Internal auditor of the quality management system (ISO 9001, ISO 19011)

This online course allows you to gain the necessary knowledge and skills to carry out an internal audit of the quality management system (QMS) based on the ISO 9001: 2015,              ISO 19011: 2018 standards.

This online course allows you to gain the necessary knowledge and skills to carry out an internal audit of the quality management system (QMS) based on the ISO 9001: 2015, ISO 19011: 2018 standards.

Duration

36 hours

Language

English/Ukrainian/Russian

Format

100% online

Objectives

• Understand the principles of QMS implementation in accordance with the requirements of ISO 9001

• Get a complete understanding of the concepts, approaches, methods and techniques necessary for the effective management of the QMS

• Gain knowledge in the scope of risks identification and opportunities related to QMS

• Understand the relationship between the QMS and compliance with the requirements of various stakeholders of the organization.

• Develop the knowledge and skills necessary to advise organizations on the best quality management and internal audit practices

• Familiarize oneself with all stages of preparing and carrying out an internal audit

• Acquire the necessary knowledge to manage a QMS audit team

• Understand the operation of the QMS in accordance with ISO 9001

• Improve the ability to analyze the internal and external environment of the organization and decision-making in the context of the quality management system

Target audience

• Internal auditors

• Project managers and consultants who wish to master the quality management system audit process

• Members of the QMS implementation team at the enterprise

• Professionals who want to gain in-depth knowledge of the QMS

• Specialists involved in daily support of QMS processes

• Students of specialized faculties

Document on completion

Certificate of internal auditor of the QMS, listed in SIC international register

Evaluation scale

60.0-100.0 

0.0-59.9

Complies

Does not comply

Thematic plan

The course program includes 2 modules:

1. Quality management system (ISO 9001)
2. Internal audit (ISO 19011)

The program is designed for 36 hours, including time for studying theoretical material and taking tests.

Objectives

Module 1 Quality management system (ISO 9001)

1.1

Introduction

1,5

1.2

General provisions of the standard

2

1.3

Organization context

2

1.4

Leadership

2

1.5

Planning

2

1.6

Provision (resources)

1,5

1.7

Functioning

5

1.8

Evaluation of results of the activities

2,5

1.9

Improvement

1

 

Testing

1

Module 2 Internal audit (ISO 19011)

2.1

Introduction

1

2.2

General provisions of the standard

1,5

2.3

Audit program management (AP)

5

2.4

Carrying out an audit

5

2.5

Competence of auditors

2

 

Testing

1

Module 1. Detailed content

1.1

Introduction:

–       Preface

–       QMS history

–       The ISO 9000 and ISO 10000 series of standards

1.2

General provisions of the standard:

–       Structure of the standard

–       QMS principles

–       PDCA

–       Scope of application of the standard

–       Terminology

1.3

Organization context:

–       Understanding the organization and its context, examples

–       Understanding the needs and expectations of stakeholders, examples

–       Determining the scope of application of the QMS

–       QMS and its processes

–       Possible inconsistencies

1.4

Leadership:

–       Leadership and obligations

–       Quality policy, examples of theses

–       Functions, responsibilities, and authorities

–       Possible inconsistencies

1.5

 

Planning:

–       Actions on risks and opportunities, examples

–       Quality goals

–       Planning changes

–       Possible inconsistencies

1.6

Provision (resources):

–       Resources: human resources, infrastructure, work environment, monitoring and measurement resources, knowledge base

–       Competence

–       Awareness

–       Information exchange

–       Documented information

–       Possible inconsistencies

1.7

Functioning:

–       Production planning and management

–       Requirements for products and services: communication with a consumer, determination of requirements for products and services, analysis and changes in requirements for products and services

–       Development and design of products and services: design and development input data, design and development controls, design and development results

–       Management of processes, products and services supplied from outside

–       Production of products and services: identification and traceability, property owned by consumers or external providers, storage, post-delivery activity, management of changes

–       Output

–       Management of irrelevant process outputs, products and services

–       Possible inconsistencies

1.8

Evaluation of results of the activities:

–       Monitoring, measurement, review and evaluation

–       Internal audit

–       Review by management

–       Possible inconsistencies

1.9

Improvement:

–       Improvement

–       Inconsistencies and corrective actions

–       Continuous improvements

–       Possible inconsistencies

Module 2. Detailed content

2.1

Introduction:

–       Audit definition

–       Classification of audits

–       Audit criteria

–       History of the standard

2.2

General provisions of the standard:

–       Structure of the standard

–       Scope of application of the standard

–       Terminology

–       Principles

–       Auditor code of ethics

2.3

Audit program management (AP):

–       PDCA

–       General provisions

–       Diagram of the AP control process

–       AP planning

–       Identification and assessment of risks and opportunities

–       Person in charge of the AP

–       Determining the scope of the AP

–       AP resources

–       AP execution

–       Determination of objectives, scope, and criteria for a specific audit

–       Selection and determination of audit methods

–       Selection of audit team members

–       AP records management

–       AP Monitoring

–       Reviewing and improving the AP

–       Unscheduled audits

2.4

Carrying out an audit:

–       Audit initiation

–       Preparation for an audit, example of the Audit Plan.

–       Distribution of tasks in an audit team

–       Preparation of working documents, example of a Checklist

–       Opening meeting

–       Exchange of information during audit

–       Collection and verification of information: examples of questions, spot check

–       Preparation of an Audit Report

–       Preparation of audit conclusions, example of a Statement of Nonconformities

–       Final meeting

–       Preparation and distribution of an Audit Report

2.5

Competence of auditors:

–       Competence assessment stages

–       Personal qualities

–       General knowledge and skills

–       General competence of an audit team leader

–       Support and improvement of the competence of an auditor