SECTION 1

1. What is the meaning of responsibility and authority?

Ans.
Authority: right to take decision and action.
Responsibility: Task assigned to person or people to be done.
2. Explain the difference between audit program and audit plan
Ans.
Audit program refers to arrangements for a set of one or more audits (3.1) planned for a specific time
Audit plan refers to description of the activities and arrangements for an audit.

3. ISO 9001 2015 requires internal audit program to be planned. In planning, it shall take into
consideration the importance of the processes concerned, changes affecting the organization. What is
your understanding of this phrase?
Ans
Risk and impact of processes.
changes in organisation

By applying risk based thinking, this requirement is intended to focus the internal audit program on those
processes and areas where past history indicates that problems have occurred, or where problems are likely to
be ongoing, or are likely to occur, because of the nature of the processes themselves. These problems may result
from issues such as human Factors, process capability, measurement sensitivity, changing customer
requirements, changes in the work environment, etc. The processes with higher levels of risk or nonconformities
should have priority in the internal audit programme. Special attention should be given to processes where risk
is influenced by factors such as: - severe consequences of failure on process capability. - customer
dissatisfaction. - noncompliance with product (or process) statutory and regulatory requirements

4. Explain in your own words the meaning of competence

Ans
Competence is the ability to use knowledge and skills to achieve intended results
Should be competence on basis of a:

1. Training
2. Appropriate education
3. Experience
5. What is audit criteria and what is audit objectives
Audit criteria refers to sets of policies, procedures or requirements that are used as a reference against
which audit evidence is compared e.g. legislation, ISO 9001;2015, regulation, contract
Audit objective refers to the result to be achieved, eg does the QMS conform to a legislation or ISO
9001;2015 or to what degree does the QMS conform to a regulation or legislation

6. Write at least 4 clauses related to top management responsibilities or activities

Ans
5.1 Leadership and commitment
5.1.2 Customer focus
5.2.1 Establishing the quality policy
5.3 Organizational roles, responsibilities and authorities
9.3 Management review
7. ISO 9001; 2015 clause 4.3 states Conformity to this International Standard may only be claimed if the
requirements determined as not being applicable do not affect the organization’s ability or responsibility
to ensure the conformity of its products and services and the enhancement of customer satisfaction
Ans
Clause 8.3 Design and development of products and services can be excluded if the organization
doesn’t design nor develop their own products such as packing companies

8. Give one example of 'infrastructure' referred to in ISO 9001;2015 clause 7.1.3, How could it affect
conformity to requirements
Ans
a) Building and facilities
b) Transportation
c) Equipment including hardware and software.
d) Information and communication technology.

And all these to be used to meet the conformity of the product and services according to QMS requirements.

9. What is the difference between design validation and design verification?

Ans
Design verification refers to a confirmation, through the provision of objective evidence (3.8.3), that specified
requirements (3.6.4) have been fulfilled while Design validation refers to confirmation, through the provision of
objective evidence (3.8.3), that the requirements (3.6.4) for a specific intended use or application have been
fulfilled
10. In context of the ISO 9001:2015 managing the risk based Audit?
Ans.
a. The critical area of product and services.
b. High risks areas.
c. High priority for completion of products and services.
d. High quality product and services completion.
11. How analysis of data is used in context of ISO 9001:2015? Give two examples? And clauses no?
Ans.
a) To evaluate performance of the external providers. 9.1.3 f
b) To evaluate conformity of the products and services. 9.1.3 a
c) To evaluate degree of customer satisfaction. 9.1.3 b
d) Improvement to the QMS. 9.1.3 g

SECTION 2
1. Explain the difference among monitoring, measuring and measuring equipment?
Ans
Monitoring is used to observe something closely so that you can record or detect
Measurement is used to determine the actual characteristics of something (e.g. sizes, volume, etc.)
Measuring equipment is equipment used for measuring
2. Clause 7.4 list the effective internal communication?
a) List internal communication
Quality policy (5.2.2), quality objective, roles and responsibility.
b) Method of communication?
Internal training, MOM, emails,
3. A) Describe the purpose of the opening meeting?
Confirm the agreement of all parties, ensure that all planned audit activates can be
performed, explaining the scope, number of days.
b) list three items conceder in an opening meeting (agenda)
role of the guides, health and safety issue and access facilities, confirm the audit scope
& objective, confirm of audit plan, Confirmation of audit timing, Reporting Procedure
and Closing

4. a) Give an example of documentation of the audit, the auditor should prepare before
the audit?
Audit Check list,
b) how the auditors going to use the documents during the audit list 2 to 4 doc?

5. List any 6-7 items that audit plan should include

a) Opening meeting
b) Audit scope
c) Audit objective
d) audit criteria
e) Corrective action
f) Report preparation
g) Reporting meeting
h) Closing meeting.

6. list three items conceder in closing meeting (agenda)

report of NCR, summary of finding, thank for cooperation, cover the points briefly

7. How an audit should be considered as an evidenced based?

Ans.

In case of conformity and non-conformity with requirements.

8. Explain in your own words what are the principals for an evidenced based audit?
Audit evidence should be verifiable.
Should be in general be based on samples of the information available,
9. how do you collect evidence to proceed for Audit?
Through the following:
a) Interview b) Verification of process/activity
c) Site visit d) Document review
e) Observation
f) Sampling
 10. a) In an audit, why it is necessary to contact person (local point) of the area/organization prior
audit?
Ans.
To ensure that there is a common understanding about the audit and to build the relationship with
auditee, also to determine the exact location of audit area (meeting).
b) What are the points to be discussed with (local point) of the Org. prior to start audit?

Ans.

1- Audit plan .
2- Arrangement of opening and closing meeting.
3- Status of PPE for all attendees (health and safety rules in the site).
4- Arrangement of transportation (vehicle)
5- Issues from the previous audit.
11. Prepare and audit check list for the purchase department as per the requirement of ISO9001:2015?
1- How did the organization determine the input required and the output expectation from the purchase
process? 4.4.1 a
2- What is the sequence and interaction of purchase processes? 4.4.1b
3- How will you apply the criteria and methods to ensure effective operation of these process? 4.4.1 c
4- What is the risk and opportunity that retain to purchase process? 6.1.1
5- How will your org. address this risk and opportunity? 6.1.2
6- How does the org. plan to achieve the quality objective? 6.2.1
7- How does the org. take action to achieve knowledge about purchase processes? 7.1.6 (mo)
8- What is the necessary competence of persons required in purchase process? 7.2a (mo)
9- How does the org. ensure externally provider purchase conform to requirement? 8.4 .1(fay)

SECTION 3
1. A company policy states:” We will meet our customer requirements 100% of the time, every time.”
The performance data shows that they have averaged 90% on-time delivery for the previous three years.
You discuss this with the Quality Manager who tells you that this is the industry average and they are
satisfied with this performance. He explains that “most of the delivery problems are caused by road
congestion, and so we do not take any action on late deliveries because this is out of our control. “You ask
to see the records to determine what percentage of the late deliveries is due to road congestion. The
Quality Manager said “we do not keep detailed records because we just know the reasons and have
concluded that at the moment we do not need to do anything” You ask whether they receive any
complaints about the late deliveries. The Quality Manager replies: “On occasion some customers
complain but I’m sure most of them understand that the traffic.

a. Outline two significant areas of potential concern in the audit situation.

b. For each issue, give two questions you would ask to investigate your initial concerns. For each question quote
the applicable clause of ISO 9001:2015
a)
No evidence for the customer complains for the company.
No record for customer feedback.
No any review of quality policy.
 b)
 When the quality policy was last reviewed was account taken of actual
delivery performance? (5.1.1)
 When the quality policy was last reviewed was account taken of actual
delivery performance? (5.1.1)
 Does the quality policy support the organization’s strategic direction?
(5.2.1.a)
 What arrangements are in place to achieve these objectives? (6.1.1.a)
 How are quality objectives established at relevant functions and levels
throughout the organization 6.2.1
 Are any quality objectives set to support this commitment in the policy
6.2.1a

RD
2. 3 Party Audit
Food Processing company has the same internal audit for _2008 food processing company. you determine that
organization internal audit program as be same for paste four years there is no any changes, each department once
in every year and an audit objective has been maintain
What are the concerns:
11.2 Internal audit
10.2 Continual Improvement

a) Outline two requirement for ISO 9001 2015 clause 9.2 most line not been met in above satiation
b) List three topics to be discussed with audit program manager
a) the audit program is not considering the important and changes which is effecting the QMS
organization, and also they are not considering the international standard requirement.
b) are you working to improve your QMS? any corrective action taken for previous audits?
3. You are conducting an ISO 9001:2015 audit of HR Department. You ask the HR manager how the organization
ensures that personnel performing work are suitably competent. He replies that all personnel are qualified and
trained.
You then sample the records of five people working in the customer service department. On each person’s record is
a list of the academic qualifications they hold, as well as a list of the in-house training courses then have attended.
You note that all five people have attended the same courses: an induction course, a behavioral safety course, a
managing people course and a basic IT Couse.

(a) Explain what a concern here maybe be.

The competence related to training to be customer services based but you found they training
courses related to basic safety.
(b) Based on A, describe four audit trails you would follow to determine conformity or non-conformity to the
requirements of ISO 9001:2015. For each, identify the applicable clause(s) and any audit evidence you would
gather 7.2

4. In ISO 9001: suggest that the extent of Doc. Info. From one Org. to anther Org.
 Outline 3 benefit of properly documented benefits?
 People can easily understand.
 Give training to people
 Easily communicate
 Easily access
  Outline 3 disadvantage of overly documents?
 Difficult to maintain documents
 People can difficult to understand.
 Can be result of confusion.
 Give 2 example of such document external origin?
 ISO 9001:2015
 Legal document s
 Tender document
 Technical drawing.

 What is control in such external documents?

 Planning and operation of QMS.
 Must be kept in safe place to avoid any damage.
 Identified as appropriate and be controlled.
5. You are carrying audit for managing director if he has an any quality objectives he said (yes) an he
objectives are:
 Increase sales
 Reduce rejections
 Reducing operation cost
Outline 10 question to support as per clause 6.2

Ans:

Clause 6.2- Quality Objectives and planning to achieve them:

1. How the org. can be establishing quality objectives? 6.2.1

2. Does the objectives are consistent with Quality Policy? 6.2.1 a
3. Does the objective are measurable ?6.2.1 b
4. Does the objectives are set by taking into account the applicable requirements? 6.2.1 c
5. Does these objectives are communicated to all relevant functions/departments? 6.2.1 f
6. Does the objectives are monitored? 6.2.1 e
7. Do the objectives support the quality of products and services? 6.2.1 d
8. How the objectives take into account the customer satisfaction? 6.2.1 d
9. How these objectives are updated and appropriate? 6.2.1 g
10. How the org. can maintain documented information in the quality objectives?6.2.1