ISO 9001 Implementation Guide

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7.5.2 VALIDATION PROCESSES FOR PRODUCTION AND SERVICE PROVISION

7.5.2 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes including to achieve planned results.

The organization shall establish arrangements for these processes include as applicable

defined criteria for review and approval of the processes,

approval of equipment and qualification of personnel,

use of specific methods and procedures,

requirements for records (see 4.2.4), and

revalidation.

(from BS EN ISO 9001:2000)

In a nutshell, some processes cannot be tested fully until in final use (new technology being used might not yet have established any test precedents, i.e., a new paint being developed to withstand 10 years of extreme weather conditions, heat treating of materials, soldering, welding, glass tempering, etc.).

In such cases, qualified personnel must carry out all stages of the production process and/or continual monitoring must take place to ensure strict compliance to the organization’s process. The qualification requirements should be specified, and records must be kept of the processes, equipment used for them and personnel carrying them out—these should be classified as quality records and should be defined according to 7.1 of this standard.

Written procedures are encouraged for the validation of these processes to ensure that personnel are qualified to perform the validation and the organization has established arrangements to achieve planned results.

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