ISO 9001:2015 Clause 8.3.4

What is ISO 9001:2015 Clause 8.3.4?

Clause 8.3.4 of ISO 9001:2015: the organization shall apply controls to the design and development process so that the results to be achieved are defined and…

Key points outlined in Clause 8.3.4 include:

Clause 8.3.4 outlines the requirements for organizations to ensure that externally provided processes, products, and services that are essential for the conformity of the organization’s products or services are controlled. This includes processes and activities that are outsourced to external suppliers or contractors.

Key elements typically covered by Clause 8.3.4 include:

Type and Extent of Control:

Define the criteria for determining the type and extent of control required for externally provided processes, products, and services.

Supplier Evaluation and Selection:

• Establish criteria for the evaluation and selection of external providers, including suppliers and contractors.
• Consider factors such as the provider’s ability to meet specified requirements, past performance, and the potential impact on the organization’s ability to deliver conforming products or services.

Supplier Communication:

• Communicate relevant information to external providers regarding requirements for products, processes, or services.
• Ensure that external providers are aware of the organization’s quality management system requirements.

Monitoring and Measurement of Externally Provided Processes:

• Implement processes to monitor and measure the performance of external providers.
• Verify that externally provided processes, products, and services meet the organization’s specified requirements.

Records:

Maintain records of evaluations, approvals, and monitoring activities related to externally provided processes, products, and services.

Change Control:

• Establish a process for managing changes in externally provided processes, products, or services.
• Ensure that changes are communicated and evaluated for their potential impact on the organization’s quality management system.

Control of Nonconforming Externally Provided Processes:

Define processes for addressing nonconformities related to externally provided processes, products, or services.

Continual Improvement:

Identify opportunities for improvement in the control of externally provided processes, products, and services.

Organizations need to demonstrate that they have effective controls in place to ensure the conformity of externally provided processes, products, and services with their specified requirements. This involves managing the entire lifecycle, from supplier selection and communication to ongoing monitoring, evaluation, and improvement. Organizations need to maintain documentation and records as evidence of compliance during audits.

Other ISO 9001:2015 Clauses:

How does a company comply with Clause 8.3.4?

Compliance with Clause 8.3.4 of ISO 9001:2015 involves implementing a systematic approach to control externally provided processes, products, and services. Here are steps that a company can take to comply with this clause:

Define Criteria for Control:

• Establish clear criteria for determining which externally provided processes, products, and services are critical for the conformity of the organization’s products or services.
• Consider factors such as impact on product/service quality, customer satisfaction, regulatory compliance, and business performance.

Supplier Evaluation and Selection:

• Develop a process for evaluating and selecting external providers, including suppliers and contractors.
• Establish criteria for supplier assessment, considering their ability to meet specified requirements, past performance, and the potential impact on the organization.

Communication with Suppliers:

• Clearly communicate the organization’s requirements to external providers, ensuring that they are aware of and understand the expectations.
• Establish effective channels for ongoing communication with suppliers, addressing any changes or updates in requirements.

Monitoring and Measurement:

• Implement processes to monitor and measure the performance of external providers.
• Conduct regular assessments, audits, or evaluations to ensure that externally provided processes, products, and services meet the organization’s specified requirements.

Records and Documentation:

• Maintain comprehensive records of supplier evaluations, approvals, and monitoring activities.
• Keep documentation that demonstrates the conformity of externally provided processes, products, and services.

Change Control Process:

• Establish a robust change control process for externally provided processes, products, and services.
• Ensure that any changes made by suppliers are communicated, evaluated for impact, and approved before implementation.

Control of Nonconformities:

• Develop procedures for addressing nonconformities related to externally provided processes, products, or services.
• Define corrective actions to address nonconformities promptly and prevent their recurrence.

Continual Improvement:

• Regularly review the performance of external providers and identify opportunities for improvement.
• Implement corrective actions and continuous improvement initiatives to enhance the effectiveness of the control processes.

Training and Awareness:

• Ensure that relevant personnel are trained on the processes and requirements related to externally provided processes, products, and services.
• Raise awareness among employees about the importance of supplier controls and their role in maintaining quality.

Documentation and Reporting:

• Maintain documented procedures and instructions for the control of externally provided processes.
• Prepare reports or summaries that provide insights into supplier performance and the effectiveness of control measures.

By following these steps, a company can establish a comprehensive and effective system for complying with Clause 8.3.4 of ISO 9001:2015. Regular monitoring, evaluation, and improvement are essential components to ensure that the control of externally provided processes contributes to the overall effectiveness of the organization’s quality management system.

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