Organisations are required by ISO 9001: 2015 to consider the following requirements as inputs into the design and development process:

1. Functional and performance requirements,
2. Previous design and development activities that are similar,
3. Statutory / regulatory requirements,
4. Applicable standards or codes of practice,
5. Consequences of failure (risk) associated with the potential of failure due to the nature of the products and services.

Inputs are required to adequate, complete and unambiguous for the design and development process undertaken and any conflicting inputs must be resolved.

Documented information on design and development inputs is required to be retained.

Comment:

Note the two specific requirements introduced in the 2015 release of the standard:

• The reference to any standards and codes of practice that the organisation has committed to complying with,
• Risks associated with design or development failure, based on the specific nature of the product or service.

(Many businesses utilise formal tools such as Failure Mode Effects Analysis (FMEA) for Risk identification / mitigation planning purposes, but such methodologies are not specifically prescribed in the standard.)

Typical inputs could include:

• Previous similar designs.
• Warranty and customer feedback.
• Competitor benchmarking.
• Specific functional and performance criteria for the product or services in the form of specifications, drawings or detailed contract documented requirements.
• Customer special / critical performance characteristics (which may require additional controls).
• Applicable customer, regulatory body, industry, or international standards.
• Reliability and serviceability requirements.
• Cost targets.
• Safety considerations.

Audit Check:

Auditors will wish to check to confirm that organisations have a planned methodology for the identification of relevant inputs and that the process has been appropriately executed, so as to ensure that all necessary inputs have been identified and obtained.