Input relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

(from BS EN ISO 9001:2000)

In a nutshell, whatever is going to be designed must be documented. For example, the requirement could be details from a contract or some other document that shows the communication with the customer. Documents must be clear, leaving no room for misunderstanding.

For example, a client wants a vehicle designed that must cover 15,000 miles without servicing. You must determine what kind of terrain it will be using, off-road or paved roads, how many people it is expected to carry, how much luggage, what kind of climate it will be operating in, etc. It might be decided that it must have off-road capability, carry four adults and their specialist luggage, with a fuel tank range of 1,000 miles. If legal or regulatory requirements apply, these must be included at this stage.

If your organization provides a service, rather than manufactures a product, it may be a case of ensuring that you are fully briefed by the client before offering advice.

It’s important to think holistically with this clause. This clause’s purpose is to ensure that the development and documentation of customer requirements occur for products and services, which should include the suitability of the product or service for the general marketplace. This means examining requirements from the 50,000-foot level often beyond customer requirements, such as:

• 1. regulatory issues—certain sectors have specific requirements, such as the Food and Drug Administration, the Federal Aviation Administration, the Occupational Health and Safety Administration, the Environmental Protection Agency, etc.
• 2. internal requirements—many organizations have their own requirements that must be followed, including labeling, handling and packaging of products. These issues should be considered as well.