Quality Requirements: Understanding the Order of Significance in ISO 9001:2015

It All Started in the QMS Course

Faith Umeaku posed an intriguing question during our recent QMS ISO 9001:2015 Foundations Certification Course: “Which of the quality requirements comes first?” This inquiry sparked a lively debate, ultimately highlighting the pivotal role of statutory and regulatory requirements in the context of quality management.

ISO 9001:2015 does not explicitly rank the quality requirements in a hierarchical order because each plays a crucial role in the comprehensive quality management system. However, understanding the contextual and practical applications can help us appreciate how they interrelate and why they might seem to have a particular order of importance in implementation. This is not the chicken or the egg paradox, but let’s examine each of these requirements:

Customer Requirements

Every organization is set up and survives because of the customer; hence, it seems that the primary focus of any quality management system is to meet customer requirements. After all, satisfying customer needs and exceeding their expectations are central to the success of any organization. This includes understanding customer needs from initial contact to after-sales support. In practice, meeting customer requirements often drives the entire quality process, as it directly impacts customer satisfaction and loyalty.

Statutory and regulatory requirements

Compliance with statutory and regulatory requirements is non-negotiable. These requirements ensure that products or services meet specific standards set by governments or regulatory bodies, which can include safety, legality, and environmental impacts. While customer requirements might drive business success, statutory and regulatory compliance ensures legality and operational permission within specific markets; it is about the law of the land, such as the constitution of the Federal Republic of Nigeria.

Organizational Requirements

Organizational requirements are those established internally to achieve specific business objectives. These can include internal policies, goals, and strategic direction that align with the mission and vision of the organization. These requirements are crucial for maintaining the alignment of the QMS with the organization’s purpose and providing a clear framework for operations and decision-making.

Standard Requirements

Standards like ISO 9001:2015 provide a framework of globally recognized best practices that help organizations ensure they are managing their processes effectively to produce quality products and services consistently. The standard itself does not come first but rather serves as a scaffold that supports the system in integrating customer, statutory, and organizational requirements into a cohesive whole.

Product and service requirements

These are specific to the quality characteristics of the products or services that the organization provides. They ensure that products and services consistently meet customer expectations along with regulatory and organizational criteria. Regulatory mandates and customer demands often drive these decisions.

Process Requirements

All the above requirements naturally incorporate these requirements, which aim to prevent the omission of any step, stage, or phase as specified in procedures and work instructions. They are critical for ensuring that the QMS can consistently deliver on its intended outputs.

Why Statutory and Regulatory Compliance Come First:

Remember the ISO Standard Speaks to Organization: ISO 9000:2015 vocabulary defines an organization as “a person or group of people that has its own functions with responsibilities, authorities, and relationships to achieve its objectives.” This definition emphasizes the need for an organizational structure that is compliant with laws and regulations as a basis for achieving any further quality objectives.

• Legal Compliance: Ensuring compliance with the laws and regulations is foundational. An organization must operate within its local legal framework. This compliance safeguards the organization against legal risks and penalties, which can be substantial.
• Operational Legitimacy: Meeting statutory requirements confirms an organization’s legitimacy to operate. This is essential before any business can consider optimizing processes or enhancing customer satisfaction.

Finally, a hierarchical yet integrated approach

Other quality management elements undoubtedly build upon statutory and regulatory compliance. Without this compliance, no organization can sustainably operate or scale. However, for a quality management system to be truly effective, it must integrate and balance all requirements—regulatory, customer, and organizational—to create a robust framework that supports continuous improvement and operational excellence.

We are open to correction today, so please continue the discussion.