ISO 9001 Implementation Guide

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7.3.3 Design and development outputs

The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.

Design and development outputs shall

a) meet the input requirements for design and development,

b) provide appropriate information for purchasing, production and for service provision,

c) contain or reference product acceptance criteria, and

d) specify the characteristics of the product that are essential for its safe and proper use.

(from BS EN ISO 9001:2000)

As with much of ISO 9001:2000, this clause is a logical next step following 7.3.2, Design and development inputs. In short, design outputs should be capable of being verified and validated against the design input requirements. For example, if you were designing that oak table and your end product was a pine bookcase instead, something went obviously awry during the development phase. There was no verification or validation of the necessary design input requirements, a necessary step toward registration.

This clause requires that verification occurs and that objective evidence is generated to show that customer and other requirements have been met. That evidence can be in the form of test results, checklists, blueprints, technical drawings and other forms of documentation that occur during product development. Evidence also could be reports detailing advice/proposals from the customer or other interested parties, including internal stakeholders.

Having the appropriate people involved in the management system is essential. The same is true for this clause—in fact, it’s required. Make sure the appropriate person or team approves the output before it is released. This ensures a level of accountability (and records) so that a product isn’t shipped to a customer without proper authorization.

The design output must be approved, and Clause 4.2.4 states records are maintained to show compliance to requirements. Although a record isn’t specifically mentioned in 7.3.3, evidence of the approval is required.

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