Design Change Procedure ISO 9001 2015 | QP1110

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ISO9001 2015 Design Change Procedure Template Word


The ISO9001 2015 Design Change Procedure Template Word is a comprehensive and easy-to-use tool that helps organizations manage design changes effectively. This template is designed to meet the requirements of ISO 9001:2015, which emphasizes the importance of managing design changes to ensure that products and services meet customer requirements and expectations.

The template includes a step-by-step procedure for managing design changes, from identifying the need for a change to implementing and verifying the change. It also includes forms and checklists to help organizations document and track design changes, ensuring that all changes are properly reviewed, approved, and implemented.

With this template, organizations can streamline their design change process, reducing the risk of errors and delays. It also helps organizations ensure that all design changes are properly documented and communicated, improving transparency and accountability.

The ISO9001 2015 Design Change Procedure Template Word is fully customizable, allowing organizations to tailor it to their specific needs and requirements. It is also easy to use, with clear instructions and guidance throughout the document.

Overall, the ISO9001 2015 Design Change Procedure Template Word is an essential tool for any organization looking to improve their design change process and meet the requirements of ISO 9001:2015. It is a cost-effective and efficient solution that can help organizations save time and resources while improving the quality of their products and services.

ISO Design Change Procedure

The ISO Design Change Procedure outlines the procedure for requesting changes to your company products or processes and implementing those changes, to assure orderly, controlled, and effective changes to every aspect of the design of your company products in conformance with ISO 9001:2015.

This procedure applies to all of your company’s design processes and to all products designed by your company; specifically, to change control. (8 pages, 1156 words)

Design change requests often come from existing customers as a result of complaints, new capabilities, or requirements. Such requests may also originate within the company (e.g., responding to news of a competitive product, production issues, supply issues, preventive actions).

ISO Design Change Responsibilities

Design Engineers are responsible for ensuring that all product design changes are recorded, communicated, and implemented; the department is also responsible for evaluating change requests and determining appropriate responses.

Document Control or an individual designated by Management is responsible for assuring that obsolete/superseded documents are removed from the work environment and only current revisions of necessary documents are available at point of use.

ISO Design Change Procedure Activities

  • Requesting Design Changes
  • Engineering Change Notice
  • Change Design and Development, Review, Verification, Validation and Testing
  • Preproduction Planning and Manufacturing

ISO Design Change Procedure References

  • ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015
  • Quality Procedures

ISO Design Change Procedure Forms




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