Continuous Assessment Record

for IRCA Certified ISO 9001:2015

Auditor / Lead Auditor training courses
Delegate Name: ___________________________________

Date of course: ___________________________________

Venue: ___________________________________

___________________________________
Principal Trainer Verification:

IMPORTANT INFORMATION:

This document will be used by course tutors and delegates. Tutors will use this document
to maintain a record of delegate performance throughout the duration of the course.

Delegates will use this document for individual continuous assessment exercises to be
undertaken during the course.

Delegates will need to achieve an overall of minimum of 120 marks for the course
continuous assessment in addition to achieving at least 50% of available marks to an
individual exercise.

A maximum of 50 marks are allocated to the daily tutor assessment of a delegate’s

performance. A maximum of 150 marks are available for the continuous assessment
exercises.

Delegates are responsible for the safe keeping of this document throughout the
course. Its loss could result in failure of the course.

ALL INFORMATION CONTAINED IN THIS DOCUMENT REMAINS

CONFIDENTIAL TO DELEGATES, TUTORS, TN CERT AND IRCA.

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 Requirements for Continuous Assessment:

1 A continuous assessment of the performance of each delegate is a requirement on all IRCA certified courses.
2 This assessment by the tutor(s) shall be documented (with notes for each delegate recorded throughout the course).
The assessment shall be performed against the criteria as indicated in this document, and will include elements of
judgement made by the tutor(s) together with the results of individual exercises.
3 At the end of each day the designated tutor(s) shall review and complete the delegate continuous assessment
summary and decide a mark for each delegate on the day’s performance.
4 Where it is identified that individual delegates are either not understanding the subject or not participating
adequately, then these delegates shall be made aware in private of the shortfall in performance.

Day 1 Day 2 Day 3 Day 4 Day 5

1 2 3 4 1 2DAILY
3 4 CRITERIA
1 2 3 /4SCORE
1 2 3 4 1 2 3 4
Contribution to discussions, questioning of
tutors, communication to the class, Reporting
of situations accurately and effective
participation in team activities and
simulation.

Clarity and technical soundness of the

delegate’s written assignments.

Personal attributes, skills and audit

management capabilities.

Attitude, manner and suitability as a future

auditor and, where appropriate, as audit team
leader.

Attendance, punctuality and participation in

all class activities.

TOTALS DAILY TOTAL

A course
Total for maximum of 50 by
(Multiply marks
0. 5) are
allocated to the daily tutor
assessment of a delegate’s
performance. Continuous Assessment Exercise Results
DAY 1 a.m. - Understanding of ISO 9001 (10 marks)
DAY 1 p.m. - Understanding ISO 9001 (10 marks)
DAY 2 a.m. - Document Review (10 marks)
DAY 2 p.m. - Assessment practice
A maximum of 150 marks (10 marks)
are
DAY 3 a.m. - Planning available
the on site audit
for the (10 individual
marks)
DAY 3 p.m. - Planning continuous assessment exercises.
the on site audit (20 marks)
DAY 4 - Auditing technique (50 marks)
DAY 5 - Writing a nonconformity statement (10 marks)
DAY 5 - Audit follow up (10 marks)
DAY 5 - 5 - Summary report (10 marks)

Contribution from daily Assessment Summary

TOTAL RESULT FOR COURSE

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Day1 CA Exercise No.1 ( 10 marks)

Respond to the following questions:

1. Give two reasons why an organization might wish to base its quality management system
on ISO 9001:2015. (1 mark)

Cost reduction
Handling for time and production

2. What do understand by the term “context of organization”? (1 mark)

Scope of organizations

Internal issues

External isues

3. What do you understand by a term “strategic direction” ? (1 mark)

Strategic direction” refers to the actions you are taking to achieve the goals of your
organizational strategy. Some companies use a “ vision ...

4. What is meant by “Risk based thinking “ in ISO 9001:2015. (1 mark)

Risk-based thinking makes preventive action part of your organization's routine. As many people
think of risk in a negative way, 

5. What is quality objective? Give one example of a measurable quality objective? (1 mark)

Clause 6.2 of ISO 9001:2015 defines quality objectives and explains how to use them.
Quality objectives are measurable goals relevant to enhancing customer

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 satisfaction and are consistent with the quality policy. These objectives are initially
established when planning your QMS and redefined in management reviews as needed.
Examples can include goals to improve on time delivery, defects, or scrap. These
objectives must be documented and updated as appropriate.

6. With reference to the requirement “Context of Organization”, the standard requires to

determine ‘external’ and ‘internal’ issues that are relevant to the organization’s
purpose. Give two examples of each of them. (1 mark)
Internal issues
1-‫وجود فريق عمل مؤهل وكفأ‬
٩٠٠١ ‫الوعي الكافي بالمواصفة‬-٢
External isues

‫المنافسة الشاملة في قطاع التوظيف‬

‫التفتيش والمراجعات الداخلية‬

7. ISO 9001:2015 requires organization to apply PDCA Cycle. Explain in your own words
what do you understand by PDCA? (1 mark).
The PDCA / PDSA cycle is a continuous loop of planning, doing, checking (or studying), and acting.
It provides a simple and effective approach for solving .

8. With reference to the requirement “Determining the Scope of Quality Management

System”, the standard requires the organization to determine the boundaries &
applicability of the management system to establish the scope. List any two important
things that are required to be considered when determining the scope ? (1 mark)

Project deliverables are tangible outcomes, measurable results, or specific items that must
be produced to consider either the project or the project phase

9. ISO 9001:2015 requires organization to “determine knowledge necessary for the

operation of processes”. List two each of internal & external sources of this knowledge.

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 9001:2015 standards were re vised in 2015. Based on this, the business risks, improvement
of internal and external ... determine knowledge necessary for the operation of processes

10. ISO 9001:2015 requires organization to “determine the controls to be applied” to

externally provided processes, products & services. List the various forms of these
externally provided processes, products & services.

ISO 9001:2015, 8.4.1 states, the organization shall determine the controls to be applied to
externally provided processes, products and services when:

products and services from external providers are intended for incorporation into the
organization’s own products and services;

products and services are provided directly to the ‫ح‬customer(s) by external providers on behalf
of the organization

Day 1 CA Exercise No. 2 (10 marks).

Identify which sub-clauses of ISO 9001:2015 are of particular relevance / importance in relation to
the process approach and improvement. For each of these sub-clauses indicate what evidence
could demonstrate that an organisation is using these principles in an effective manner. (you
should aim to identify at least 6 sub-clauses)

Assigned duties/process owners; (Clause 5.3)

Assessed risks and opportunities; (Clause 6.1)
Provided resources; (Clause 7.1)
Maintained and retained documented information. (Clause 7.5.1)
Implemented measurement criteria; (Clause 9.0)
Improved the management system and its processes; (Clause 10.3)

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Day 2 CA Exercise No. 3: ( 10 marks)

DOCUMENT REVIEW SUMMARY

Claus ISO 9001:2015 Requirement Complianc Comment

e no. e
Y/N
4.0 Context of the organization Page 5
4.1 Understanding organization & its Y Page 17
4.2 context Y
Understanding needs &
4.3 expectations of interested parties Y Page8
4.4 Determining the scope of QMS N Procedure not complete
QMS & its processes

5.0 Leadership
5.1 Leadership & commitment Y Page 11
5.2 Quality policy Y Page 6
5.3 Organizational roles & Y Page 13
responsibilities

6.0 Planning Page11

6.1 Actions to address risks & Y
opportunities
6.2 Quality objectives & planning to Y Page 6
achieve them
6.3 Planning changes N Not done

7.0 Support
7.1 Resources Y Page 35
7.2 Competence Y Page 35
7.3 Awareness Y Pages 35 36
7.4 Communication Y Page 35
7.5 Documented information Y Page 35

8.0 Operations
8.1 Operational planning & control Y 18
8.2 Requirements for products & N Not done
services
8.3 Design & development of Y 25
products & services
8.4 Control of externally provided Y 20
processes, products & services
8.5 Production & service provision N Not done
8.6 Release of products & services
8.7 Control of non-conforming outputs Y Page 30

9.0 Performance evaluation

9.1 Monitoring, measurement, Y Page 29
analysis & evaluation
9.2 Internal audit
9.3 Management review Y Page 40
Y Page 41
10 Improvement
10.1 General 39 Page 39
10.2 Non-conformity & corrective 33 Page 39
10.3 action

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 Continual improvement 39 Page 39

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Day 2 pm - CA Exercise No. 4 (10 marks).

Respond to the following questions:

1. Explain why an audit team leader might wish to undertake a pre-audit visit to the
organisation to be audited. (1 mark)

A pre-audit is the first step in the process of an audit. During a pre-audit, a company documents
are examined to ensure that all information is correct before the company or individual undergoes an
official audit.

2. In relation to the on-site audit of the case study company, what is the “Scope” of the audit
?. (2 marks)

The scope of  auditing within an organization is broad and May involve topics such as an

organization's governance, risk management and management controls over:
efficiency/effectiveness of operations and management reporting, and make sure that compliance
with iso 9001...

3. Identify two considerations that should be made by an audit team leader in determining the
size and composition of the audit team ? (2 marks)
1-Competence
2- Neutrality

4. Identify two duties of audit “Guides”. (2 marks)

1-making check list of the Audit

2-making corrective actions for non conformity

3- making final report

5. In relation to the case study company identify six ISO 9001:2015 clauses that you would
wish to verify in order to establish that the case study organisation is effectively managing
and has adopted the “Risk based & process approach” in relation to the “ home delivery”
process. (3 marks)

Clause 6.1 Actions to address risks and opportunities

Clause 6.3 Planning of Change

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ISO 9001:2015 Clause 7.1.4 Environment for the Operation of Processes

ISO 9001:2015 Clause 8.1 Operational Planning

Clause 8.3 Design and development of products and services

Implemented measurement criteria; (Clause 9.0)
Improved the management system and its processes; (Clause 10.3)

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Day 3 - CA Exercise No. 5 (10 marks).

With reference to the “Role Play” audit that you are to undertake in the case study company.
produce a “Check List” containing closed ended questions as directed by your tutor(s). This
check list should also be written onto flip chart sheets to enable you to make a formal
presentation and also for use during the audit role play.

Does the product have batch no ? 8.2

Has the organization discuss the internal and external isues ? 4.1

Is the employee have awareness on the organization policy? 7.3

Does the organization having archive system ? 8.3

Does the organization implement internal Audit ?9.2

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Day 3 CA Exercise No. 6a (10 marks).

With reference to the “Role Play” audit that you are to undertake in the case study company.
you have already produced check lists containing closed ended questions in order to verify that
the organization is meeting the ISO 9001 requirements of Clause 4.1, 4.2 & 6.1 in relation to
Strategic Planning and Clause 8.4 in relation to Outsourced process of ‘home delivery service’

Your team leader also requires you to assess the organization’s approach in : (1) implementing
‘process based quality management system’, and (2) evaluating performance & effectiveness to
meet customer requirements & enhance customer satisfaction, in relation to the ‘Home Delivery
Service Process’ .
a) Produce a Check List containing closed ended questions, for the ISO 9001 requirement
4.4.1 (Quality management system & its processes) to respond to team leader’s query
(1) as above. (5 marks)
b) Identify 5 other ISO 9001 clauses that you would wish to verify to respond to team
leader’s query (2) as above. (5 marks)

Does the organization determine the input and output of the process?

Does the organization implement the thinking based on risk?

Does the organization determine the sequence interaction of the process

Does the organization determine the sources which needs for the process?

Does the organization doing internal Audit on its process and system?

B
Clause 7.12
Clause7.3
Clause8.2.4
Clause 8.2.1
Clause 9.1

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 Day 3 CA Exercise No. 6b (10 marks)

In relation to these peviously identified six clauses identify where in the organisation you would
visit and what evidence you would wish to see in order to evaluate the effectiveness of the
organisation’s approach to performance evaluation, customer satisfaction and the
implementation of the company Quality Policy in relation to the “Home Delivery Service
Process” (you are producing a limited auditor’s “Plan of Action” and associated checklist
containing closed ended questions).

1. Asking customer service manager for measuring and monitoring input and output of the
process?
2. Asking about complaints and recalling system is that implemented ?
3. Asking about policy and are the employee's are understand it?
4. Asking about organization plane and objectives?

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 5. Day 4 - CA Exercise No. 7 (Auditing Technique) (50 marks).

The tutor(s) will judge each delegate against the following criteria:

S. Parameter Marks out of 10

No.

1 Interpersonal skills
(Rapport with auditee / Sensitivity to auditee / Feedback of
information)

2 Use of Check List / Audit sample selection

3 Questioning / listening skills

4 Interpretation and evaluation of audit evidence / Trail

following

5 Note taking

Total Marks

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Day 4 - CA Exercise No. 8 (10 marks).

Following your audit of the case study company, review your personal notes and write what you
consider to be the most significant nonconformity on the assessment nonconformity report form
below. Complete the form as it would be completed by an auditor during the assessment
process:

XYZ CERTIFICATION LTD.

Company audited: 17 -6 - 2020

Date:

Auditor’s name:
Asem abdelhamid

Non conformity statement:

Failure in the planning of design

Evidence
Page. 17
Clause

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Day 5 - CA Exercise No. 9 (10 marks).
_____________________________________________________________________________

Non Conformity Report

Report Ref. No. 201y/1 Audit Date : 12/03/201y
Process : Operations (Storage) Auditor : Soames Auditee : Y. Chug

AUDIT FINDINGS : (Non-Conformity):

The various packets of grocery material were not being handled as per work instruction
GSM/Op/WI/9, rev 3,. This was resulting in damages of the goods and loss of goods due to
scrap.
Acceptance By : Y. Chug
_____________________________________________________________________________

CORRECTION - MITIGATING ACTION :

The personnel in stores were new and were not aware about the work instructions and were
keeping the material in an incorrect way.
Replaced the packets and repacked into proper packing as instructed by the customer service
manager.
CORRECTIVE ACTION -ON THE CAUSE:
The induction training of stores persons shall be modified to include this concern.
One point lesson shall be communicated to relevant personnel who are working in stores as of
date.

Audit Management : Y. Chug

_____________________________________________________________________________
Suggest a suitable approach that an auditor might take to verify that the corrective action is
effective in dealing with the root cause of the problem.

Making training for ISO 9001 and storage procedure to new employee

Making sops explained goods storage and training the employee on it

Making handling for logbooks and delivery orders

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 Day 5 - CA Exercise No. 10 (10 marks).

You have been requested to provide an executive summary report for your 'client'
communicating the assessment results (to a busy senior director). This report needs to
address only the headings given below:

Objectives and scope of the assessment .

Scoop from quality manual

Objective from iso 9001 :2015

Conclusions (positive findings / main areas of weakness).

Positive.. organization chart

Weakness .. employee not have enough training

Overview of findings (related to areas of the company or requirements of ISO

9001:2015).

Have the ISO 9001:2015 certificate after clothing Non conformity pints

Recommendations (Your recommendation to company audited).

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