General Notes
The requirements of this section do not apply to ISO 9002 systems (i.e. if your organisation does not conduct design activities)
Clause 4.4.1 - General
This Clause requires that your procedures must ensure that design activities are properly conducted, recorded and reviewed.
Clause 4.4.2 - Design & Development Planning
Prior to commencement of design work, you must prepare plans covering all design activities. These plans must define the responsibilities for each stage of the design. The plan must be updated as the design evolves.
In practice, the design will often be led by a particular person, who should be identified in the design plan.
Persons involved in the design work must be suitably qualified and/or experienced. You must be able to demonstrate this if required. (See also clause 12 - Training)
Clause 4.4.3 - Organizational & Technical Interfaces
The design plan must identify the different groups of people involved in the design (e.g. Development Team, Drawing Office, Production Department, Customer, etc) The means by which these groups communicate should also be stated (e.g. during weekly development meetings, etc)
The interfaces between these groups may alter as the design work proceeds, and this element of the plan must be updated and reviewed on a regular basis.
Clause 4.4.4 - Design Input
All of the information required in order to produce the design must be specified. This may include :
The inputs should be reviewed prior to commencement and during the design. Any ambiguous or incomplete information must be resolved with the originators of the information, or with the persons responsible for imposing the requirement.
Clause 4.4.5 - Design Output
The design output (which may be physical goods as well as documentation) must be documented. The documents must be expressed in quantifiable terms (i.e. such that they can be verified and validated against the specified requirements)
The output must :
All design documents must be reviewed by the persons or functions specified in section 4.4.3 (above) before release.
Clause 4.4.6 - Design Review
At appropriate stages, the design must be reviewed by representatives of the various technical interfaces specified in section 4.4.3, which are relevant to the stage under review.
Where required, other technical personnel or the customer or users maybe involved in the review.
The review must be recorded.
Clause 4.4.7 - Design Verification
As the design work proceeds, it must be verified at appropriate stages. This verification may include :
Records must kept of the verifications conducted.
Clause 4.4.8 - Design Validation
Validation is similar to verification (see 4.4.7 - above) but whilst verification is the process of checking to ensure that the design is in accordance with the design requirements, validation is the process of ensuring that the designed item actually performs correctly (i.e. in accordance with the specifications and the expectations of the Customer - e.g. its working life, time between breakdowns, cost of maintenance, etc)
For example, in the case of a car design, the validation would include checks to ensure that the vehicle components could be expected to last for the required minimum mileage, or that the percentage of cars breaking down after 50,000 miles was within the design limits, etc.
Clause 4.4.9 - Design Changes
Any changes to the design, whether changes to the requirements or as changes following testing, etc, must be documented, reviewed and approved, then notified to all of the persons affected by the changes. This may include the Customer, or other departments.
