7.3 Design and Development
In this section of ISO 9001:2000 you get a lot of the original requirements for design control from the 1994 edition. However, it has an important subtlety, it allows for the design and development of new services as well as the design of a new physical product. Thus, a much wider range of companies and companies can (and will be expected to) use this part of the standard.
In element 7.3.1 you get the expected requirements that you need a documented system for the planning of design and development work. In so many words, you are being told to have a strict project management system.
In 7.3.2 - Design inputs, you are now sitting down with the list of customer needs, contractual obligations, and regulatory requirements. From this you create the engineering design inputs. Specifically, the functional and performance characteristics of the product or service, a list of the statutory (legal) requirements, information from previous product designs or service methods similar to this project, and any other important design aspects to be considered.
ISO 9004:2000 lists many details to be considered. These include risk assessment, marketplace situation, codes of practice, internal policies, life cycle issues, environmental impact, operation characteristics, and disposal plan.
Potential Audit Questions
1. If your company manufactures a product, do you go to these lengths for the design process?
2. If your company delivers a service, are you using project management to design new services?
7.3.1 Design and Development Planning
Planning output shall be updated, as appropriate, as the design and development progresses.
7.3.2 Design and Development Inputs
NOTE: There are no new requirements in Design and Development Inputs from the 1994 version.
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