Introduction

Overview of ISO 9001:2015

Key Principles of ISO 9001:2015

Key Changes in ISO 9001:2015

Key Changes in ISO 9001:2015 Introduction to Quality Management Systems (QMS)

Structure of ISO 9001:2015

Process Approach in ISO 9001:2015

Risk-Based Thinking

Principles of Auditing

Types of Audits

Objectives of Auditing

Auditor Roles and Responsibilities

Skills and Competencies of an Auditor

Overview of ISO 19011:2018 Guidelines for Auditing

Introduction

Understanding and Defining the Audit Scope

Preparing for an Onsite Audit

Conducting Onsite Audits Effectively

Evaluating Compliance and Identifying Non-Conformities

Communicating Findings and Observations

Ensuring Safety and Ethical Standards

Developing Corrective Action Plans (CAPA)

Review and Close the Audit

Introduction

Purpose and structure of ISO 9001:2015

Quality Management Principles (QMPs) – ISO 9001:2015

Key Clauses of ISO 9001:2015 and Their Significance in a Quality Management System (QMS)

Process Approach and Risk-Based Thinking to Organizational Operations

Requirements for Documentation, Leadership Commitment, and Continuous Improvement

Assessing How ISO 9001:2015 Enhances Customer Satisfaction and Business Performance

Introduction

ISO 9001 and other relevant quality standards

Developing Quality Policies and Objectives

Process mapping and documentation

Roles and responsibilities in QMS implementation

Performance measurement and continuous improvement

Common challenges and best practices for successful implementation

Introduction

Introduction to audit types and objectives

Defining the audit scope, criteria, and approach

Creating an audit plan and timeline

Resource allocation and audit team responsibilities

Risk-based approach to audit planning

Developing audit checklists and tools

Preparing for fieldwork and data collection

Introduction

Understanding audit objectives and types

Defining the scope, criteria, and focus of an audit

Creating a comprehensive audit plan and timeline

Assigning responsibilities to audit team members

Risk-based planning in audits

Preparing checklists, audit tools, and documentation

Communicating with stakeholders and setting expectations

Introduction

Initiating the audit and setting the tone

Data collection methods

Site inspections and process evaluations

Recording and verifying audit evidence

Handling challenges and unexpected issues during audits

Ethical considerations and auditor responsibilities

Communicating findings in real time

Introduction

Purpose and importance of audit reporting

Key components of an audit report

Structuring the report for clarity and impact

Communicating audit results to different stakeholders

Providing actionable recommendations and corrective actions

Best practices for presenting audit findings

Handling confidential information and sensitivity in reports

Introduction

Importance of audit follow-up and accountability

Developing corrective and preventive action plans

Methods for tracking and monitoring corrective actions

Conducting follow-up audits and verification activities

Effective communication with management and stakeholders

Documentation and reporting of follow-up results

Continuous improvement strategies

Introduction

Key roles and responsibilities in the audit team

Building an effective audit team

Leadership and management strategies for audit teams

Coordinating audit team activities and ensuring effective communication

The relationship between audit team and management: Collaboration and support

Training and development for audit team members

Managing audit team performance and maintaining morale

Handling challenges and conflict within the audit team

Final Exam