ISO 9001 Implementation Guide

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7.2.1 Determination of requirements related to the product

The organization shall determine

Requirements specified by the customer, including the requirements for delivery and post-delivery activities,

requirements not stated by the customer but necessary for specified or intended use, where known,

statutory and regulatory requirements related to the product, and

any additional requirements determined by the organization.

(from BS EN ISO 9001:2000)

This section should stand out as one of the most important clauses relating to customer satisfaction because it sets the framework for establishing customer requirements.

Establishing customer requirements is a must with ISO 9001:2000. An organization must document what the customer wants and prescribe a process for delivery of that product. For example, if you're a ball bearings manufacturer and your customer needs 8-inch bearings delivered by July 1, then there should be a process established to make it happen, as well as a contingency plan if the product malfunctions. (For example, a toll-free number the customer can call to make a complaint and a cost- free way to ship the nonconforming product back to the manufacturer.)

Portions of this clause are new concepts within the quality management system framework, particularly sub-clauses B and C that address requirements not specified by the customer. An easy way to implement this section is to use a checklist approach with these issues.

Additionally, there is no requirement to have a documented procedure or records for determining customer requirements, but because it is such a critical function of the quality management system and the business, it is highly recommended. Depending on the business, establishing customer requirements can be a very complicated process, and if you have a lot of people taking sales calls and speaking with customers, having a documented procedure and records can ensure everyone is on the same page and complying with the process.

One more thing… Sub-clause 7.2.1.C can be complicated, but it is very important to the business and to your stakeholders. For example, imagine your organization has a large contract to supply a company in Brazil with your product, but it never arrives with the customer because it's stuck on the dock in Santos. After performing a root-cause analysis, it turns out that there is a strange law with the port authority that no one knew about, and it could take weeks to get the situation straightened out. With this in mind, it's a good idea to have the legal department play a role in establishing statutory and regulatory requirements related to the product. This can help you manage risk significantly.

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