What is ISO 9001? The Key to Mastering Quality Management

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ISO 9001 is a globally recognised standard that outlines the criteria for a quality management system (QMS).

 

It is based on several quality management principles, including a robust customer focus, the involvement of top management, a process approach, risk-based thinking and continual improvement.

Understanding ISO 9001 and Its Importance

The ISO 9001 standard is applicable to any organisation, regardless of its size or the industry it operates in.

 

It is designed to help organisations ensure they meet the needs and expectations of both customers and other stakeholders, while meeting statutory and regulatory requirements related to the product or service.

A mermaid diagram showing the principles and applicability of ISO 9001.
The ISO 9001 standard is applicable to any organisation, regardless of its size or the industry it operates in.

ISO 9001 Core Principles

Customer Focus

Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements, and strive to exceed customer expectations.

Leadership

Leaders establish unity of purpose and direction for the organisation. They should create and maintain an internal environment in which people can become fully involved in achieving the organisation’s objectives.

Engagement of People

People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit.

Process Approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

 

Further reading: A Process-Based Approach to Quality Management and ISO 9001:2015: Why it makes sense

Evidence-based Decision Making

Effective decisions are based on the analysis of data and information.

Relationship Management

An organisation and its external providers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

The Benefits of Implementing ISO 9001

Implementing a QMS based on ISO 9001 can provide a number of benefits to an organisation. These include:

 

  • Increased Efficiency: By following industry best practices and focusing on quality, you can reduce costs by minimising waste and errors, and increasing productivity.

 

  • Improved Customer Satisfaction: When you can efficiently deliver a product that meets customer needs and expectations, customer satisfaction increases.

 

  • Access to New Markets: Some industries require ISO 9001 certification for doing business. By obtaining this certification, you can access markets you were previously unable to do business with.

 

  • Improved Employee Morale: A clear and defined workflow promotes job satisfaction and creates an environment for improved performance.

ISO 9001 Certification Process

The process of becoming ISO 9001 certified involves a thorough review of your organisation’s processes by a third-party auditor.

 

Here are the steps involved:

 

  1. Preparation: The first step is to understand the requirements of ISO 9001 and how they apply to your business.
  2. Documentation: Document all processes and procedures in your QMS.
  3. Implementation: Implement your QMS throughout your organisation.
  4. Internal Audit: Conduct an internal audit to check that your QMS meets ISO 9001 standards and identify areas for improvement.
  5. Certification Audit: A third-party auditor will verify that your organisation’s QMS meets all the requirements of ISO 9001.
  6. Certification: If you pass the audit, the certification body will issue an ISO 9001 certificate.
A diagram showing the ISO 9001 Certification process.
The ISO 9001 certification process.

Remember, compliance and certification with ISO 9001 is not a one-time event but a continuous commitment to uphold the highest standards of quality.

Current Version of ISO 9001 - ISO 9001:2015

The current version of ISO 9001 is ISO 9001:2015. This version introduced several significant changes, including a greater emphasis on risk-based thinking to enhance the application of the process approach, improved applicability for services, and increased leadership requirements.

 

ISO 9001:2015 is structured in ten sections: 

 

  • Scope
  • Normative References Terms and Definitions
  • Context of the Organisation 
  • Leadership
  • Planning, Support
  • Operation
  • Performance Evaluation
  • Continual Improvement

This structure is designed to provide a coherent presentation of requirements, making it a more accessible and user-friendly standard.

 

Further reading: The Definitive Guide to Document Control for ISO 9001:2015

Future of ISO 9001 - ISO 9001:2025

While the specifics of the next revision, tentatively named ISO 9001:2025, are not yet known, we can anticipate that it will continue to evolve in response to the changing needs of the global business environment.

Embracing Technological Advancements

One area that the ISO 9001:2025 revision is likely to address is the rapid advancement of technology.

 

As digital transformation continues to reshape industries, the standard may incorporate more guidelines related to data management, cybersecurity, and the integration of emerging technologies in quality management processes.

Enhancing Sustainability and Social Responsibility

The ISO 9001:2025 revision may also place greater emphasis on sustainability and social responsibility.

 

Organisations might be encouraged to consider their environmental impact and social responsibilities as integral parts of their quality management systems.

Strengthening Risk Management

Risk management is another area that could be further strengthened in the ISO 9001:2025 revision.

 

The standard may provide more detailed guidance on identifying, assessing, and mitigating risks in a volatile, uncertain, complex, and ambiguous (VUCA) business environment.

 

While these are educated projections, the actual changes will be determined by the ISO Technical Committee. The goal, as always, will be to ensure that ISO 9001 remains a relevant and effective tool for quality management in a rapidly evolving world.

The Next Steps

ISO 9001 is a powerful tool for improving your organisation’s overall performance and providing a sound basis for sustainable development initiatives.

 

By understanding and implementing this standard, your organisation can realise benefits such as increased efficiency, improved customer satisfaction, access to new markets, and improved employee morale.

 

The Agility System integrated management system software supports the need to be both ISO-compliant and process-based. Our business analysts can help transform your current traditional management system into an ISO 9001-compliant quality management system that provides improved operational performance and maintains compliance.


Book your free demo today, and a member of our team will be in touch to discuss your bespoke business needs and help you begin your journey to ISO 9001 compliance.

 

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Peter Shields
Peter Shields
Peter is a Quality, Risk & Compliance expert with extensive experience working with process-based management systems in the Energy, Nuclear & Defence sectors since 1979.
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