The Requirements of UNI EN ISO 9001:2015 Certification

The requirements of ISO 9001:2015 (more than 300, divided into seven sections) are derived from the seven quality management principles and are designed to enable an organization to provide customers with a guarantee of product and service quality. Contrary to popular belief, their purpose is not to develop a quality management system.

To determine which requirements to include in the standard and how to do so, the members of the committee responsible for its development (TC 176) asked themselves four key questions:

• Is the requirement easy to understand?
• Is the requirement easy to use or apply?
• Is the requirement easy to translate from English into other languages (as ISO 9001 is originally drafted in English and then translated)?
• Is the requirement easy to verify?

The requirements of ISO 9001:2015 can all be categorized into one of the following eight management requirements:

1. Purpose – Requirements in this category serve to review the organization's purpose and the needs and expectations of interested parties.
2. Context – Context-related requirements ensure that the organization scans its operating environment to determine the factors influencing its ability to fulfill its purpose, set priorities, and establish a strategy.
3. Policy – Policy-related requirements help define the organization's general intentions, principles, and guiding values regarding quality.
4. Planning – This category includes requirements for setting objectives and the necessary measurements to achieve the organization's purpose and policies, assessing risks, developing relevant plans and processes to address them, and determining the resources needed to achieve objectives while considering these risks.
5. Implementation – This section includes requirements related to the resources needed to implement and manage the plans and processes required to deliver planned outputs and results.
6. Measurement – Measurement-related requirements serve to assess and monitor the achievement of objectives, adherence to the organization's policies, and stakeholder satisfaction.
7. Review – These requirements ensure the analysis and evaluation of measurement results to determine performance outcomes relative to objectives and to identify necessary changes in policies, objectives, measurements, and processes to ensure the ongoing suitability, adequacy, and effectiveness of the quality system.
8. Improvement – This final category includes all requirements necessary to drive improvements through better control systems, more efficient resource utilization, and a deeper understanding of stakeholder needs.

This section could also encompass everything related to innovation and learning. Additionally, all ISO 9001 requirements could be grouped into five overarching “assurance” requirements. Let's examine them:

1. The organization must demonstrate its commitment to achieving quality.
2. The organization must demonstrate the existence of effective policies that create an environment motivating employees to meet customer needs and expectations as well as legal and regulatory requirements.
3. The organization must demonstrate that it has effectively translated customer needs and expectations, legal requirements, and applicable regulations into measurable and achievable objectives.
4. The organization must demonstrate the existence of a network of processes that enable it to achieve these objectives in the most efficient manner.
5. The organization must demonstrate, through measurements, that it has achieved its objectives in the best possible way while remaining aligned with stakeholder needs and expectations.