ISO 9001 Implementation Guide

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8.2.4 Monitoring and measurement of product

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4).

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

From BS EN ISO 9001:2000

This clause will not allow product release or service delivery until planned arrangements are complete or approved by a relevant person or the customer. In other words, it throws out the stereotype and criticism that an organization could create a “concrete life vest” for a customer and still become registered. This clause requires that the organization test for conformance of customer requirements and specifications before release, so creating a life vest made of concrete would be out of the question.

However, 8.2.4 also allows some flexibility for an organization. ISO 9001:2000 simply requires the organization to perform inspections at appropriate stages of the product realization process in accordance with planned arrangements (see 7.1). The point is, you decide when and where to inspect the product or service. The standard (and this section in particular) now is written in the language of business, basing important decisions on criteria such as risks, costs and avoiding bureaucracy.

It’s a good idea to keep records to ensure product acceptance criteria have been achieved. If you don’t keep records of inspections, they did not take place. Receiving, inspection and testing also are addressed in Clause 7.4.3, and test records also are addressed in Clause 7.5.3 (regarding test status)

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