3 2 2 IRCA QMSLA Slides.-15-07-2020 [PDF]

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Session-1 CQI-IRCA Accreditation No. 1898

ISO9001 2015 Quality Management Systems Auditor/Lead Auditor Training Programme

Copyright © 2015 IRCLASS. All rights reserved.

Session-1

IRCLASS Systems and Solutions Private limited Welcome you all for

Quality Management Systems Auditor/Lead Auditor Training Course Session # 1

Day 1

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Duration 00:45:00

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Training method Slide # 1 to 30

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Session-1

Instructions!

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Lead Auditor Course

CQI-IRCA Accreditation No. 1898 Trainer: Location: Dates:

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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

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Session-1

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. Revision 15-JULY-2020 -

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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. Revision 15-JULY-2020 -

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Session-1

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

Session-1

Indian Register Quality Systems

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Session-1

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 2.United Kingdom 3.South Korea 4.Singapore

5.China 6. U.S.A. 7.Thailand 8.Greece 9. UAE

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Session-1

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; • of management system audit; • of third-party certification.

Have the skills to: • Plan; • Conduct; • Report; • And follow up… SKILLS

KNOWLEDGE Explain the role of an auditor to plan, conduct, report and follow up an QMS audit in accordance with ISO 19011 (and ISO 17021 where appropriate).

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…an audit of QMS to establish conformity (or otherwise) with ISO9001 2015; ISO 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) Revision 15-JULY-2020 -

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Session-1

Continuous Assessment

• Participation in class and team activities • Written assignments • Attitude and personal attributes • Attendance and punctuality • Communication skills • Feedback

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Session-1

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 Revision 15-JULY-2020 -

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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. Revision 15-JULY-2020 -

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Session-1

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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CQI-IRCA Course Certification

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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CQI-IRCA Course Certification

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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CQI-IRCA Course Certification

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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Session-1

Enabling Objectives

Knowledge Revision 15-JULY-2020 -

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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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Session-1

Learning Outcomes

– Conducting audit activities – Reporting on audit findings – Conducting post-audit activities

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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: 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. 1.

Session # 2

Day 1

Duration 00:15:00 Revision 15-JULY-2020 -

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Training method Slide # 31 & 85 31

Activity-1 : Terms & Definitions related to audit

Session-3

Session #

Day

Duration

Training method

3

1

00:30:00

Slide # 32/Activity

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

Session # 4

Day 1

Session-4

Duration

Training method

00:30:00

Slide # 33 to 39/Activity

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Session-4

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. Revision 15-JULY-2020 -

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Session-4

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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Session-4

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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Session-4

Third-party Accredited Certification

Third-party Accredited Certification

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Session-4

Third-party Accredited Certification SEQUENCE INTERNATIONAL ACCREDITATION FORUM

CERTIFIED TO

AGENCY

-----

ACCREDITATION BODIES

ISO/IEC 17011Conformity assessment -- General 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 Revision 15-JULY-2020 -

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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 reaudit your business Revision 15-JULY-2020 -

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Activity: 3 Audit Process and its Deliverables INPUTS

AUDIT ACTIVITY

Session-5 OUTPUTS

AUDIT CRITERIA (REQUIREMENTS)

AUDIT FINDINGS

AUDIT EVIDENCE (OBJECTIVE)

Session # 5

EVALUATION

Comparison (1st, 2nd 3rd party certification audit) Guidelines for auditing Management systems (ISO 19011:2011) Duration Day Training method 1 00:30:00 Slide # 40 to 43/Activity Revision 15-JULY-2020 -

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Session-5

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 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 Revision 15-JULY-2020 -

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Session-5

Typical Audit Activities 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 Preparing the audit plan 6.2.3 Determining feasibility of audit 6.3.3 Assigning work to the audit team 6.3.4 Preparing work documents

6.3 Preparing audit activities. 6.4.1 General information 6.3.1 Performing review of documented

6.3.2 Audit planning 6.3.3 Assigning work to

6.4.2 Conducting the opening meeting 6.4.3 Performing document review while conducting the audit 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 audit 6.4.7 teamGenerating 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) Revision 15-JULY-2020 -

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Session-5

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. 6.5 Preparing and distributing audit report 6.5.1 Preparing audit report 6.5.2 Distributing audit report 6.6 Completing audit 6.7 Conducting audit follow-up Revision 15-JULY-2020 -

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NOTE: Sub-clause numbering refers to the relevant sub-clauses of this International Standard.

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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?

Session #

Day

Duration

Training method

6

1

00:30:00

Slide # 44 /Activity

-----

1

00:15:00

Tea Break

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

Session-7

Session #

Day

Duration

Training method

7

1

00:30:00

Slide # 45 to 48/Activity

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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. Revision 15-JULY-2020 -

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

Session-7

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 Revision 15-JULY-2020 -

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

Session-7

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 Revision 15-JULY-2020 -

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Session-8

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. Session # 8 --

Day 1 1

Duration 00:45:00 00:45:00 Revision 15-JULY-2020 -

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Training method Slide # 49 & 50/Activity Lunch Break 49

Session-8

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 Revision 15-JULY-2020 -

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Session-9

Activity:6 Roles & Responsibilities

Session # 9

1

2

3

Guide(s)

Audit Client

Person(s) managing the audit programme

Auditee(s) (including management)

Auditors

Lead Auditor

Observer(s)

Technical experts

Person(s) managing the audit programme

Day 1

Duration 00:45:00 Revision 15-JULY-2020 -

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Training method Slide # 51/Activity 51

Session-10

Activity:7 Audit methods

Session # 10

Day 1

Duration 00:30:00 Revision 15-JULY-2020 -

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Training method Slide # 52 to 56/Activity 52

Session-10

Auditor Confidentiality

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Session-10

Stage-1 Audit Process & Deliverables Audit Plan Ensure an adequacy of Organization established documentation Ensure the relevant procedures to be used during audit

Principle of Stage 1 audit

Identify any specific needs, skills, Personal protective equipments

Understand the hazards, risks & identify relevant legal requirement Gain an understanding Context of the organization Demonstrate scope and objective

Ensure Organization readiness for an audit Resolve any misunderstandings Identify organization/plant layout and its context of QMS

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Session-10

Stage -2 Audit Process & Deliverables Consider: • Past results (if available) • Present issues/ risks • Management's issues • Management's priorities Establish level of audit and resources necessity

Organize work documents

Determine the importance/risk (including legal Requirements)

Identify the hazard potential of: • Activities • Products • and Services

Establish and concur audit plan

Contact auditee and confirm date(s)

Audit Team assignment

Brief the audit team

Stage 1 Report Consideration

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Session-10

Initial certification audit – Stages 1 & 2 From ISO 17021

Opening Meeting 17021:2011

Checklists

Audit Plan

Stage 2

From ISO 17021

Opening Meeting 17021:2011

Audit Plan

Nonconformity Reports

Onsite Audit Checklists

Closing Meeting

3 Yearly Recertification

Objective evidence Audit Recommendation & conclusion

Closing Meeting

Stage 1

Corrective Actions

Document Review

Objective evidence Audit Recommendation & conclusion

Audit report

Corrective Actions

Nonconformity Reports

Audit report

Surveillance Assessment Visits (1 & 2 ) followed by Renewal Audit

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Session-11

Activity:8 Audit Plan 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. Session # 11 ---

Duration 00:30:00 00:15:00

Day 1 1

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Training method Slide # 57 to 59 /Activity Tea Break

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Session-11

Work Documents

1. Checklists 2. Audit Sampling Plan 3. Formats for capturing the evidences 4. Non-conformity format

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Session-11

Work Documents

Advantages/Dis-advantages of Checklist

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Session-12

Activity:9 Conducting Opening meeting

Session # 12

Day 1

Duration 01:00:00

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Training method Slide # 60 & 61 and Slide 80 /Activity

60

Session-12

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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Session-13

Activity:10 Audit Evidence

Session # 13

Duration 00:45:00

Day 1

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Training method Slide # 62 to 67 /Activity

62

Session-13

Evidences

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Session-13

Sources of (Evidence) Information

1. 2. 3. 4. 5. 6. 7. 8.

Interviews Observations Documents Records Data summaries Reports Database and Website Performance Indicator

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Session-13

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 Revision 15-JULY-2020 -

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Session-13

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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Session-13

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? End of day-1 Revision 15-JULY-2020 -

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Activity:11 Effective Communications Protocol

Session-14 &15

Session- 14- OVERVIEW OF DAY-1

Session- 15- ACTIVITY-11 Session # 14 15

Duration 00:15:00 00:30:00

Day 2 2 Revision 15-JULY-2020 -

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Training method Slide # 30 to 67, Overview of day-1 Slide # 68 to 71/Activity-11 68

Session-15

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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Session-15

Questioning Technique

1. 2. 3. 4. 5. 6. 7.

Open ended Closed ended Questions Specific Leading Hypothetical Reflective Probing

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Session-15

Effective Communication

55%

38%

7%

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• Body Language

• Tone of Voice

• Words

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Session-16

Audit Findings

Positive audit findings Nonconformity ; ref. (ISO9000:2015,non fulfilment of a requirement)

Session # 16

Duration 00:30:00

Day 2

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Training method Slide # 72 to 77 72

Session-16

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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Session-16

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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Session-16

Nonconformity Statement (Cont’d)

1. 2. 3. 4. 5. 6. 7.

State the exact nature of the problem clearly Avoid generalities Communicate the extent of the problem fully Do not draw legal opinion Avoid extreme language Use familiar terminology Give legislative, site or good management practice reference 8. Avoid contradictory messages Revision 15-JULY-2020 -

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Session-16

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 Revision 15-JULY-2020 -

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Session-16

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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Session-17

Audit Meetings

1. Audit Briefing meetings 2. Progress meetings 3. Audit Team meetings

Session # 17

Duration 00:30:00

Day 2

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Training method Slide # 78 to 79 78

Session-17

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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Session-12

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) Revision 15-JULY-2020 -

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Session-18

Audit Report The audit report should include 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Session # 18

Audit Team Leader responsible for preparing the Audit Report Audit Objectives, scope & criteria Identification of audit client Identification of processes audited and time period. dates and locations where the audit activities were conducted Identification of audit team leader & members Audit findings and related evidence Recommendations for improvement Audit conclusions Statement of Confidentiality Next audit date/s Distribution list for the audit report Duration 00:15:00

Day 2

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Training method Slide # 81 to 83 81

Approving & Distributing the Audit Report

1. 2. 3. 4.

Session-18

Report should be issued within agreed time or communicate reason for delay to the audit client Report to be dated, reviewed and approved in accordance with the audit programme procedure Distributed to recipients designated by the audit client Audit Report is the property of the audit client, hence audit team should maintain confidentiality of the report

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Session-18

Audit Report Contents

Generation of Audit report No

Technical review Yes

Report Clearance

Client (Audit Report) communication

Client Acceptance

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Session-19

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 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.

Session # 19

Duration 00:45:00

Day 2

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Training method Slide # 84/ Activity-12 84

Session-2

Benefits of ISO9001 2015

To Customers To Orgnization & To other interested parties.

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85

Session-20

Activity:13 Terminology (ISO9001 2015)

Session # 20 ---

Duration 00:15:00 00:15:00

Day 2 2 Revision 15-JULY-2020 -

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Training method Slide # 86 & 87/Activity-13 Tea Break 86

Session-20

PdCa

Plan Do Check Act

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Session-21 & 22

Activity-14 & 15 : Structure of QMS

Activity-14, understanding the ISO9001 2015, Activity-15, Audit Trail ( Forward Tracing, Backward Tracing)

Session # 21 22 ---

Duration 00:30:00 01:00:00 00:45:00

Day 2 2 2

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Training method Slide # 88 Slide # 88 Lunch Break

88

Session-23

Activity-16: Documented Information

Documented Information to be maintained

Documented information to be retained

Session # 23

Duration 00:45:00

Day 2

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Training method Slide # 89

89

Session-24

Enabling Objectives

Skills Session # 24

Day 2

Duration 00:30:00

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Training method Slide # 90 & 91

90

Session-24

Activity:17 Initiating the audit PREPARE FOR THE AUDIT

• •

• • • •

INITIATE THE AUDIT Establishing initial contact with the auditee Determine feasibility of Audit

Gather background information Prepare the audit plan Assign work to the audit team Prepare work documents

CONDUCT THE AUDIT PREPARE & DISTRIBUTE AUDIT REPORT • Prepare the audit report • Distribute the audit report

• • • • • •

CONDUCT AUDIT FOLLOW-UP ( if specified in the audit plan)

Conduct opening meeting Manage communication Collect & verify information Generate audit findings Prepare audit conclusions Conduct closing meeting

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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Session-25

Activity:18 Document review

The auditors should consider if the information in the documents provided by client shall be: 1. 2. 3. 4. 5. 6.

complete correct consistent current cover the audit scope and provide sufficient information to support the audit objectives the use of information and communication technologies Session # 25

Day 2

Duration 01:00:00

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Training method Slide # 92

92

Session-26 & 27

Activity:19 Audit Plan

Session # 26 27

Day 2 2

Duration 01:30:00 00:15:00 Revision 15-JULY-2020 -

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Training method Slide # 93 Specimen Exam paper

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. Session # 28 29

Day 3 3

Duration 00:15:00 01:00:00 Revision 15-JULY-2020 -

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Training method Slide # 68 to 93 Slide # 94 to 97/ Activity-20 94

Session-29

Checklists (Aide Memoir)

1. 2. 3. 4.

Used by the auditor as an Aide Memoir and an audit trace record A checklist is a systematic set of questions/prompts A checklist should not be a list of questions to ask the auditee. 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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Session-29

Aide Memoirs -Benefits

1. 2. 3. 4. 5. 6. 7. 8. 9.

Keep audit objectives clear Provide evidence of audit planning Maintain audit pace and continuity Reduce auditor bias Reduce workload during audit Can be adapted for use in other audits Can be modified and improved based on experience Provides structure -questions arranged in a logical order Allows for review of the questions beforehand, to determine if an expert is needed Revision 15-JULY-2020 -

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Session-29

Checklist drawbacks

1. 2. 3. 4. 5. 6.

Tick lists Questionnaires Too focused (may limit the scope of inquiry) Inflexible and may miss valuable audit trails Used as a master and may distract from active listening Asked in a tone of ‘interrogation’

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Activity:21 Conducting Opening Meeting

Session-30

Opening Meeting

Session # 30 --

Day 3 3

Duration 01:00:00 00:15:00 Revision 15-JULY-2020 -

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Training method Slide # 98 Tea Break 98

Session-31

Activity: 22 HOW TO MAKE EFFECTIVE PLANT TOUR?

Session # 31

Day 3

Duration 01:00:00

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Training method Slide # 99 99

Session-32

Activity: 23 Interviewing ‘Top Management'

Session # 32 ---

Duration 01:00:00 00:45:00

Day 3 3

Training method Slide # 100 Lunch Break

PS:- to view power point notes kindly refer delegate workbook Revision 15-JULY-2020 -

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100

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” Session # 33 --33

Duration 02:00:00 00:15:00 02:00:00

Day 3 3 3 Revision 15-JULY-2020 -

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Training method Slide # 100 to 108 Tea Break Slide # 100 to 108 101

Activity: 24 ‘Context and Interested Parties’

Session-33

Internal issues External Issues Interested Parties

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102

Session-33

Activity: 24 ‘Risk & Opportunities’

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103

Session-33

‘Legal requirements related to products’

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 standard

ISO9001:2018 and respective legal and other requirements.

Legal and other requirements.

Role

Can verify the compliance by checking the evaluation documents/records

Can actually take a sample and send it for the verification TO APPROVED LABORATORY. He can take the statement of any employee for the same.

Appeals and Complaints

Certification Body

Law of court

Visits

Shall be planned audit

May carry out surprise checks. Revision 15-JULY-2020 -

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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. Revision 15-JULY-2020 -

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Activity: 24“Environment for the operation of processes & Infrastructure. ’

Session-33

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.

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Session-33

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.

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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.

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Activity: 24 ‘Operations & Performance Evaluation’

Session-33 & 34

SESSION-34 : HOME WORK DISCUSSION DAY-3 Session # 34

Duration 00:15:00

Day 3

Training method Specimen Exam Paper

End of Day-3 Revision 15-JULY-2020 -

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Session-35,36, 37

Activity: 24 ‘Improvement’

SESSION-35 : OVER VIEW DAY-3

SESSION-37 : HOME WORKDAY-3 Session # 35 36 --36 ---36 --36 37

Day 4 4 -4 --4 -4 4

Duration 00:15:00 02:00:00 00:15:00 02:00:00 00:45:00 02:00:00 00:15:00 01:45:00 00:15:00

Training method Slide # 94 to 109; Overview Slide # 110/ Activity-24 Tea Break Slide # 110/ Activity-24 Lunch Break Slide # 110/ Activity-24 Tea Break Slide # 110/ Activity-24 Specimen exam paper

End of Day-4 Revision 15-JULY-2020 -

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110

Session-38 &39

Activity: 25 Nonconformities & Closure

SESSION-38 : OVER VIEW DAY-4

Major & Minor Session # 38 39

Day 5 5

Duration 00:15:00 01:15;00 Revision 15-JULY-2020 -

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Training method Slide # 110 & 111; Overview Slide # 111 / Activity-25 111

Session-40

Activity: 26 Conducting Closing meeting

Closing Meeting

Session # 40 --

Day 5 5

Duration 01:00:00 00:15:00 Revision 15-JULY-2020 -

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Training method Slide # 112/ Activity-26 Tea Break 112

Activity: 27 Preparing Audit report (Stage-2)

Session # 41

Day 5

Duration 01:00:00 Revision 15-JULY-2020 -

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Session-41

Training method Slide # 113/ Activity-27 113

Session-42

Activity: 28 Audit follow-up

Session # 42 ---

Day 5 5

Duration 01:15:00 00:45:00 Revision 15-JULY-2020 -

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Training method Slide # 114/ Activity-28 Lunch Break 114

Session-43

Activity: 29 Specimen exam paper

Session # 43

Day 5

Duration 00:15:00 Revision 15-JULY-2020 -

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Training method Speciman exam Paper 115

Session-44

CQI-IRCA Certified Auditor

Session # 44

Day 5

Duration 00:10:00 Revision 15-JULY-2020 -

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Training method Slides 116 to 125/ IRCA registration Process 116

Session-44

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?

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Session-44

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 CQIIRCA 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

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Session-44

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

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Session-44

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.

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Session-44

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)

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Session-44

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

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Session-44

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 Revision 15-JULY-2020 -

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Session-44 & 45

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: [email protected] Website: www.quality.org

Session 45 Written Examination Session # -45

Day 5 5

Duration 00:15:00 02:05:00 Revision 15-JULY-2020 -

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Training method Tea Break WRITTEN EXAMINATION 124

Session-46

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 Session # 46

Day 5

Duration 00:45:00 Revision 15-JULY-2020 -

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Training method Course Feedback & Closure Slide # 125 to 127 125

Session-46

Questions & Course Feedback

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126

Session-46

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