Implementing ISO 9001 Clause 8, which focuses on "Operation," involves the detailed planning and control of the processes necessary to meet requirements for the provision of products and services. This clause is central to the functioning of the quality management system (QMS). Here’s how to implement this key clause effectively:
Step 1: Plan and Control Processes
- Operational Planning and Control: Establish criteria for the processes and for the acceptance of products and services. Plan, implement, and control these processes in accordance with the criteria. Determine the resources needed, ensure process control, and document the processes in a way that can be consistently followed and replicated.
Step 2: Determine Requirements for Products and Services
- Customer Communication: Ensure effective communication with customers regarding information relating to their requirements, handling inquiries, contracts or order handling, including changes, and customer feedback.
- Determine Requirements: Determine the requirements for the products and services being offered. This includes statutory and regulatory requirements, as well as any considered necessary by the organization.
- Review Requirements: Before committing to supply a product or service to a customer, ensure that the organization can meet the defined requirements. This includes reviewing requirements specified by the customer, not explicitly stated but necessary for specified or intended use, and statutory and regulatory requirements.
Step 3: Design and Development of Products and Services
- Planning: Establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
- Inputs: Determine the requirements for the products and services. Inputs should include functional and performance requirements, applicable statutory and regulatory requirements, standards or guidelines for design and development, and potential consequences of failure due to the nature of the products and services.
- Controls: Apply controls to the design and development process to ensure that the results meet the requirements and are effectively implemented. Review the design stages and design changes.
- Outputs and Changes: Ensure the design and development outputs meet input requirements. Manage changes during the design and development process to ensure that there is no adverse impact on conformity to requirements.
Step 4: Control of Externally Provided Processes, Products, and Services
- Type and Extent of Control: Determine and apply criteria for the evaluation, selection, monitoring, and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with requirements.
- Information for External Providers: Ensure that the external providers are aware of their responsibilities, including requirements for the products or services, approval of products, procedures, processes, and equipment, the competence of personnel, and their interaction with the organization’s QMS.
Step 5: Production and Service Provision
- Control Production and Service Provision: Control the production and service provision through planned arrangements that meet requirements. Ensure the availability of documented information that defines the characteristics of the products to be produced, the services to be provided, and the results to be achieved.
- Release of Products and Services: Implement arrangements for the controlled release, delivery, or provision of products and services.
Step 6: Release, Monitor, and Control Nonconforming Outputs
- Assessment of Nonconformity: When nonconforming outputs occur, take appropriate actions to control and correct them, and deal with the consequences.
- Corrective Actions: Evaluate the need for action to eliminate the causes of nonconformities in order to prevent recurrence.
Implementing Clause 8 of ISO 9001 requires careful attention to the design, development, execution, and monitoring of all operational processes. It ensures that the products and services meet customer requirements and statutory and regulatory requirements, thereby enhancing customer satisfaction.