ISO 9001:2015 Clause 8.4.3

What is ISO 9001:2015 Clause 8.4.3

Clause 8.4.3 of ISO 9001:2015 is titled “Control of externally provided processes, products, and services.” This clause addresses how organizations should control processes, products, and services that are provided by external parties (such as suppliers, contractors, or outsourced service providers) to ensure that they meet the organization’s quality requirements.

Key points outlined in Clause 8.4.3 include:

Identification of Externally Provided Processes, Products, and Services:

Organizations must identify processes, products, and services that are provided by external parties and determine their potential impact on the quality of the organization’s own products or services.

Establishment of Controls:

Organizations should establish controls for externally provided processes, products, and services to ensure that they meet specified requirements. This may include defining criteria for supplier selection, establishing agreements or contracts with external parties, and specifying requirements for monitoring and evaluating external providers’ performance.

Supplier Evaluation and Selection:

Organizations should have processes in place for evaluating and selecting external providers based on their ability to meet the organization’s quality requirements. This may involve assessing suppliers’ quality management systems, capabilities, performance history, and compliance with applicable standards and regulations.

Communication with External Providers:

Organizations should communicate their quality requirements to external providers clearly and effectively. This may include providing specifications, quality standards, inspection criteria, and any other relevant information to ensure that external providers understand and meet the organization’s expectations.

Monitoring and Measurement:

Organizations should monitor and measure the performance of external providers to ensure that they consistently meet quality requirements. This may involve conducting audits, inspections, or performance reviews, as well as collecting and analyzing data on external providers’ performance.

Control of Changes:

Organizations should have processes in place for controlling changes to externally provided processes, products, and services. This may include assessing the impact of changes, obtaining approval from relevant stakeholders, and communicating changes to external providers.

Records and Documentation:

Organizations should maintain records of activities related to the control of externally provided processes, products, and services. This may include records of supplier evaluations, contracts or agreements, communication with external providers, monitoring and measurement results, and any actions taken to address nonconformities or improve performance.

Overall, Clause 8.4.3 emphasizes the importance of effectively managing relationships with external providers to ensure that externally provided processes, products, and services meet the organization’s quality requirements and contribute to the achievement of its quality objectives.

Other ISO 9001:2015 Clauses:

How do companies comply with clause 8.4.3?

To comply with Clause 8.4.3 of ISO 9001:2015, which addresses the control of externally provided processes, products, and services, a company typically follows several key steps and implements various procedures within its quality management system (QMS). Here’s how a company can achieve compliance:

Supplier Evaluation and Selection:

• Establish criteria for evaluating and selecting external providers based on their ability to meet the organization’s quality requirements.
• Conduct supplier assessments, audits, or evaluations to ensure that potential suppliers have the necessary capabilities, resources, and quality management systems in place.

Contractual Agreements:

• Develop clear and comprehensive contracts or agreements with external providers that outline the quality requirements, specifications, responsibilities, and expectations.
• Ensure that contracts include provisions for monitoring, measuring, and evaluating the performance of external providers.

Communication of Requirements:

• Clearly communicate the organization’s quality requirements, specifications, and expectations to external providers.
• Provide suppliers with relevant information, such as product specifications, quality standards, inspection criteria, and any changes to requirements.

Monitoring and Measurement:

• Establish processes for monitoring and measuring the performance of external providers.
• Conduct regular performance evaluations, audits, inspections, or reviews to assess compliance with quality requirements and identify areas for improvement.

Control of Changes:

• Implement procedures for controlling changes to externally provided processes, products, or services.
• Assess the impact of changes, obtain approval from relevant stakeholders, and communicate changes to external providers in a timely manner.

Nonconformity Management:

• Establish procedures for identifying, documenting, and addressing nonconformities related to externally provided processes, products, or services.
• Take corrective actions to address nonconformities and prevent recurrence, which may involve working collaboratively with external providers to implement solutions.

Records and Documentation:

• Maintain accurate records of activities related to the control of externally provided processes, products, and services.
• Document supplier evaluations, contracts or agreements, communication with external providers, monitoring and measurement results, nonconformities, corrective actions, and any other relevant information.

Continuous Improvement:

• Continuously review and improve the processes for managing externally provided processes, products, and services.
• Use performance data and feedback from external providers to identify opportunities for enhancement and optimization.

By following these steps and implementing robust procedures within their QMS, companies can effectively comply with Clause 8.4.3 of ISO 9001:2015 and ensure that externally provided processes, products, and services meet their quality requirements and contribute to the organization’s overall quality objectives.

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