What is the difference between ISO 9001 2015 and ISO 19011 2018?

This comprehensive blog will explore the key differences between these two Standards and highlight their specific roles in ensuring organisational quality and effectiveness.

Overview of ISO 9001:2015

ISO 9001:2015 is an internationally recognised Standard that specifies a number of requirements for a quality management system. It helps organisations ensure consistent quality in their products and services by implementing effective quality management practices. The Standard is applicable to organisations of all sizes and industries, providing a framework for improving processes, enhancing customer satisfaction, and achieving continuous improvement.

Key Components of ISO 9001:2015

The ISO 9001:2015 Standard comprises several key components that form the foundation of an effective quality management system:

• Leadership: Emphasises top management's role in establishing quality policies and objectives.
• Planning: Focuses on risk-based thinking and addressing potential issues.
• Support: Covers necessary resources, competence, and communication.
• Operation: Outlines processes for delivering quality products and services.
• Performance Evaluation: Involves monitoring, measurement, and analysis of quality management system performance.
• Improvement: Encourages continuous enhancement of the quality management system.

These components, known as the ISO 9001:2015 clauses, provide a structured approach to quality management, ensuring that organisations can consistently meet customer and regulatory requirements.

Overview of ISO 19011:2018

ISO 19011:2018 (Guidelines for auditing management systems) provides a framework for conducting audits of management systems. This Standard offers guidance on the principles of auditing, managing audit programs, and conducting internal or external audits. Unlike ISO 9001:2015, ISO 19011:2018 is not a certifiable Standard but serves as a valuable resource for organisations implementing various management systems.

Key Components of ISO 19011:2018

ISO 19011:2018 encompasses several crucial elements:

• Principles of Auditing: Includes integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach.
• Managing an Audit Program: Provides specific guidance on planning, implementing, and monitoring audit programs.
• Conducting Audits: Offers detailed steps for preparing, conducting, and reporting audits.
• Auditor Competence and Evaluation: Emphasises the importance of auditor competence and provides guidelines for evaluating auditors.

Differences Between ISO 9001:2015 and ISO 19011:2018

The primary focus of ISO 9001:2015 is on establishing and maintaining a quality management system that enhances organisational processes to meet customer requirements and improve satisfaction. It outlines requirements for implementing a quality management system, including leadership commitment, risk-based thinking, and continual improvement.

ISO 19011:2018, in contrast, provides guidelines for auditing management systems of various types, including quality management systems, environmental management systems, and occupational health and safety management systems. It details principles of auditing, managing audit programs, conducting audits, and evaluating the competence of auditors. The Standard aims to ensure audits are conducted effectively, covering the full scope of management system processes and verifying conformity and effectiveness.

While ISO 9001:2015 sets out requirements for organisations to follow in establishing their quality management system, ISO 19011:2018 guides auditors on how to assess and audit these systems to ensure they meet the desired Standards and goals effectively.

Purpose and Scope

ISO 9001:2015 and ISO 19011:2018 serve distinct yet complementary purposes within the realm of quality management and auditing practices. ISO 9001:2015 is specifically designed to enhance organisations' ability to consistently provide products and services that meet customer and regulatory requirements. It emphasises a process-based approach to quality management, aiming to enhance customer satisfaction through the effective application of a quality management system.

 
On the other hand, ISO 19011:2018 addresses the methodologies for auditing management systems. It provides guidance on the principles of auditing, managing audit programs, conducting audits, and evaluating the competence of individuals involved in the audit process. Unlike ISO 9001:2015, which focuses on enhancing internal processes to meet quality Standards, ISO 19011:2018 is geared towards ensuring effective and efficient auditing of various management systems, including quality, environmental, and occupational health and safety management systems. In essence, while ISO 9001:2015 aims to improve organisational processes and customer satisfaction, ISO 19011:2018 supports the systematic and thorough evaluation of these processes through auditing methodologies.

Implementation and Application

ISO 9001:2015 is implemented to establish a quality management system within an organisation. It involves defining processes, setting quality objectives, and continuously improving operations to meet customer requirements. Organisations seeking ISO 9001:2015 certification must demonstrate compliance with the Standard's requirements through external audits. 

ISO 19011:2018, on the other hand, is used to guide the auditing process. It helps organisations plan and conduct audits of their management systems, whether for internal purposes or to prepare for external certification audits. The Standard provides a framework for developing audit programs, selecting and evaluating auditors, and conducting effective audits.

Benefits of Implementing ISO 9001:2015

Implementing ISO 9001:2015 offers a number of advantages:

• Improved product and service quality
• Enhanced customer satisfaction
• Better operational efficiency
• Continuous improvement of processes
• Compliance with regulatory requirements
• Increased market competitiveness

Benefits of Using ISO 19011:2018

Utilising ISO 19011:2018 provides organisations with:

• Improved audit consistency
• Enhanced auditor competence
• Better-managed audit programs
• Effective evaluation of management systems
• Identification of areas for improvement
• Increased confidence in audit findings

In conclusion, while ISO 9001:2015 and ISO 19011:2018 serve different purposes, they are designed to complement each other in the pursuit of organisational excellence. ISO 9001:2015 provides the framework for establishing a robust quality management system, while ISO 19011:2018 offers guidance on how to effectively audit and evaluate that system. By understanding and implementing both Standards, organisations can ensure they are not only meeting quality requirements but also continuously improving their processes and performance.