Understanding clause 8 of ISO 45001:2015 requirements.
ISO 9001 is an international standard that specifies requirements for a quality management system (QMS).
This clause titled “operations” 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.
Now let’s look at the sub-clauses.
1. 8.1 Operational planning and control: This sub-clause requires organizations to plan, implement, and control the processes needed to meet product/service requirements and enhance customer satisfaction. It emphasizes the importance of defining criteria for operations and ensuring that they are carried out effectively.
2. 8.2 Requirements for products and services: This sub-clause details the requirements for determining and reviewing product and service requirements, including customer requirements, statutory and regulatory requirements, and any additional requirements determined by the organization… It addresses the issue of communicating requirements, determining the requirements, reviewing the requirements and also any changes to the requirements.
3. 8.3 Design and development of products and services: This sub-clause outlines the requirements for organizations that design and develop products or services. It includes planning, input requirements, controls, reviews, verification, validation, and changes to the design and development process.
4. 8.4 Control of externally provided processes, products, and services: This sub-clause covers the requirements for organizations to control externally provided processes, products, and services that are necessary for the QMS.
5. 8.5 Production and service provision: This sub-clause focuses on the requirements for the control of production and service provision processes, including the control of equipment, processes, and personnel to ensure conformity of products and services. A very crucial part of this sub-clause is identification and product traceability which covers the requirements for organizations to identify products and services through suitable means and maintain traceability when required. There is also a requirement for Preservation. This outlines the requirements for organizations to preserve the conformity of products and services during internal processing and delivery to prevent damage or deterioration. We also have post delivery activities which can be actions under warranty provisions, contractual obligations such as maintenance, follow-up operations etc.
6. 8.6 Release of products and services: This sub-clause specifies the requirements for organizations to ensure that products and services meet the organization’s requirements before their release.
7. 8.7 Control of nonconforming outputs: This sub-clause outlines the requirements for organizations to identify, control, and take actions on nonconforming products and services to prevent their unintended use or delivery.
These sub-clauses within Clause 8 of ISO 9001 provide a structured framework for organizations to operate their quality management systems effectively, ensuring that products and services meet customer requirements and that processes are continually monitored, measured, analyzed, and improved.
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