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What's Clause 8 on Operation?

The ISO 9001:2015 standard is a set of requirements that set the framework for an organization's quality management system. Clause 8 of the standard addresses operation. We'll give you a brief and easy-to-understand overview of this clause.

In clause 8, the ISO 9001:2015 standard sets the requirements for the processes needed to achieve the product or service. This is how your product or service is designed, produced, tested, handled, shipped, etc. Emphasis is placed on how the company understands, communicates and meets customer requirements, and what it does if customer requirements change.

Design and development reviews, verification, and validation must be planned for at the very beginning of the design and development process.

This clause also addresses the purchasing of products and services and outsourcing. Controls include supplier evaluations, selection, disqualification and receiving inspections.

The clause specifies several controls for the actual production and service provision, ranging from work instructions to QC inspections. There are also requirements for the identification of components and the ability of tracing a product or service back, as well as for handling products that belong to customers or suppliers.

Then the standard addresses how the final product or service can eventually be released to the customer.

Lastly this clause addresses cases in which output is found as not conforming to requirements, including cases in which such a nonconformance is only detected after the product has been delivered or the service provided.

More ISO 9001:2015 Requirements

There are another six clauses in ISO 9001:2015 that contain requirements for a quality management system. For an overview and an explanation of how they all fit together, please see our article on ISO 9001:2015 Requirements.