Relationship of ISO 9001: 2015 with ISO 9000: 2015

“Interlinking knowledge is more important than having it more!” ― Naman Vohra

Introduction

There is a strong relationship between what we say and what we do. Numerous people preach so many things but they do not follow and people also do not trust them. But there are a few people who believe in ‘walking the talk’. That is why whatever they say is easily understood and implemented. Who are we?

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Content: ISO 9000 / ISO 9001

1. What is ISO 9001?
2. What is ISO 9000: 2015?
3. What is the Relationship between them?
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 9000: 2015, what 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 relationships 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

External Provider (Cl 3.2.6): Provider that is not part of the organization

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

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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 that 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 are directly and indirectly interacting 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 that 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 9000: 2015 is as follows

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What is ISO 9000: 2015 (As per www.iso.org)

ISO 9000: 2015 is the 4^th edition which cancelled and replaced the 3^rd edition ISO 9000: 2005.

ISO 9000:2015 describes the fundamental concepts and principles of quality management which are universally applicable to the following:

• organizations seeking sustained success through the implementation of a quality management system.
• customers seeking confidence in an organization’s ability to consistently provide products and services conforming to their requirements.
• organizations seeking confidence in their supply chain that their product and service requirements will be met.
• organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management.
• organizations performing conformity assessments against the requirements of ISO 9001.
• providers of training, assessment or advice in quality management.
• developers of related standards.

The overall aim is that the organization should have.

• Awareness of its duties
• Commitment to fulfilling the needs and expectations of the relevant interested parties.
• Achieving satisfaction with products and services

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ISO 9000:2015 describes the following 3 key aspects to implement the quality management system effectively and efficiently.

• Fundamental concepts (Cl 2.2)
• Principles (Cl 2.3)
• Vocabulary (terms and definitions) for the quality management system (Cl 3.0)

Clause 2.2        Fundamental Concepts:

2.2.1      Quality: culture, satisfy the customer and relevant interested part requirement, need and expectations.

2.2.2      Quality Management System: Objectives, resources, interacting processes, top management, actions.

2.2.3      Context of an organization: Internal Factors like values, culture, and knowledge, External factors like legal, technology, social, economic

2.2.4      Interested parties: Customer, other relevant interested parties,

2.2.5      Support: People, Competence, Awareness, Communication

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Clause 2.3        Quality Management Principles:

The quality Management Principles are not specific to any one industry and can be applied to organizations of any size.

       As per ISO 9000: 2015, clause 2.3, the following are the 7 principles of Quality Management

1. Statement
2. Rationale
3. Key Benefits
4. Possible actions

1. Customer Focus:

 It takes months to get a customer and seconds to lose: Vince Lombard

 What does it mean?

The prime focus of the organization should be to meet the customer requirements, create more value and enhance their confidence in them.

What is its purpose?

For sustained success, the organization should understand the current and future needs and expectations of the customer and relevant interested parties. Once understood, the key focus should be to not only achieve but continue to strive to exceed them.  

What benefits the organization can achieve?

• Increased customer satisfaction and loyalty
• Repeat business.
• Enhanced reputation
• Increased revenue and market share

2. Leadership:

A leader is the one who knows the ways, goes the way and shows the way: John C. Maxwell

What does it mean?

The key role of leadership is to create unity among all levels of the organization so that everyone can work towards the same objective.

What is its purpose?

For sustained success, Leadership helps to establish a culture of trust and integrity. Leaders at all levels of the organization should be able to become role models for their colleagues, customer and relevant interested parties.   

What benefits the organization can achieve?

• Improved effectiveness and efficiency in the processes
• Clarity of the purpose
• Better coordination among different processes

3. Engagement of People:

When people are financially invested, they want their return; when people are emotionally invested, they want to contribute: Simon Sinek

What does it mean?

The organization should create a culture where employees at all levels can work together as a team and can add value to their processes.

What is its purpose?

For sustained success, in the organization, there should be a culture of openness and transparency so that employees at all levels can work together as a team to achieve the overall objective of the organization. 

What benefits the organization can achieve?

• Enhanced development of the people
• Enhanced people satisfaction
• Involvement in improvement activities will improve.

4. Process Approach:

We should work on the process, not on the outcome of our process: W Edward Deming        

What does it mean?

In any organization, the processes are interrelated and interact with each other. For consistent and predictable results, the processes should work in tandem with each other.

What is its purpose?

For sustained success, the organization should understand its interrelated and interacting process and how they can work together to achieve consistent and optimized results.

What benefits the organization can achieve?

• The consistent and predictable outcome
• Confidence in relevant interested parties about the effectiveness and efficiency of their processes

5. Improvement:

Strive for continuous improvement rather than perfection: Kim Collins

What does it mean?

In any organization, the improvement should be an ongoing process.

What is its purpose?

For sustained success, the organization should not only ensure to maintain its existing performance level but also adapt itself as per the changes proposed by interested parties and create new opportunities.

What benefits the organization can achieve?

• Creates a learning environment in the organization.
• Creates an environment for innovation.
• Enhance ability to predict and change as per ensuing risk and opportunities.

6. Evidence-Based Decision Making:

It is better to be approximately right than precisely wrong: Warren Buffet

What does it mean?

When the decision is taken based on the facts and discussion, the possibility of getting desired results increases.

What is its purpose?

In the present times, the business is getting more complex and complicated and no one is sure about the right decision. But by using data and analyzing with a cross-functional team, the organization can improve the possibility of desired results.  

What benefits the organization can achieve?

• Improved decision-making process.
• Increases the ability to demonstrate the correctness of decisions taken.
• Increase the ability to analyze, question and decide.
• Creates an environment for innovation.

7. Relationship Management:

What you do not do to yourself, do not do to others: Confucius

What does it mean?

A transparent and warm relationship with all the relevant stakeholders is a must for the sustained success of the organization.

What is its purpose?

Any organization’s success is interdependent on its relevant interested parties. The organization should understand their needs and expectation and fulfill them to the best of their ability.

What benefits the organization can achieve?

• Well-managed supply chain
• Can create value for the interested parties

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Clause 3.0       Terms and Definitions

The following is the summary of the 137 definitions which are bifurcated into 13 sections of clause 3.0

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Conclusion:

Adoption of ISO standards is strictly voluntary. The ISO 9000 requirements address the fundamentals of quality management in any organization. They specify in detail the standards that must be met throughout the process of planning, producing, and delivering a product or service. ISO 9000 standards were developed to help organizations effectively document the quality system elements that need to be implemented to maintain an efficient quality system. 

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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 191^st 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.