2.exercises & Workshops

Delegate Hand-out
Exercise and Workshops Bureau Veritas Certification
EXERCISES
Dec’19 CQI-IRCA Certified PR 328: QMS ISO 9001:2015 Lead Auditor Training Course (17929) Page 1 of 51
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EXERCISE No. 0: DELEGATE INTRODUCTION- MINI INTERVIEW
Learning Objectives:
The purpose of the exercise is:
To achieve understanding on the interview process and why it is important in the context
of process audit to obtain appropriate information and evidences, how to evaluate this
information and then present to the organization.
Duration:
Refer to the time table for overall time duration and follow instructions by the Trainers for
break up
Nature of the Activity
Delegates in team of 2 work on this exercise.
Material and Equipment
- Check list format

- Blue/ White Tack or pin board.
Delegates Tasks and Deliverables
Delegates are divided into pairs of 2 each. Each team (pair) will conduct this exercise.
Initially, one member of the team will interview the other (max time allowed is 5 minutes
per delegate) and collect all relevant information in the checklist template provided to
them.
Subsequently the 2nd member of the team will repeat the exercise. After the delegate
exercise trainer will explain how to use this information.
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Delegate Introduction Checklist Template
Interviewee Name:
Employer name:
Position:
Education:
Career background:
Quality management
experience:
Knowledge of ISO 9001:2015

grade from 1 (low) to 10 (high)
Auditing experience: Type: 1st party 2nd party 3rd party

(Please write the numbers in respective No. of (Internal) (Supplier) (Certification)
columns)
audits:
Nil
Up to 5
5 – 10
10 & more
Personal objectives in
attending the course
Other information about

interviewee that may be
useful for auditor to know
Date:
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Auditor name:
EXERCISE No.1: Preparation prior to Audit - Case Study Review
1. To achieve an understanding and familiarity about the organization to be audited

so that auditors can objectively evaluate all aspects of their QMS and processes
2. To enable the students to carry out further exercises and workshops in an
informed manner
Duration:
break up
Team work on gathering a quick overview of the organization being audited, similar
to pre audit visit/discussion with a client organization before planning stage 1 &
stage 2 audit
- All documentation of Beta Training.

- Note books/ plain white sheets and pens
Delegates are divided into teams (see exercise 0) and expected to work in team to
carry out a quick reading of all provided documented information by Beta Training
in order to achieve familiarity about the organization.
Delegate Instructions
Read individually/or in team the documented information provided by Beta Training

as part of pre visit preparation by the audit team
The outcome of the exercise is to be written down by the team in note pad / white
papers as important information/ questions to be asked to seek further information
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EXERCISE No. 2: Auditing Terminology
Learning Objectives:
To achieve the required understanding on and be able to explain the terminology and
concepts related to auditing a Quality Management System and apply them in real life
audits
Duration:
break up
Team work on analysis of concepts and terminology related to auditing.
- Cards.
- Blue/ White Tack or pin board.
Delegates are divided into teams (see exercise 0) and expected to work in team to match
correctly the cards with terms (printed on coloured card paper and cut into the shape of a
card) with their definitions (differently coloured cards).
DELEGATE INSTRUCTIONS
Delegates as a team receive packs of cards that include:
- One set of cards in one colour with printed text giving various terms related to
auditing
- Another set of cards (differently coloured) containing printed text giving definitions of
those terms.
Teams are required to match the terms with their definitions (there may be more than one
definition for a term) and prepare a display by:
- Using blue (white) tack and board

- Using pin board
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- Placing the cards in order on the table.
EXERCISE No 3.
COMMUNICATION
FACT OR INFERENCE?
“Jones, a buyer with the XYZ Company, was scheduled for a 10 o’clock meeting in Mr
Smith’s office to discuss the terms of a large order. On the way to that office the buyer
slipped on a freshly waxed floor, and as a result received a badly bruised leg. By the
time Smith was notified of the accident, Jones was on the way to the hospital for X-rays.
Smith called the hospital to enquire and no one there seemed to know anything about
Jones. It’s possible that Smith called the wrong hospital.”
Having read the above paragraph, please classify each of the following statements as
“fact” or “inference”. Use the following as descriptions:
FACT = truth; something that has actually happened.
INFERENCE = May be a truth; something that may or may not have happened.
Statement Fact Inference
1. Jones was supposed to meet with Smith.
2. Jones was scheduled for a 10 o’clock meeting.
3. The accident occurred at the XYZ Company.
4. Jones was taken to the hospital for X-rays.
5. No one at the hospital which Mr Smith called knew

anything about Jones.
6. Smith had called the wrong hospital.
7. Mr Jones is a buyer.
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EXERCISE 4.
Reviewing Corrective Actions
Format :-
Individual exercise by delegates
Purpose :
To enable delegates to understand the challenges in evaluating the corrections and

corrective actions proposed / presented by organizations in response to the Non
Conformities reported during a 3rd party audit
Duration:
break up
Exercise Material
Exercise 04- Delegate hand-out
Delegate Instructions
Now that as an auditor you have issued non conformities, the organization’s
representatives submit proposed corrective action plan to you. As an auditor you are
expected to review these actions and advice the organization whether they can go ahead
with implementation.
Review in team the case studies allocated by the Trainer and comment as follows:
- Are they acceptable?
- If they are not acceptable, justify why
- If they are acceptable, what evidence will you look for accepting the proposed
corrective action?
The outcome of the discussions and group work can be written on the hand-out against
the case study (NCR) allocated to you.
Delegate Hand-out
CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 1
Auditor: Auditee:
Non-conformity:
The process of documentation control is not effective
Objective Evidences:-
While auditing the Quality Department, it was discovered that three new procedures have been
released onto the intranet, but there is no evidence of prior approval.
Requirements:-
ISO 9001:2015 7.5.3.2, For the control of documented information, the organization shall
address the following activities as applicable :
a) Distribution, access, retrieval and use
Signed: Date:
Cause & Proposed Corrective Action:
Corrective Action – Approval records will be created and added on file.

Recommended by – Quality Manager
Proposed Completion Date:
DATE: SIGNATURE
Corrective Action Review:
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of planning for the necessary documentation is not effective
In the process manual established for description of the processes, there was no
description of the interaction between the processes of the quality management
system. This according to the auditee is a requirement as determined by them.
Requirements:-
ISO 9001:2015 4.4 requires “The organization shall maintain documented information
to the extent necessary to support the operation of processes”.
Signed:
Date:
The Quality Manager will, together with the Production Manager, define the processes
for the quality management system.
DATE: SIGNATURE
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of evaluation and selection of suppliers is not implemented fully
During the audit it was noted that there were no records in support of the names of any
of the organisations listed on the ‘Approved Suppliers List’.
Company procedure for Purchase (QPR/PUR/001) requires that records of the results of
evaluations and any necessary actions arising from the evaluation of all suppliers shall be
maintained.”
Requirements:-
ISO 9001:2015-8.4.1 The organization shall determine and apply criteria for the evaluation,
selection, monitoring of performance, and re-evaluation of external providers, based on their
ability to provide processes or products and services in accordance with requirements. The
organization shall retain documented information of these activities and any necessary actions
arising from the evaluations.
Signed: Date:
Corrective Action - From now on records will be created of all evaluations and re-
evaluations of suppliers, and will be maintained on file.
DATE: SIGNATURE
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of managing customer property is not effectively implemented
Evidence of customer owned materials was found in manufacturing – valves for incorporation
into the pumps – but these were not identified as customer property.
Requirements:-
ISO 9001:2015-8.5.3 requires “The organization shall identify, verify, protect and safeguard the
customer’s or external provider’s property provided for use or incorporation into the products and
services
Signed: Date:
Corrective Action - All valves will be suitably identified, protected and verified.
DATE: SIGNATURE
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of creating awareness among employees not implemented effectively
Objective
During an audit of pump assembly in the production area the auditor established that four
employees did not know the implications of not following process controls in their equipment as
laid down in their process data sheets which are part of their Quality Management System
Requirements:-
ISO 9001:2015-7.3 requires that persons doing work under the organizations control shall be
aware of : (d) the implications of not conforming with the quality management system
requirements
Signed: Date:
Cause :
The roles, responsibilities and authorities of employees including the implications of not
conforming to QMS requirements were neither defined nor communicated within the
organisation.
Corrective action - An employee handbook defining roles, responsibilities and

authorities has been published and distributed to all employees. Training programmes
were conducted covering each employee. A test was conducted and it is now ensured
that all current employees, including the above stated four employees, are aware of
their roles. All future recruits will be routed through a formal induction programme
which will include this subject.
Recommended by – Management Representative
Signature
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of identification of process outputs (products) is not implemented effectively
Objective evidences:-
During the audit of packaging and despatch area of a pharmaceutical products, the auditor
discovered that there was no identification of any unit leaving the company. The contract
requires that every unit be uniquely identified at all stages of product realization chain and
records maintained.
Requirements:-
ISO 9001:2015 8.5.2 requires “Where necessary to ensure conformity of products and
services, the organization shall use suitable means to identify the process outputs:
Signed: Date:
Corrective action – The Production Manager shall ensure that a suitable identification
system is implemented for the next contract.
DATE: SIGNATURE
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of identifying the status of measuring equipment is not implemented effectively
Objective evidence:-
During the audit, several items of measuring equipment were discovered in use in the
production areas that were not identified by any means (e.g. micrometers, pressure gauges
etc.).
Requirements:-
7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is considered by the organization to be an

essential part of providing confidence in the validity of measurement results, measuring
equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards; when no such
standards exist, the basis used for calibration or verification shall be retained as
documented information;
b) identified in order to determine their status;
Signed: Date:
Corrective Action –All items of measuring equipment will be suitably identified, records raised,
and their current calibration status determined.
Recommended by - The Quality Manager
DATE: SIGNATURE
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of Corrective actions has not been implemented effectively
During review of the internal audit programme, in many cases, actions taken in response to
nonconformities only corrected the immediately identified symptom(s) without removing the
cause of the problem.
Requirements:-
ISO 9001:2015 9.2.2 requires “The organization shall……take necessary correction and
corrective actions...”
Signed: Date:
The quality manager will review and amend the procedures for internal audits and
corrective actions to make it clear that root cause analysis is necessary and that
corrective actions must address the root causes of the problems.
She will also support implementation of the revised procedures by conducting

additional training for the audit team and department manager to cover the
nonconformity investigation, root cause analysis, developing of corrective actions and
evaluation-of-effectiveness of corrective action.
DATE: SIGNATURE
Signed: Date:
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Auditor: Auditee:
Non Conformity:
There was no evidence of any documented quality objective.
ISO 9001:2015 -6.2.1 requires “The organization shall retain documented information on
the quality objectives”
Signed: Date:
Cause – Lack of awareness/understanding of QMS requirements.
Correction : All identified employees and top management will undergo a detailed QMS
awareness training programme and the effectiveness of the programme will evaluated
by a third party.
Any documentation, including quality objectives, that were not included, will be added to
the QMS.
DATE: SIGNATURE
Signed: Date:
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Auditor: Auditee:
Non Conformity:
The process of maintaining the traceability of authority to release the products
Objective Evidence:-
During the audit it was noted the records did not indicate who the authority was, for the final
release of the product. It could not be identified as to who was the one who released the
products
Requirements:-
ISO 9001:2015 8.6 requires “Documented information shall provide traceability to the
persons(s) authorizing release of products and services for delivery to the customer.”
Signed: Date:
Corrective Action – The Chief Inspector is the authority to sign for release of the
product. The final release form will be modified to allow the Chief Inspector to sign for
final release.
Recommended by – Management Representative
DATE: SIGNATURE
Signed: Date:
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WORKSHOPS
Delegate Hand-out
Workshop 1- Auditing Context, Planning and Support
Format: Skill based Practical Evaluation - delegates will be evaluated on their ability
to meet the exercise objectives
Objectives:
- To prepare delegates for interpretation and develop skills to audit particular
requirements in the background of a case study organization.
- To develop the skills for developing audit checklist
- To enhance the understanding of process and system approach to
management and its consequences for auditing
- To be able to develop a process focused Checklist
- To enable delegates to appreciate the “Planning” part (PDCA) of the QMS
of an organization and how to audit this segment of the PDCA Cycle
Documentation of Beta Training

ISO 9001:2015 Standard
Flipchart & Markers
Duration:
break up
Delegate briefing.
The background scenario:
Beta Training is an organization / company who is into design, development and delivery of
training modules to industry. They have implemented a quality management system based on
ISO 9001:2015 standard
You are scheduled for conducting an on-site audit. You need to develop knowledge and skills
required to carry out a detailed audit of requirements of Clauses 4, 6 & 7 of ISO 9001
Standard.
Part 1 of Workshop
To start with, first prepare a set of questions related to the internal and external issues
encountered and all possible interested parties and their needs and expectations
related to ‘Beta Training’in the following format :
Sr Issues Interested parties

No External Internal Interested Party Needs and
expectations
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This information is not be shared with Beta, but required for you to conduct the
audit in a systematic manner when you are on site.
Part 2 of Workshop:
- Based on the review of the documentation of the organization the teams shall
prepare a detailed checklist with the information collected in part 1 of this
workshop in the background.
- You must cover the clauses 4, 6 & 7
Sr What to check /ask / look for Related Related Remarks/

No evidence Clause Comments
to look for No
Since 4, 6 and 7 Clauses would practically apply to all processes/ departments of Beta,
delegates can make a generic checklist keeping in mind any process(es) of Beta
Training.
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Workshop 2-Auditing ‘Operation’
Objectives:
- To prepare delegates for appropriate interpretation and developing the skills
required to audit particular requirements in the background of a case study
organization.
management and its consequences on auditing
- To enable delegates to appreciate the “DO” part (PDCA) of the QMS of an
organization and how to audit this segment of the PDCA Cycle

ISO 9001:2015
Flipchart & Markers
Duration:
break up
Delegate briefing.
Beta Training is an organization / company who is into design, development and delivery
of training modules to industry. They have implemented a quality management system
based on ISO 9001:2015 standard
You are scheduled to conduct an onsite audit. You need to develop the knowledge and
skills sets required to carry out a detailed audit of requirements of Clause ‘8 Operation’ of
ISO 9001 Standard to verify conformance of their QMS.
prepare a detailed checklist to verify conformance of the QMS of Beta Training
with the requirements.
The teams shall prepare the checklist in the following format
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Following sub clauses of ‘8.Operation’ are allocated to teams as follows:
Team 1- Clause 8.2 Determination of requirements related to products and services &
Clause 8.7 Control of non-conforming outputs
Team 2- Clause 8.4 Control of externally provided processes, products and services
Team 3- Clause 8.3 Design of products and services
Team 4- Clause 8.5 Control of Production and Service Provision

Clause 8.6 Release of products and services
(Trainer may allocate the above sets of clauses to different teams, if they wish. However
the combination / group of clauses must not change)
Sr What to check /ask / look for Related Related remarks

No evidence to Clause No
look for (Leave this
column
blank)
All teams must produce the outputs on flip charts. All questions and check points must be
related to Beta and not generic.
Please leave the 4th column (Clause Number) blank to facilitate group work later.
Discussion and Feedback :
Please follow the trainer’s instructions after all the teams have finished their tasks.
Delegate Hand-out
Workshop 3-Auditing ‘performance evaluation and improvement’
Objectives:
- To prepare delegates for appropriate interpretation and developing the skills
required to audit particular requirements in the background of a case study
organization.
management and its consequences on auditing
- To enable delegates to appreciate the “CHECKING” & “ACTING” part
(PDCA) of the QMS of an organization and how to audit these segments of
the PDCA cycle.

ISO 9001:2015
Flipchart & Markers
Duration:
break up
Delegate briefing.
Beta Training is an organization / company who is into design, development and

delivery of training modules to industry. They have implemented a quality
management system based on ISO 9001:2015 standard
You are scheduled to conduct an onsite audit. You need to develop the knowledge and
skills sets required to carry out a detailed audit of requirements of Clause ‘9
Performance evaluation’ and 10.’Improvement’ of ISO 9001 Standard to verify
conformance of their QMS to these requirements
prepare a detailed checklist to verify conformance of the QMS of Beta Training
with the requirements.
The teams shall prepare the checklist in the following format
Delegate Hand-out
Sr What to check /ask / look for Related Related remarks

No evidence to Clause No
look for
All teams must produce the outputs on flip charts. All questions and check points must be
related to Beta and not generic
Discussion and Feedback :
Please follow the trainers’ instructions after all the teams have finished their tasks.
Delegate Hand-out
Workshop 4 - Planning for Stage 1 Audit
Objectives:
- To prepare delegates for planning for on-site stage one audit.
- To develop the skills for audit planning
management and its consequences for auditing
- To develop the ability to determine the audit scope and determine resource
requirements including audit day determination
- To be able to develop a process focused plan.
Material – Documentation of Beta Training

ISO 9001 & 19011 Standards.
Flipchart & Markers
Duration:
break up
Delegate briefing.
The background:
Delegates must remember that ‘Certification audits’ are conducted in 2 stages (Stage
1 & Stage 2). But each activity involved in audit process must be adequately planned,
documented and the organisation personnel being audited must be well informed
about such plans and the time scale.
prepare an audit plan for a stage 1 audit of this organisation as part of the
certification contract signed with Bureau Veritas Certification.
- Based on the size of the company (No of employees) delegates must

determine the number of person-days required for the audit (delegates can use
the table derived from relevant IAF Mandatory Document, provided in this hand-
out.)
- Audit plan must include the scope of the audit and identification of the audit
team.
Feedback session
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Teams in turn shall present their conclusions and outputs. Trainer animates and
moderates the discussion.
Guidelines on allocation of auditor days
1. Determine the amount of work involved and the time duration that will be required –
size and complexity of the audit will mainly decide this – but remember, audits cost
money therefore try to keep the time as short as possible. There are requirements
specified by IAF for Quality Management System audits
2. It must be understood that the time required for the audit depends on number of
factors as outlined in the text that follows the table 1 given below
Table 1:Guide for auditor time for initial assessment (stage 1 & stage 2 together)
(Derived from IAF MD5:2019)
Effective Number Audit Time Effective Audit Time

of Personnel (Stage 1 + Stage Number of (Stage 1 +
2) Personnel Stage 2)
1-5 1.5 626-875 12
6-10 2 876-1175 13
11-15 2.5 1176-1550 14
16-25 3 1551-2025 15
26-45 4 2026-2675 16
46-65 5 2676-3450 17
66-85 6 3451-4350 18
86-125 7 4351-5450 19
126-175 8 5451-6800 20
176-275 9 6801-8500 21
276-425 10 8501-10700 22
426-625 11 >10700 Follow
progression
above
Term “effective number of personnel” has been referred to in ISO 17021 as “personnel”
and is typically “person doing the work under the control of the organization”. Certain
factors are to be considered while determining the effective number of employees, viz.,
the number of shifts of working where similar work is carried out or many persons doing
the repetitive type of work (Ex: Data entry / front office work / identical products being
produced on similar machines in a manufacturing set up etc) :-
Table 1 sets out typical number of audit days to be used in an initial assessment.
Experience has shown that it is appropriate to base this upon the number of employees
of the organization and the nature, scale and complexities of operations for a typical
organization in that industry sector.
The auditors’ time should then be adjusted based on any significant factors that uniquely
apply to the organization to be audited.
Delegate Hand-out
The additional factors that need to be considered shall include but are not limited to:-
Increase auditor time:
 Client System Complexity (Physical area of the audit site, Number of processes, Unique
processes, Design Responsible etc)
 Complicated logistics involving more than one building or location where work is carried
out.
 Staff speaking in more than one language (requiring interpreter(s) or preventing individual
auditors from working independently);
 Very large site for the number of personnel (e.g., a forest);
 High degree of regulations (e.g., food, drugs, aerospace, nuclear power etc);
 System covers highly complex processes or relatively high number of unique activities;
 Activities that require visiting temporary sites to confirm the activities of the permanent
site(s) whose management system is subject to certification.
Decreased auditor time:
 Very small site for number of employees (e.g., office complex only)
 Very Few processes,
 Maturity of management system
 High percentage of employees doing the same, repetitive and simple tasks
 Work being carried out in shifts where the nature of work remains identical
Once the audit days are determined, the delegates in team shall draw out a detailed plan
for conducting Stage 1 audit of the Beta Training
Audit Plan shall be prepared on Flip Charts to facilitate effective presentations and group
discussions
Delegate Hand-out
AUDIT PLAN PROFORMA
Organisation:
Date(s): Location
Team Leader:
Team Members:
Audit Criteria
Audit scope:
Day Time Area/Activity Auditor Guide
Delegate Hand-out
WORKSHOP No.5 – CONDUCTING STAGE 1 AUDIT
The objectives of this workshop are to understand:
 How to prepare delegates for conducting Stage 1 audit

 How to perform stage 1 audit of an hitherto unknown organisation in order to be
able to assess their readiness with respect to all necessary documentation for a
stage 2 audit in order to verify conformance with ISO 9001:2015.
 How to find the relation between a Quality Manual and the appropriate clauses of
ISO 9001:2015.
 To familiarise delegates with the background scenario for the case study and
further workshops.
 To better understand how to plan the audit in order to ensure that not only
individual processes are reviewed but also their intended results, interaction and
sequence.
 To enhance the knowledge of the standard.
 To create a basic understanding of the applicability of different clauses of the
standard for different processes of an organisation and thus be ready to prepare
the process matrix.
The case study is based on a third party audit initiated by Beta Training.
The company has signed the contract with Bureau Veritas Certification for a
third party audit next month.
As part of the third party registration process, the certification body will require
the auditee to send them a copy of the documentation that contains their intent
in respect of the standard’s requirements, in order that they can evaluate its
adequacy. Under the above mentioned contract, Bureau Veritas Certification
management has appointed you to audit Beta Training’s quality management
system against the requirements of ISO 9001:2015 standard
As a first step you will be conducting a part of the stage 1 audit of the
organisation on the basis of the documentation submitted by the organisation at
site.
Each team will act as an audit team in this scenario and shall perform a part of
the stage 1 audit (documentation part) of the Organisation.
Each team is required to make a presentation on the following:
1. The team’s overall judgement about the preparedness of the organisation

for a stage 2 audit.
2. The team’s judgement on the positives and potential areas of concern.
Delegate Hand-out
WORKSHOP No. 6 – PLANNING for Stage 2 audit
The objectives of this workshop are to prepare the delegates as to:
1. How to plan audit time and perform a stage 2 audit of an organisation.
2. To cover appropriate clauses of ISO 9001:2015 with the processes defined in their
system based on the outcome of documentation audit.
Material for Workshop:

ISO 19011 Standard
Flip Charts and markers
Duration:
break up
Workshop
Each team will act as an audit team.
Each team shall prepare plan for third party audit of Beta Training based on
time
Duration and team members.
The client organization has Head office which has the following processes:
- Top Management.
- Supplier Management
- HR
Audit plan shall determine number of days and number of auditors.
Each team shall present their plan on a flip chart in the pro-forma given below
Delegate Hand-out
AUDIT PLAN PROFORMA
Organisation:
Date(s): Location
Team Leader: Specialist :
Team Members:
Audit
Criteria:
Audit scope:
HOURS AUDITOR 1 HOURS AUDITOR 2
Delegate Hand-out
WORKSHOP No. 7- Auditor Competence

Purpose
The purpose of this workshop is to:
 Make delegates aware of the knowledge and skills required for developing
competence as a 3rd party auditor.
Hand-outs and Material
The following material must be issued to the delegates for this exercise:
 ISO 19011:2018
 Flip Charts and marker
Additionally, CQI-IRCA Documents on Auditor certification (provided in pre course

material) and PowerPoint Handout 10 (provided along with delegate manual) shall
also be referred to.
Duration:
break up
THE WORKSHOP
Delegates in team should work on the Clause 7 of ISO 19011 Standard. The clause
provides guidance on technical and auditing skills as well as soft skills required for
management system auditors.
Additionally they shall refer to the PowerPoint slides on Auditor Certification given as a
hand out
The task is to read the clause 7.Competence and evaluation of auditors (of ISO 19011) of
and summarise the guidelines /their understanding on flipcharts
All teams must prepare the flipcharts covering all important elements of this clause.
Trainers will ask each team to make a brief presentation on any one or more sub clauses
Delegate Hand-out
WORKSHOP No. 8- Identification and reporting ‘Non Conformity’
Purpose
The purpose of this workshop is to:
 Develop the ability to assess the available information to determine if sufficient

evidence of conformance or non-conformance has been gathered;
 Develop the ability to identify the missing information and the ways to establish this
information (audit trail);
 Develop the ability to prepare correct non-conformance report.
Hand-outs and Material
The following material must be issued to the delegates for this exercise:
 Delegate hand-outs – Workshop 8

 Flip Charts and markers
Duration:
break up
THE WORKSHOP
The following are descriptions of incidents observed by you during the course of an
external audit.
They contain descriptions of situations where a nonconformity report may be required. The
delegates should read the descriptions of all incidents. The teams are then required to
carefully examine the incidents allocated by the trainer, and then take one of the two
following actions:
a) If you think that there is sufficient objective evidence of nonconformity then you should
complete a nonconformity report.
b) If you do not think that there is sufficient objective evidence of nonconformity then you should
state your reasons in the space below the report. You should also state what the auditor should
do next i.e. identify what must be checked before it can be determined whether or not there is
any non-conformance.
The reports should then be prepared using FLIP CHARTS and markers issued by the
trainer.
The delegates must strictly present their reports in the format as given at the end of
this hand-out in either of the situations as appropriate
Incident 1
Delegate Hand-out
The XYZ Ltd. is a service inspection and testing company. In the Food Analysis
Laboratory two operators were not wearing nylon caps, one operator had her laboratory
coat undone and was wearing jewellery. Other three operators were OK. Procedure FAL
002 rev.2 (which is current version) available in area clearly describes, in clause 7, the
dress code which requires that laboratory coats must be buttoned up, nylon caps must be
worn and wearing jewellery is not permitted.
Incident 2
The XYZ Ltd. is manufacturing food products. Whilst conducting an audit in the
production area you are observing the reactor unit on the production line number 5 which
is in normal operation. The pressure gauge shows 2.8 bar. The temperature gauge
shows 128 degree centigrade. Flow meter shows 1.2 cum/min. All instruments have
valid calibration stickers. You wish to see Process Specification for this station. The
operator shows the current version of specification PSC02 that stipulates the following
process parameters:
Pressure: 2.5  0.1 bar

Temperature: 130  2 centigrade
Flow: 1.15 – 1.2 cum/min
You ask the operator how often the parameters are checked. The operator explains that
this normally is done every hour and recorded in process chart. You check the charts for
past few days and notices that the parameters reading are not recorded since last shift
changeover four hours ago. The operator explains that he was busy cleaning the
reactors on another line and did not have time to take readings. You had previously
reviewed the procedure PP16 that indeed required checking and recording the process
parameters every hour. Further investigation showed that the whole batch produced on
that shift did not meet the requirements.
Incident 3
In the Quality Manager’s office you reviewed a number of internal audit reports. You
notice that regularly in all audit rounds for past two years around 70% of non-
conformances were noted in the design department. The procedures required auditing
all departments at six monthly intervals and this was followed strictly ever since
implementation of the system.
Incident 4
In the production hall you noticed two weighing machines. Weighing machine serial no.
1624 had an affixed label stating due date for calibration which was over 4 months ago.
Weighing machine serial no. 1636 had no calibration label attached.
Incident 5
During the audit in the design department in XYZ Ltd., you reviewed the Design and
Development Manual and noticed that it did not contain procedures for design validation.
Further you reviewed the documentation pertinent to a selection of ten completed
projects # 99/007, 99/010, 99/020, 99/025, 99/031, 99/042, 99/051, 99/054, 99/062 and
Delegate Hand-out
99/070 and were unable to find any records of design validation activity. Design Director
explained that as every design was unique and one off kind, the requirement for design
validation was not applicable to the products they were designing.
Incident 6
In the design department you reviewed the list of five-quality objective for that
department. You asked if the results of planning that was carried out to achieve these
objectives were documented. The design director replied that any such document was
not prepared, as he believed that it would suppress the creativity.
Incident 7
In the material stores you noticed that there were no tags or stickers to show the
inspection status of the materials. You previously visited the assembly line and noticed
that tags or stickers were being used to identify the inspection status. The storekeeper
explained that there was no need to use stickers or tags as all incoming material was
kept in the receiving area until verified and accepted. Only accepted material was being
allowed into designated areas.
Incident 8
In the Quality Manager’s office you review the internal audit reports and note the
following:
Report 03 shows two corrective actions outstanding (due ten months ago)
Report 05 shows one corrective action outstanding (due six months ago)
Report 07 shows one corrective action outstanding (due four month ago)
There is no evidence of follow-up action.
Incident 9
The hospital, XYZ plc, operates emergency ambulance services. Whilst auditing the
Ambulance Department you ask if there were any documented procedures or instructions
for paramedics covering first aid, resuscitation, etc. The head of the department
explained that as all paramedics are highly competent there was no need to have any
such instructions in writing.
Incident 10
XYZ plc manufactures various cosmetics. In the despatch area you are reviewing the
products released for shipment and notice that the quantity of anti-wrinkle night cream
“Gloria” (Production Order Number 99/6802) which was kept on three pallets and marked
‘ready for shipment’, did not have the following marked on the boxes:
 Batch number.
 Production date.
 Expiry date.
Procedure FP 001, clause 7.8 requires that the above-mentioned information must be
printed on the boxes for all creams and lotions
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Incident 11
In the organization ABC, while auditing Purchase function for Risk Process, the Purchase
Manager replied that he has only one risk identified due to the external issue related to a
single supplier for a key input material PA 6. When asked how they have planned to
address this risk she informed that they have decided to always maintain 180 days of
inventory to face any potential crisis situations due to the supply chain issues arising out
of this single supplier. On further investigation, it was found that during the past 12
months period after this decision was implemented, there are several occasions when
the inventory levels were found to be much lower than stipulated level. When questioned,
the Manager said it is always not possible to maintain this level of inventory. In fact, in the
production line that you had visited earlier, it was indeed found that production had been
stopped due to shortage of this key input.
Incident 12
During an audit of multidiscipline engineering design, consulting and project management

firm you review the project control process. The process involves number of gateways at
which approvals by authorised personnel are required. Gateway 3 – authorisation to
submit fee proposal involves a risk assessment where number of questions related to
financial, commercial, quality, OH&S, environmental and other issues need to be
answered. The software then calculates the level of risk (low, medium and high).
Depending on the risk, gateway approval would require authorisation at differed
organisational level (Low Risk – Project Manager; Medium Risk – Regional Director; High
Risk - Technical Director. You reviewed a sample of ten large projects and noted the
following:
a) Project number 20XX/0078 – the fee proposal was issued to the client on 16 th of
June 20XX, the clients purchase order was received on 28 th of June 20XX and the
work on the project work commenced on the 1 st of August 20XX. Gateway 3
approval was signed off on the 30th of November (ten days before the audit).
b) Project number 20XX/0137 – The project control process records showed that
project was classed as high risk, yet gateway 3 approval was authorised by the
regional Director.
c) Project number 20XX/0162 – The project control records showed that 17 out of 42
questions included in the risk assessment questionnaire were not answered.But
the project found to have been completed
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If you think there is sufficient evidence to report your findings as a nonconformity, complete
the following nonconformity report.
Incident Number......
NONCONFORMITY REPORT
Description of the nonconformity:
Objective Evidence
ISO 9001:2015 clause and requirement:
OR
Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as
a nonconformity.
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Describe how you would investigate further to determine conformity or nonconformity.
Include audit trails you would follow and specific examples of audit evidence you would seek
and for what purpose.
Incident Number......
Audit investigation template:
Reason why there is not yet sufficient evidence for reporting nonconformity
Audit trails you would follow, including, evidence sought and purpose
Audit Trail Evidence Sought Purpose
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WORKSHOP No.9 – AUDIT PLAN MATRIX
The objectives of this workshop are to prepare the delegates to:
 How to develop a workable and useful audit plan to perform third party audit in an
auditee organisation in the context of certification process.
 To cover appropriate clauses of ISO 9001:2015 with their processes.
Duration:
break up
Handouts and material
Documented information of Beta Training

Flip Charts and Markers
Process Matrix Template giving in this handout
ISO 9001:2015 Standard
BACKGROUND
In the previous workshops you have prepared a detailed audit plan covering all the
processes of Beta Training to be audited during Stage 2 audit. Being a new auditor you
may find it difficult to remember which clauses (and requirements of) ISO 9001:2015
would apply to the process being audit and at times you may be at a loss to realize as to
how to approach the audit or where to start from. Therefore if you have a matrix
document which identifies the applicability of various clauses of the standard to different
process of the organization it would come handy to approach the audit systematically
Workshop
In continuation of the preparation for the Stage 2 audit of Beta Training, the teams shall
prepare an “Audit plan Matrix”. The audit plan matrix must ensure that the team will be
able to assess individual processes but also ensure the intent and depth of audit of each
process by understanding the applicability of relevant clauses of the Audit Criteria.
Based on “Workshop-Planning for Stage 2 audit” the team shall use the information to
prepare the matrix
The audit plan matrix shall indicate what elements of the standards will be looked at in
various departments / processes.
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ISO9001:2015 Process Matrix Page of
COMPANY:
Processes (Functions)
Scope of audit:
4.1 Understanding the organization and context

4.2 Understanding the needs and expectation of
interested parties
4.3 Determining the scope of the QMS
4.4 QMS and its processes
5.1 Leadership and Management commitment
5.2 Quality policy
5.3 Organizational roles, responsibilites and authorities
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information
8.1 Operational planning and control
8.2 Determination of requiements for products and
services
8.3 Design and or development of products and
services
8.4 Control of externally provided products and
services
8.5 Production and Service Provision
8.6 Release of products and services
8.7 Control of non conforming process outputs ,
products and services
9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal Audit
9.3 Management Review
10.1 General
10.2 Non Conformity and corrective action
10.3 Continual Improvement
Workshop 10: Identification of Audit Trails
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The objectives of this workshop are:
1. To understand the process identifying audit trails using the knowledge of interaction/
interfacing of various requirements of clauses with each other
2. To gain an insight into how to identify specific, promising audit trails
3. To achieve an understanding on the questioning to be done, evidences to be sought and
analyse the evidences in the light of the requirements
Duration:
break up
Material provided for Workshop:
Documented Information of the Beta

Flip-chart and markers
Workshop
The trainer will allocate one clause of the standard to each team. Thus each team will have
different clauses of the standard to work upon
The delegates will have studied the organisation’s documentation. However they are advised to
understand the organisation in more details.
With this knowledge and that of ISO 9001 Standard, they are expected to work in teams and
identify which other clauses of the standard interact or interface with the clause allotted to the
team
Teams shall prepare their presentation in the format given below with the allocated clause shown
at the centre of the diagram (This diagram is known as Octopus Diagram)
Make reference to the relevant clauses of the standard. While presenting the information,
delegates must also depict the direction of the arrows to indicate which clause gives input to the
central clause and vice versa.
(It must have been realised by the delegates during this workshop that each clause of the
standard has one or more output(s) which become(s) input to one or more other clause(s) of the
standard and vice versa. (i.e.,output of other clauses become inputs to them )
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8.2
Determinatio
n of
requirement
for products
and services
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WORKSHOP No. 11- Developing an AUDIT CHECKLIST
 Understand how to develop a workable and useful audit checklist to perform third
party audit in the auditee organisation.
 To cover appropriate clauses of ISO 9001:2015 with their business activities

including processes and procedures.
Duration:
break up
Workshop Material:
 The Documentation of Beta Training

 Flip Charts and markers OR
 Outputs of earlier workshops
WORKSHOP
The case study is based on a third party audit contract agree between Beta
Training and Bureau Veritas Certification for conducting Stag 2 audit of the QMS
and has to ensure under contract requirements and of ISO 9001.
Based on Workshop-Stage 2 Audit Planning and Workshop-Audit Plan Matrix the team
shall use the time planned for the audit. TRAINER shall allot one process to each team
to prepare the checklist for subsequent workshop on auditing role play.
The audit checklist could be based on a process matrix indicating what elements of the
standards will be looked at in various departments and/or on process activities indicating
the schedule of the audit.
Then prepare the checklist for the process allotted to your team by the trainer in any
appropriate format, having at least the following headings:
 Process Activities
 Reference documents
 ISO 9001 clauses
 Items to check
 Space for notes
 Time allocation
Checklist
Company: Process: Page Nº:
ISO 9001 Cl.

Process / Ref To Check Notes Time
Activities Documents
Auditor: Date: Signat

ure:
Oct’18 CQI-IRCA Certified PR 328:QMS ISO 9001:2015 Lead Auditor Training Course (17929) P age 43 of 51
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Exercises and Workshops Bureau Veritas Certification
WORKSHOP No. 12 – CONDUCTING OPENING MEETING
Purpose of this workshop:
To prepare the delegates to understand and practice:
 How to conduct a successful opening meeting as part of a third party audit of an

auditee organisation in accordance with the requirements of ISO 19011 and
ISO 17021.
Duration:
Refer to the time table for overall time duration and follow instructions by the Trainers
for break up
Workshop Material:
Documented information of Beta Training

Plain Paper & pen/ Pencils
Stage 2 audit preparation documents (Audit Plan, Matrix & Checklist)
Workshop
The case study is based on a third party audit initiated by an external

organisation which Bureau Veritas Certification has to conduct under
contractual requirements to verify their conformance to the requirements of ISO
9001:2015.
Each team has to prepare to conduct an opening meeting with the management of the
auditee organisation in line with the recommended agenda given in ISO 19011 & Pre
course reading material
As directed by the trainer an Opening Meeting of Stage 2 audit shall be conducted
Oct’18 PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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Workshop 13: Auditing Top Management

The objectives of this workshop are:
1. How to approach the audit of the Top Management in the context of understanding
their commitment for the QMS and their overall responsibility and accountability for the
QMS
2. To gain an insight into how to frame right questions and seek appropriate evidences
from Top Management to verify conformance to the requirements
3. To understand the auditors’ attitude and skills required to be practiced while auditing
Top Management of any organization
This workshop is to be conducted in 2 parts.
Part 1 - is on preparing to audit and

Part 2 -is the role play of ‘auditing the Top Management’
Part 1 of the workshop - Preparation for auditing Top Management
Materials: Documentation of the Organisation provided by the trainers

Flipcharts and marker pens / acetates and pens/ plain paper
Time Allocation:
for break up
Workshop
Delegates in team are required to familiarize themselves with the documentation of the
organization, understand who the Top Management in the company are and their specific
roles and responsibilities within their organization and prepare for auditing Top Management.
At the end of group work they must come out of a set of logical and sequential questions,
relevant documents to be seen and records to be obtained while auditing Top Management of
the organisation.
Teams are expected to document the output of planning in either flip charts/ acetate sheets /
plan papers
Part 2 of the workshop- Auditing the Top Management
Each team is assigned to audit the Top Management of this organisation.
Each group will then act as an audit team and audit the Top Management. Here trainer(s) will
facilitate as Top Management of the Organisation.
Time Allocation:
for break up
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WORKSHOP No. 14 – ROLE PLAY – INTERVIEWS-Process Audits
The objectives of this workshop are to be prepare the delegates to:
 How to use a workable and developed audit checklist to perform third party ‘process
audit’ in the auditee organisation.
 To learn audit techniques, seeking appropriate audit evidences and evaluating
objectively to determine conformance or otherwise to the requirements
 Develop the art of time management and prioritization during audit
 Develop ability to decision making in difficult / unexpected situations and act
appropriately.
Duration:
for break up
Workshop
Part 1 preparation for the Process Audit (role play)
The case study is based on the third party audit initiated by an external
organisation which Bureau Veritas Certification has to ensure under contract
requirements and of ISO 9001:2015.
Based on results of Workshops on Stage 1 audit, Stage 2 audit planning, Process

Matrix and the learning achieved by the delegates and with the help of prepared
checklists in Workshop 7, the team will conduct interviews with the members of the
external organisation in order to verify conformity to all the relevant requirements.
Part 2 Role Play – Process audits (role play)
The trainers will provide the necessary arrangements to facilitate actual conduct of
audits of processes. There would be auditees representing the organisation and they
would provide all answers for the auditors’ queries and also relevant documents and
records.
Trainers will invite each team separately the teams have to visit the meeting venue
and conduct a formal audit. Trainers will observe the audit process and evaluate the
team and each team members on various parameters.
Time for individual group’s role play: will be decided by the trainers on the interview
spots depending on the number of teams available
Feedback and discussion
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WORKSHOP No. 15 – Observing an acceptable–through Role Play by trainers.
The Purpose of the Workshop
The purpose of the workshop is to:
 Enable delegates analyse good and bad practices in interviewing;

 Provide visual display to the delegates of the good practices followed in an actual
audit.
 Relate their own auditing experience with the auditing practice demonstrated in the
video.
Material
Not Applicable.
Duration:
for break up
Workshop:
Delegates are required to keenly observe the Role Play enacted by the Trainer(s) and
make notes about the whole audit process.
The delegates should bring out the following points during Video presentation
- Introduction of the auditor

- Beginning with ‘warm-up’ sentences, and generic subjects
- Conversing with the auditee and not ‘bombarding’ him with questions
- Asking open questions
- Providing positive feedback to the auditee when deserved
- Asking only relevant questions
- Clarifying questions when the auditee is in doubt
- Showing real interest in the subject while conducting the interview
- Good observation skills
- Taking notes
- Informing the auditee when non-conformities are found
- Closing the audit with summarization
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WORKSHOP No. 16 – PREPARATION FOR CLOSING MEETING
 Write nonconformity reports/corrective action requests during /after the audit in

an ORGANIZATION.
 To practice writing an accurate summary of the audit, including positive audit
findings and opportunities for improvement.
 To enable delegates to understand the essential elements of a good audit
report and understand how the auditee organization would evaluate their audit
report and Non Conformity Reports
Hand-outs and material
CAR forms as needed (Workshop hand-out CAR forms)

Blank paper for preparing the audit summary report
Duration:
for break up
Workshop
Based on the findings of Role Play on auditing processes each team has to prepare to
conduct a closing meeting with the management of the auditee organisation in line
with the recommended agenda described in the pre course study material (PowerPoint
Chapter on - Audit Management) and ISO 19011 standard
Each team shall prepare and present any nonconformities that they have identified
during the role play interviews of process audits, using the forms provided (CAR
forms).
The teams shall at the end prepare a formal Audit Summary Report in line with the
recommendations described in Pre course study material (PowerPoint slides on –
Reporting) to hand over to the Top Management (maximum one page).

Company: Date: CAR No:
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Auditor: Auditee:
Nonconformity:
Objective Evidence:
Requirement of the ISO 9001 standard (including Clause number):
Signed: Date:
Correction:
Root Cause
Proposed Corrective Action:
SIGNED DATE:
Verification of Corrective Actions :
Signed Date:
Review of effectiveness of Corrective Action:
Signed: Date:
WORKSHOP No. 17 – Role Play- CLOSING MEETING
The objectives of this workshop are to be prepare the delegates to know:
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 How to conduct a successful closing meeting during a third party audit of an

auditee organisation in accordance with the requirements of ISO 19011 &
17021
Hand-outs and material
Delegates CAR’s and Audit Summary Report prepared in Workshop 16.
Duration:
for break up
Workshop
The case study is based on a third party audit initiated by an external

organisation which Bureau Veritas Certification has to ensure under contract
requirements to verify conformance to ISO 9001:2015.
Based on the prepared audit findings and summary report of earlier workshop, the
team will conduct closing meeting with the members of the auditee organisation in
order to clarify that third party audit is completed and the audit conclusions are
communicated to the organization in a summarized manner

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Exercise and Workshops Bureau Veritas Certification

EXERCISE No. 0: DELEGATE INTRODUCTION- MINI INTERVIEW

The purpose of the exercise is:

Nature of the Activity

Delegates in team of 2 work on this exercise.

Material and Equipment

- Check list format

Delegates Tasks and Deliverables

Delegate Introduction Checklist Template

Knowledge of ISO 9001:2015

Auditing experience: Type: 1st party 2nd party 3rd party

Other information about

EXERCISE No.1: Preparation prior to Audit - Case Study Review

The purpose of the exercise is:

1. To achieve an understanding and familiarity about the organization to be audited

Nature of the Activity

Material and Equipment

- All documentation of Beta Training.

Delegates Tasks and Deliverables

Read individually/or in team the documented information provided by Beta Training

EXERCISE No. 2: Auditing Terminology

The purpose of the exercise is:

Nature of the Activity

Team work on analysis of concepts and terminology related to auditing.

Material and Equipment

Delegates Tasks and Deliverables

Delegates as a team receive packs of cards that include:

- Using blue (white) tack and board

FACT = truth; something that has actually happened.

Statement Fact Inference

1. Jones was supposed to meet with Smith.

2. Jones was scheduled for a 10 o’clock meeting.

3. The accident occurred at the XYZ Company.

4. Jones was taken to the hospital for X-rays.

5. No one at the hospital which Mr Smith called knew

6. Smith had called the wrong hospital.

Individual exercise by delegates

To enable delegates to understand the challenges in evaluating the corrections and

Exercise 04- Delegate hand-out

- Are they acceptable?

- If they are not acceptable, justify why

CORRECTIVE ACTION REQUEST

The process of documentation control is not effective

a) Distribution, access, retrieval and use

Corrective Action – Approval records will be created and added on file.

Proposed Completion Date:

Corrective Action Review:

CORRECTIVE ACTION REQUEST

The process of planning for the necessary documentation is not effective

Proposed Completion Date:

Corrective Action Review:

CORRECTIVE ACTION REQUEST

The process of evaluation and selection of suppliers is not implemented fully

Recommended by – Quality Manager

Proposed Completion Date:

Corrective Action Review:

CORRECTIVE ACTION REQUEST

The process of managing customer property is not effectively implemented

Recommended by – Quality Manager

Proposed Completion Date:

Corrective Action Review:

CORRECTIVE ACTION REQUEST