Management system guidance
8.3 Design and development of products and services
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8.3.3 Design and development inputs
This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.2 - Design and Development Inputs 7.3.1. You should seek and record evidence that your organization has documented and retained information concerning the need for internal and external resources and the potential consequences of design or development failure.
Define which deign and development inputs are required to carry out the design and development process. The inputs should be determined according to the design and development activities. For example, which employees are required or what information is required for every step of the development. When determining design input requirements, ensure the retention of documented information such as:
- Statutory and regulatory requirements e.g. legislation, regulation, directives;
- Standards or codes of practice e.g. policies, standards, specifications, rules and aids, protocols, guidance, industry codes
- Functional and performance requirements informed by customer requirements, operational and performance charateristics, usability, reliability, availability, maintainability, and safety (e.g. Human factors and RAMS);
- Knowledge exchange from other, similar proven designs, lessons-learned, performance data, in-service data, customer feedback, external feeback, best practice, benchmarking;
- Design assumptions and associated risks;
- Methods of validation and verification;
- Adequacy of inputs e.g. clear, complete, unambiguous, and authorized;
- Conflicting inputs are resolved by communicating with interested parties/contract amendments.
The auditor will need to review evidence that the inputs have been addressed based on the nature of the product being produced, that they have been reviewed for adequacy and that records are maintained of the activity. An organization may include design personnel in the contract review stage; these records may suffice the review of design input requirement.
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