Understanding ISO 9001:2015 Clause 8: Operation

7 January 2024

Let's take a closer look at Clause 8 of the ISO 9001:2015 standard. Clause 8 is the largest and most critical clause of ISO 9001. This clause addresses the entire production process, from understanding and communicating customer requirements to the final release of the product or service. It emphasizes the significance of meeting customer expectations, adapting to changing requirements, and ensuring the quality of the delivered product or service. By breaking down this clause into easily digestible parts, we can gain a comprehensive understanding of its requirements and explore practical implementation tips.

Identifying Product and Service Requirements

Before organizations accept an order, they need to review customer requirements thoroughly. Comprehending product or service requirements is vital to achieving satisfying results. Clause 8 also emphasizes that everybody in the organization must understand customer requirements and how they relate to their work responsibilities. Communicating requirements and changes and understanding what needs to be done in case of requirements changing is essential.

Design and Development

Design and development are critical to creating a product or service that meets customer requirements. Planning design and development reviews, verification, and validation early on helps identify and address potential issues, minimizing the risk of producing faulty products or services.

Managing External Providers

Control of external providers, such as suppliers of raw materials or outsourced processes, is another aspect covered by Clause 8. ISO 9001:2015 requires organizations to establish effective processes for controlling and managing these external providers. Proper supplier selection, regular reviews, and checks for material quality, and monitoring supplier performance are crucial aspects of this process.

Production and Service Provision under Controlled Conditions

To ensure consistent quality, it's essential to carry out production and service provision under controlled conditions. This means implementing documented processes and work instructions that guide your operations in detail. Controlled conditions also include clearly defining activities to be performed, utilizing suitable monitoring and measuring resources, ensuring proper infrastructure, employing competent personnel, and validating process results. These controls not only optimize operations but also guarantee that products or services meet acceptance criteria and are delivered flawlessly.

Maintaining control throughout the entire production process also includes the identification and labeling of the components used in your production process. In some cases, you are required to establish a traceability system that allows you to track the flow of your products or services from start to finish. And if your organization handles products that belong to customers or suppliers, establish appropriate procedures for their handling. This includes storage, protection, and ensuring that these products are not mixed up or mistakenly used in your own production processes.

Release, Delivery, and Post-Delivery

Establishing a defined process for releasing products or services to the customer is required by ISO 9001:2015. This may involve final QC inspections, testing, or verification. Next, you need effective procedures for the delivery of your products or services to the customer. This includes considering packaging, transportation, and any necessary documentation or instructions that need to accompany the product or service. Even after the product has been delivered or the service has been provided, you still have responsibilities. Address any issues or non-conformances that may arise post-delivery and take prompt corrective actions to maintain customer satisfaction.

Dealing with Non-Conformance

Clause 8 also addresses the challenging scenarios where output, which can be both products and services, is found to be non-conforming to requirements. This includes instances where non-conformances are only detected after the product has been delivered or the service has been provided. It is crucial for organizations to have effective procedures and protocols in place to handle such situations promptly and ensure necessary corrective actions are taken. This approach mitigates potential future non-conformance issues and enhances customer satisfaction.


By adhering to the requirements of ISO 9001:2015 Clause 8 and implementing effective processes, your organization can enhance customer communication, design and develop products/services that meet customer expectations, collaborate effectively with external providers, maintain control during production and service provision, and swiftly address non-conformance situations. Embracing Clause 8 not only optimizes your operations but also ensures customer satisfaction and drives the success of your business.

For a comprehensive overview of all the requirements and how they interconnect, please see our article on ISO 9001:2015 Requirements. Alternatively, you may consider our comprehensive ISO 9001:2015 Foundation Training online course to deepen your understanding and skills related to quality management systems.

Simon Keller

Simon Keller

Training Manager, Instructor and Lead Author

Simon is the lead author of our ISO 9001 courses, templates and instructions, and is a passionate contributor to our articles and learning resources.

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