Relationship of ISO 9004: 2018 with ISO 9001: 2015

Continuous improvement is better than ….” ― Mark Twain

Introduction

While every person has his or her own view of success, when it comes to organizations, true success is only that success that lasts and is sustained. Generally speaking, sustained success means the ability of an organization to meet the needs and expectations of users and other relevant stakeholders over a long period of time.

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Content: ISO 9004: 2018

  1. What is ISO 9004?
  2. What is the purpose of ISO 9004: 2018?
  3. What is the Relationship of 9004 with 9001?
  4. Conclusion

Objective

The ISO 9000 series provides a globally recognized framework for organizations to establish effective quality management systems. By implementing these standards, organizations can enhance their operational efficiency, meet customer requirements, and drive continual improvement.

Once you read this blog, you will understand, what is ISO 9001: 2015, what is ISO 9004: 2018, what is its purpose of it and their interrelationship.

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Definition: ISO 9000: 2015

Organization (Cl 3.2.1): Person or group of people that has its own functions with responsibilities and authorities and relationship to achieve its objectives.

Customer (Cl 3.2.4): Person or organization that could or does receive a product or a service that is intended for or required by this person or organization.

Quality Management (Cl 3.3.4): Management with regard to quality

Quality (3.6.2): Degree to which a set of inherent characteristics of an object fulfils requirements.

Requirements (Cl 3.6.4): Needs or expectations that are stated, generally implied or obligatory.

Sustained Success (Cl: 3.7.4): Success over a period of time

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Detailed Information

In the ISO 9000 series, the most popular standard is ISO 9001:2015 – Quality Management System – Requirements. There are 3 more standards which are closely related to ISO 9001:2015. They are:

  • ISO 9000:2015 – Quality Management System: Fundamentals and Vocabulary
  • ISO/TS 9002:2016 – Quality Management System: Guidelines for the application of ISO 9001:2015
  • ISO 9004: 2018 – Quality Management – Quality of an organization – Guidance to achieve sustained success.

The above three standards directly and indirectly interact with the base standard ISO 9001: 2015. Only ISO 9001 is a certifiable standard. It means an organization can be certified by a third party (like DNV) only for ISO 9001:2015.

Although there are many other standards which are related to ISO 9001. It includes ISO 19011 (Internal Audit), ISO 31000 (Risk Management) and ISO 10000 series. All these standards have been developed by ISO/TC 176.

The linkage and relationship with ISO 9001: 2015 are as follows.

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What is ISO 9004: 2018 (As per www.iso.org)

  • ISO 9004:2018 gives guidelines for enhancing an organization’s ability to achieve sustained success. This guidance is consistent with the quality management principles given in ISO 9000:2015.
  • ISO 9004:2018 provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document.
  • It covers leadership, strategy, management system, resources, and processes to identify areas of strength and weakness as well as opportunities for improvement and innovations.
  • ISO 9004:2018 applies to any organization, regardless of its size, type and activity.
  • Provides a wider focus on quality management than ISO 9001. It addresses the needs and expectations of all relevant interested parties.
  • ISO 9004 also guides the systematic and continual improvement of your organization’s overall performance.
  • Can be used alongside ISO 9001 and other management system standards but can also be used independently.
  • Is not intended for certification, regulatory or contractual use.

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Structure of ISO 9004: 2018 Standard

Clause No. ISO 9004: 2018
4.0 Quality of an organization and sustained success
5.0 Context of an organization: Relevant interested parties, Internal and external issues
6.0 Identity of an organization: Mission, Vision, Values and Culture
7.0 Leadership: Policy & Strategy, Objectives, Communication
8.0 Process Management: Determination of process, responsibility and authority, managing process
9.0 Resource Management: People, Empowerment, Motivation, Competence, Knowledge, Technology, Infrastructure, Work Environment, Externally provided resources, Natural Resources
10.0 Analysis and evaluation of organization’s performance: Performance indicator, performance analysis, performance evaluation, internal audit, self-assessment, Review
11.0 Improvement, Learning and Innovation (Timing, Risk)

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How ISO 9004 Can Help the Organization

The ISO 9004:2018 standard serves as a valuable tool for organizations of any size or industry, aiding their pursuit of sustained success. Here’s how this standard can benefit any organization:

  • Guides in Achieving Long-Term Success: ISO 9004 provides a roadmap for organizations to attain lasting success through a comprehensive quality management strategy. It applies to businesses of all types and sizes.
  • Encourages Self-Assessment: The standard promotes self-assessment as an effective method for evaluating the maturity level of an organization. It scrutinizes areas like leadership, strategy, management system, resources, and processes, identifying strengths, limitations, potential improvements, and opportunities for innovation.
  • Broader Scope than ISO 9001: While ISO 9001 focuses primarily on quality management, ISO 9004 addresses the needs and expectations of all relevant stakeholders. It guides systematically and continuously enhancing your organization’s overall performance.
  • Complements Other Management System Standards: ISO 9004 is designed to work in harmony with ISO 9001 and other management system standards, providing a more holistic approach to organizational success.

Self-Assessment Tool:

There are 31 different questions (elements) and for each question, there are 5 different levels (L1-Lowest to L5-Highest) and the last column is related to ‘Comments’ wherein the assessor can specify the evidence and justification for rating each element.

Conclusion:

Adoption of ISO standards is strictly voluntary. This document has been developed to assist users in applying the quality management system requirements of ISO 9001:2015. This document provides guidance,  with a  clause-by-clause correlation to  Clauses  4  to  11   of ISO 9004:2018, however, it does not guide ISO 9001:2015. ISO 9004 is an International Standard that guides organizations in support of their achievement of sustained success in a complex, demanding and changing environment, by a quality management approach. It provides organizations with guidelines and tools for using the principles of quality management to achieve long-term success.

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References:

ISO 9001: 2015

ISO 9000:2015

ISO/TS 9002: 2016

ISO 9004: 2018

IATF 16949: 2016

Industry Experts

This is the 194th article of this Quality Management series. Every weekend, you will find useful information that will make your Management System journey Productive. Please share it with your colleagues too.

In the words of Albert Einstein, “The important thing is never to stop questioning.” I invite you to ask anything about the above subject. Questions and answers are the lifeblood of learning, and we are all learning. I will answer all questions to the best of my ability and promise to keep personal information confidential.

Your genuine feedback and response are extremely valuable. Please suggest topics for the coming weeks.

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