QMS - Delegate Acitivity Manual

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PR328 ISO 9001:2015; Lead Auditor
(Quality Management Systems)
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IRCLASS/TRG/QMS/LAC/TSP/Rev 9, dtd: 01-NOV-2022 © IRCLASS Systems and Solutions Private Limited 2019 Page 1 of 40
CQI and IRCA Certified
PR328 ISO 9001:2015; Lead Auditor
(Quality Management Systems)
Training Course
Delegate Activity Manual
This material is for the personal use of a delegate attending a course presented by IRCLASS.
No part of the materials may be reproduced, stored electronically, or transmitted in any form or by any
means without the prior written consent of IRCLASS.
Course Schedule
Day 1
Time Sessions
0830~ Registration
Welcome Note & Course Introduction
Course Aim & Objectives and structure
KNOWLEDGE SESSIONS
Term & definitions as per ISO19011
Types of Audits (1’st Party, 2’nd Party and 3’rd Party Audits)
Auditing Process (Input, Process and Output)
Objectives, Scope and Criteria for (1’st Party, 2’nd Party and 3’rd Party Audits)
Auditing Resources
Roles & Responsibilities & Confidentiality of auditing resources
Audit Methods (1’st Party, 2’nd Party and 3’rd Party Audits)
Stage-1 Audit
Stage-2 Audit
Audit Plan Requirements
Work Documents for Auditing
Opening Meeting
Collecting and verifying Audit Evidences
Allocation Homework on specimen questions for online exams Closure for day-1
1745~1755
Day 2
Time Sessions
0830 Overview of Day-1
KNOWLEDGE SESSIONS
Effective communication during the audit
Audit Findings
Audit Meetings
Closing meeting
Audit Reports
Audit Follow-up
Benefits of QMS
Terms & Definitions as per ISO 9001:2015
P-D-C-A
ISO 9001:2015, structure of clauses
Role of the Auditors
Documented Information (To be maintained and to be retained)
SKILLS SESSIONS
Initiating the QMS Audit
Document Review
Audit Plan
Review of Specimen questions, Closure for day-2
Allocation Home work on specimen questions, if any
1745~1800
Day 3
Time Sessions
SKILLS SESSIONS
Work documents, checklist, Sampling
Opening Meeting
Plant Tour
Auditing Top Management
Auditing Context; Auditing Risk & Opportunities; Auditing ‘Objectives,
Competence and Awareness’; Auditing ‘Operation and performance evaluation’;
Auditing ‘Improvement’….
Review of Specimen questions,
Allocation Homework on specimen questions if any
1745~1800 Closure of Day-3
Day 4
Time Sessions
0830 Overview of Day- 3
SKILLS SESSIONS
Auditing Context; Auditing Risk & Opportunities; Auditing ‘Objectives,
Competence and Awareness’; Auditing ‘Operation and performance evaluation’;
Auditing ‘Improvement’….
Lunch
Identifying Nonconformities
Review of Specimen questions,
Allocation Homework on specimen questions if any
Closure of Day-4
1745~1800
Day 5
Time Sessions
Identification of Non-conformity
Closing meeting
1735 Audit Report preparation
Explanation on Examination Process
Vote of thanks and Closure.
Activity 1: Terms & Definitions related to audit
Purpose: To understand the terms of audit as given in ISO 19011.

Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback;
Individual Exercise, reference Slide # 32
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10: excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment Sheet.
Directions:
Audit related terms are given below and the definitions as per ISO 19011 are provided. You have to read
the definition and place the term which it defines against it.
Terms Answer Definition
Outcome of an audit, provided by the au-
1 Audit Criteria F A dit team after consideration of the audit
objectives and all audit findings
I
2 Competence B Organization being audited
L
3 Audit Program C Extent and boundaries of an audit
C Person who provides specific knowledge or ex-

4 Audit Scope D pertise to the audit team
A
5 Audit Conclusion E Non-fulfilment of a requirement
G
6 Auditor F Set of policies, procedures, or requirements
K
7 Audit Client G Person with the competence to conduct an audit
H Systematic, independent and documented pro-

cess for obtaining audit evidence and
8 Audit H evaluating it objectively to determine the
extent to which the audit criteria are fulfilled
N Demonstrated personal attributes and demon-
9 Audit Evidence I strated ability to apply knowledge and skills
M Results of the evaluation of the collected audit
10 Audit Team J evidence against audit criteria
J
11 Audit Findings K Organization or person requesting an audit
B Set of one or more audits planned for a specific

12 Auditee L time frame and directed towards a specific pur-
pose
E One or more auditors conducting an audit, sup-
13 Non-conformance M
ported if needed by technical
O Records, statement of fact or other infor-
14 Audit Plan N mation, which are relevant to the audit cri-
teria and verifiable
D Description of the activities and arrangements
15 Technical Expert O
for an audit
Activity-2
Difference between 1’st party, 2’nd party and 3’rd audits;
Purpose:
Understand various types of audits and differentiate between them into 1’st, 2’nd and 3’rd party
Audits.
Duration:
5 Minutes Introduction+ 15 minutes+10 minutes feedback; Individual Exercise
Slide # 33 to 39
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6:
acceptable, 7-8: good, 9-10: excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to
Continuous assessment Sheet.
Direction: Based on your understanding of audit identify key differences in 1’st, 2’nd and 3’rd party
audit. You can write your answer on the flipchart/notepad.
First Party Audit is performed within the same Organization on its own QMS
2’nd Party Audit is where a customer/client audits their contractor Organizations and another case of
Contractor Organization auditing their Subcontractors, Suppliers, and Vendors
3rd Party Audits are those audits where an independent third party neither related to the Customer or the
Supplier audits any of these organizations (eg. Certification body in case of management system certification)
Activity-3 To understand the audit activities
Purpose: Understand sequence of activities related to audits.
Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback.
Individual Exercise.
Slide # 40 to 43
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10:
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous
excellent.
assessment Sheet.
Direction: Fastest Finger first……….Refer the activities mentioned below with respect to typical audit,
please try and arrange these activities in chronological order.
Task-B …..Subgroup above activities into following categories
Initiating the audit; preparing the audit activities; conducting the audit activities; conducting & distrusting
the audit report
CHRONOLOGICAL Subgroup
AUDIT ACTIVITIES
ORDER (As per task-B)
Distributing the audit report Establishing the initial Initiating the audit
contact with the auditee
Assigning the work to the audit Determining the feasibility of the Initiating the audit
team audit
Conducting the opening meeting Preparing the audit plan preparing the audit activities
Establishing the initial contact Assigning the work to the audit preparing the audit activities
with the audi-tee team
Collection and verification of Prepare work document preparing the audit activities
information
Prepare work document Role responsibility of guides and conducting the audit activities
observers
Conducting the audit follow up Conducting the opening meeting conducting the audit activities
Conducting the closing meeting Communication during the audit conducting the audit activities
Preparing the audit plan Document review conducting the audit activities
Audit findings Collection and verification of conducting the audit activities

information
Role’s responsibility of guides Audit findings conducting the audit activities
and observers
Determining the feasibility of the Audit conclusions conducting the audit activities
audit
Audit conclusions Conducting the closing meeting conducting the audit activities
Communication during the audit Preparing the audit report Preparing & distributing the
audit report
Document review Distributing the audit report Preparing & distributing the
audit report
Preparing the audit report Conducting the audit follow up Preparing & distributing the
audit report
Activity-4:
Difference in Methodology of 1’st Party, 2’nd Party & 3’rd party audits
Purpose:
Understand key difference amongst three types of the audit w.r.t. Duration, Methods and object-
tives.
Duration:
5 Minutes Introduction+ 15 minutes+10 minutes feedback
Individual Exercise
Slide # 44
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10: excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment
Sheet.
Direction:
As per activity #2 you already know the difference between first party; second party and third-party
audits; now further classify them w.r.t. approach, duration, methodology, and audit objectives.
Audit Type Duration Methods Objectives

Internal Auditor as per 3 days Verify the policies and To very compliance
ISO9001:2015 procedures without a
checklist, only findings
summarised
Audit of Legal Compliance 2 days Verify compliance w.r.t. Compliance to Legal
applicable legal
requirements
Audit of Supplier by 1 day checklist used by Auditor Compliance with Contractor
Contractor requirements, Procedures,
Process related to the
product
3rd Party Audit of an 3 days Format Audit Plan Conformity to ISO
organization 9001:2015
End Duration Training

Session # Day Start Time
Time method
After Activity # 1 00:15:00
1130 1145 Tea Break
4
Activity-5
Determine Audit Objectives, Scope and Criteria
Purpose:
To Outline the Audit Objectives, Scope and Criteria for 1’st 2’nd and 3’rd party audits.
Duration:
5 Minutes Introduction+ 15 minutes+10 minutes feedback.
Individual Exercise
Slide # 45 to 48
excellent.
assessment Sheet
Task-A: Refer the Activities 2 & 4. You have already understood the 1’st; 2’nd and 3’rd party audits.
Now identify the AUDIT OBJECTIVES, SCOPE AND CRITERIA laid down for each type of the audit.
Audit Type AUDIT OBJECTIVES SCOPE CRITERIA

1st Party Audit / Internal audit To verify compliance Scope covering all Policies, QC Procedures,
as per ISO 9001 fabrication yards/ Painting Specifications, Engineering
shops, Storage yards, Standards, WPS, NDT procedures
including remote and reports
temporary construction
facilities TCF -5
Audit of Legal Tracking Compliance to legal body Boundary of an Applicable Legal Requirements eg.
Organization Factory act
2nd Party Audit Compliance to Customer Boundary of an QC Procedures, Customer

Requirements, Process and Organization and Supplier Specifications and Engineering
Standards Customer INterface Standards, for Design,
Construction, Inspection and
Testing
Offsite Audit an Compliance to Documentation Scope covering all / few Applicable ISO9001:2015
Organization’s Supplier / as per ISO 9001 products of an requirements Customer
Vendor Documentation organization Boundary of Specifications and Engineering
an organization Standards, for Design,
Construction, Inspection and
Testing
3rd party Audit ISO 9001:2015 Boundary of an ISO 9001: 2015 Requirements
Organization
Activity-6: Responsibility and authority of the personnel associated with audit activities
Purpose: Determine the Responsibility and Authority of Team Leaders, Auditors, Guides, Observ-
ers, Technical Expert and Auditee & Client.
Duration: 10 minutes Introduction +20 minutes+15 minutes feedback.
Group Exercise
Slide # 49 to 51
tutor will distribute the 35 statements given below; among the groups.
excellent.
assessment Sheet
Task : Read the statement given below and place them under appropriate box/es; so as to acquire
the knowledge about the responsibility & authority of audit personnel. Reference 19011:2018
1. Team Leaders …deny observers from taking part in certain audit activities.
2. Guides ….assist the audit team
3. Guides ….assisting the auditors in identifying individuals to participate in interviews and
confirming tim-
ings;
4… Guides.ensuring that rules concerning location safety and security procedures are known and
respected by the audit team members and observers.
.…. 5. Organisation Representative witnessing the audit on behalf of the auditee
6. providing clarification or assisting in collecting information.
7.........Team Leader Establishing initial contact with the auditee
8. Team Leader assign to each team member responsible for auditing specific processes, activities,
functions or locations.
9. … Auditors …….collect and review the information relevant to their audit assignments and
prepare work
documents,
10.Team Leader communicate the progress of the audit and any concerns to the auditee and audit
client,
11.Any concern about an issue outside the audit scope should be noted and reported to Team
Leader
12.Conducting the closing meeting TEAM LEADER
13.Auditee should agree on the time frame for an action plan to address audit findings.
14.should advise the auditee of situations encountered during the audit that may decrease
the confidence that can be placed in the audit conclusion TEAM LEADER
15.report the audit results in accordance with the audit programme procedures TEAM LEADER
16. Auditee give permission and access to those parts of the audit site, to be visited in
accordance with the audit scope;
17.avoid any unnecessary disturbance of the operational processes AUDITOR
18.reach agreement on whether the audit should be interrupted, rescheduled or contin-
ued; TEAM LEADER
19. …AUDITOR…..if taking photographs or video material, ask for authorization from
management in advance and consider security and confidentiality matters and avoid taking
photographs of individual persons without their permission;
20. Selecting the audit team members TEAM LEADER
21. operate under the direction of an auditor, but should not act as auditors. OBSERVOR
22. PROGRAM MANAGER…..if a conflict of interest or competence issue arises, it should be
discussed with…..
23. ……should develop, maintain and improve their competence through continual profes-
sional development and regular participation in audits AUDITOR
24. should exhibit professional behaviour during the performance of audit activities, AUDITOR
25. plan and organize the work effectively; TEAM LEADER
26. ….prioritize and focus on matters of significance understand and consider the experts’
Opinions AUDITOR
27. …confirm the sufficiency and appropriateness of audit evidence to support audit findings
and conclusions TEAM LEADER
28. …use work documents to record audit activities AUDITOR
29. maintain the confidentiality and security of information, data, documents and records
30. preventing and resolving conflicts, as necessary; TEAM LEADER
31. Those documents involving confidential or proprietary information should be suitably
safeguarded at all times by the…AUDITEE…….
32. …..sought confirmation to the agreement of all parties to the audit plan;
33. acknowledge the audit report… TEAM LEADER
34. …..accept the nonconformities as closed….AUDITOR
35. ….provide specific knowledge or expertise related to the organization, the process or ac-
tivity to be audited,or language or culture.AUDITEE
Program Manager Guides/Inter-

Auditee/
Team Auditors from Certification preter/Tech- Observers
Organization Client
Leaders Body nical Expert
Representative
Activity-7 Purpose: To understand different audit methods,
Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback.
Slide # 52
excellent.
assessment Sheet
TASK: Onsite & Remote are the different methods of the audits, further it can be classified into Human Inter-
action and Non-human Interaction. List down +ve and -ve points of these different methods of an audit.
Refer ISO19011; Annex A.1 Applying audit methods; page # 35
Audit
Method On- Remote
site
1stParty, 2nd Part, 3rd Party Skype
Conducting Interviews, Completing Via interactive communications means:
checklists and questionnaires with auditee - Conducting interviews
Interaction
participation - Completing checklists and questionnaires

Conducting document review with auditee - Conducting document review with auditee
Human
participation participation
Sampling
Conducting document review (eg. Records, Conducting document review (eg. Records, data analysis)
data analysis)
Non-human Interaction
Observation of work performed Observing work performed via surveillance means,

Conducting onsite visits considering social and legal requirements
Completing checklists Analyzing data
Sampling
+ve points of Site Human Interactions
1. Actual situation and documents can

be verified at the place of Audit
2. Can take decision on spot about +ve points of OnSite with remote Human Interactions
compliance and non-compliance
3. More information can be obtained 1. Saves time
related to the requirement 2. Saves efforts
4. Can verify 100% basis as per 3. Saves resources
objective and scope of the audit 4. Minimum or No Hazards as not being Physically
present at Site
-ve points of Site Human Interactions -ve points of OnSite with remote Human Interactions
1. Samplings can carry risks 1. Actual Situation unknown

2. Logistics costs 2. Effective communication is limited unless you
3. Safety of the Audit Team, due to have an expert in this technique
exposure to Hazards 3. Limited scope
4. Verification of documents may take 4. Actual situation may be different
longer time 5. Additional information may be missing
Start End Duration

Session # Day Training method
Time Time
1300 1345 Lunch Break
6
Activity-8
Purpose:
To understand the audit plan requirements,
Duration:
5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback
Group Exercise
Slide # 57 to 59
excellent.
Sheet
TASK: Refer ISO19011 clause # 6.3.2; and prepare the structure for Audit Plan based on these requirements.
Also identify the risk in achieving the Audit Objectives (With respect to Objective, Scope, Criteria, locations etc.)
refer clause 6.3.2.2 Audit planning details ISO19011
Risks in Achieving the Audit Objectives:

Audit is a process with the following process map
RISKS
Scope, Criteria, location, number of AUDIT PROCESS Conformity to QMS
sites, Dates, time, availability of Conducting Audits, coverage of ISO 9001: 2015
auditee, Cultural differences, audit requirements of ISO 9001: 2015,
sampling, Audit method, roles and grading of NC’s
responsibilities of team members,
the language barrier.
End Duration Trainin

Session # Da Start
Time g
y Time
metho
d
After Activity 1 00:15:00
1545 1600 Tea Break
#
8
Activity-9:
Purpose: Opening Meeting
Duration:5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback

Group Exercise
Slide # 60, 61 & 80
excellent.
assessment Sheet
TASK: Refer ISO19011 clause 6.4.3 - Conducting the opening meeting, and prepare your points for the coverage of
opening meeting presentation.
Activity-10:
Purpose: Capturing & verifying Audit Evidences
Duration:
5 minutes Introduction + 30 Minutes Presentation + 10 minutes feedback
Group Exercise
Slide # 62 & 67
excellent.
assessment Sheet
TASK: Refer ISO19011 clause 6.4.7 – methods of collecting information are INTERVIEW, OBSERVATION and REVIEW
OF DOCUMENTS & RECORDS… capture how to convert various methods of collecting the information into Audit Evi-
dence………
Methods of collecting information How to convert it into Audit evidence

Understanding of product special characteristics
Knowledge of process
Training Effectiveness
Customer complaints and actions taken
INTERVIEW
Knowledge of legal requirements
Verifying procedures w.r.t actual work carried out at site

The sequence of activities followed and not followed by the construction
team
Competence of persons using the Measuring instruments
OBSERVATION
Actual checking of Service/part meeting the relevant specification
Observe whether continual improvement is implemented or not.
Whether Fabrication techniques are followed according to the specific
QC procedures and requirements
Check compliance w.r.t specifications

REVIEW OF DOCUMENTS and Check customer complaints
RECORDS Check NCR’s, corrective and preventive actions and close out
Check Audit Schedules, reports and outcome
Check project design and development, procurement, material storage
and issuance record
SOLVE SECTION-1 OF SPECIMEN EXAMINATION PAPER AS A HOME-WORK and DISCUSS THE HOME
WORK AT THE END DAY-2, likewise solve Section-2 as a home work on day-2 and discuss it at the endof day-3……
last section i.e. section-4 shall be discussed on day-4.
Session # Day Start Time End Time Duration Training method
After session 13 1 1745 ----- End of day-1
END OF DAY-1
Activity-11:
Purpose: Questioning Technique
Duration: 05 minutes Introduction +15 Minutes+10 minutes Feedback
Group Exercise.
Slide # 68 to 71
excellent.
assessment Sheet
TASK: From the learning of various questioning technique now read following paragraph and identify the
questioning types.
Question: Do you measure customer satisfaction?

Answer; Yes! We did CLOSED
Question: Are your customer satisfied? Yes!
They are? CLOSED
Question: How satisfied or dissatisfied are customers? CLOSED
Answer: We send questionnaire to our customer every quarter, then we seek feedback from them. Once
feedback is received we analysis overall satisfaction and individual dissatisfaction level, if any.
Question: How many customers are satisfied? CLOSED
Answer: Out of 21 customers 3 had shown strong dissatisfaction, 18 are rated us “excellent”
Question: What Actions are the opportunities to improve the dissatisfied customers? CLOSED
Answer: We have very less presence in that segment of Refrigerated Vans. We are hiring a person you has
got expertise in this area in all functions. This was explained to customers and they gave time frame of 3
months. Person already on board.
Question: Have you done risk analysis on newly added project “refrigerated Vans”? CLOSED
Answers: Yes!
Question: what is risk of high priority”? OPEN
Answer: it was “competence” which I already explained.
Q; How many customer complaints lodged since last year?
OPEN A; 3!
Q: How many them are repetitive? How many of them are related to single customer? How many are them
related to competence and how many of them are attributable to supplier? OPEN
A: There was competence related area for which we hired a expert and that person has already on the board.
Q: What are analysis of these complaints? Do you use any specific problem-solving technique to arrive at the
root cause after analysis? OPEN
A: We use FISH-BONE diagram for root cause analysis.
Q. what is highest level concern from analysis? OPEN
A. it was competence and agility.
Q. What actions are initiated to tackle this issue? OPEN
A. Trainer hired and he is on the task to align all training with respect to customers.
Activity-12:
Purpose:
Follow up audit scenario
Duration:
05 minutes Introduction +30 Minutes+10 minutes Feedback
Group Exercise
Slide # 84
excellent.
assessment Sheet
TASK: Recollect the leaning from today’s session
1. Who decides the follow up audit?

TEAM LEADER
2. What could be the Objective, Scope, and duration of follow up audit?

Check Major NC Objective
3. Who will conduct this follow up audit?

TEAM LEADER
4. Does it require audit plan? YES REQUIRED

5. Opening meeting required? YES REQUIRED
6. What will be the possible outcome from the follow-up audit?
Closure of NC
Activity 13: Quality Management System Terms & Definitions
Purpose: Familiarization with terms and definition related to QMS ISO 9001:2015
Duration:10 Minutes+ 5 minutes Feedback

Slide # 86
excellent.
Sheet
Directions: Individually, review he terms and definitions and determine which definition belongs to which
term, Enter the correct letter of the definition next to the appropriate term in the table on the following page.
Definition of terms used in QMS ISO 9001:2015 has been provided.
Terms Definition
E Set of interrelated or interacting elements of an organi-
1 Competence A zation to establish policies and objectives and processes
Continual Im- L Person or group of people that has its own functions
2 B with responsibilities, authorities and relationships to
provement
Corrective Ac- F Person or group of people who directs and controls an
3 C
tion organization at the highest level
Documented In- K
4 D Results to be achieved
formation
O Ability to apply knowledge and skills to achieve intended
5 Process E results
P
Action to eliminate the cause of a nonconformity and to
6 Interested Party F
prevent recurrence
A
Management
7 G Effect of uncertainty
System
N Make an arrangement where an external organization
8 Measurement H
performs part of an organization’s function or process
M
9 Monitoring I Measurable result
D Need or expectation that is stated, generally implied or
10 Objective J obligatory
B Information required to be controlled and maintained
11 Organization K by an organization and the medium on which it is con-
tained
H
12 Outsource L Recurring activity to enhance performance
I Determining the status of a system, a process or an ac-
13 Performance M
tivity
14 Requirement J N Process to determine a value
G
Set of interrelated or interacting activities which trans-
15 Risk O
forms inputs into outputs
C
Top Manage- Person or organization that can affect, be affected by, or
16 P
ment perceive itself to be affected by a decision or activity
End Duration
Session # Day Start Time Training method
Time
After Activity # 13 2 1115 1130 00:15:00 Tea Break
Activity 14: Understanding EDIM (Establishment, Documentation, Implementation &
maintenance of QMS
Purpose:
Establishment of QMS ISO 9001:2015
Duration:
05 minutes Introduction +15 Minutes+10 minutes Feedback
Slide # 88
excellent.
Sheet
Directions:
Fastest finger first….. Please arrange following statement in correct chronological order.
QMS objectives
Planning
c
Performance Evaluation
Interested parties
Management review
Risk assessment
Monitoring & measurement
Corrective action
Resource provision
Operations
Internal audit
Continual improvement
Internal issues
Strategic direction
External issues
Interested parties
Internal issues
Strategic direction
Planning
Risk assessment
QMS objectives
Resource provision
Operations
Monitoring & measurement
Performance Evaluation
Internal audit
Management review
Corrective action
Continual improvement––
Activity 15: Understanding audit trail
Purpose: How to generate audit trail while auditing ISO9001 2015 requirements

Individual Exercise
Slide # 88
excellent. Each delegate shall be graded as per above criteria. These marks to be linked to Continuous
assessment Sheet
Directions:
You are auditing a transport service providing organization, M/s METAPHORA. You are auditing mar-
keting function. When you asked about the customer complaints; marketing manager, replied that
there are 6 customer complaints reported in the current year. He further explains that 3 customer
complaints are repetitive in nature and related to truck drivers. Customers of M/s Metafora were bit
annoyed because of delay in delivery of goods caused by the M/s Metafora’s truck drivers. Further
marketing manager states that drivers not providing correct information about the exact location of
their trucks, which causes difficulty in planning the production process, secondly; material was either
reaching late, or in damaged condition.
As an auditor how will you trace this matter further…. what all things will you verify within marketing
and all other departments of M/s Metafora to evaluate the effective implementation of QMS? List
down these items and correlate items with ISO9001:2015 clauses.
End Duration
Time
1300 1345 Lunch Break
15
Activity 16: Understanding QMS documented information
Purpose: What are the documents and records required by ISO9001 2015
Documents Required
1) QMS Scope
2) Quality Policy
3) Objectives
4) Procedures
5) Organization Chart
6) Supplier List
Document Retained
1) Evidence of Resources
2) Records of Products and Services
3) Results of Quality Evaluation Reports
4) Results of Corrective Action

Slide # 89
Marks for Continuous ev aluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10:
assessment Sheet
Directions: Start from clause number 4 to clause number 10 of ISO 9001:2015 require-
ments, search for the phrases “documented information to be maintained – with the
phrase, “shall be available as documented information ”” and “documented
information to be retained – with the phrase, “shall be retained as documented
information””. And list down these documents, records and corresponding clause numbers.
Activity 17: Initiating the audit.
Purpose: To acquire skill for initiating the audit.

Individual Exercise
Slide # 91
assessment Sheet
Directions:
You are working for a certification body as programme manager ….and received a request to
plan
surveillance audit…..for the automotive client who has two manufacturing units one at Mumbai
and other at Chennai, head office is in Bangalore, this Bangalore office gives support both the
manufacturing sites for activities like Sales & marketing, Design Of Products, Strategic Planning,
Central purchase and Human Resource,
Previous audit was certification audit and both manufacturing sites had received 4 NCs each and
Bangalore support function 2 NCs,
What information you will seek from the and Organization Representative (Auditee Management)
and Certification Body’ Audit planning Team.
CB’s Audit planning team Auditee Mgmt./
Orgnization
Representative
Activity 18: Document Review
Purpose: Conduct document review for METAFORA (a case study)

Group Exercise
Slide # 92
assessment Sheet
Directions: Perform a general review of the QMS Manual of the Case study – “METAFORA”
against the requirementsof the standard, focusing first and foremost on the scope of your audit.
Formu- late in writing: any non-conformances and check points during the audit.
Each team is briefly to present its findings to the whole group. Following the class discussion, each
team is required to hand-in their report for evaluation by the tutor.
Star End Duration Trainin

Session # Day
t Time g
Time metho
d
After Activity # 18 2 160 1615 00:15:00 Tea Break
0
Activity 19: AUDIT PLAN
Purpose: To test the skill for preparing the ON-SITE audit plan based on the
Criteria, Scope and objectives of an audit.

Group Exercise
Slide # 93
assessment Sheet
Directions:
Your team is required to produce an audit plan for the initial certification audit of the “METAFORA” for the
whole scope (not just the department allocated to them). (refer Activity 8 for template)
- Consider this as stage-2 initial certification audit of “METAFORA”.
- The audit is scheduled to take place on one week from today
- The duration of the audit is 4 mandays
- The audit team is to comprise a Lead Auditor and one team member
Your team is required to produce a draft audit time plan in table form describing per day; time period,
topic – controls to be verified, auditor.
Following the class discussion, each team is required to hand-in their audit-plan for evaluation by the tutor.
Refer Clause # 6.3.2.1 ISO19011:2018

After session 27 2 ---- 1745 ----- End of day-2
End of Day 2
HOME WORK: Specimen Exam paper Section 2.0 only…… this home work will be discussed in the
class at the end of day-3
Activity 20: Work Document
Purpose: TO test the skill for preparing the audit checklist for TOP MANAGEMENT
Duration: 05 minutes Introduction +40 Minutes+15 minutes Feedback.

Group Exercise
Slide # 94 to 97
assessment Sheet
Directions: This will be group activity.

Prepare a checklist to audit top management of METAFORA (A sample case study)
Please consider clause 5 & Clause 9.2.2 and 9.3 for preparing the checklist.
Activity 21: Opening Meeting

Group Exercise
Slide # 98
excellent.
assessment Sheet.
Purpose: To practice and test the skills to conduct an opening meeting for QM audit.
Directions: This is group activity
This is group activity.

Plan and carry out the opening meeting, in accordance with your audit plan
Please refer ISO19011 section 6.4.3 for the agenda and coverage of opening meeting. Be ready
for the presenting opening meeting.
While one group is conducting the meeting, other groups will have to take notes and ready for
your comment during class discussion.
Session # Day Start Time End Time Duratio Training method

n
After Activity 21 3 1045 1100 00:15:0 Tea Break
0
Activity 22: How to conduct effective plant tour
Purpose: TO test the skill required for a site tour, and collect evidences while conducting the round.

Group Exercise
Slide # 99
excellent.
Sheet
Directions: Please look at the photos in your reference material. Assume you are as
part of audit team and making these observations. Please record your observations you would
like to verify in the subsequent audit.
OR
In a group have discussion on the following points and then ready with your presentation…
1. Who all should participate in the Plant Tour?
2. Who should accompany the audit team while taking plant tour from client orgnization, what
is his/her role?
3. Any precautions with respect to Safety, Security and emergency norms?
4. How much time shall be spent on plant tour?
5. What to focus during plant tour?
6. How to take best help from Industry Expert/Technical Expert?
7. After plant tour is it necessary to have meeting amongst the audit team members?
8. How to reflect the plant tour into subsequent audits?
Activity 22: how to conduct effective plant tour…©IRCLASS SYSTEMS & SOLUTIONS PVT. LTD. IRCA AP-
PROVED ISO9001:2015 QUALITY MANAGEMENT SYSTEM AUDITOR COURSECOURSE # 1898
VEHICLE PARKING AREA VEHICLE PARKING AREA
Office Area Office Area
Working Desk Office entrance
WORK-SHOP WORK-SHOP
WORK-SHOP OFFICE DESK
MATERIAL LOADING/UNLOADING WORK-SHOP

BAY
WORK-SHOP WORK-SHOP
WORK-SHOP WORK-SHOP
CARGO LOADING WORK-SHOP
WORK-SHOP DIRECTOR’S AREA
From Activity 23, Each audit team needs to interview auditee tutor during role play covering all
applicable ISO9001:2015 clauses across the specific departments assigned to the team by the tutor
Activity 23: Auditing Top management
Purpose: To test the skill required, as an auditor, to interview and audit top management
of an orgnization.

Group Exercise
Slide # 100
assessment Sheet
Directions: This is group activity.

Interview top management of METAFORA (A sample case study ).
Tutor will play the role of top management.
Each group will have to ask questions in turn.
When you are not asking the question, please make notes and gather audit evidences. This
information may be useful for subsequent audit.
Then while class room discussion please share your information and explain to class how are you
going to use this information in the subsequent audit.
Please also discuss the attributes of Auditor as well as Auditee.
Audit Objective: Stage-2 Certification audit of METAFORA
Audit Criteria: ISO9001 2015 & Documented information of METAFORA
Scope: Entire Metafora activities.
Direction: Audit evidences gathered during this shall be used for preparation of
audit report.

After Activity 23 3 1300 1345 00:45:0 Lunch Break
0
From Activity 24, Each audit team needs to interview auditee tutor during role play covering all appli-
cable ISO9001 clauses across the specific departments assigned to the team by the tutor.
Activity 24: Auditing Context, Risk & opportunity, Support, Operation, Perfor-
mance evaluation and Improvement, related to various departments of case
study METAFORA.
Purpose: TO test the skill required, as an auditor, auditing ISO9001:2015 requirements.
Duration: Total time spread over 11 Hrs:30 Minutes (Spread over two days)
Group Exercise
Slide # 101 to 110
assessment Sheet
Each team will get sufficient time to prepare checklist for their allocated department and then once
class is ready auditee tutor shall be audited, in turn.
After every department’s audit is over feedback session is planned by the Tutor.

Audit the department allocated to you by a Tutor.
Interview the tutor Auditee.
While delegates of other teams are not actively participating in the simulated audit, they
should be observing audits of other groups for offering subsequent comments on how audit
could have been done better,
Then while class room discussion please share your information and explain to class how are
you going to use this information in the subsequent audit.
Audit Objective: Stage-2 audit of METAFORA

Direction: Audit evidences gathered during this shall be used for preparation of audit report.
Process Approach
Demonstrates priority is given to questioning the organisation’s identification of processes, their se-
quence and interactions, and performance against the objectives / measures defined, with focus on
the processes which directly impact the customer
 Questioning the client’s processes, the sequence, interactions and performance against the
measures defined, with focus on the processes which directly impact the customer.
 Questioning the process objectives/targets, with focus on where targets are not being met and on
issues that have the greatest impact on the customer.
 Questioning what plans are in place to ensure targets are met, and corrective action plans are in
place where objectives are not being met. ( e.g. Customer complaints, Customer dissatisfaction, etc.)
 Following audit trails to linkages between customer concerns, performance against objectives and
relevant process documents
 Questioning the client’s process for gathering, communicating and implementing customer specific
requirements.
 Verify the identification and application of the appropriate ISO9001 2015, requirements in the
context of an audit of the organisation processes.
Risk based auditing:
 Demonstrates priority is given to questioning risks and opportunities identified by the orgnization
with focus on the processes which directly impact the customer.
 Prioritization of high risk area and focusing the auditing to risk mitigation, opportunities to reduce
the risk and operational control
 Monitoring of the risk by the organization’s top management; which are highest concern to
business
and strategic direction.
 Identification and focusing the KEY PROCESS/PRODUCT characteristics and analysing the potential
risk associated with it.

After session 33 3 1545 1600 00:15:00 Tea Break
Session # Day Start Time End Time Duration TrainingMethod

After session 34 3 --- 1800 --- End of day-3
End of Day 3
HOME WORK: Specimen Exam paper Section 3.0 only…… this home work will be discussed in the
class at the end of day-4
Day 4
End Duration
Time
36 4 0845 1045 02:00:00 Ppts /Activity
---- 4 1045 1100 00:15:00 Tea Break
36 4 1100 1300 02:00:00 Ppts /Activity
----- 4 1300 1345 00:45:00 Lunch Break
36 4 1345 1545 02:00:00 Ppts /Activity
--- 4 1545 1600 00:15:00 Tea Break
---- 4 1600 1745 01:45:00 Ppts /Activity
End of Day 4
HOME WORK: Specimen Exam paper Section 4.0 only…… this home work will be discussed on day-5
Day 5
Activity 25: Nonconformity and closure
Purpose: TO test the skill required, as an auditor, to identify and grade the
nonconformity based on the its impact to system and customer.
Group Activity.
Slide # 111
assessment Sheet
Refer the scenarios allocated to you.

Each group has identified nonconformity/es during audit of their allocated department from
METAFORA case study.
Please write the nonconformity into 3 elements
1. Statement of Nonconformity.
2. Requirement of ISO9001:2015
3. Objective Evidences against the nonconformity.
Audit Criteria: ISO9001 2015 & Documented information of METAFORA Clause 10.2.1
Direction: Audit evidences gathered during this shall be used for preparation of audit report.
PLEASE REFER ACTIVITY # 28 in next pages
Activity 26: Closing meeting
Purpose: TO test the skill required, as an team leader to plan and conduct closing meeting.

Group Exercise
Slide # 112
assessment Sheet
Directions:
Please prepare for the closing meeting based on the requirements of ISO19011.
Tutor will select one delegate as team leader.
This closing meeting is for the stage-2 certification audit of METAFORA.
All other class member will have to prepare minimum one nonconformity based on their audit
finding and be ready to present it when your team leader will prompts you for the during the
closing meeting.


After 40 5 1100 1115 00:15:00 Tea Break
Activity 27: Audit Report
Purpose: TO test the skill required, to prepare audit report, based on the conclusions
and recommendation given in the closing meeting

Group Exercise
Slide # 113
assessment Sheet
Directions: Please prepare the audit summary report based on the Metafora’s audit.
Then hand it over to the tutor.
Please use A4/Note pad for the summary report.
Please refer ISO19011 requirements related to Audit Report.
Activity 28: Audit Follow-up
Purpose: TO test the skill required, to evaluate proposed corrective actions

received from the client Organization. To understand the various aspects of NC closure.

Group Exercise
Slide # 114
assessment Sheet
Directions: You have conducted audit of METAFORA for stage-2 certification audit.
Refer the nonconformities ISSUED DURING STAGE-2 AUDIT along with the METAFORA’s
response
in the form of Correction and corrective action. Review it to decide whether NC closure accepted
or Not.
Corrective Action
Plan
Stage-2 Audit NC by
METAFORA STAGE-2 NC # :CB AD-01
a Certification Body
Date: Sept-xx
CLAUSE # 7.1.5 Department Logistics

A] Problem Statement: Lubricants are repacked in METAFORA for one of the customers. In this
activity Lubricants were filled in small packs and weighed by weighing scale. These small packs
then dispatched to the customer. The Weighing Scale (Metafora/WS-04/May-xx) was not found
calibrated during the audit. Quality In-charge stated that they do not feel the necessity of calibra-
tion
Process Owner : Logistics Supplier representative:
B] Correction: Containment Action/s. (Immediate actions taken)
Weighing scale re-calibrated Not applicable.
C] Root Cause Analysis: (Attach separate sheet for problem solving technique used to arrive at Root cause (s).
Root Cause (s):
missed one of error, M.D.’s son manufactures this weighing scale
D] Proposed Corrective Action/(s) (PCA) E] Corrective Action implemented / Initiated:

Weighing scale re-calibrated Weighing scale re-calibrated
E] Changes made in the Documents / systems (kindly attach the proof)
Document Document
F] Effectiveness of corrective action to prevent recurrence of cause of NC.

NC Reviewed and Accepted by
Corrective Action Plan
Stage-2 Audit NC by
STAGE-2 NC # :CB AD-02 Date: Sept-xx
METAFORA a Certification Body
CLAUSE # 7.2 Department Training
A] Problem Statement: In Metafora, drivers and cleaners were trained on “Safe driving of Tank-
ers”. Records of effectivess of training not available with HR department.
Similar training was also given by client of Metafora and they issued Identity Cards to Drivers
and Cleaners after verification of skills. When driver Mr. Sandy was being interviewed for “safe
Driving”; he hardly could explain it, HR personnel said that he was nervous because of audit.
This service was started six months back and no incident or complaint raised by client.
Supplier representative: Head
Process Owner : HR
Mkt.
Drivers ID issued by customer now All other training records are available.
retained as record of effectivess
Root Cause (s):
missed one of error,
Record of Driver ID made available Record of Driver ID made available.
Document Document
NIL

.
STAGE-2 NC # :CB Stage-2 Audit NC by Date: Sept-

METAFORA AD-03 a Certification Body xx
CLAUSE # 8.2.1 Department Procurement

A] Problem Statement: Customer “Cambridge Logistics” had given one of their trucks (Truck #
UWE 5648-SD) for cargo shipment within the 100km area. As per contract this truck was to be
used only for “Cambridge Logistics” cargo handling.
In Aug-XX there were 2 occasions, that this truck was being used for other customers as well.
This was not at all informed to “Cambridge Logistics”. Logistics in-charge said that contract is
old and we will be buying this vehicle in Dec-XX. But such contract termination or maturity doc-
uments were not available.
Supplier representative: Head
Process Owner : HR
Mkt.
Inform to customer. Customer had proposed to buy this vehicle, we are buying it
in Dec-xx
Root Cause (s):
There was no truck available to ship a cargo of “Northern Roadways”

Truck which was owned by “Cambridge Logistics” was available.
We decided to use it and it was duty of Marketing to inform to customer
Marketing in-charge failed to inform.
Lack of communication skill
D] Proposed Corrective Action/(s) (PCA) Train- E] Corrective Action implemented / Initiated:
ing on Communication Skill. Training provided on Sept-xx and verified the
effectiveness by monitoring the person.
Document Document


STAGE-2 NC # :CB Stage-2 Audit NC Date: Sept-
METAFORA AD-04 by a Certification xx
Body
CLAUSE # 8.4.1 Customer Complaint CC- nil
A] Problem Statement: METAFORA had outsourced cargo transportation to “ZEBRA Trans-lines”. As part of
contract Zebra picks up the material up from client’s and deliveres to intended destination.
When quality objectives were being audited; it was evident that since last three months, 9 customer com-
plaints were reported. These customer complaints attributed to service quality of ZEBRA.
Metafora had Supplier selection process in place and one of the selection criteria of testing was psychologi-
cal mapping of drivers. This test was not being carried out through an expert agency due to exigencies.
There were 8 complaints attributable to 2 drivers who had behavioural issues.
Supplier representative: HEAD
Process Owner : PURCHASE
PURCHASE
ALL drivers are appraised of the ALL other Customer complaint reviewed and found
corrective action and impact on cus- no repetition of any other complaint. Resp., Logistics
tomers, Completed Sept-XX head; Completed – Sept-XX
Root Cause (s):

Before selection of “Zebra Trans-lines”, Metafora knew that they had shortage of drivers.
The drivers’ list approved by Metafora was not being used, because of heavy workload on the “Zebra Trans-
lines”
So “Zebra Trans-lines” hired few new drivers on contract basis, which was not informed to Metafora
Metafora accepted the things because of urgency and big order in the pipeline.
Violation of supplier selection process.
Training on
Procedure MET/SOP/01 reviewed and updated
procedure for Supplier selection not ad- dt. Sep-XX
hered to. Re-trained all process owners on Sept-XX.
Express way of psychological mapping mod- Understood the impact on business because
ule to be designed with expert- by Oct-XX of customer complaints.
Express psychological mapping model “MAP-
Intelligence” developed and results are useful.
12 drivers disqualified.
Document Document
Procedure for Supplier selection
amended.
Express psychological mapping model
“MAP-Intelligence” is part of selection
of drivers.

STAGE-2 NC # :CB Stage-2 Audit NC by Date: Sept-
METAFORA AD-05 a Certification Body xx
CLAUSE # 9.2.2 Internal Audit Process ----
A] Problem Statement: Orgnization has conducted the internal audit at the frequency of once in
six months.
While going through internal audit documents, it was evident that “risk and opportunities”
clause 6.1 not being audited. Further investigation reveals that internal auditor not trained
on “risk and opportunities”, although one of the customers had specific requirement to have
trained internal auditor on the risk and opportunity auditing. Third party auditor could able
to identify many potential risk and opportunities. Latest management review record states
risk
and opportunities process is effective.
Process Owner : INTERNAL AU- Supplier representative: HEAD SYS-
DITS TEMS
Training to ALL internal auditors. NIL
Root Cause (s):

inadvertently missed the points during internal audit.
D] Proposed Corrective Action/(s) (PCA) : E] Corrective Action implemented / Initiated:
In the next internal audit ( 8’th month of next
calendar year) risk and opportunities will
have to be covered by each internal auditor Training planned in July-XY next year.
as there was nonconformity in 3’rd party au- Next internal audit – Next year Aug -XY
dit. Date of 3’rd party audit was 9’th month
of the calendar year.
Document Document

End Duration
Time
--- 5 1330 1415 00:45:00 Lunch Break
Activity 29: Specimen examination paper
Purpose: To attempt specimen exam paper for balance activities.
Duration: 15 minutes Class discussions

Slide # 115
Directions: This is individual exercise.
Attempt and complete balance part of the specimen examination paper.
End Duration Training

Session # Day Start Time
Time method
After activ- 5 00:15:00
1440 1455 Tea Break
ity 29
END OF ACTIVITIES------------------------------------
We hope you enjoyed your course
You will be contacted by the CQI and IRCA for feedback on the course and your Ap-
proved Training Partner.
Completing this short survey will help to ensure the continuing high standards of
these courses.
You can also record your certificate and receive information about the CQI
and IRCA, auditing and quality news, ISO updates and much more.
To record your certificate, visit www.quality.org/record-your-certificate
You will be contacted by the CQI and IRCA for feedback on the course and your Ap-
proved Training Partner.
Completing this short survey will help to ensure the continuing high standards of
these courses.
End Of Course Material------------------------------------

QMS - Delegate Acitivity Manual

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Welcome

CQI and IRCA Certified

About the CQI and IRCA

Find out more about the CQI and IRCA at www.quality.org

Delegate Activity Manual

Purpose: To understand the terms of audit as given in ISO 19011.

C Person who provides specific knowledge or ex-

H Systematic, independent and documented pro-

B Set of one or more audits planned for a specific

Task-B …..Subgroup above activities into following categories

Audit findings Collection and verification of conducting the audit activities

Audit Type Duration Methods Objectives

End Duration Training

Audit Type AUDIT OBJECTIVES SCOPE CRITERIA

2nd Party Audit Compliance to Customer Boundary of an QC Procedures, Customer

Program Manager Guides/Inter-

Refer ISO19011; Annex A.1 Applying audit methods; page # 35

participation - Completing checklists and questionnaires

Observation of work performed Observing work performed via surveillance means,

1. Actual situation and documents can

1. Samplings can carry risks 1. Actual Situation unknown

Start End Duration

Risks in Achieving the Audit Objectives:

End Duration Trainin

Purpose: Opening Meeting

Duration:5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback

Purpose: Capturing & verifying Audit Evidences

Methods of collecting information How to convert it into Audit evidence

Verifying procedures w.r.t actual work carried out at site

Check compliance w.r.t specifications

Session # Day Start Time End Time Duration Training method

After session 13 1 1745 ----- End of day-1

Question: Do you measure customer satisfaction?

TASK: Recollect the leaning from today’s session

1. Who decides the follow up audit?

2. What could be the Objective, Scope, and duration of follow up audit?

3. Who will conduct this follow up audit?

4. Does it require audit plan? YES REQUIRED

Activity 13: Quality Management System Terms & Definitions

Duration:10 Minutes+ 5 minutes Feedback

Activity 15: Understanding audit trail

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback

Duration: 05 minutes Introduction +30 Minutes+10 minutes Feedback

Activity 17: Initiating the audit.

Purpose: To acquire skill for initiating the audit.

Activity 18: Document Review

Purpose: Conduct document review for METAFORA (a case study)

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback

Star End Duration Trainin

Duration: 05 minutes Introduction +60 Minutes+25 minutes Feedback

Session # Day Start Time End Time Duration Training method

Duration: 05 minutes Introduction +40 Minutes+15 minutes Feedback.

Directions: This will be group activity.

Activity 21: Opening Meeting

Directions: This is group activity

This is group activity.

Session # Day Start Time End Time Duratio Training method

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback.

Office Area Office Area

Working Desk Office entrance

WORK-SHOP OFFICE DESK

MATERIAL LOADING/UNLOADING WORK-SHOP

CARGO LOADING WORK-SHOP