Design and development
The ISO Navigator™ database hyperlinks the ISO 9000:2005 principles and the ISO 9001:2008 requirements; and explains them in plain English with practical guidance.
This guidance has been superseded by ISO 9001:2015 Clause 8.3.2 Design and Development Planning. If you want to see a comparison matrix that correlates the requirements of ISO 9001:2008 to the revised requirements of ISO 9001:2015, please click here to begin comparing.
Our range of ISO 9001:2015 quality manuals and integrated manual templates cover the requirements of ISO 14001:2015 and ISO 45001:2018, and offer an easy way to implement and document your organization's quality management system or integrated management system.
ISO 9001:2008: Design and development planning 7.3.1 (superseded)
Who is going to do it? How and when will they communicate? You must have an overall plan for your design. The plan must specify the design and development stages, activities and tasks; responsibilities; timeframe and resources; specific tests, validations and reviews; and outcomes. Plan and control product design and development by determining:
- All design development phases
- All review, verification and validation techniques for each phase
- Responsibility for design and development
- Authorities for design and development
- The types of records that are required
Although the standard does not require a documented procedure, the design process needs to demonstrate how it is controlled and planned. The organization will need to provide objective evidence as to what the planning activities include and can be accomplished with the use of time-lines, Gantt charts or any other planning method such as Microsoft project manager.
In addition, auditors would expect see objective evidence of how the interfaces between other processes are managed, either through statements in associated procedures or process mapping.
Want to know more?
- Read our customer's feedback
- Client list - who's using our templates?
- How the templates are formatted and download examples
- Why we use turtle diagrams and process maps
- What's the difference between a process and a procedure?
- About documented information
A certificate guarantees the information your internet browser is receiving now originates from the expected domain - https://www.iso9001help.co.uk. It guarantees that when you make a purchase, sensitive data is encrypted and sent to the right place, and not to a malicious third-party.
Free PDCA guidance
ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.