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ISO 9001 8.4 - Control of externally provided processes, products and services

wilkshireconsulting
Mar 21
5 min read

In ISO 9001 8.4 - Control of externally provided processes, products and services focuses on organizations properly controlling any process, products or services obtained from external providers such as suppliers, contractors, or partners. The goal of 8.4 is to ensure that externally sourced elements meet specified requirements and also do not negatively impact the overall quality of the final product or service.

In this blog post we will be discussing the following:

8.4 consists of 3 sections –

· 8.4.1 General

· 8.4.2 Type and Extent of Control

· 8.4.3 Information for External Providers

· Why is 8.4 Important?

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

8.4 Control of externally provided processes, products and services

8.4.1 General

The organization shall ensure that externally provided processes, products and services conform to requirements.

The organization shall determine the controls to be applied to externally provided processes, products and services when:

a) products and services from external providers are intended for incorporation into the organization’s own products and services;

b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;

c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

8.4.2 Type and extent of control

The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services toits customers.

The organization shall:

a) ensure that externally provided processes remain within the control of its quality management system;

b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

c) take into consideration:

1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;

2) the effectiveness of the controls applied by the external provider;

d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements.

8.4.3 Information for external providers

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.

The organization shall communicate to external providers its requirements for:

a) the processes, products and services to be provided;

b) the approval of:

1) products and services;

2) methods, processes and equipment;

3) the release of products and services;

c) competence, including any required qualification of persons;

d) the external providers’ interactions with the organization;

e) control and monitoring of the external providers’ performance to be applied by the organization;

f) verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises.

8.4.1 General

Organizations must ensure that any external provided process, product, or service:

· Meets specified requirements – Customer, legal, regulatory, and quality requirements

· Does not negatively impact the organization’s ability to consistently deliver quality products/ services.

· Is properly controlled to prevent defects or non-conformance.

An example of this would be if your are a car manufacturer and your purchasing engines from and 3rd party you must ensure that they meet the safety and performance standards.

8.4.2 Type and Extent of Control

The organization must apply appropriate controls based on the risk level and impact of the externally provided product/ service.

Factors to consider when determining control levels:

· Critically of the external product/ service – such as a defective aircraft part can cause safety issues.

· Potential risks to quality, safety and compliance.

· Past performance of the supplier – such as pervious quality issues & reliability.

· Legal and regulatory - requirements affecting the externally provided product/ service.

Types of Controls Mechanisms

1. Supplier Audits & Assessments – Conduct periodic evaluations of suppliers.

2. Incoming Inspections – Check raw materials/ components before use.

3. Performance Monitoring – Review supplier defect rates and delivery performance.

4. Process Approvals – Require supplier process validation before full-scale production.

5. Contractual Agreements – Define quality requirements, penalties, and expectations.

An example of this would be if you are a pharmaceutical company and you audit your API (Active Pharmaceutical Ingredient) suppliers to verify compliance with Good Manufacturing Practices (GMP).

8.4.3 Information for External Providers

The organization must communicate clear requirements to external providers, including:

· Product/ service specifications – such as technical requirements, quality standards.

· Approval criteria – such as certifications, test reports, and sample validation.

· Competency expectations – supplier must meet ISO standards or industry regulations.

· Performance monitoring – such as quality targets & on-time delivery requirements.

· Non-conformance handling – such as corrective actions for defects.

An example of this would be if you are an IT company and you are outsourcing software development you must specify these things:

· Programming languages & frameworks to be used.

· Expected security protocols and compliance.

· Testing requirements before delivery.

Why is 8.4 Important?

Why is ISO 9001 Clause 8.4 important?

1. Prevents quality issues

2. Reduces risks

3. Ensures compliance

4. Strengthens supplier relationships

5. Improves overall operational efficiency

In conclusion, implementing Clause 8.4 Control of externally provided processes, products and services ensures organizations consistency, reliability and compliance, reducing the risk of defects and maintaining customer satisfaction. In the next blog post we will be diving deeper into Clause 8.5 Production and service provision.