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1.1 Course Introduction-Self Learning

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Evolution of Quality and ISO 9001 Standard

1

Organization

2

Quality

3

Quality Management System(QMS)

4

Quality Policy

5

Quality Objective

6

Context of an Organization

7

Documented Information

8

Process

9

Risk

10

Statutory , Regulatory Requirement

11

Measurement , Monitoring

12

Review, Verification , Validation

13

Audit, Non-Conformity, Correction and Corrective Action

14

Improvement

15

Quiz- Terms and Definition-Management System Common

14 questions

1

Purpose and Benefit of ISO 9001.2015 Standard

2

7 Quality Management Principles-Foundation of ISO 9001:2015 standard

3

7 QMS Principles

2 questions

4

Risk Based Thinking-Explained

5

ISO 9001:2015 Model and 10 Element HLS-Overview

6

1. Scope

7

2. Normative Reference

8

3.Terms and definitions

9

4.Context of the organization

10

5.Leadership

11

6.Planning

12

How to Address Risks -A real Life Example of TCB Inspection Services

13

7. Support

14

7.2 Assessing Competence

15

Measuring and Monitoring Resources

16

7.5 Control of Dcumented Information

17

8. Operation

18

8.1 Operational Planning and Control

19

8.2 Requirements for products and services

20

8.3 Design and development of products and services

21

8.4 Control of externally provided processes, products and services

22

8.5 Production and service provision

23

8.6 Release of products and services

24

8.7 Control of nonconforming outputs

25

9. Performance Evaluation

26

9.1 Monitoring, measurement, analysis and evaluation

27

9.2 Internal audit

28

9.3 Management review

29

10. Improvement

30

Quick Revision of ISO 9001:2015

31

Additional Documentation Requirement as per ISO 17020:2012

32

QMS Conformity Assessment

10 questions

1

First Party Second Party Third Party Audit

2

Audit Process Flow Chart

3

Audit Method

4

Audit Parameters, Scope-objectives and Criteria

5

Types of Audit-Certification-Surveillance-Renewal-Special Audits

6

2 stage Audit Approach-Stage 1 Audit

7

2 stage Audit Approach-Stage 2 Audit

8

Audit Process flowchart (ISO 19011)

9

Stage 1 and Stage 2 Audit Quiz

6 questions

10

Process Approach Audit-Linking Various Processes while Auditing

11

Risk Based Approach for Audit

12

Non-Conformity-Major and Minor

13

Quiz-Conducting Audit

12 questions

1

Check list, Advantage and Drawbacks

2

Audit Check list-Top Management Commitment

3

Audit Check List

1

Audit Planning process

2

Audit Team Selection

3

Prepare an Audit Plan- Explained with Demo

4

Audit Plan Quiz

6 questions

1

Opening Meeting Role Play-Video Demo

2

Auditing Competence Awareness and Training-Video

3

Control of Measuring and Monitoring Resources

4

Prepare an Audit Report- Explained with Demo

5

Review a sample Audit Report

6

Review a Closing Meeting Guide

7

Simulated Certification Audit Closing Meeting Role Play

8

Follow up Audit Process

9

Follow up Audit Quiz

10

Audit Report Quiz

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Certification and Accreditation

2

Briefly Explain Risk Based approach to Audit

3

Briefly Explain the evidence based approach to Audit

4

Briefly Explain the Importance of Confidentiality in an Audit

5

Quiz Certification and Accreditation

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TCB Examination-CBT(Classmarker)