Design & Development

In today’s dynamic world, innovation is life. There are many examples in the history of the corporate world where organisations that commanded a huge market share and led the market at one point in time were wiped out. Those companies failed to keep pace with the changing requirements of customers and markets; they also neglected innovation.

The design and development of a process, service or product is a very important phase in the product life cycle. The future of an organisation depends largely on how customer and interested party requirements are captured and converted to design and development outputs.

The ISO 9001:2015 standard requires an organisation to control the entire design and development cycle. The organisation should plan for design projects while considering other business variables and capture design and development input to enable the design team to start working on the project. The design and development process also covers regular review, verification and validation at appropriate stages to ensure you are developing a product as identified in the input. Finally, the standard requires an organisation to capture design and development output. Any change in the design and development must also be captured to exercise change control.

The Design and Development module of Effivity ensures you meet all these requirements in an effective, efficient and simple manner. The steps below demonstrate the capabilities of this module and show how you can comply with the requirements relevant to the design and development related clause of the standard.

  1. Identify and create a new design and development project.
  2. Define and carry out planning for the project covering the required steps, responsibilities and resources.
  3. Define inputs for the project. Inputs can be brief, prototype, competing product, service or design related, market survey findings, customer requests, internal intelligence recommendations or any other method wherein you capture the information you receive as well as the expectations of the final output.
  4. Capture outputs for the project. The system allows you to upload design output files, drawings, specifications, etc.
  5. During the design phase and depending on requirements of the regular design and development review, verification and validation may happen. All these can be monitored under the requirements of the design and development control clause for the project.
  6. Any changes in design and development projects based on feedback received through internal and/or external stakeholders can be documented to ensure proper change control. All phases of change can be captured effectively.
  7. Define, plan and track design and development quality objectives or KPIs.
  8. Procedures and forms related to the Design and Development module can be captured in the Documented Information module.

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The comprehensive capabilities of this module enable all requirements from design and development clauses to be addressed in a quick and simplified manner while ensuring 100% compliance with the ISO 9001:2015 standard. Contact us at for further information or visit ISOCertification/Register.htm to subscribe to our award winning and one of a kind Quality Management software.

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