ISO 9001:2015 Clause 8.4

What is ISO 9001:2015 Clause 8.4?

Clause 8.4 of ISO 9001:2015 deals with the control of externally provided processes, products, and services within an organization’s quality management system (QMS). This clause focuses on ensuring that external providers, including suppliers and contractors, meet the organization’s requirements to maintain and enhance product or service quality.

Key points outlined in Clause 8.4 include:

General Requirements:

Organizations are required to determine and apply criteria for the selection, evaluation, and re-evaluation of external providers based on their ability to provide products, services, or processes that meet specified requirements.

Type and Extent of Control:

Determine the type and extent of control to be applied to external providers based on the potential impact on the organization’s ability to provide conforming products and services to customers.

Information for External Providers:

Provide necessary information about product or service requirements to external providers to ensure they understand and meet these requirements.

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Monitoring and Measurement of Performance:

Establish processes for monitoring, measuring, or otherwise evaluating the performance of external providers to ensure they continue to meet the organization’s requirements.

Maintaining Records:

Maintain documented information about the performance of external providers and the conformity of their products or services, including any actions taken regarding non-conformities.

Change Control with External Providers:

Establish processes for communicating changes in requirements to external providers and managing any changes that could affect the quality of products or services provided.

Preservation of Conformity:

Ensure that externally provided products or services remain in conformity with specified requirements throughout their use or delivery to customers.

Risk Management with External Providers:

Consider risks associated with external providers and implement appropriate measures to manage and mitigate these risks.

Compliance with Clause 8.4 involves establishing a robust system for managing relationships with external providers to ensure that they meet the organization’s quality requirements. This includes clear communication, performance monitoring, risk assessment, and continuous improvement of processes related to externally provided products, services, and processes.

How do you comply with Clause 8.4?

Complying with Clause 8.4 of ISO 9001:2015, which focuses on controlling externally provided processes, products, and services, involves several steps and practices within an organization.

Here’s a guide to ensure compliance:

Criteria for Provider Selection:

Establish clear criteria for selecting external providers. Consider factors such as their ability to meet your quality requirements, delivery schedules, financial stability, past performance, and compliance with relevant standards or regulations.

Documentation and Communication:

Document your organization’s requirements and communicate them effectively to external providers. This ensures they understand what is expected of them in terms of product or service quality, delivery, and any other specific criteria.

Supplier Evaluation and Monitoring:

Develop processes to evaluate and monitor the performance of external providers. Regularly assess their performance against established criteria, including on-time delivery, quality of products or services, responsiveness, and adherence to specifications.

Establish Performance Metrics:

Define key performance indicators (KPIs) or metrics to measure the performance of external providers. These could include defect rates, delivery time accuracy, customer complaints related to their products or services, etc.

Contractual Agreements:

Establish clear and comprehensive contracts or agreements with external providers. Ensure that these contracts include all necessary quality-related clauses, specifications, responsibilities, and requirements.

Risk Management:

Identify and assess risks associated with relying on external providers. Develop strategies to mitigate these risks, such as having backup suppliers or implementing contingency plans in case of disruptions.

Monitoring and Record-Keeping:

Implement a system to monitor and document the performance of external providers. Maintain records of evaluations, communications, non-conformities, corrective actions, and improvements related to these providers.

Feedback and Improvement:

Encourage feedback from internal stakeholders regarding the performance of external providers. Use this feedback to drive improvements in the relationship, processes, or specifications if necessary.

Continuous Improvement:

Regularly review and improve processes related to managing external providers. Use performance data and feedback to identify areas for enhancement and implement corrective actions or improvements.

Audit and Review:

Conduct regular audits and reviews of your external provider management processes to ensure compliance with ISO 9001 requirements and to identify opportunities for enhancement.

Compliance with Clause 8.4 requires a systematic approach to managing relationships with external providers, ensuring they meet your organization’s quality requirements, and maintaining a robust system for monitoring, evaluation, and improvement.

Other ISO 9001:2015 Clauses:

What is the History of Clause 8.4?

Clause 8.4, focusing on the control of externally provided processes, products, and services, within ISO 9001:2015, reflects the evolution of standards in managing external relationships within a quality management system.

In previous versions of ISO 9001:

ISO 9001:2000:

This version marked a significant shift in emphasizing the need to consider processes that are outsourced or provided by external parties. It introduced the concept of “supplier control” and included requirements for organizations to evaluate and monitor their suppliers to ensure they met specified standards.

ISO 9001:2008:

Minor revisions were made to improve clarity and alignment with other management system standards. While the clause addressing external providers didn’t see substantial changes, the focus on supplier evaluation, monitoring, and management remained an integral part of the standard.

ISO 9001:2015:

This version brought a significant restructuring and introduced a high-level structure (HLS) shared among various ISO management system standards. Clause 8.4 emphasizes a more holistic approach to controlling externally provided processes, products, and services. It stresses the need for clearer communication, risk assessment, performance monitoring, and the preservation of conformity when relying on external parties.

Over time, the evolution of Clause 8.4 reflects a growing recognition within the ISO 9001 standard of the importance of effectively managing external relationships and ensuring that external providers align with an organization’s quality objectives.

The changes across different versions indicate an increased focus on establishing comprehensive control mechanisms, clearer communication, risk mitigation strategies, and performance evaluation when dealing with external providers. This evolution aligns with the broader goal of ensuring that externally provided processes, products, and services contribute positively to an organization’s ability to deliver quality products or services to its customers.

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