ISO 9001:2015 Clause 8.4.2

What is ISO 9001:2015 Clause 8.4.2

Clause 8.4.2 of ISO 9001:2015 pertains to the control of externally provided products and services within the quality management system.

Key points outlined in Clause 8.4.2 include:

The key points of Clause 8.4.2 of ISO 9001:2015 include:

  • Ensuring that externally provided products and services conform to specified requirements.
  • Establishing criteria for the evaluation, selection, monitoring, and re-evaluation of external providers.
  • Implementing processes to ensure that externally provided products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers.
  • Maintaining documented information to demonstrate the conformity of externally provided products and services.

How do companies comply with clause 8.4.2?

A company can comply with Clause 8.4.2 of ISO 9001:2015 by following these steps:

  • Establishing clear criteria for evaluating and selecting external providers based on their ability to meet the organization’s requirements.
  • Implementing processes for monitoring and re-evaluating external providers to ensure ongoing compliance.
  • Documenting procedures for the control of externally provided products and services, including verification of conformity.
  • Ensuring that external providers understand the organization’s quality requirements and expectations. Monitoring the performance of external providers through regular reviews and audits.
  • Taking appropriate corrective actions if external providers fail to meet requirements.
  • Maintaining records of externally provided products and services to demonstrate conformity.
  • Continuously improving processes related to the control of externally provided products and services based on performance data and feedback.

Helpful Resources:

Episode 22 – ISO 9001 Clause 8.4.2 – Purchasing – Part 2 Podcast

ISO 9001 Clause 8.4.2 consultants

In the second part of “Purchasing” on the Quality Hub podcast, Xavier Francis, along with Murphy Shaw and Matthew Pilley from Core Business Solutions, delve into Clause 8.4.2 of the ISO 9001 standard, focusing on supplier controls. Murphy explains the importance of controlling supplier quality to prevent negative impacts on the organization and its customers. Matthew describes Core’s approach, which includes drafting a supplier management process within the quality manual and defining purchasing as a key process.  Listen Now

 

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Related Standards

We provide consulting support for various other standards, as well as support for companies seeking multiple certifications through an Integrated Management System.

 

AS9100

Aerospace Manufacturers

AS9120

Aerospace Distributors

ISO 14001

Environmental Management Systems

ISO 27001

Information Security Management Systems

ISO 20000-1

Service Management Systems

ISO 45001

OH&S Management Systems

ISO 13485

Medical Device Manufacturers

AS9100

AS9120

ISO 14001

ISO
20000-1

ISO 27001

ISO 45001

ISO 13485

Equip Your Business to Meet ISO 9001 With CORE

At Core Business Solutions, we’re here to equip your company for success in meeting ISO 9001 requirements. We’ve helped hundreds of small businesses grow and deliver the best solutions to their clients. We provide ISO training services, consulting help, and compliance software and to help you get certified and stay certified. We focus on optimizing your processes and helping you implement an ISO-compliant QMS. When you partner with us, you’ll get the tools and help you need for success. For more information on the ISO 9001:2015 standard, please visit our articles page. You can also call our consulting office at 866-354-0300 or contact us online.

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