ISO 9001 Certification

Clause 1 describes the scope and sets the boundaries and intentions of the ISO 9001 quality management systems standard.

Clause 2 refers to the ISO 9000 quality management systems – Fundamentals and vocabulary standard, which is a separate standard, referenced in the ISO 9001 quality management systems standard.

Clause 3 provides definitions and terms that are used throughout the ISO 9001 quality management systems standard. This clause is crucial for ensuring that all personnel involved in implementing the quality management systems (QMS) possess a consistent understanding of key concepts, which in turn aids in preventing misunderstandings and also ensures uniform terminology across various contexts.

Clause 4 requires organisations and all relevant stakeholders to determine its context, by evaluating both internal and external factors that are relevant to its purpose and strategic direction. This is to be taken into account when developing, implementing and maintaining its QMS.

This clause also requires an understanding of the needs and expectations of interested parties, the determination of the scope of the QMS, and the QMS and its processes, to be developed.

Clause 5 requires top management to demonstrate leadership in relation to the QMS. Leadership is required to be demonstrated through top management taking accountability of the QMS, ensuring a quality policy and objectives are established, ensuring integration of the QMS into the organisation’s processes, ensuring sufficient resources are provided and promoting improvement.

Clause 6 focuses on addressing risks and opportunities that could affect the desired outcomes of the QMS, both regarding implementation and long-term performance. This clause outlines the need to set specific, measurable, and achievable quality objectives and outline the necessary steps to feasibly achieving these goals. This proactive approach helps ensure that the implemented QMS remains relevant and effective over time.

This clause also requires customer focus, communication of the quality policy, and organisational roles, responsibilities and authorities to be assigned and communicated.

Clause 7 deals with the support structure required for the QMS, which includes managing human resources, ensuring sufficient knowledge within the organisation, and ensuring relevant resources are provided and maintained for the QMS.

This clause also requires the relevant training and competencies related to the QMS to be in place, sufficient communication processes to be implemented, and the control of documented information.

Clause 8 outlines the implementation of processes necessary for fulfilling the performance requirements of the proposed QMS. This clause is the largest and most detailed in the ISO 9001 quality management systems standard, and is broken down to cover multiple topics including:

• Design and development processes, and their management;
• The management and control of procurement activities;
• Control of production and service provision, including traceability, care of customer and supplier property, post-delivery activities;
• Release activities, and their management, and
• The control of nonconforming products and services.

Clause 9 requires the ongoing monitoring and measurement of the QMS to ensure it meets the established quality processes and objectives.

This clause also requires internal audits to be conducted, and management reviews of the QMS to occur.

Clause 10 outlines processes for the continuous improvement of the implemented QMS. This concluding clause encourages organisations to enhance their processes and outputs through innovative practices, correcting any identified nonconformities, and making adjustments based on performance data. This commitment to ongoing improvement helps organisations to maintain and enhance quality over time, ensuring they meet the evolving needs of their customers and other stakeholders.