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1.1 Course Introduction and Purpose

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Management System

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Quality Management System

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Hazards, Risks and Risk Assessment

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Audit

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Conformity and Non conformity

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Correction , Corrective Action

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Documented, Documented Information

8

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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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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First Party Second Party Third Party Audit

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Audit Process flowchart (ISO 19011)

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Audit Method

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Audit Parameters, Scope-objectives and Criteria

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Types of Audit

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2 stage Audit Approach-Stage 1 Audit

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2 stage Audit Approach-Stage 2 Audit

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Certification Audit Process Steps

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Remote Audit

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Special Audits-Extension/reduction of scope

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Special Audits-Short Notice

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Special Audits- suspension, withdrawal

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Auditing Top Management

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Role of Auditors

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Responsibility of Auditors

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Auditor and Lead Auditor

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Auditors Knowledge

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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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Managing Difficult Situation during Audit -Cases

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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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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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Certification

2

Accreditation

3

Principles of Credible Certification

4

Credible certification process