0.2 Precourse Assignment-Understanding ISO 9001

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Pre- course Assignment Bureau Veritas Certification
CQI-IRCA Certified PR 328: QMS ISO 9001-2015 Lead

Auditor Training Course (17929)
Pre- course Assignment
Introduction:
QMS Auditor/ Lead Auditor Training Course conducted by Bureau Veritas is under the
accreditation of International Register of Certificated Auditors (IRCA)
The aim of this course is to provide delegates with the knowledge and skills required to perform
first, second and third-party audits of quality management systems against ISO 9001, in
accordance with ISO 19011 and ISO 17021 as applicable. This course requires delegates to audit
a QMS against the requirements of ISO 9001, including the ability to identify audit evidence to
establish conformity or nonconformity.
Before starting this course, the delegates are expected to have the following prior knowledge:
a) Knowledge of the following quality management principles and concepts:

The Plan, Do, Check, Act (PDCA) cycle.
The relationship between quality management and customer satisfaction.
Commonly used quality management terms and definitions and the 8 Quality Principles
as given in ISO 9000.
The “process approach” used in quality management.
The Model of a Process Based Quality Management System, the structure and content
of ISO 9001.
Concept of Risk Management, including identification of “risk”, “risk assessment” “Risk
evaluation” and controls to prevent risks from actually happening.(Delegates are
recommended to refer to ISO 31000 standard or any related material for a more
detailed understanding of the subject)
b) Knowledge of the requirements of ISO 9001.
In view of this, Bureau Veritas has developed this pre-course study material in order to
familiarize delegates from different backgrounds with some fundamental Quality Management
principles. This pre-course assignment is aimed to help the delegates develop basic
understanding of ISO 9001 and its application within an organization.
Instructions
Read the standard & pre-reading material and answer the pre-assignment questions. Please
take a print out of this assignment and answer the questions by hand.
Kindly carry the printed and duly answered assignment sheets to the training venue for
discussions.
Important Copyright Notice:

Please note that unauthorised copying of this precourse material is not permitted
May’18 PR 328 QMS ISO 9001-2015 Lead Auditor Training Course (17929) Page 1 of 10
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Delegate name:
Company name:
Position:
Date of the course:
ASSIGNMENT No. 1: Documentation

Objective
1. To read Section 4 to 10 – “Context of the organization” to “Improvement” from ISO 9001:2015
2. To understand the scope of documentation that may be required for a QMS & where the
requirement is referenced within ISO 9001:2015
ASSIGNMENT
1.1 List below various requirements of “documented information” that need to be developed by an
organisation as part of their quality management system (e.g. Scope as specified in clause
4.3…).State the applicable clause number
Sr Is it a Clause No
No Requirement for the “Documented Information” record/or a
Document…?
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ASSIGNMENT No. 2: LEADERSHIP

Objective :
1. To read section 5 – “Leadership” of ISO 9001:2015 to understand the role of ‘Top Management’
in any Quality Management System
2. To understand the methodology of auditing ‘Top Management’ and the ‘management review’
processes using “Process Approach”
ASSIGNMENT
2.1 During an audit how will you verify conformance to the following specific requirement related
to Leadership :-
5.1.1 (f) communicating the importance of effective quality management and of conforming to
the quality management system requirements &
5.1.1 (i) promoting improvement
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2.2 How will you verify the conformance to the implementation of “Customer Focus” (Clause 5.1.2)
?
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2.3 How will you audit the effectiveness of the Management Review Process (Cl 9.3)?
ASSIGNMENT No. 3: PLANNING

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Objective
1. To read Section 6 of ISO 9001:2015-“Planning for the QMS”.
2. To understand how to identify the risks and opportunities that need to be addressed
ASSIGNMENT
3.1 What are the typical risks and opportunities that an organization needs to address in a quality
management system..?
3.2 Write a short note on “Quality Objectives”
ASSIGNMENT No 5: OPERATION
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Objective
To understand the requirements of section 8.“Operation”and to know how it is Important to
understand what IS a requirement of the standard, and what IS not.
Tick the statements as ‘True’ or ‘False’ & state the relevant ISO 9001:2015 clauses
Sr. No. STATEMENT True False Clause
1. All measuring instruments must be verified before use
2. All incoming material must be inspected to ensure that it meets

specified requirements.
3. In establishing, implementing, maintaining and continually

improving the processes needed, the organisation shall retain
documented information to the extent necessary to have
confidence that the processes are carried out as planned .
4. All the process outputs must be identified with tags throughout

production and service provision
5. In determining the extent of post-delivery activities that are

required, organisations shall consider the risks associated with
the products and services
6. Every supplier must have been assessed on site by the

organisation as part of the selection process.
7. An organisation must determine and define the requirements
related to the products & services including applicable statutory
and regulatory requirements.
8. Design validation is conducted to ensure that the resulting
product and services are capable of meeting the requirements
for the specified application or intended use
9. When customer property is incorrectly used, lost, damaged or
otherwise found to be unsuitable for use, must be reported to
the customer.
10. Design & development output must include acceptance criteria
for the product as applicable
11. Documented Purchase Orders must be raised for all purchased
products
12. If there is no international or national standard, calibration and
or verification of measuring equipment need not be carried out.
13. Work instructions must be available for all processes
14. The organisation need not address unplanned changes
15. There must be an approved supplier list
Total
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ASSIGNMENT No. 5: MEASUREMENT, ANALYSIS & IMPROVEMENT

Objective
1. To read Section 9 of ISO 9001:2015“Performance Evaluation”
2. To understand interrelationship between section 9 & Top Management responsibility
ASSIGNMENT
5.1 Identify the interrelation between internal audit requirements with other requirements of the
Standard. Present your answer through pictorial representation.
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5.2 Give 5 examples of “Data” being converted to “information”
5.3 How will you audit “improvement” process in an organisation..? give appropriate examples
for the evidences you will seek to verify the process..?
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5.4 What actions are expected to be taken by an organisation when Non Conforming Process
output is detected. Give one practical example for each of the actions.
5.5 What are the actions to be taken by an organization when a Non Conformity occurs
**********End of assignment **********
Now please answer the Pre- course Test enclosed in this folder

0.2 Precourse Assignment-Understanding ISO 9001

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0.2 Precourse Assignment-Understanding ISO 9001

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Handout

Pre- course Assignment Bureau Veritas Certification

CQI-IRCA Certified PR 328: QMS ISO 9001-2015 Lead

Pre- course Assignment

a) Knowledge of the following quality management principles and concepts:

b) Knowledge of the requirements of ISO 9001.

Important Copyright Notice:

ASSIGNMENT No. 1: Documentation

ASSIGNMENT No. 2: LEADERSHIP

ASSIGNMENT No. 3: PLANNING

3.2 Write a short note on “Quality Objectives”

Sr. No. STATEMENT True False Clause

1. All measuring instruments must be verified before use

2. All incoming material must be inspected to ensure that it meets

3. In establishing, implementing, maintaining and continually

4. All the process outputs must be identified with tags throughout

5. In determining the extent of post-delivery activities that are

6. Every supplier must have been assessed on site by the

15. There must be an approved supplier list

ASSIGNMENT No. 5: MEASUREMENT, ANALYSIS & IMPROVEMENT

5.2 Give 5 examples of “Data” being converted to “information”

End of assignment

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