Standards of ISO 9001 full review

The ISO 9001 standard is one of the most popular standards related to quality management in the world today. It provides a framework for organisations to systematically improve all areas of their processes by implementing a Quality Management System (QMS). More than a million organisations worldwide of different sizes and from various sectors are certified to ISO 9001. Its flexible nature, is one of the biggest reasons for its popularity as it allows organisations to drive lasting change across all aspects. The ISO 9001 is the answer for any organisation that is seeking a quality management system that creates an environment of continuous improvement.

By adopting the ISO 9001 standards, organisations can support risk management strategies and highlight growth opportunities. In this article, the ISO Council explored and expanded on the standards of ISO 9001.

ISO 9001 outlined

At its core, the ISO 9001 certification standard can be utilised by organisations to develop a quality management system that provides best practice for all processes. It prepares a framework for analysing an organisation’s existing processes and implementing positive changes that are meant to be constantly evaluated. Improvement in processes can not only increase efficiency and productivity, but can also cause a positive change in the work environment and culture.

Choosing the ISO 9001 standard means that organisations have clearly identified quality objectives.

It also means that the organisation has identified potential risks and set procedures to mitigate them. This allows organisations to highlight trends and opportunities for future growth, improving efficiency across all areas. As a result, a customer-first organisation is forged, focusing on quality service.

ISO 9001 clauses explained

The ISO 9001 requirements are expanded in 10 clauses, further divided into mandatory and non-mandatory requirements. The organisation must meet the mandatory requirements to become certified. The requirements of ISO 9001 help to ensure that the organisation successfully implement the QMS. The first three clauses comprise of the scope statement, the references and the terms of the ISO 9001 standard.

These are categorised as non-mandatory requirements; however, they provide useful information to the organisation, explaining terminology related to quality management. Closest 4 to 10 covers seven aspects of the organisation that a mandatory. When these clauses are appropriately adopted within the organisation, it provides a framework that allows efficient planning, implementation and evaluation of the QMS.The ISO 9001 clauses are:

Scope: goals of the quality management system

This clause outlines the scope statement of the system. It outlines the goals of the quality management system, which is to strengthen the customer experience by providing high-quality goods or services.

Normative references

This clause explains the terms and references utilised throughout the ISO 9001 standard.

Terms and definition:

This clause expands upon the key terms, vocabulary and definitions used within the ISO 9001 standard.
Context of the organisation: This clause addresses the purpose of the organisation. It highlights the factors that affect the service product quality. It also helps organisations identify different stakeholders within the organisation, helping to define the need for the quality management system.

This is an important step in the implementation of the quality management system as each organisation has unique needs. Another requirement within this section is to include the systematic definitions of policies and procedures related to QMS policy direction.

Leadership: Responsibility of the senior management

This clause outlines the responsibility of the senior management to establish a QMS by setting quality-related objectives and policies. It also contains recommendations related to the communication process, annual review, and stakeholder meetings.

Planning: Opportunities and risks

The sixth clause provides a framework for documenting opportunities and risks within the organisation. The goal of this clause is to build processes that mitigate any potential negative effects and enhance positive effects. As a result, the likelihood of recurring issues reduces. This section also covers how management system objectives should be set and how plans should be made to achieve them.

Support: Monitoring QMS

The aim of this clause is to ensure that the organisation is in a position to deliver a successful quality management system by allocating the adequate resources. This section focuses on people in the working environment. Additionally, by studying the interaction between the people and the working environment, it enhances processes for monitoring and building the QMS. This section also deals with embedding the quality management processes within the organisation in an organic manner. Focusing on different communication channels allows the organisation to adopt the quality management system completely.

Operation: measuring quality objectives

This clause outlines the objectives of the organisation concerning the delivery of products or services. The emphasis is on operational planning and delivery, while considering the reality of risks and opportunities that were identified in the previous section. It includes processes for measuring quality objectives, testing products, record storages and process evaluation.

Performance evaluation

This clause ensures that organisations can measure the effectiveness of their QMS-related processes. As a result of the evaluation, the changes that are adopted create a lasting and positive impact. This section provides companies with a framework for monitoring, auditing, and analysing processes and products, helping organisations to react practically to risks and trends.

Improvement: Sustainable improvement systematically

The last clause of this standard focuses on continuous improvement by implementing corrective and objective evaluation. By encouraging continuous and regular evaluation, this clause allows organisations to acquire sustainable improvement systematically.