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1.1 Course Introduction and Purpose

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Quality Management System(QMS)

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Management System

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Quality Management System

4

Hazards, Risks and Risk Assessment

5

Audit

6

Conformity and Non conformity

7

Correction , Corrective Action

8

Documented, Documented Information

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Quiz- Terms and Definition

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3.1 Hazard Identification, Risk Assessment and Controls

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3.2. HIRA Process

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3.3 -Overview of HIRA and Controls

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3.4 Review a sample HIRAC document and Identify Inadequacies

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Purpose and Benefit

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ISO 9001:2015 Model and 10 Element HLS

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1.Scope

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2.Normative Reference

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3.Terms and definitions

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4.Context of the organization

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5. Leadership

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6. Planning

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7. Support

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8. Operation

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9. Performance Evaluation

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10. Improvement

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Conformity Assessment Cases

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Case Study-Conformity Assessment 1

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Case Study Conformity Assessment 2

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Role of Auditors

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Responsibility of Auditors

3

Auditor and Lead Auditor

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Auditors Knowledge

5

Auditors Behavioral Attributes

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Technical Expert

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Audit Guides

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Auditors Competence Evaluation Process

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Auditors skill sets

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Types and Questions and Auditors Questioning `skill

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Selecting Audit Team

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Quiz -Auditors Roles and Responsibility

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Managing Difficult Situation during Audit -Cases

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Managing Difficult Situation during Audit – Case 2

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Managing Difficult Situation during Audit – Case 3

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Audit Check List

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Usefulness of Check list

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Limitation and Drawback of Check list

4

Q

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How to Audit Purchase Process

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How to Audit Measuring and Monitoring Resources (Calibration)

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How to Audit Control of Non-conforming Output

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How to Audit Internal Audit

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How to Audit Improvement

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WSE 2 :Prepare a Check List – Auditing Top Management

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Audit Planning

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Selection of Team

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Prepare an Audit Plan -Consideration

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What is Audit Plan and Audit Schedule

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WSE 6 : Opening Meeting Role Play

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WSE 7: Auditing Competence Awareness And Training -UMS Case study

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WSE 8: Auditing Control of Measuring and Monitoring resources -UMS Case study

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WSE 9 : -Customer Related Process -External and Internal Communication

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WSE 10: Procurement and outsourcing

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WSE 11: Planning for Product Realization

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WSE 12: Product and Service Provision

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WSE 13: Measurement and monitoring ,NC Output, Release of Products

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WSE 14: Auditing Internal Audit Process

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WSE 15: Prepare a Certification Audit Report

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WSE 16: Close out Meeting Role Play

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WSE 17: Conducting a Follow-up Audit

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Certification

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Accreditation

3

Principles of Credible Certification

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IAF , Accreditation and Certification Bodies Hierarchy

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Credible certification process

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ISO 9001:2015 Lead Auditor Exam -Certificates with IACET CEU

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12.2 : Written Exam by CQI/IRCA Online CBT (Certificates issued by TCB with ICQ/IRCA Logo and Unique Learner No.)