 8.4.1)
4. Process Validation by the Auditee : Impact of external procured process
meeting customer requirements. Effectiveness of such process,
Determine , verification activities necessary to meet service requirements
( 8.4.2)
.n
( ) CQI •••• I
•••• RCA
by ATP xxxx
Page 14 of 34
3.2 Taking into account the requirements of clause 10.2 of ISO 9001:2015,
describe in terms of a sequence or illustrate using a diagram the corrective
action process starting from a non-conformance being raised by an auditor
through to close out of the finding.
Identify who is responsible for each element of the process and identify
where in the corrective action process decisions need to be taken.
(10 marks)
- After Receipt of NC, the following sequence of steps are

required to be completed and offered to Audit team to help
closure of NC.
- Step 1: Auditee reviews and agrees the NC...

- Step 2: Auditee conducts Root Casuse Analysis and finds root cause.
- Step 3: Auditee evaluates the process to stop recurrence.
- Step 4: Auditee checks whether action is needed
- Step 5: IF NO then the facts are recorded and take decision by
Auditee
- IF YES then corrective action is determined by Auditee
- Step 6: Offer the Improved process to Audit
- Step 7 : Auditor verifies the effectiveness of corrective action through
records review, RCA process and results.
- Step 8 : Auditor Decides and records results of action taken
- Step 9: Auditor may accept and close the NC OR continue NC
-
Page 15 of 34
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( ) CQI •••• I
•••• RCA
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Page 16 of 34
3.3 You are conducting an ISO 9001:2015 audit in an injection moulding
company (a process by which plastic components are manufactured). The
next activity on your audit plan is the organisation’s final product testing
laboratory.
Outline in a checklist how you will perform this audit by developing a series
of ten audit checkpoints. For each checkpoint, identify examples of the
audit evidence you would want to gather and give the appropriate ISO
9001:2015 reference.
(10 marks)
5.3 : Who is involved in the testing process and the process of

determination of their responsibility and authority.
7.1.3 Infrastructure and env reqmts have been determined and

maintained, Equipment needed to carry out testing
7.1.3 how is the eqpt maintained
7.1.5.2 whether the eqpt was calibrated by certified authority
8.5.2 How are samples selected, received and preserved (8.5.4)during

the testing process with appropriate documentation
8.5.1 What are the expected results of the test
8.5.2 What happens to samples after the testing is done
8.7 what happens to non confirming product
9.1.1 monitoring of performance of process monitored
9.1,1 and 10.2 evidence of performance of test monitored wrt targets

along with corrective action , if reqd
Page 17 of 34
.n
( ) CQI •••• I
•••• RCA
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Page 18 of 34
Section four – three questions worth 10 marks each – maximum 30
marks
Questions in this section are designed to test your ability to analyse audit
situations, evaluate audit evidence and apply knowledge of the audit criteria
correctly.
Delegates are required to

either:
• Complete the nonconformity report

template.
Marking scheme for a nonconformity:

• For correctly identifying the scenario as a nonconformity (2 marks)
• For a clear description of the nonconformity (3 marks)
• For correctly quoting relevant evidence (3 marks)
• For correctly identifying the relevant ISO 9001 requirement (1 mark)
• Overall clarity of the nonconformity report (1 mark)
Note: if you raise a nonconformity report when there is no nonconformity,

0 (zero) marks will be awarded.
OR
• Complete the audit investigation template, clearly

stating:
• Your reason(s) for thinking there is not yet sufficient evidence to

report your findings as a nonconformity
(2 marks)
• How you would investigate to determine conformity or

nonconformity, including audit trails you would follow and specific
examples of audit evidence you would seek and for what purpose.
(8 marks)
Note: If you complete the audit investigation template for a situation

where there is evidence that a nonconformity exists, a maximum of 7
marks may be awarded as follows:
• Providing a valid reason why there is insufficient evidence for

a nonconformity
(2 marks)
• Providing relevant audit trails as above.
(5 marks)
Page 19 of 34
4.1 – Audit situation one:
In the final inspection and despatch area you are examining the inspection and
despatch records for order number 1234. This relates to product XYZ that is due to
be sent out to a customer.
You note that in the final inspection section of the records the word ‘OK’ is written
with the initials JW alongside it. The Despatch Supervisor tells you that JW is one
of the junior inspectors.
You ask the supervisor: ‘Who has authorised the release of the product?’ The
supervisor replies that authorisation is not necessary for this type of routine
product and it is clear from the records that the inspection was satisfactory. He
says: ‘If there has been any problem we get a signature from David Manvers,
the Chief Inspector, but only if they had to do some rework to the product.’
You check the organisation’s documented information for the product release
process and find it states that the Chief Inspector is responsible for authorising
final release of all products.
If you think there is sufficient evidence to report your findings as a nonconformity:
• Complete the nonconformity report on the following
page. Or
• Complete the audit investigation template.
QMS AUDIT - NONCONFORMITY REPORT 1
Nonconformity (2 marks)
Description of the nonconformity (Max 3 marks):
CQI and IRCA Specimen exam paper QMS, September 2018. Amended for use on certified course XXXX operated
by
ATP xxxx
Page 20 of 34
The product is not released in compliance to the planned process ISO 9001 2015 clause 8.6
Relevant evidence (Max 3 Marks):
The Inspection document of the work order no 1234 related to product XYZ was not signed by
Chief inspector as per the product release process in confirmation of product conformity with
acceptance of criteria.
ISO 9001:2015 clause and requirement:
8.6: The release of products and sevices to the customer shall not proceed until the planned
arrangements have been satisfactorily completed unless otherwise approved by relevant authority.
Note: 1 mark for clause and requirement plus 1 mark for clarity of answer
OR
Complete your answer on the following page.
QMS AUDIT - AUDIT INVESTIGATION 1

Reason why there is not yet sufficient evidence for reporting nonconformity
(Max 2 marks):
Four audit trails you would follow, including, evidence sought and
purpose. (Max 2 marks for each audit trail):
.n
••••
4.2 -Audit
situation
two:
You are
auditing
CQIand IRCA Specimen exam paper QMS, September 2018. Amended for use on certified course XXXX operated by
ATP xxxx
Page 24 of 34
the design and development process in an organisation that
designs and manufactures industrial equipment.
ATP xxxx
Page 25 of 34
They are currently dealing with a serious customer complaint relating to faulty safety
mechanisms. They have sent engineers to this customer to repair some equipment
they designed, manufactured and supplied two years earlier for contract number
A123.
You find a recent note on file that states that the engineers are currently having
difficulty in repairing the equipment. They have been issued with the latest drawings
for the equipment (serial number X134, revision 3). The drawings do not contain a
modification to the safety mechanism that was made prior to delivery and installation
of the equipment.
You confirm with the Design Manager that revision 3 is the current version of the
drawings and that revision 3 does not include the change to the safety mechanism.
You ask the Design Manager why the modification to safety mechanism was not made
to the drawing and he replies that the change was reviewed and considered to be
minor with no impact on the equipment and it didn’t affect the customer’s contract
specification.
page. Or
Nonconformity (2 marks) Description of the nonconformity (Max 3 M A R K S

The organisation has not conducted a review before committing supply product to
customer , to include requirements not stated by customer but necessary at a later
stage during the life cycle of the product.
8.3.5 the organisation shall ensure that design and development outputs specify the characteristics
of the products and services that are essential for their intended purpose for safe and proper provision.
OR
(Max 2 marks):
.n
••••
4
.
3
A
ATP xxxx
Page 29 of 34
udit
situa
tion
thre
e:
During an audit of an insurance company, you ask the

Training Manager to show you the training records for three
people who work in the Claims Department. You see from
the training records that each has attended a course on
customer care.
ATP xxxx
Page 30 of 34
You ask the Training Manager how they evaluated the training and are told “We ask
every person who attends a training course to complete a questionnaire on whether
they enjoyed the course, how useful they found the training and how good the tutor
was. This information helps us decide whether to send other staff on the course”.
You examine the questionnaires completed by the three people who attended the
customer care course. All three awarded high marks on how enjoyable they found
the course and the usefulness of the course. All three also awarded a satisfactory
score for the tutor.
page. Or
NOT A nonconformity (2 marks) Description of the nonconformity

(Max 3 marks):
CQI and IRCA Specimen exam paper QMS, September 2018. Amended for use on certified course XXXX operated
by
ATP xxxx
Page 30 of 34
OR
(Max 2 marks):
Who is assigned to assess the responsibility and authority for evaluating

competence of clause department staff (53)
Has the risk of competency of claims dept staff been identified (6.1.1a)
Are the key performance measures which are measurable for the claims dept staff
(6.2.1b) and they are being met (9.3.2c) 2
Find out if claims dept manager or authorised person has determined the competencies of
the staff in the claims dept(7.2a)
Find out if claims dept manager or authorised person has determined the qualification and
experience of the staff in the claims dept(7.2b)
To check if attending the customer care training has been determined as the necessary
action to address competency deficiency. ( 7.2 c)
THIS IS THE END OF THE EXAMINATION PAPER
Activity 18: Document Review
Purpose: Conduct document review for METAFORA ( a case study)
30 minutes, Class discussions
Directions: Refer METAFORA document. And conduct document review
Document review
Clause Detail Docs From Matafora Manual
4.4.2 Required procedures Transportation & Logistics; Vehicle Maint;
Biz Plng; HRD &Training
Control Documents Quality Manual - QR 01

Control Forms
5.2.2 Quality Policy Metform 0
6.2.1 Quality Objectives Metform 0
7.1.5.2 Basis for Calibration
a
7.1.6a Knowledge shared
7.2 d Evidence of competence MT/MR/03
7.5.1a Documentation reqd for ISO 9001 Resources
7.5.1a Documented Info for effectiveness of QMS
8.1 Determining , maintaining and documenting Info
necessary
8.2.3.2 Retain info on results of the review In place
a
8.2.3.2 Any new requirement of products and services
b
8.3.2j Docs to determine that design and dev reqmts have Metform 14
been met
8.3.3 Retain docs on design & dev Metform 15
8.4.f Retain docs design & dev validation Metform 16
8.3..5 Retain design & dev outputs
8.3.6 Retain design & dev changes
8.4.1 Retain doc Evaluation , selection, monitoring of Metform 20
performance, re-evaluation o external providers
8.5.2 Retain documented info to enable traceability
8.5.6 Results of review of changes
8.7.2 Info on non confirmity, actions taken, concessions Metform 21
obtained
9.1.1 Evidence of results on perf of QMS
9.2.2f Evidence reg implementation of audit & results Metform 22
9.3.3 Results of Management review Form
10.2.2 Nature of non confirmities, subsequent actions taken and Metform 28,29,30
corrective actions taken
7.2.2 Personal behaviour / attributes
Auditors should possess the necessary attributes to enable them to act in accordance with the principles of auditing
a) ethical, i.e. fair, truthful, sincere, honest and discreet;
b) open-minded, i.e. willing to consider alternative ideas or points of view;
c) diplomatic, i.e. tactful in dealing with individuals;
d) observant, i.e. actively observing physical surroundings and activities;
e) perceptive, i.e. aware of and able to understand situations;
f) versatile, i.e. able to readily adapt to different situations;
g) tenacious, i.e. persistent and focused on achieving objectives;

h) decisive, i.e. able to reach timely conclusions based on logical reasoning and analysis;
i) self-reliant, i.e. able to act and function independently while interacting effectively with others;
j) able to act with fortitude, i.e. able to act responsibly and ethically, even though these actions may not always be
popular and may sometimes result in disagreement or confrontation;
k) open to improvement, i.e. willing to learn from situations;
l) culturally sensitive, i.e. observant and respectful to the culture of the auditee;
m) collaborative, i.e. effectively interacting with others, including audit team members and the auditee’s personnel.
Name of File No.:
the Client:
HO
Address:
OCTOBER 9,2019-
Date:
Site #R1
Kind Attn.:
Designatio Head – Unit Quality Fax No.:

n:
Audit
ISO 9001:2015 E-mail:
Criteria(s) Senthil.Prabhu1@ashokleyland.com
[Standard(s)]
Type of Date of
Audit:
Surveillance #1 22nd to 24th
OCTOBER 2019
Joint/ Combined / Integrated Audit
Scope:
Manufacture of Plastic moulded components
Audit Objectives to verify: [Delete whichever Type of Audit is not applicable]
Stage 2 /  Information and evidence about conformity to all requirements of the applicable
Renewal/ management system standard or other normative document
 Performance monitoring, measuring, reporting and reviewing against key
Surveillanc performance objectives and targets (consistent with the expectations in the
e#1 applicable management system standard or other normative document)
 The Organization's management system and performance as regards legal
compliance
 Operational control of the Organization’s processes
 Internal auditing and management review
 management responsibility for the Organization's policies
 Links between the normative requirements, policy, performance objectives and
targets (consistent with the expectations in the applicable management system
standard or other normative document), any applicable legal requirements,
responsibilities, competence of personnel, operations, procedures, performance data
and internal audit findings and conclusions.
 Enquiries from the IRQS to the Organization on aspects of certification
 Review of actions taken on nonconformities identified during the previous audit,
 Handling of complaints,
 the effectiveness of the management system in its entirety in the light of internal and
external changes and its continued relevance and applicability to the scope of
certification;
 To evaluate the suitability and effectiveness of the Management System in meeting
the organization’s objectives and demonstration of Continual Improvement
 To identify areas for potential improvement of the Management System
Audit Scope:
To evaluate the Organisation’s implemented Management System(s) for the Scope of


Certification against the above identified Criteria(s).
Audit Purpose:
To arrive at appropriate conclusion(s) based on the Audit Findings & Evidence(s) as noted

during the Audit.
Auditing Methodology:
 For the current audit, the audit team is responsible for executing the plan and the processes
involved for the audit .
 Audit is conducted on sampling basis, focusing on verification for compliances against the audit
criteria’s based on the evidences gathered.
 Verification of the status of the previous audit findings.
 Due diligence for selection ( i.e number, type) of samples based on criticality of processes,
competency, non conformities etc shall be taken into consideration due to the adoption of sampling
methodology, since sampling methodology has its own element of uncertainty, advantages and
disadvantages.
 To verify the audit evidences utilizing the computer-assisted techniques such as Skype, Video
conferencing, webinar, information available in soft etc would be applied as applicable.
Audit Team Details:
Leader Auditor Amod Deshpande Mobile No.: 9819904186
Industry Expert: Mobile No.:
Evaluator: Mobile No.:
Audit Schedule Details
Date 22nd October-2019

Time Lead Auditor
0900–0930 Opening Meeting
0930 –1130 Top Management Process – M-01- M-02
Business plan and objectives.
Management Review – Review CSR, Resource Planning - M-07( 5.1, 5.2, 5.3, 10.3,
9.2.2)
1130 –1300 Internal Audit – M-05, System, process, Product (9.2, 10.3)
13.00 –1400 Lunch;
1400 -1500 Internal Audit – M-05, System, process, Product(9.2, 10.3)
1500 -1600 Continual Improvement – M -06 (10.3)
1600- 800 Customer Complaint Management – MSC/QM/002 ( 8.2.3, 91.2)
1800 –1815 Feedback Session with Orgnization Representative
23rd October-2019
09.00–1100 Process Planning – MSC/PP/001 ( 8.5.1)
1100 -1230 Manufacturing – (Single shift Opn)
(8.5)
1230 1300 Manufacturing – (Single shift Opn)
(8.5)
1300 -1400 Manufacturing – (Single shift Opn)
(8.5)
1400 –1800 Manufacturing – (Single shift Opn)
(8.5)
1800~815 Feedback Session with Orgnization Representative

24th October-2019
0900 – 1300 Inspection and Testing – MSC/VA/001 ( 8.6)
1300 – 1400 Lunch
1400 – 1530 Stores process – MSC/SCM/002.1, MSC/SCM/002.2 (8.5.2)
1530 – 1630 Report Writing
1630 -1730 Feedback to Top Management
1730 - 1815 Closing Meeting
Shift Audit As per mail dt. 09/Oct/2019; only single shift operation is there.
If not audited / applicable, Please justify.

9kla21-24 April A M Rao Activities

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9KLA 21-24 APR A M RAO ACTIVITY 1-3

!!Shree Swami Samarth!!

Activity 1: Terms & Definitions related to audit

Purpose: To understand the terms of audit as given in ISO 19011.

Terms Answer Definition

C Person who provides specific knowledge or

H Systematic, independent and documented

B Set of one or more audits planned for a specific

O Records, statement of fact or other

1st Party - An internal audit that an organization performs on itself

Activity-3 To understand the audit activities

AUDIT ACTIVITIES CHRONOLOGICAL ORDER Subgroup ( As per task-

Conducting the opening meeting Preparing the audit plan

Prepare work document Prepare work document

Preparing the audit plan Document review

Audit findings Collection and verification of information

Roles responsibility of guides and observer Audit findings

Determining the feasibility of the audit Audit conclusions

Audit conclusions Conducting the closing meeting

Preparing the audit report Conducting the audit follow up

Task-B …..Subgroup above activities into following categories

Activity-5 Determine Audit Objectives, Scope and Criteria

AUDIT OBJECTIVES SCOPE CRITERIA

Team Leaders, Auditors, Guides Observers, Auditee Client.

IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 9

Activity-7 Purpose: To understand different audit methods,

Understand body language

Emotions, eye contact

Review documents without auditee help Feasibility of Audit

Complete checklists Review documents without auditee assistance.

Analyze information Analyze information without auditee assistance.

Collect samples Observe work without auditee assistance.

IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 1

Activity-8 Purpose: To understand the audit plan requirements,

Activity-9: Purpose: Opening Meeting

Duration: 45 minutes in group

g) Complaint resolution process

IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 10

m) Circumstances under which Audit can be terminated

Activity-10: Purpose: Capturing & verifying Audit Evidences

Duration: 60 minutes in group

Completely filled out records

The review of records and documents , Log books ( Document No,

IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 11

Activity-11: Purpose: Questioning Technique

Question: Do you measure customer satisfaction? – Close ended

Activity-12: Purpose: Follow up audit scenario

1. Recollect the leaning from today’s session

2. Who decides the follow up audit?

IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 13

Activity 13: Quality Management System Terms & Definitions

Duration: 10 minutes Work Individually &

12 Outsource H L Recurring activity to enhance performance 2

14 Requirement J N Process to determine a value

IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 14

Activity 14: Understanding EDIM (Establishment, Documentation,

Purpose: Establishment of QMS ISO 9001:2015

Duration: 20 minutes Work individually &

Activity 15: Understanding audit trail

Duration: 45 minutes Work Individually &

IRCLASS/TRG/QMS/LAC/TSP/Rev 6, dtd: 05/03/2019 © IRCLASS Systems and Solutions Private Limited 21

Duration: 30 minutes Work in group &

5.2. Quality Policy