QMS - 9KLA - IRCA Slides.-6-08-2021

Session-1
CQI-IRCA Accreditation No. 1898

PR328 ISO 9001:2015
Lead Auditor Training Programme
Full-time Virtual classroom /Class-room.
(Quality Management Systems)
Copyright © 2015 IRCLASS. All rights reserved.

CQI-IRCA Accreditation # 1898 Session-1
IRCLASS Systems and Solutions Private limited

Welcome you all
For
PR328 ISO 9001:2015

Lead Auditor
(Quality Management Systems)
Session # Day Duration Training method

1 1 00:45:00 Slide # 1 to 30
Revision 05-2021 - Copyright © 2015 IRCLASS All rights reserved. 2

Instructions! Session-1

Lead Auditor Course Session-1
CQI-IRCA Accreditation No. 1898
Trainer:
Location:
Dates:

Session-1
Welcome to your CQI and IRCA Certified

ISO 9001:2015 Quality Management Systems Auditor/Lead
Auditor course
IRCLASS Systems and Solutions Pvt. Ltd. has been independently assessed and approved by the CQI and IRCA. This
means they have the processes and systems in place to deliver certified courses to the highest standard.
About the CQI and IRCA

The CQI is the only chartered professional body dedicated entirely to quality.
IRCA is its specialist division dedicated to management system auditors.
Take the next step in your career and become a member. Join a unique global network of nearly 20,000 quality
professionals and gain unrivalled professional recognition as an individual and in your career.
Find out more about the CQI and IRCA at www.quality.org

We hope you enjoy your course

Course Prerequisite Session-1
Delegates must have prior knowledge of ..

• Plan-Do-Check-Act
• “7” Quality Management Principles –
• Process and Process Approach
• Activities happening at Customer and Supplier interface.
• Knowledge of requirements of ISO9001 2015 and commonly used terms and definition in
quality management system
• Knowledge of the requirements of ISO 9001 and the commonly used quality management
terms and definitions, as given in ISO 9000, which may be gained by completing an CQI
and IRCA Certified ISO 9001:2015 Foundation (QMS)Training or equivalent.

CQI-IRCA Benefits Session-1
60,000 delegates in over 100 countries across the world take CQI and IRCA
Certified Training every year, delivered by our trusted network of Approved
Training Partners.
The right training will enhance your career prospects – and we offer some of
the best training for quality and auditing professionals in the world.
CQI-IRCA certified training courses provide you with the skills and knowledge
to support your application for CQI membership or CQI-IRCA certification.
Membership offers you infinite development opportunites and is an invaluable

way of gaining professional recognition for your expertise and commitment.
Welcome Note Session-1

Delegates Introduction Session-1
➢ Name
➢ Academics
➢ Organization
➢ QMS Auditing Experience, if any
➢ Your Expectations from the Course
9 Revision 05-2021 Copyright © 2015 IRCLASS All rights reserved. 9

IRclass Session-1

IRQS is a department of IRCLASS Systems and Solutions Pvt Ltd Session-1
Indian Register Quality Systems
Revision 05-2021 - Copyright © 2015 IRCLASS All rights reserved 11

IRQS is a department of IRCLASS Session-1
IRQS is a Multinational Certification Body with 9 operational locations abroad and

with 16 offices in India.
IRQS is the first certification body in the entire Asia to receive direct accreditation
from RvA (RAAD VOOR ACCREDITATIE), the Dutch Accreditation Council in 1993 and
NABCB.
IRQS has certified more than 2500 Organizations till date with more than 2200
active certificate.

Our Strengths
Session-1
Established Legal Entity

Robust Quality Assurance system
Proactive Customer communication
Well established Professional Setup
Regular professional development of auditors
Value addition during audits

IRClass on Global Presence
Session-1
1.Sri Lanka 5.China

2.United Kingdom 6. U.S.A.
3.South Korea 7.Thailand
4.Singapore 8.Greece
9. UAE

Course Aim
Session-1
Provide knowledge & skills required to perform 1st, 2nd, and 3rd
party audits of Quality Management Systems against ISO9001 2015,
in accordance with ISO 19011, ISO 17021, as applicable.
Refer Delegate Activity Manual for detail Course Schedule

Learning Objectives
Session-1
Describe the purpose of:

• an QMS;
• of QMS Standards; Have the skills to:
• of management system audit; • Plan;
• of third-party certification. • Conduct;
• Report;
• And follow up…
KNOWLEDGE SKILLS
Explain the role of an auditor to plan,

conduct, report and follow up an QMS …an audit of QMS to establish conformity
audit in accordance with ISO 19011 (and (or otherwise) with ISO9001 2015; ISO
ISO 17021 where appropriate). 19011 (and ISO17021where appropriate).

Course Structure
Session-1
Materials
• Tutorials
• Exercises & Role-Plays
• Daily evening work
Evaluation:
– Continuous assessment
– Exam
Continuous Assessment (70% to pass)

Two-hour written examination (70% to pass)
Continuous Assessment
Session-1
• Participation in class and team activities

• Written assignments
• Attitude and personal attributes
• Attendance and punctuality
• Communication skills
• Feedback

Online Examination ( on 5’th Day of the training course)
Session-1
The ONLINE examination shall evaluate the students’ comprehension of the audit
process and the application of ISO9001:2015 and their ability to provide written
justification of their evaluations.
course examination questions could relate to any requirement of ISO 9001 and the
expected prior knowledge.
the ONLINE examination is split into four sections. There is a maximum of 90 marks
available; the pass mark is 70% (63 marks) and delegates must also achieve at least 50%
in each of the four sections.
break ups of marks for 4 Sections are Section one – Five questions worth two marks
each, Section two – Four questions worth Five marks each, Section three – Three
questions worth Ten marks each, Section Four- three questions worth Ten marks each
Examination
Session-1
The time allotted for taking the ONLINE examination shall be two hours.
Additional 20 minutes for the learners whose spoken language is different from
English.
only permissible materials during Exam are one unmarked copy of the
Management System Standard ( ISO9001) and a bilingual dictionary.
Adherence to the time limit shall be automatically maintained as per Desktop;

Laptop clock. Exam will stop after the stipulated time.
The trainer may allow a student with particular disability that adversely affects
the delegates capability to complete the examination in the allotted time up to
30 minutes additional time for taking the ONLINE examination ( 2hrs:30Minutes)
Examination
Session-1
Students who are unsuccessful in written Exam only, can re-appear the
examination within a 12 months period from the last day of the Exam;
however, students who fail in ‘continual assessment’ need to repeat the entire
course again

Certificates Session-1
“Certificate of Achievement”:
else
“Certificate of Attendance” will be issued

Complaints/Appeals Session-1
May send in writing to IRQS

Written response within 7 working days
Right of appeal to CQI-IRCA in writing if not resolved by IRQS

CQI-IRCA Course Certification Session-1
You are attending a course certified by the International Register of

Certificated Auditors (CQI-IRCA) Certification; a division of the Chartered
Quality Institute (CQI)
This means that your training provider has voluntarily achieved the rigorous
requirements set by CQI-IRCA to provide you with confidence that:
“Your course content covers key knowledge and skills that you will need on
your journey as a management systems auditor”

Your tutors are experienced and competent auditors and trainers, who will use a
variety of practical student-focused learning techniques to help you learn and
enjoy the course
Your achievement of the learning objectives will be fairly assessed through

monitoring and coaching and, where required by CQI-IRCA, written examination

You have access to a robust complaints process and recourse to complain to

CQI-IRCA if you are unable to resolve your complaint with the training provider
and think that the course has not met the criteria set down by CQI-IRCA

You can verify the training organisations we approve and the courses we certify
directly with CQI-IRCA at www.quality.org
At the end of this course we will provide you with some useful information on
what to do next, from becoming an CQI-IRCA Certificated Auditor to finding a
job.

Enabling Objectives Session-1
Knowledge
Learning Outcomes Session-1
Upon completion of this course, participants should be able to:

• Correlate Terminologies related to QMS
• Demonstrate the processes involved with
– First, Second & Third-party Certification audits
– Managing audit programs
– Communication skills
– Auditor Personal and interpersonal skills
– Initiating an audit
– Preparing for an audit

Learning Outcomes Session-1
– Conducting audit activities

– Reporting on audit findings
– Conducting post-audit activities

Why Management System Audit is essential? Session-2
Management System Audits are an essential element of the quality assurance
function. The general objectives of quality audits are:
1. To determine conformity or non-conformity of the QUALITY management system

element
2. with specified requirements.
3. To determine the effectiveness of the implemented QUALITY management in
4. meeting specified quality objectives.
5. To provide an opportunity to improve the QUALITY management.
6. To provide managers with information.
Audits may also consider for meeting regulatory requirements.
2 1 00:15:00 Slide # 31 & 85

Activity-1 : Terms & Definitions related to audit Session-3

3 1 00:30:00 Slide # 32/Activity

Activity:2 First, Second & Third-party Certification audits Session-4

4 1 00:30:00 Slide # 33 to 39/Activity
First Party Audit Session-4
An organization auditing its own systems, a self-assessment
Used to measure the strengths and weaknesses against requirements,

and an organizations own standards
Provide feedback to management that the QMS system is both

implemented and effective, and
Gauged for continuous improvement effort as well as measuring the

return on investment for sustaining that effort.

Second Party Audit Session-4
Inspections/Audits of Other Facilities

One organization auditing another with which it either has, or is going to
have, a contract or agreement for the supply of goods or services with
safe practices
Supplier audit will include the QMS Management System involved in the
items or service provided

Third Party Audit- Benefits Session-4
control costs with the help of knowledge transfer since accredited

certification bodies can be a good source of impartial advice
offer market differentiation and leadership by showing to others credible

evidence of good practice
demonstrate due diligence in the event of legal action
reduce paperwork and increase efficiency by reducing the necessity to re-

audit your business

Third-party Accredited Certification Session-4
Third-party Accredited Certification

Third-party Accredited Certification Session-4
SEQUENCE CERTIFIED TO AGENCY

INTERNATIONAL
ACCREDITATION -----
FORUM
ACCREDITATION ISO/IEC 17011Conformity assessment -- General

BODIES requirements for accreditation bodies accrediting
conformity assessment bodies
Certification Bodies ISO/IEC 17021 Conformity assessment --

Requirements for bodies providing audit and
certification of management systems
Orgnization ISO 9001:2015 Quality management systems --

Requirements

Third-Party Accredited Certification- Benefits Session-4
control costs with the help of knowledge transfer since accredited

certification bodies can be a good source of impartial advice
offer market differentiation and leadership by showing to others credible

evidence of good practice
demonstrate due diligence in the event of legal action
reduce paperwork and increase efficiency by reducing the necessity to re-

audit your business

Activity: 3 Audit Process and its Deliverables Session-5
INPUTS AUDIT ACTIVITY OUTPUTS
AUDIT CRITERIA
(REQUIREMENTS)
AUDIT FINDINGS
OBJECTIVE EVIDENCE
EVALUATION
Comparison (1st, 2nd 3rd party certification audit)

Guidelines for auditing Management systems (ISO 19011:2018)

Audit Process Session-5
REMEMBER …. THE
TERMINOLOGY…………..Establish………….Document……….Implement……….Maintain
1. Does Leadership exhibits intent of QMS?
2. Does Orgnization need mere certificate or really interested in the system?
3. Has leadership demonstrate it through their daily activities?
4. Is policy is in place, objective s are derived and deployed?
Establishment of QMS
1. Is intent of leadership translated and what needs to be where w.r.t. QMS decided?
Documentation of QMS
1. Does this translated to adequate procedures, instruction, records and monitoring?
Implementation of QMS
1. Is implementation meets the expectations of the requirements?
Maintenance (Effectiveness) of QMS
1. Selection of audit team; concerns reporting and closure, continual improvement
Typical Audit Activities Session-5
6.2 Initiating audit
6.2.1 General
6.2.2 Establishing contact with auditee

6.3.1 Performing document review in preparation for the audit
6.3.2
6.2.3 Determining feasibility of Preparing the audit plan
audit
6.3.3 Assigning work to the audit team
6.3.4 Preparing work documents
6.3 Preparing audit activities.
6.3.1 Performing review of documented

6.4.1 General information
6.4.2 Conducting the opening meeting
6.4.3 Performing document review while conducting the audit
6.3.2 Audit planning 6.4.4 Communicating during the audit
6.4.5 Assigning roles and responsibilities of guides and observers
6.4.6 Collecting and verifying information
6.3.3 Assigning work to audit 6.4.7
team Generating audit findings
6.4.8 Preparing audit conclusions
6.4.9 Conducting the closing meeting
6.3.4 Preparing documented information for audit
Cont’dplan)
Typical Audit Activities Session-5
6.4 Conducting audit activities

6.4.1 General.
6.4.2 Assigning roles and responsibilities of guides and observers
6.5.1 Preparing the audit report
6.4.3 Conducting opening meeting
6.5.2 Distributing the audit report
6.4.4 Communicating during audit
6.4.5 Audit information availability and access
6.4.6 Reviewing documented information while conducting audit
6.4.7 Collecting and verifying information.
6.4.8 Generating audit findings.
(if specified in the audit plan)
6.4.9 Determining audit conclusions.
6.4.10 Conducting closing meeting. NOTE:
6.5 Preparing and distributing audit report Sub-clause numbering
6.5.1 Preparing audit report refers to the relevant
sub-clauses of this
6.5.2 Distributing audit report International Standard.
6.6 Completing audit
6.7 Conducting audit follow-up

Activity:4 Key Difference in methodology of 1’st; 2’nd &
3’rd party Audits Session-6
What are the key differences in the methodology of various audits?

6 1 00:30:00 Slide # 44 /Activity
----- 1 00:15:00 Tea Break

Activity:5 Establishment of Objectives, Scopes & Criteria's Session-7


Establishment of Objectives, Scopes & Criteria's (cont’d) Session-7
Audit objectives could …

1. Recommendation for issuance of certificate.
2. Recommendation for the approval supplier.
3. Conformance to effective implementation of ISO9001 2015
requirements.
4. Verification of Customer complaint status
5. Verification of non-conformity on-site by an auditor for effective
implementation of proposed corrective action.
So objective is ultimate outcome of an Audit, which the Orgnization

aims for at the beginning of the audit.

Audit scope – extent and boundaries of an audit.
NOTE: The audit scope generally includes a description of the physical

locations, organizational units, activities and processes, as well as the
time period covered.
It advise
when audit shall be conducted (start and end date)
what/who are we going to audit
where the audit shall be done
Audit scope shall be derived from the QMS Scope

Audit criteria – set of policies, procedures or requirements.
NOTE: Audit criteria are used as a reference against which audit evidence is
compared.
It advise
what we are going to check (or audit) the conformance.
what are the requirements of the audit.
Audit criteria could be a combination of the following
Standard requirement (ISO9001 2015)
Statuary or Regulatory Requirement
Organization Process/Policies/Procedures, etc.
Customer Requirement
Resources Session-8
Audit team – Auditors, Subject Matter Experts, Translators, Legal Expert.
Technical Expert – person who provides information relates to the organization, the
process or activity to be audited, or language or culture to the audit team
A technical expert does not act as an auditor in the audit team.
Logistics : Travel between two processes/sites, availability of meeting rooms, internet

access, printing facility, Specific PPEs, Security requirements,
Auditee – Top management, Coordinator from the Orgnization, Process heads in the
organizations.
Documents :- Manuals, Procedures, Contracts, Records either hard and soft.

8 1 00:45:00 Slide # 49 & 50/Activity
-- 1 00:45:00 Lunch Break

Resources- Competency Session-8
Personal Behaviors
Generic knowledge and skills of management system auditors
Knowledge of Management System requirements ISO9001: 2015
Organization’s business environment,
Applicable legal and contractual requirements and other requirements
Discipline and sector-specific knowledge and skills

Activity:6 Roles & Responsibilities Session-9
1 2 3
Person(s) managing
Guide(s) Audit Client
the audit programme
Auditee(s) (including
Auditors Lead Auditor
management)
Observer(s) Technical experts Trainee Auditor

9 1 00:45:00 Slide # 51/Activity

Activity:7 Audit methods Session-10


Auditor Confidentiality Session-10
To gain the privileged access to

information that is needed for the
certification body to assess conformity
to requirements for certification
adequately,
it is essential that a certification body does

not disclose any confidential information

Stage-1 Audit Process & Deliverables Session-10
Audit Plan
Ensure an adequacy
of Organization established
documentation
Ensure the relevant
procedures
to be used during audit
Understand the hazards, risks
& identify relevant legal
requirement
Identify any specific needs,
skills, Personal protective Gain an understanding
Principle of equipments Context of the organization
Stage 1 Demonstrate scope and
audit objective
Ensure Organization
readiness for an audit
Resolve any
misunderstandings
Identify organization/plant
layout and its context of QMS

Stage -2 Audit Process & Deliverables Session-10
Consider:
• Past results (if available) Organize
• Present issues/ risks work
• Management's issues documents
• Management's priorities
Establish Identify the hazard potential of:

level of audit • Activities
• Products Audit
and resources Determine the importance/risk
• and Services Team assignment
necessity (including legal Requirements)
Establish
Contact Brief the
and concur
auditee and audit team
audit plan
confirm date(s)
Stage 1 Report
Consideration

Initial certification audit – Stages 1 & 2 Session-10
From ISO 17021
Opening Meeting
17021:2011 Perform Document Review Corrective Actions
Audit Plan Checklists Objective evidence Areas of Concerns (AOC/s) Reports
Audit Recommendation
Closing Meeting & conclusion Audit report
Stage 1
Stage 2 From ISO 17021

Opening Meeting
17021:2011 Onsite Audit Corrective Actions
Audit Plan Checklists Objective evidence Nonconformity Reports
Audit Recommendation
Closing Meeting & conclusion Audit report
3 Yearly Recertification Surveillance Assessment Visits (1 & 2 ) followed by Renewal Audit

Activity:8 Audit Plan Session-11
The audit plan enveloped by
1. Audit objectives
2. Audit scope
3. Functional units, as well as processes to be audited
4. Audit criteria
5. Any reference documents
6. locations, dates, expected time and duration of audit activities to be conducted
7. Audit methods
8. Audit evidence
9. Roles and responsibilities of the audit team members, including guides & observers
10. Allocation of critical areas of the audit.
11. Reference : ISO 19011:2018 clauses 6.4.3 ISO/IEC-17021-1:2015 clauses 9.4.2
11 1 00:30:00 Slide # 57 to 59 /Activity
--- 1 00:15:00 Tea Break

Work Documents Session-11
TEMPLATE FOR CHECKLIST

Clause # Checklist How to look For Conformity/
1. Checklists - Question ( EVIDENCES) Non-
Doc/record/data conformity
2. Audit Sampling Plan
3. Formats for capturing the evidences
4. Non-conformity format

Work Documents Session-11
Advantages/Dis-advantages of Checklist

Activity:9 Conducting Opening meeting Session-12

12 1 01:00:00 Slide # 60 & 61 and Slide 80 /Activity

Conducting Opening meeting Session-12
Covers following agenda

1. Audit objectives
2. Audit scope
3. Functional units, as well as processes to be audited
4. Audit criteria
5. Any reference documents
6. locations, dates, expected time and duration of audit activities to be conducted
7. Audit methods
8. Audit evidence
9. Roles and responsibilities of the audit team members, including guides & observers
10. Allocation of critical areas of the audit.

Activity:10 Audit Evidence Session-13

13 1 00:45:00 Slide # 62 to 67 /Activity

Evidences Session-13

Sources of (Evidence) Information Session-13
1. Interviews
2. Observations
3. Documents
4. Records
5. Data summaries
6. Reports
7. Database and Website
8. Performance Indicator

Sources of (Evidence) Information Session-13
Recording the objective evidence:

1. Admissible statements (Quotes and statements)
2. Document numbers and issue/revision levels
3. Identifiers (Product identification)
4. Rough sketches
5. Work Environment
6. Departments
7. Name of auditee or preferably job titles
8. Issues which may impact other functions

Audit Evidence Session-13
Audit evidence should be evaluated against the audit criteria

should be verifiable.
support conformity
qualitative or quantitative.
checklists
Audit sampling plans
forms for recording information, such as supporting evidence,
audit findings and records of meetings

Audit Sampling Session-13
Audit Sampling Approach

1. 100% can not be checked.
2. Relevant and non-relevant information
3. How to select sample from large data which is offered to auditors.
4. Sampling shall give confidence that Audit objective will be met.
5. Sampling carries RISK, may not represent the full population and judgment
may go wrong.
6. Systematic approach to collect the evidence is needed to confidently answer
the questions:
7. Is the sample size sufficient to establish conformance or deficiency?
8. Would another auditor draw the same conclusion based on the sample?
End of day-1
Activity:11 Effective Communications Protocol Session-14 &15
Session- 14- OVERVIEW OF DAY-1
Session- 15- ACTIVITY-11

14 2 00:15:00 Slide # 30 to 67, Overview of day-1
15 2 00:30:00 Slide # 68 to 71/Activity-11

Communications Protocol Session-15
1. establish communications with the auditee’s representatives

2. formal communication channels between the audit team and the auditee
3. interactive communication means
— conducting interviews
— completing checklists and questionnaires
— conducting document review with auditee participation

Questioning Technique Session-15
1. Open ended & Closed ended Questions

2. Specific
3. Leading
4. Hypothetical
5. Reflective
6. Probing

Effective Communication Session-15
• Body Language
55%
• Tone of Voice
38%
• Words
7%

Audit Findings Session-16
Positive audit findings
Nonconformity ; ref.
(ISO9000:2015,-
non fulfilment of a requirement)

16 2 00:30:00 Slide # 72 to 77

Nonconformity Session-16
Non fulfillment of a requirement

1. Specified QMS requirements
2. ISO9001 2015 standard requirements
3. Organization QMS manual & procedures
4. Control of risk identification and process criteria
5. Legislative requirements

Nonconformity Statement Session-16
Use auditee’s terminology

Make it retrievable
Must be factual
Make it complete
Make it concise
Do not draw unsubstantiated conclusions

Nonconformity Statement (Cont’d) Session-16
1. State the exact nature of the problem clearly

2. Avoid generalities
3. Communicate the extent of the problem fully
4. Do not draw legal opinion
5. Avoid extreme language
6. Use familiar terminology
7. Give legislative, site or good management practice
reference
8. Avoid contradictory messages

Minor Non-conformance Session-16
As per Clause 3.13 of ISO/IEC17021-1:2015 standard…..

Definition of minor nonconformity
nonconformity that does not affect the capability of the management system
to achieve the intended results
Examples…..
1. Management of Change process not established by the Orgnization when
an alternative material developed from the supplier to reduce cost of
input material but changes are implemented effectively.
2. There was no established system to retaining the organizational
knowledge
Major Non-conformity Session-16
As per Clause 3.12 of ISO/IEC17021-1:2015 standard…..

Definition of MAJOR nonconformity……
nonconformity that affects the capability of the management system to achieve the intended
results.
Nonconformities could be classified as major in the following circumstances:
— if there is a significant doubt that effective process control is in place, or that products or
services will meet specified requirements;
— a number of minor nonconformities associated with the same requirement or issue could
demonstrate a systemic failure and thus constitute a major nonconformity.

Audit Meetings Session-17
1. Audit Briefing meetings

2. Progress meetings
3. Audit Team meetings

17 2 00:30:00 Slide # 78 to 79

Audit Conclusions Session-17
Audit team should meet prior to the closing meeting to :

1. Review audit findings and other appropriate information
2. Prepare list of audit findings
3. Reach consensus on audit conclusions
4. Agree on roles and tasks for closing meeting
5. Prepare recommendations –if specified
6. Discuss audit follow-up –if appropriate

Closing Meeting Session-12
A closing meeting, facilitated by the audit team leader, should be held to present
the audit findings and conclusions.
As appropriate,
— audit evidence collected was based on a sample of the information available
— method of reporting
— process of handling of audit findings and possible consequences
— presentation of the audit findings and conclusions, understood & acknowledged
by the auditee’s management
— any related post-audit activities (e.g. corrective actions,
audit complaint handling & appeal process)
Reference : ISO 19011:2018 clauses 6.4.10 ISO/IEC-17021-1:2015 clauses 9.4.7
Audit Report Session-18
The audit report should include
1. Audit Team Leader responsible for preparing the Audit Report
2. Audit Objectives, scope & criteria
3. Identification of audit client
4. Identification of processes audited and time period.
5. dates and locations where the audit activities were conducted
6. Identification of audit team leader & members
7. Audit findings and related evidence
8. Recommendations for improvement
9. Audit conclusions
10. Statement of Confidentiality
11. Next audit date/s
12. Distribution list for the audit report
13. Reference : ISO 19011:2018 clause 6.5.1 & ISO/IEC-17021-1:2015 clauseo. 9.4.8.2 & 9.4.8.3.
18 2 00:15:00 Slide # 81 to 83
Approving & Distributing the Audit Report Session-18
1. Report should be issued within agreed time or communicate reason for

delay to the audit client
2. Report to be dated, reviewed and approved in accordance with the audit
programme procedure
3. Distributed to recipients designated by the audit client
4. Audit Report is the property of the audit client, hence audit team should
maintain confidentiality of the report
Reference :
ISO 19011:2018 clause 6.5.1 &
ISO/IEC-17021-1:2015 clause no. 9.4.8.2 & 9.4.8.3

Audit Report Session-18
Contents
Generation of
Audit report
No
Technical review
Yes
Report Clearance
Client (Audit
Report)
communication
Client Acceptance

Activity:12 Audit Follow-up Session-19
The conclusions of the audit can be include with,

1.depending on the audit objectives
2.indicate the need for corrections & /or corrective actions
3.undertaken by the auditee within an agreed timeframe.
4.communication - status of these actions.
5.effectiveness of these actions should be verified.
6.This verification may be part of a subsequent audit.

19 2 00:45:00 Slide # 84/ Activity-12

Benefits of ISO9001 2015 This is already covered in Session-2
To Customers
To Orgnization
&
To other interested parties.

Activity:13 Terminology (ISO9001 2015) Session-20

20 2 00:15:00 Slide # 86 & 87/Activity-13
--- 2 00:15:00 Tea Break

PdCa Session-20
Plan
Do Holistic approach – Auditor

The auditor should focus on the achievement of Quality
Check Policy through the processes and their interactions;
evaluate the organization’s capability to Quality
management system;by considering the intent,
Act implementation, and effectiveness.
Refer Delegate manual for more details.
Activity-14 & 15 : Structure of QMS Session-21 & 22
Activity-14, understanding the ISO9001 2015,
Activity-15, Audit Trail ( Forward Tracing, Backward Tracing)

21 2 00:30:00 Slide # 88
22 2 01:00:00 Slide # 88
--- 2 00:45:00 Lunch Break

Activity-16: Documented Information Session-23
Documented Information to be maintained
Documented information to be retained

23 2 00:45:00 Slide # 89

Session-24
Enabling Objectives
Skills

24 2 00:30:00 Slide # 90 & 91

Activity:17 Initiating the audit Session-24
PREPARE FOR THE AUDIT

INITIATE THE AUDIT • Gather background information
• Establishing initial contact with the auditee • Prepare the audit plan
• Determine feasibility of Audit • Assign work to the audit team
• Prepare work documents
CONDUCT THE AUDIT

PREPARE & DISTRIBUTE AUDIT REPORT • Conduct opening meeting
• Prepare the audit report • Manage communication
• Distribute the audit report • Collect & verify information
• Generate audit findings
• Prepare audit conclusions
CONDUCT AUDIT FOLLOW-UP
• Conduct closing meeting
( if specified in the audit plan)
NOTE: The dotted lines indicate that any audit follow-up actions are usually not considered to be part of the audit.
Source: ISO 19011

Activity:18 Document review Session-25
The auditors should consider if the information in the documents provided by
client shall be:
1. complete
2. correct
3. consistent
4. current
5. cover the audit scope and provide sufficient information to support the
audit objectives
6. the use of information and communication technologies
25 2 01:00:00 Slide # 92

Activity:19 Audit Plan Session-26 & 27

26 2 01:30:00 Slide # 93
27 2 00:15:00 Specimen Exam paper
Revision 05-2021 - Copyright © 2015 IRCLASS All rights reserved. End of Day 2 93
Activity:20 Work Documents Session-28 &29
SESSION-28 : OVERVIEW OF DAY-2

Preparation of work documents, as necessary, for
reference and for recording audit evidence.
Such work documents may include the following:
— checklists
— audit sampling plans
— forms for recording information, such as
supporting evidence, audit findings and records of
meetings.

28 3 00:15:00 Slide # 68 to 93
29 3 01:00:00 Slide # 94 to 97/ Activity-20

Checklists (Aide Memoir) Session-29
1. Used by the auditor as an Aide Memoir and an audit trace record

2. A checklist is a systematic set of questions/prompts
3. A checklist should not be a list of questions to ask the auditee.
4. Are compiled from the results of a detailed study of the process
descriptions, procedures and the standard
5. Used to ensure that all elements & relevant requirements contained in
the standard are covered without any omissions

Aide Memoirs -Benefits Session-29
1. Keep audit objectives clear

2. Provide evidence of audit planning
3. Maintain audit pace and continuity
4. Reduce auditor bias
5. Reduce workload during audit
6. Can be adapted for use in other audits
7. Can be modified and improved based on experience
8. Provides structure -questions arranged in a logical order
9. Allows for review of the questions beforehand, to determine if an
expert is needed
Checklist drawbacks Session-29
1. Tick lists
2. Questionnaires
3. Too focused (may limit the scope of inquiry)
4. Inflexible and may miss valuable audit trails
5. Used as a master and may distract from active listening
6. Asked in a tone of ‘interrogation’

Activity:21 Conducting Opening Meeting Session-30
Opening
Meeting

30 3 01:00:00 Slide # 98
-- 3 00:15:00 Tea Break

Activity: 22 Session-31
HOW TO MAKE EFFECTIVE PLANT TOUR?

31 3 01:00:00 Slide # 99

Activity: 23 Interviewing ‘Top Management' Session-32

32 3 01:00:00 Slide # 100
--- 3 00:45:00 Lunch Break
PS:- to view power point notes kindly refer delegate workbook
Activity: 24 ‘Something about this activity’
(Total Time Allocated to this exercise is 9 Hrs covering two days) Session-33
From Slide Numbers 102 to 110 tutor.
Tutor will cover these slides at the end of each role-play to sum-up. And also to ensure the effective
coverage of the audit by the teams.
Activity 24 will be performed in a group and as per process approach auditing.
Lead Tutor/Tutor will play a role of Auditee in all scenarios.
Each audit team needs to interview auditee tutor during role play covering all applicable ISO9001
clauses across the specific departments assigned to the team by the tutor.
This activity to be performed on the case study “METAFORA”

33 3 02:00:00 Slide # 100 to 108
--- 3 00:15:00 Tea Break
33 3 02:00:00 Slide # 100 to 108

Activity: 24 ‘Context and Interested Parties’ Session-33
Internal issues
External Issues
Interested Parties

Activity: 24 ‘Risk & Opportunities’ Session-33

‘Legal requirements related to products’ Session-33
These are some of the products which require product certification in India.
Electrical appliances ; Milk products; Packaged drinking water; Cement; TMT bars; Pressure Cooker;
Automotive Tyres; Household Cables.
How will you audit this?
Difference between Legal Compliance evaluation between QMS Auditor and the regulatory-role of evaluating legal compliance.
Key element QMS AUDITOR Regulatory role of evaluating legal compliance

Reference ISO9001:2018 and respective legal and other Legal and other requirements.
standard requirements.
Role Can verify the compliance by checking the Can actually take a sample and send it for the verification TO
evaluation documents/records APPROVED LABORATORY.
He can take the statement of any employee for the same.
Appeals and Certification Body Law of court

Complaints
Visits Shall be planned audit May carry out surprise checks.

Activity: 24“Communication, Calibration and Environment for the
operation of processes, Infrastructure. ’
Session-33
1. internal and external parties with whom orgnization need to communicate, to ensure the
effective operation of the quality management system
2. Communication may include relevant interested parties (such as customers, external

providers used to source products and services, or regulatory bodies).
3. External Communication might require reports, specifications, invoices or service level

agreements, might be required for external relevant interested parties.
4. For internal communication, methods such as daily contact, regular department meetings,
briefing sessions, email or an intranet may be used.
5. written reports or job specifications could also be required for internal communication,
depending on the nature of the information and how critical the issues are that need to be
communicated.
Activity: 24“Environment for the operation of processes & Session-33
Infrastructure. ’
The requirements for the process environment can vary greatly depending on the type of
product and service provided. In some cases the process environment only needs to
address physical issues such as temperature, lighting, hygiene, airflow, noise, etc. In other
circumstances physical issues such as cleanliness can be a critical factor, for example, in
computer chip manufacturing which requires clean room environments.
organization has the facilities, equipment and services needed to consistently provide
conforming products and services to its customers.

Activity: 24 ‘Calibration’ Session-33
provides suitable resources to ensure valid and reliable monitoring and measuring results, when evaluating the
conformity of the organization’s products and services.

Activity: 24 ‘Objectives, Competence and Awareness’ Session-33
What, Who When and HOW of quality objectives.
Awareness is attained when persons understand their responsibilities and

authorities and how their actions contribute to the achievement of the
organization’s quality objectives.
Competence can be audited through education, training, and experience

records.

Activity: 24 ‘Operations & Performance Evaluation’ Session-33 & 34
SESSION-34 : HOME WORK DISCUSSION DAY-3

34 3 00:15:00 Specimen Exam Paper
End of Day-3
Activity: 24 ‘Improvement’ Session-35,36, 37
SESSION-35 : OVER VIEW DAY-3
SESSION-37 : HOME WORKDAY-3

35 4 00:15:00 Slide # 94 to 109; Overview
36 4 02:00:00 Slide # 110/ Activity-24
--- -- 00:15:00 Tea Break
36 4 02:00:00 Slide # 110/ Activity-24
---- --- 00:45:00 Lunch Break
36 4 02:00:00 Slide # 110/ Activity-24
--- -- 00:15:00 Tea Break
36 4 01:45:00 Slide # 110/ Activity-24
37 4 00:15:00 Specimen exam paper
End of Day-4
Activity: 25 Nonconformities & Closure Session-38 &39
SESSION-38 : OVER VIEW DAY-4
Major & Minor

38 5 00:15:00 Slide # 110 & 111; Overview
39 5 01:00;00 Slide # 111 / Activity-25

Activity: 26 Conducting Closing meeting Session-40
Closing
Meeting

40 5 01:00:00 Slide # 112/ Activity-26
-- 5 00:15:00 Tea Break

Activity: 27 Preparing Audit report (Stage-2) Session-41

41 5 01:00:00 Slide # 113/ Activity-27

Activity: 28 Audit follow-up Session-42

42 5 01:15:00 Slide # 114/ Activity-28
--- 5 00:45:00 Lunch Break
Activity: 29 Specimen exam paper Session-43

43 5 00:15:00 Speciman exam Paper

Session-44
CQI-IRCA Certified Auditor

44 5 00:15:00 Slides 116 to 125/ IRCA registration Process

CQI-IRCA Certificated Auditor Session-44
Congratulations from CQI-IRCA on completing your CQI-IRCA certified

training course!
We hope that you enjoyed the experience and that you achieved your
objectives.
what next?

Your Professional Development Session-44
Ask your CQI-IRCA approved training organization how they can help you
develop your management systems and auditing skills.
For information and support from CQI-IRCA and the CQI : Register in CQI-
IRCA for free on-line auditing magazine
Register for the CQI-IRCA and CQI on-line Linked-In discussion groups,
where you will find a community of management systems auditors who
can provide support and guidance

CQI-IRCA Auditor Status Session-44
Apply to become an CQI-IRCA Provisional Auditor.
Remember that your certificate is valid for three years for this purpose
To achieve full CQI-IRCA Internal Auditor, Auditor or Lead Auditor status, start using
your audit knowledge and skills in real audit situations.
We recommend that you do this under the supervision of a certificated Lead Auditor
until you have achieved the audit experience

CQI-IRCA Auditor Status (cont’d) Session-44
Delegates seeking a certification grade for ‘Provisional’ and beyond must

apply directly to CQI-IRCA, and demonstrate the additional skills, personal
attributes, qualifications and competencies required for the grade they
seek.
Refer to IRCA website www.quality.org for further details.

CQI Membership Session-44
If your focus will not be auditing, or you want to include wider management
systems responsibility, you should consider membership of the Chartered
Quality Institute (CQI) .
CQI-IRCA Lead Auditor courses will meet the learning requirements for the
higher CQI Practitioner membership.
This provides you with an excellent platform to progress on to becoming a

Quality Council of India (CQI)

Auditor / Lead Auditor Certification Session-44
The Criteria for Certification as a QMS Auditor

1. Auditor training course
2. Education and qualifications
3. Work experience (general and specific)
4. Auditing experience
5. Continuing professional development (CPD)
6. Code of conduct declaration

Auditor Registration Session-44
QMS Provisional Auditor:

A person who meets all the requirements for certification, except for audit
experience
QMS Auditor:
Person who is qualified to perform as an audit team member
QMS Lead Auditor:

An auditor who is qualified to manage and lead a QMS audit team
Note: Certificates are valid for FIVE (5) years from the last day of the course
for IRCA registration purposes.
Auditor Certification – Contact Details Session-44 & 45
For any Enquiries
Third floor
90 Chancery Lane
Holborn
London WC2A 1EU
T: + 44 (0) 7562168914
Email: training@quality.org
Website: www.quality.org
Session 45 Written Examination
-- 5 00:15:00 Tea Break
45 5 02:05:00 WRITTEN EXAMINATION
We hope you enjoyed your course Session-46
You will be contacted by the CQI and IRCA for feedback on the course and your Approved 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

46 5 01:00:00 Course Feedback & Closure Slide # 125 to 127

Questions & Course Feedback Session-46

Session-46

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Session-1

CQI-IRCA Accreditation No. 1898

Copyright © 2015 IRCLASS. All rights reserved.

IRCLASS Systems and Solutions Private limited

PR328 ISO 9001:2015

Session # Day Duration Training method

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CQI-IRCA Accreditation No. 1898

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Welcome to your CQI and IRCA Certified

About the CQI and IRCA

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

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Delegates must have prior knowledge of ..

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Membership offers you infinite development opportunites and is an invaluable

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9 Revision 05-2021 Copyright © 2015 IRCLASS All rights reserved. 9

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Indian Register Quality Systems

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IRQS is a Multinational Certification Body with 9 operational locations abroad and

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Established Legal Entity

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1.Sri Lanka 5.China

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Refer Delegate Activity Manual for detail Course Schedule

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Describe the purpose of:

Explain the role of an auditor to plan,

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Continuous Assessment (70% to pass)

• Participation in class and team activities

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Adherence to the time limit shall be automatically maintained as per Desktop;

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“Certificate of Attendance” will be issued

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May send in writing to IRQS

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You are attending a course certified by the International Register of

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Your achievement of the learning objectives will be fairly assessed through

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You have access to a robust complaints process and recourse to complain to

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Upon completion of this course, participants should be able to:

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– Conducting audit activities

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1. To determine conformity or non-conformity of the QUALITY management system

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Session # Day Duration Training method

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Session # Day Duration Training method