Preview ISO 9001:2015 Internal Auditor training

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Module 1: Introduction to Quality management System and process approach

Introduction to ISO 9001:2015 internal Auditor

Session Objectives

About ISO

Why ISO

ISO 9001:2015 Definition

Need for Quality

Cost of Quality

Origin and History of ISO 9000

Review and revision of Standards

ISO 9001 - Relevance in other Industry

The Revised Quality Principles

Process Approach

0.3 Process approach - Model of a process based QMS

0.3 Process approach

Evidenced based decision making

Relationship Management

3 Core concepts

Section 1 assessment ISO 9001

Module 2: Quality management system principles & HLS

Management System

Quality Management System

What is quality management all about?

Key Changes

Key Benefits of High Level Structure

Benefits for the Organization

Process based model of QMS-Cl. 4

HLS and the new ISO 9001:2015 Structure

Overview of ISO 9001:2015

1.0 Scope

3.0 Terms and definition Sl-1

3.0 Terms and definition Sl-2

3.0 terms and definition SL-3

Section 2 assessment ISO 9001

Module 3: Context of the Organization

4.0 Context of the organization

4.1 Context of the Organization SL-1

4.1 Context of the Organization SL-2

4.1 Context of the Organization SL-3

4.2 Understanding the needs and expectations SL-1

4.2 Understanding the needs and expectations SL-2

4.3 Determining the scope of QMS

4.4 Quality Management System & its Process- 4.4.1

4.4 Quality Management System & its Process- 4.4.2

Clause 4.0 Summary

Auditing Clause 4.0 Hints

Section 4 Assessment ISO 9001

Module 4: Leadership Principles

5.0 Leadership

5.1 Leadership and Commitment

5.1.2 Customer focus

5.2 Quality Policy

5.3 Organizational Roles, Responsibilities & Authorities

Clause 5.0 Summary

Auditing Clause 5.0 Hints

Section 5 assessment ISO 9001

Module 5: Planning

6.0 Planning

6.1 Actions to address risks & opportunities QMS

Risks and opportunities

What is risk based thinking?

What is risk based thinking?- Why Should I adopt

What is risk based thinking?- What Should I do?

Risk management- What is Risk

6.2 Quality Objectives and planning to achieve

6.3 Planning of changes

Clause 6.0 Summary

Auditing Clause 6.0 Hints

Section 6 assessment ISO 9001

Module 6: Support process

7.0 Support Processes

7.1 Resources 7.1.1 General

7.1.2 Resources - People

7.1.3 Resources - Infrastructure

7.1.4 Resources – Environment for the operation of processes

7.1.5 Monitoring & Measuring Resources

7.1.5.2 Measurement traceability

7.1.6 Organizational Knowledge QMS

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented Information

7.5 Documented Information 7.5.1 General

7.5 Documented Information 7.5.2 Creation and updating

7.5 Documented Information 7.5.3 Control

7.5 Documented Information

Clause 7.0 Summary

Auditing Clause 7.0 Hints

Module 7: Operation

8.0 Operation

8.1 Operational planning and control

8.2 Requirements for products and services

8.2.3 Review of the requirements for products and services

8.2.4 Changes to requirements for products and services

8.3 Design and Development of Products and Services 8.3.1 General

8.3.2 Design and Development Planning

8.3.3 Design and Development Inputs

8.3.4 Design and Development Controls

8.3.5 Design and Development Outputs

8.3.6 Design and Development change

8.4 Control of externally provided Products & Services

8.4.2 Control of externally provided Products & Services - Type and extent of control

8.4.3 Control of externally provided Products & Services – Information for external providers

8.5 Production and service provision 8.5.1 Control of Production and service provision

8.5.2 Identification and Traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

8.5.6 Control of changes

8.6 Release of products and services

8.7 Control of nonconforming outputs

8.7 Control of nonconforming outputs 8.7.2

Clause 8.0 Summary

Auditing Clause 8.0 Hints

Section 7 Assessment ISO 9001

Module 8: Performance Evaluation

9.0 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction

9.1 Monitoring, measurement, analysis and evaluation 9.1.3 analysis and evaluation

9.2 Internal audit 9.2.1

9.2 Internal Audit 9.2.2

9.3 Management Review 9.3.1

9.3 Management review Inputs 9.3.2

9.3 Management Review 9.3.3

Clause 9.0 Summary

Auditing Clause 9.0 Hints

Module 9: Improvement

10.0 IMPROVEMENT

10.1 General

10.2 Nonconformity and corrective action 10.2.1

10.2 Nonconformity and corrective action 10.2.2

10.3 Continual improvement

Clause 10.0 Summary

Auditing Clause 10.0 Hints

External Audit Cycle ISO 9001

THANK you

Section 8 & 9 Assessment ISO 9001

Module 10: Internal Audit introduction ISO 19011:2018

Introduction to ISO 19011- Internal audit

Audit definition

Audit - Terms and Definitions

Principles of Auditing

Audit Objectives

Internal Vs External Audits

Module 11: Planning and preparation for an audit

Planning and preparation of audit - different stages in an audit cycle

Audit Management

Internal Audits

Planning and preparation for an audit

Planning and preparation of audit

Planning and preparation for an audit- Initiating the audit

Audit criteria Vs audit scope

Planning & Preparation of an Audit Selection of an audit team

Planning & Preparation of an Audit - Document review

Planning & Preparation for an Audit Preparation for on-site audit

Module 12: Performing an audit

Performing an audit- Audit Management

Performance of an Audit

Performing an Audit – From collecting information to audit conclusions

Audit team - Participants

Key qualities of an auditor

Performing an Audit – Audit Approach – Attitude of Auditor

Audit approach - Communication process

Audit Approach – Questioning techniques

Audit approach - Communication process- clarifying questions

Documentary evidence and follow up actions

Performing an Audit – How do auditors find evidence ?

Time management - Preparing a Checklist Format

Preparing a Checklist Format

Purpose of checklists

Visit the field – Move around

Performing an Audit -Observe Operational Control

Section Quiz IQA

Follow Audit trials

Module 13: Audit reporting and NCR writing tips

Audit Management - reporting an audit

Audit reporting

Audit reporting – Writing Non-conformity reports

NCR’s & Corrective actions Concepts relating to requirements

Audit reporting – Writing Non-conformity reports

NCR’s and Corrective actions -Examples of Objective Evidence

Audit reporting – Writing Non-conformity reports

NCR’s and Corrective action

Writing Non-conformity reports Do and donts

Writing Non-conformity reports- scenario- 1

Writing Non-conformity reports- scenario- 2

Writing Non-conformity reports- matrix

Writing Non-conformity reports- auditor and auditee

Writing Non-conformity reports- corrective action

Difficulties encountered during internal audits

A piece of counsel

THANK you

Final Assessment

ISO 9001 Final assessment

Preview - ISO 9001:2015 Internal Auditor training