Clause 5.1.1 c of ISO 9001:2015 requires that the quality system requirements (which include policies, procedures, standards, process descriptions, general principles, and all other directives, etc.) be integrated into the business processes of every organization.
This is a completely new requirement introduced by ISO 9001:2015. In previous versions, it was only required that a quality system be established and implemented in compliance with the standard’s requirements. The quality system was often perceived as something separate from a company’s daily business activities. This new requirement aims to change that perception and to emphasize that quality should not be viewed as something detached from the way an organization operates.
A quality system is not an independent system but rather a systematic way of viewing an organization from the perspective of creating and retaining customers over time. A closer examination of this specific clause reveals that integration refers to the quality system requirements, not the system as a whole. This does not mean that the quality system should become a subset of business processes that merely integrate it. Instead, each quality system requirement should be implemented through the functioning of the organization’s various business processes. It is crucial to understand this distinction because it clarifies that quality must be fully embedded in daily operations—only then can organizations attract new customers and retain existing ones.
To ensure that each requirement is applied within business processes, organizations must demonstrate how it is satisfied through specific actions. If necessary, top management should identify any factors that hinder the transmission of quality system requirements to the specific process points where they need to be implemented. One of the main barriers to integration is developing the quality system as a purely document-based system with little relevance to daily work—designed solely to satisfy auditors.
Top management must personally ensure that any obstacles preventing the proper implementation of quality system requirements through business processes are promptly removed. This can be achieved, for example, by directly involving employees working on specific processes in this important integration effort. Ultimately, it is these employees who will be responsible for applying the requirements. For this reason, they should be encouraged to transform the requirements into habits or actionable information that can be effectively used in their daily work.
To demonstrate that top management has exercised its leadership and made a strong commitment to ensuring the proper integration of quality system requirements within specific business process points, the following actions can be taken:
- Provide evidence that quality management requirements have been extensively documented;
- Present proof of which specific processes are responsible for implementing each individual requirement of the applicable standard (if necessary, a clarifying overview can be prepared);
- Explain, using a representative process, what actions and decisions were taken during its implementation under the guidance of quality requirements, and outline the steps followed to meet them.