Design and Development Planning

The seven parts of the design process

Like all requirements in ISO 9001, the standard does not tell you how to implement the design process, but only
what needs to be included in your implementation. The seven parts of the requirements tell you a few things that
need to be included in your process to ensure a proper design. Below I will go through the seven sections of the
ISO 9001 requirements and explain what the requirements call for in the design process.
Design and Development Planning. Simply put, this section just says you need to have a plan on how you do
designs. All that may be needed is a _ow similar to the one above, with the inclusion of who is responsible for
the steps to ensure that handoffs between different groups are managed. Additionally, the review steps
should check if changes are required to the design output documents, and update them if required… The
requirements do not, however, require that this be a written process. Since this is not one of the six required
documented processes you can decide if you need to write it out or not. The main deciding factor is if there
could be errors due to the fact that the process is not written out.
8.2.3.2
Review of the requirements for products and services Record
The organization shall retain Documented information, as applicable, on the results of review and on any new
requirements for products and services.
8.3.2 j Design and development planning Record
The Organization shall consider the documented information needed to demonstrate that design and
development requirements have been met.
5.0 RESPONSIBILITY AND AUTHORITY
The Design Manager is responsible for implementation and management of this procedure.
6.0 DETAILS OF PROCEDURE
6.1. Design Planning
6.1.1. The Design Manager plans the stages and controls for
Design and development, by taking into account:
Nature, duration and complexity of design activities
Required process stages, including applicable design activities
Required verification and validation activities
Internal and external resources needed
Interfaces between persons involved in Design
Design regulations, standards
6.1.2. The design planning documentation shall be recorded electronically and/ or in hard copy form, as
appropriate. This will include the Design Team comprising of the assigned design engineers, support staff,
subordinate third party providers, and the responsibilities and authorities for each. Where third parties are
utilized, this shall define the approved points of contact.
6.1.3. The Design Manager must ensure that the Design Team:
Implements design control
Generates the design plan and schedule
Reviews changes to product or service design
Defines activities of verification and validation
3.1.4. At any stage, the Designers must maintain design control with history of changes as per Design Change
Log.
6.3 Developing the Design Plan
6.3.1 According to the Design Task, the Design Team creates the Design Plan and defines:
• The design phases
• All activities related to phase realization
• Input elements of each phase
• Responsibilities of team members for each phase
• Phase realization deadlines
• Phase deliverables
• Resources needed
• Changes in phases and approval of changes
• Design phase status (reviewed, validated, verified and completed)
6.3.2 The Design Plan will be updated as the design work progresses.