ISO 9001:2015 Clause 8.2.3

What is ISO 9001:2015 Clause 8.2.3?

Clause 8.2.3, which is titled “Review of requirements for products and services.” This clause is part of Section 8, titled “Operation,” within the ISO 9001 standard.

Key points outlined in Clause 8.2.3 include:

Clause 8.2.3 in ISO 9001:2015 outlines the requirements for organizations to review and ensure they understand the requirements for the products and services they offer. Here are key aspects of this clause:

Understanding the Requirements:

  • Organizations are required to ensure that they have a clear understanding of the customer’s requirements, including any applicable statutory and regulatory requirements.
  • This understanding should also extend to any additional requirements determined by the organization.

Review Before Commitment:

  • The review of requirements should occur before the organization commits to supplying products or services to the customer.
  • This process is essential to confirm that the organization has the capability to meet the defined requirements and can ensure customer satisfaction.

Changes in Requirements:

In case there are changes in the requirements for products or services, organizations should ensure that relevant documents are amended, and relevant personnel are made aware of these changes.

Record Keeping:

Organizations are typically required to maintain records of the results of the review of requirements, demonstrating that this process has been carried out and that the organization is aware of customer requirements.

The intent of this clause is to establish a systematic process for organizations to review, understand, and confirm that they can meet the requirements for the products or services they offer. By doing so, organizations can enhance customer satisfaction and minimize the risk of non-conformities.

How does a company comply with Clause 8.2.3?

To comply with Clause 8.2.3 of ISO 9001:2015, which pertains to the review of requirements for products and services, organizations can follow a systematic approach. Here are steps that a company can take to ensure compliance with this clause:

Establish a Review Process:

  • Develop a documented process for reviewing and understanding customer requirements, as well as any applicable statutory and regulatory requirements.
  • Clearly define the criteria for the review process.

Identify Applicable Requirements:

  • Identify and document all relevant requirements related to the products or services the organization offers.
  • Consider customer specifications, applicable standards, and legal requirements.

Involve Relevant Stakeholders:

  • Involve key stakeholders, including individuals responsible for sales, marketing, design, production, and quality assurance, in the review process.
  • Ensure effective communication between relevant departments to capture and understand all requirements.

Ensure Understanding:

  • Verify that there is a common understanding of customer requirements and any other applicable requirements among the various departments and individuals involved.
  • Address any ambiguities or uncertainties in the requirements through communication with customers or relevant parties.

Document the Review:

  • Document the results of the review, including the decisions and actions taken.
  • Keep records of the reviewed requirements and any changes made as a result of the review process.

Review Before Commitment:

  • Conduct the review of requirements before committing to the supply of products or services to customers.
  • Confirm that the organization can meet the identified requirements and ensure customer satisfaction.

Manage Changes:

  • Establish a process for managing changes in requirements.
  • If there are changes in customer requirements or other applicable requirements, ensure that relevant documents are updated, and communication is made to all affected parties.

Training and Awareness:

  • Provide training to employees involved in the review process to enhance their understanding of customer requirements and the importance of the review process.
  • Ensure awareness of the critical role each individual plays in ensuring compliance.

Continuous Improvement:

Periodically review and improve the process for reviewing requirements based on feedback, audit findings, and changes in the business environment.

Documented Information:

Maintain documented information to demonstrate that the organization has implemented the review of requirements by the requirements of ISO 9001.

By following these steps, an organization can establish a robust process for the review of requirements, contributing to effective planning, customer satisfaction, and overall compliance with Clause 8.2.3 of ISO 9001:2015. It’s essential to adapt these steps to the specific context and nature of the organization’s products or services.

Helpful Resources:  ISO Audits – How to Conduct Effective Management Reviews

ISO Certification Management Reviews

In this episode, we’re joined by our guest Joe Hill who shares his invaluable insights on conducting an effective management review. Joe discusses the key purpose of the review and outlines strategies for involving pertinent stakeholders such as representatives from various departments. We delve into the critical risks and requirements that management must address to achieve optimal results. 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

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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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