ISO 9001 CERTIFICATION

ISO 9001 Design and Development

ISO 9001:2015 includes requirements for organizations to establish and maintain a design and development process for their products and services. The design and development process should be planned and controlled to ensure that products and services meet customer needs and are delivered in a consistent and reliable manner.

The design and development process in ISO 9001:2015 includes the following steps:

  • Planning: Establish a plan for the design and development process, including objectives, timelines, resources, and responsibilities.
  • Input: Gather and analyze information about customer needs, regulatory requirements, and other factors that may impact the design and development process.
  • Process design: Develop a design and development process that meets the requirements of the organization and is appropriate for the product or service being developed.
  • Output: Develop the product or service design output, including drawings, specifications, and other documentation as necessary.
  • Verification: Verify that the design output meets the requirements of the organization and is appropriate for the product or service being developed.
  • Validation: Validate the design output to ensure that it meets customer needs and is appropriate for the intended use.
  • Change control: Establish a process for controlling changes to the design output, including identifying changes, evaluating their impact, and ensuring that necessary approvals are obtained.
  • Documentation: Maintain documentation related to the design and development process, including records of design input, design output, verification, and validation activities.

By following these steps, organizations can ensure that their products and services are designed and developed in a systematic and controlled manner, and that they meet customer needs and regulatory requirements. The design and development process should be continuously improved to ensure that it remains effective and aligned with business needs.

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