Examination Paper-v3.

2c

ISO 9001:2015QMS-Lead Auditor Training Course

Name of Delegate: _Abhijeet A. Kshirsagar________

Date of Examination: _01/08/2022____

Section 1
Five questions, each two marks – maximum 10 marks

a) ISO 19011:2018 Clause 4 provides guidelines on ‘Evidence based approach’.

EXPLAIN in your own words on these guidelines. (2 marks)

Evidence based approach means that the evidence collected during audit should be verifiable and should
be based on samples of information available. This information must be gathered by using appropriate sampling
methods as the audit is conducted during a limited period of time and with limited resources.
__________________________________________________________________________________

___________________________________________________________________________________________________________________________________

___________________________________________________________________________________________________________________________________

b) DESCRIBE in your understanding on Audit Conclusion(2 marks)

_Audit conclusion can be described as outcome of an audit, after consideration of all audit

objectives and audit findings. In other words, it is the result of audit based on audit findings
and
objectives._______________________________________________________________________
____

_________________________________________________________________________________

_________________________________________________________________________________

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c) LIST 6 factors that should be addressed in an Audit Plan as given in ISO 19011 > Clause
[Link]. (2 marks)

a) The audit objectives;

b) The audit scope, including identification of the organization and its functions, as well as
processes to be audited;

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 c) The audit criteria and any reference documented information;
d) The locations (physical and virtual), dates, expected time and duration of audit activities to be
conducted, including meetings with the auditee’s management;
e) The need for the audit team to familiarize themselves with auditee’s facilities and processes
(e.g. by conducting a tour of physical location(s), or reviewing information and communication
technology);
f) The audit methods to be used, including the extent to which audit sampling is needed to obtain
sufficient audit evidence;
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 d) As per ISO 19011 > Clause 4, briefly EXPLAIN your understanding on Risk-based
approach in auditing. (2 marks)

A risk based approach to audits enables the auditors to identify risks correctly and allows management to
put the right internal controls in place for the best performance. This provides us with a better
understanding of the risks and enables us to manage risks in a better
way._______________________________________________________________________________
________________________________________________________________________________
__________________________________________________________________________________

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e) ISO9001:2015>Clause 10.2 addresses Corrective action. EXPLAIN your understanding on

corrective action in ISO 9001:2015. (2 marks)

Corrective action is described as action to eliminate the cause of a nonconformity and to prevent its
recurrence. In other words, it is the step taken to correct the process or work activity that was a nonconformity.

 For eg: Redesigning or replacing equipment, installation of alarms, signals etc.

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 Section 2
Four questions, five marks each – maximum 20 marks

1) ISO 19011 in clause # 6.4.10 outlines the details of Closing Meeting. LIST an Agenda for Closing
Meeting with 8 points(5 marks)

1. Informing the client on the good practices

2. A summary of the review findings
3. A list of problems identified and their descriptions
4. Clarification of any concerns
5. Summarizing and the inclusion points agreed upon
6. The Closing and Record of thanks to all the participants
7. Saving the audit findings as records
8. The method of reporting

2) You are the QMS Lead auditor conducting a 2-day ISO 9001:2015 Certification
audit in a large Food Manufacturing organization; During the Opening Meeting, the
Executive Director presents a new laptop to each of your auditor team conveying
that the laptop contains ISO Standards, and also complete set of Controlled
documentation related to their organization; He also adds that you and your team can
keep the laptop for your use after the audit since it is a matter of goodwill from their
organization.

DESCRIBE how you would respond to this situation. (5 marks)

I will responds to this situation as below:


Thankyou sir for your kind gesture. As per our company’s code of conduct, we are not allowed to accept any
gifts from clients. As I am bound to my company’s policy, I cannot keep this laptop with me after the audit is
over. I can use it during the audit process as it contains the audit related information which will be useful for
me to conduct the audit.
As mentioned above, I will not accept the laptop as a gift and deny it politely.
______________________________________________________________________________

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3) LIST 4 benefits of implementing ISO 9001:2015. (5 marks)

Following are the benefits of implementing ISO 9001:2015:

1) The ability to consistently provide products and services that meet customer and applicable statutory

and regulatory requirements.

2) Facilitating opportunities to enhance customer satisfaction

3) Addressing risks and opportunities associated with its context and objectives

4) The ability to demonstrate conformity to specified quality management system requirements. This

International Standard can be used by internal and external parties.

______________________________________________________________________________

______________________________________________________________________________

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4) BRIEFLY DESCRIBE your understanding on ISO 9001:2015 > Clause 4.2 on

Interested parties. (5 marks)

The ISO 9001:2015 standard talks about understanding the needs and expectations of interested parties in clause 4.2,
Justification for this is that interested parties will have an impact on the organization’s ability to provide products and
services that consistently meet customer needs and legal requirements. The requirements are to determine
what interested parties are relevant to the QMS, and the requirements of these parties that can affect the QMS.

This information, especially the requirements from interested parties, is used throughout the QMS, so it is important to
gather all the information that is needed.

Examples of interested parties are:

1) Customers
2) Suppliers
3) Employees
4) Shareholders
5) Governments & non-government organizations

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 Section 3
Three questions worth 10 marks each – maximum 30 marks

3.1 You are carrying out a Certification audit on ISO 9001:2015 in a fully networked
Trading organization having 68 employees. Your next schedule in the audit is to audit
the Top Management on QMS Policy and Management Review.

FURNISH an Audit Checklist, with 6 audit checkpoints. (8 marks)

Audit checklist:

Clause # What to query What to look for (as evidence)

7.2 Has the organization Interviews,
b ensured that people are competence
competent based on mapping, skill
appropriate education matrix, eligibility
training, or experience matrix, training
records, training
needs, education,
job description
7.3 Has the quality policy has Display boards,
a ensured that persons training records,
doing work under the Interviews,
organization’s control are Emails to
aware of the quality policy employees
5.1. Has the top management Risk and
1d ensured the use of process opportunities
approach and risk-based register, Process
thinking? plans with PDCA
cycle
5.1. Has top management Risks and
2b ensured the risks and opportunities
opportunities that can register, Process
affect conformity of plans with PDCA
products and services and cycle, customer
the ability to enhance satisfaction
customer satisfaction are reports
determined and
addressed?
6.1. Has the organization Risk and
1a determined the risks and opportunities
opportunities that need to resister, Quality
be addressed to give objectives review
assurance that the quality records
management system can
achieve its intended results
6.1. Has the organization Risks and
2a planned the actions to opportunities

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 address the risks and register, Process
opportunities? plans with PDCA
cycle
9.1. Has the organization Monitoring and
3e analyzed and evaluated measurement
appropriate data and records, Risk and
information arising from opportunities
monitoring and register.
measurement to evaluate
the effectiveness of actions
taken to address risks and
opportunities?

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 3.2 You are the lead auditor responsible to conduct Opening Meeting for a
certification audit next week. PREPARE an Agenda covering 5 factors for
conducting Opening Meeting as per ISO 19011 > Clause 6.4.3. (10 marks)

Agenda for conducting Opening Meeting:

1) Introduction of the Audit team, Auditee’s management and other participants including observers and guides,
interpreters, and an outline of their roles.
2) Confirmation of 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 changes
needed.
3) Confirmation of the audit objectives, scope and criteria should be considered.
4) Confirmation of the language to be used during the audit.
5) Confirmation of the matters relating to confidentiality and information security.
6) Confirmation of availability of resources and facilities needed by the audit team.
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 3.3 For the next Surveillance audit, the auditee management of a major retail chain
has set the Audit Objective as ‘managing risk’ in ISO 9001:2015 in all the process
areas.

You are an auditor of the Certification body.

PREPARE an Audit Checklist, with 5 audit checkpoints. (10 marks)

Audit checklist:

Clause # What to query What to look for (as evidence)

6.1 Check with the relevant auditee whether the
related risk has been
Risks and opportunities
register
identified/determined.

6.1. if the risk has not been identified or if the

organization has no established process for
Risks and opportunities
register
2 ‘action to address risks and
opportunities.

6.1. Check the competence of the personnel

responsible for managing risks that
Risks and opportunities
register
2a completed the risk identification in the area in
which the hazard was found

6.1. Check how long the hazard has been present.

If this is a new hazard
Risks and opportunities
register
2b determine why the hazard was not identified.

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 Section 4
Three questions worth 10 marks each – maximum 30 marks

DELEGATES TO WRITE EITHER A NONCONFORMITY REPORT OR AUDIT INVESTIGATION

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.

Scoring pattern for writing 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 Clause of Audit Criteria (1 mark)

Overall clarity of the nonconformity report (1 mark)

Note: If the delegate writes a nonconformity report when there is no nonconformity,0(zero) marks
will be awarded.

OR
Complete the audit investigation template, clearly stating:

The reason(s) for considering there is not yet sufficient evidence to report their findings as
nonconformity (2 marks)

How the delegate would investigate to determine conformity or nonconformity, including audit trails
they would follow and specific examples of audit evidence they would seek and for what purpose.
(8 marks)

Note: If the delegate completes the audit investigation template for a situation where there is
evidence that nonconformity exists, a maximum of 7 marks will be awarded as follows:

a) Providing a valid reason why there is insufficient evidence for a nonconformity (2 marks)

b) Providing relevant audit trails as above. (5marks)

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 4.1 – Audit situation one:

As a QMS auditor of a Certification body auditing a leading textile manufacturing

organization, your next schedule is to audit Recruitment Manager.

To your query on ‘how competence of employees is carried out at the time of recruitment or
transfer of employees or promotion of employees’, HR Manager replies that the related
Process Owner conveys telephonically the requirements to respective HR Executives to
arrange obtaining profiles. HR, then carries out initial screening; Subsequently, the Process
Owner organizes Technical Interviews, and shares his ‘List of selected candidates’ and the
HR Deptt., issues Letter of Offer.

When you seek related records of a sampled Role of ‘Consultant (Functional-MM), HR

Manager provides a Letter of Offer duly accepted by the candidate, and adds that the
Management has instructed that there are no other records considered necessary to be
maintained since the Managing Director approves all recruitments or transfers or promotions.

You observe that the auditee organization has no records on determination of competence.

NONCONFORMITY REPORT-1

1) Description of nonconformity:

____The organization has failed to maintain the records determining the competency of its
employees____________________________________________________________________________

_____________________________________________________________________________________

2) Relevant Evidence: During sampling audit of ‘Consultant (Functional-MM), only the employee
offer letter was provided. Other important documents such as educational certificates,
experience letters, competency skills records were missing.

__________________________________________________________________________________

3) ISO 9001:2015 Clause/requirement: 7.2 (d)

_______________________________________________________________________________

OR

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 Audit investigation-1:

A. A. Reason for there is no sufficient evidence for non-conformity:

_________________________________________________________________________

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B. 4 Points of audit investigation (i.e., Audit Trail):(10 marks)

Audit Trail = (Clause # + What to query + What evidence to look for)

__________________________________________________________________________

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4.2 – Audit Scenario-2:

As a QMS auditor of ISO 9001:2015 from a certification body auditing an organization

engaged in sea food processing industry, your next schedule in the audit is to audit the Top
Management on Clause # 9.3. The auditee responds that the Management Review normally
involves a Presentation displayed on the projector which includes ‘Timely delivery,
Improvement in Client base, Optimized Process Management, summary of incidents,
regulatory compliance reports, internal audits, 3rd party audit reports, and action taken on
continual improvement’.  

While asking on Continual improvement, the management appointee indicated that he has
been fully empowered by Board of Directors to make any improvement without incurring any
additional cost.

You review the Minutes of Management Review dated ddmmyyyy which reflects poor
financial status of the organization. The Minutes have been approved by the Managing
Director and has related Action Plan as well.

NONCONFORMITY REPORT-2

1) Description of nonconformity:

_____________________________________________________________________________________

_____________________________________________________________________________________

2) Relevant Evidence:

___________________________________________________________________________________

3) ISO 9001:2015 Clause/requirement:

_______________________________________________________________________________

OR
 Audit investigation-2:

C. A. Reason for there is no sufficient evidence for non-conformity:

__There is no clear evidence of non conformity as most of the things are not clear
from minutes of management review. If the continual improvemt should take place
without any cost incurred, then still the Financial condition of organization is
poor._____________________________________________________________________
__

__________________________________________________________________________

D. 4 Points of audit investigation (i.e., Audit Trail):(10 marks)

Audit Trail = (Clause # + What to query + What evidence to look for)

As per clause 9.3.1

Top management shall review the organization’s quality management system, at
planned intervals, to ensure
its continuing suitability, adequacy, effectiveness and alignment with the strategic
direction of the
organization.
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 4.3 – Audit Scenario-3:

You are an auditor from a certification body auditing an Engineering company in its Outbound
Logistics division; In Dispatch area, you review the Outbound Delivery Note # 418 for Order
Number AW-523 for 25 numbers of Flanges, about to be dispatched to the customer.

On one of the sampled Flanges, you observe a sticker with a marking: “Inspection cleared”
with the signature of Inspection Supervisor (Employee ID: 21).

When you review the Procedure for Final Release of products (Procedure # F-INSP84), it
indicates that the Final Release Stickers must bear the signature of Manager-Inspection for all
outbound deliveries.

NONCONFORMITY REPORT-3

1) Description of nonconformity: The organization failed to follow the inspection standard

procedure during dispatch
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2) Relevant Evidence: “Inspection cleared” sticker from Outbound Delivery Note # 418 for
Order Number AW-523 was having the sign of inspection supervisor (Employee ID: 21).
where as the standard dispatch procedure (# F-INSP84) clearly mentions that it should
have a signature of Manager – Inspection.
___________________________________________________________________________________

3) ISO 9001:2015 Clause/requirement: Clause 9.1: Monitoring, measurement, analysis and

evaluation
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OR
 Audit investigation-3:

E. A. Reason for there is no sufficient evidence for non-conformity:

_________________________________________________________________________

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F. 4 Points of audit investigation (i.e., Audit Trail):(10 marks)

Audit Trail = (Clause # + What to query + What evidence to look for)

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END OF ISO 9001:2015 QMS LATC EXAMINATION PAPER v 3.2c