Quality Management Systems: Auditor/Lead Auditor Training Programme

ISO9001 2015
Quality Management Systems

Auditor/Lead Auditor Training Programme
IRCLASS Systems and Solutions Private limited
Welcome you all
for
Quality Management Systems
Auditor/Lead Auditor Training Course
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Instructions!

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Lead Auditor Course
CQI-IRCA Accreditation No. 1898
Trainer: Mr. XXXXXX XXXXXXXXXXX
Location: YYYYY
Dates: 19th November to 23th November-2018

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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

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Course Prerequisite
Delegates must have prior knowledge of ..

• Plan-Do-Check-Act
• “7” Quality Management Principles – CLIP E2R
• 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.

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CQI-IRCA Benefits
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.
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Welcome Note

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Delegates Introduction
Name
Academics
Organization
QMS Auditing Experience, if any

Your Expectations from the Course
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IRclass

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IRQS is a department of IRCLASS Systems and Solutions Pvt Ltd
Indian Register Quality Systems
IRCLASS
Departments Industrial
Marine Services IRQS
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IRQS is a department of IRCLASS
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.

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Our Strengths
Established Legal Entity

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

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IRClass on Global Presence
1.Sri Lanka 5.China

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

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Course Aim
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

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Learning Objectives
Describe the purpose of:

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

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

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

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

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

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Examination
The written 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 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
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Examination
The time allotted for taking the examination shall be two hours.
only permissible materials during Exam are one unmarked copy of the
standard and a bilingual dictionary.
Strict adherence to the time limit shall be maintained.
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 written examination.

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Examination
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

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Certificates
“Certificate of Achievement”:
else
“Certificate of Attendance” will be issued
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Complaints/Appeals
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

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CQI-IRCA Course Certification
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”

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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

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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

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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.

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Enabling Objectives
Knowledge
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Learning Outcomes
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

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Learning Outcomes
– Conducting audit activities

– Reporting on audit findings
– Conducting post-audit activities

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Why Management System Audit is essential?
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.

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Activity-1 : Terms & Definitions related to audit

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

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First Party Audit
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.

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Second Party Audit
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

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Third Party Audit
Independent of the organization being audited

Compared to first and second party audits where auditors are either from
same orgnization or from customer/supplier, in the third party audit it is by an
independent orgnization.
Generally used to certify, register or verify
Reasons to Perform: Verify compliance to specific regulations or standards
For example : ISO9001:2015 requirements.

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Third-party Accredited Certification

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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

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Third-Party Accredited Certification- Benefits
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

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Activity: 3 Audit Process and its Deliverables
Comparison (1st, 2nd 3rd party certification audit)
INPUTS AUDIT ACTIVITY OUTPUTS
AUDIT CRITERIA
(REQUIREMENTS)
AUDIT FINDINGS
AUDIT EVIDENCE
(OBJECTIVE) EVALUATION
Guidelines for auditing Management systems (ISO 19011:2018)

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Audit Process
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
5. Is intent of leadership translated and what needs to be where w.r.t. QMS decided?
Documentation of QMS
6. Does this translated to adequate procedures, instruction, records and monitoring?
Implementation of QMS
7. Is implementation meets the expectations of the requirements?
Maintenance (Effectiveness) of QMS
8. Selection of audit team; concerns reporting and closure, continual improvement
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Typical Audit Activities
6.2 Initiating audit

6.2.1 General
6.2.2 Establishing initial contact with the auditee
6.2.1 General 6.2.3 Determining the feasibility of the audit
6.2.2 Establishing contact with auditee

6.3.1 Performing document review in preparation for the audit
6.2.3 Determining feasibility 6.3.2
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 information
6.3.2 Audit planning
6.3.3 Assigning work to audit team
6.3.4 Preparing documented information for audit

Cont’dplan)
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Typical Audit Activities
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 ISO19011
6.5.2 Distributing audit report International Standard.
6.6 Completing audit
6.7 Conducting audit follow-up

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

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

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Establishment of Objectives, Scopes & Criteria's (cont’d)
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.

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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

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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
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Resources
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.

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Resources- Competency
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

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

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Auditor Confidentiality
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

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Activity:7 Audit methods

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

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Stage -2 Audit Process & Deliverables
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

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Initial certification audit – Stages 1 & 2
From ISO 17021
Opening Meeting
17021:2011 Document Review Corrective Actions
Audit Plan Checklists Objective evidence Nonconformity 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

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Activity:8 Audit Plan
The audit plan enveloped by

1. Risks to achieving the audit objectives created by ineffective audit planning;
2. Risks to the auditee created by performing the audit.
3. Audit objectives
4. Audit scope
5. Functional units, as well as processes to be audited
6. Audit criteria
7. Any reference documents
8. locations, dates, expected time and duration of audit activities to be conducted
9. Audit methods
10. Audit evidence
11. Roles and responsibilities of the audit team members, including guides & observers
12. Allocation of critical areas of the audit.
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Work Documents
1. Checklists – Hard or Digitial
2. Audit Sampling Plan
3. Formats for capturing the evidences
4. Non-conformity format

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Work Documents
Advantages/Dis-advantages of Checklist

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Activity:9 Conducting Opening meeting

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Conducting Opening meeting
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.

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Activity:10 Audit Evidence

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Evidences

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

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Sources of (Evidence) Information
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

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Audit Evidence
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

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Audit Sampling
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?

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Activity:11 Effective Communications Protocol

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Communications Protocol
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

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Questioning Technique
1. Open ended Closed ended

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

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

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Audit Findings
Positive audit findings
Nonconformity ; ref.
(ISO9000:2015,- Non Fulfilment of a requirement)

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Nonconformity
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

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Nonconformity Statement
Use auditee’s terminology

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

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Nonconformity Statement (Cont’d)
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

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Minor Non-conformance
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
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Major Non-conformity
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.

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Audit Meetings
1. Audit Briefing meetings

2. Progress meetings
3. Audit Team meetings

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Audit Conclusions
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

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Closing Meeting
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)
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Audit Report
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
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Approving & Distributing the Audit Report
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

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

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Activity:12 Audit Follow-up
The conclusions of the audit can be include with,
1.depending on the audit objectives

2.indicate the need for corrections & /or corrective action improvement
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.

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Benefits of ISO9001 2015
To Customers
To Orgnization
&
To other interested parties.

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Activity:13 Terminology (ISO9001 2015)

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PdCa
Plan
Do
Check
Act

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Activity-14 & 15 : Structure of QMS
Activity-14, understanding the ISO9001 2015,
Activity-15, Audit Trail ( Forward Tracing, Backward Tracing)

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

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Enabling Objectives
Skills
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Activity:17 Initiating the audit
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

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Activity:18 Document review
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

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Activity:19 Audit Plan

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Activity:20 Work Documents
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.

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Checklists (Aide Memoir)
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

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Aide Memoirs -Benefits
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
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Checklist drawbacks
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’

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Activity:21 Conducting Opening Meeting
Opening Meeting

98
Activity: 22
HOW TO MAKE EFFECTIVE PLANT TOUR?

99
Activity: 23 Interviewing ‘Top Management'
PS:- to view power point notes kindly refer delegate workbook

100
Activity: 24 ‘Something about this activity’
(Total Time Allocated to this exercise is @9 Hrs covering two days)
From Slide Numbers 102 to 110 tutor.
Tutor will cover these slides at the end of each role-play while giving feedback to
delegates this also to ensure the effective coverage of the audit by the teams.

101
Auditing ISO9001:2015 requirements
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”

102
Activity: 24 ‘Context and Interested Parties’
Internal issues
External Issues
Interested Parties
Scope
QMS Management Processes

103
Activity: 24 ‘Risk & Opportunities’

104
‘Legal requirements related to products’
These are some of the products which require product certification in India.
1. Electrical appliances
2. Milk products
3. Packaged drinking water
4. Cement
5. TMT bars
6. Pressure Cooker
7. Automotive Tyres
8. Household Cables.
How will you audit this?

105
‘Legal requirements related to QMS’
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 standard ISO9001:2018 and respective Legal and other requirements.
legal and other
requirements.
Role Can verify the compliance by Can actually take a sample and send it for the verification
checking the evaluation TO APPROVED LABORATORY.
documents/records 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.

106
Activity: 24“Communication, Calibration and Environment for the operation of
processes, Infrastructure. ’
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.
107
Activity: 24“Environment for the operation of processes & 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.

108
Activity: 24 ‘Calibration’
provides suitable resources to ensure valid and reliable monitoring and measuring results, when evaluating the
conformity of the organization’s products and services.

109
Activity: 24 ‘Objectives, Competence and Awareness’
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.

110
Activity: 24 ‘Operations & Performance Evaluation’

111
Activity: 24 ‘Improvement’

112
Activity: 25 Nonconformities & Closure
Major & Minor

113
Activity: 26 Conducting Closing meeting
Closing
Meeting

114
Activity: 27 Preparing Audit report (Stage-2)
- 1) ge-2)
e a
(St
a g (St

115
Activity: 28 Audit follow-up

116
Activity: 29 Specimen exam paper

117
CQI-IRCA Certified Auditor

118
CQI-IRCA Certificated Auditor
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?

119
Your Professional Development
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

120
CQI-IRCA Auditor Status
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

121
CQI-IRCA Auditor Status (cont’d)
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.

122
CQI Membership
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)

123
Auditor / Lead Auditor Certification
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

124
Auditor Registration
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 three (3) years from the last day of the course

125
Auditor Certification – Contact Details
For any Enquiries
2nd Floor North

Chancery Exchange
10 Furnival Street
EC4A 1AB, London.
Telephone: +44 (0)20 7245 6833
Fax: +44 (0)20 7245 6755
Email: training@quality.org
Website: www.quality.org

126
We hope you enjoyed your course

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

127
Questions & Course Feedback

128
129

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ISO9001 2015

Quality Management Systems

Revision MAR-2019 - Copyright © 2019 IRCLASS All rights reserved. 2

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CQI-IRCA Accreditation No. 1898

Trainer: Mr. XXXXXX XXXXXXXXXXX

Dates: 19th November to 23th November-2018

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About the CQI and IRCA

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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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QMS Auditing Experience, if any

9 Revision MAR-2019 - Copyright © 2019 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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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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Strict adherence to the time limit shall be maintained.

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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:

Revision MAR-2019 Copyright © 2019 IRCLASS All rights reserved. 29

– Conducting audit activities

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Management System Audits are an essential element of the quality assurance

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

Audits may also consider for meeting regulatory requirements.

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An organization auditing its own systems, a self-assessment

Used to measure the strengths and weaknesses against requirements,

Provide feedback to management that the QMS system is both

Gauged for continuous improvement effort as well as measuring the

Revision MAR-2019 Copyright © 2019 IRCLASS All rights reserved. 34

Inspections/Audits of Other Facilities

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Independent of the organization being audited