ISO 9001 / 9002 INTERNATIONAL STANDARD

Clause 4.14 - CORRECTIVE & PREVENTIVE ACTIONS

General Notes

"Corrective Actions" are the actions that an organisation takes in order to fix the immediate problem.

"Preventive Actions" are the actions that an organisation takes in order to prevent recurrence of the problem. It can also be taken to imply that an organisation must take steps to consider what aspects of its syetm can fail, and what can be taken to prevent it. (This interpretation varies considerably between Quality Registrars)

NOTE : This requirement causes a lot of misunderstanding, both in organisations attempting to achieve the requirements of ISO 9000, and also from the Quality Assessment Registrars. For example, QMI (a Canadian-based assessment body, operating in the USA) recently informed me that ISO 9002 required that a client for whom I was working must "review the effectiveness of actions prior to implementation."

I had to explain to the assessor that the standard did not make this requirement, which would otherwise have been very costly, if possible at all, for my client to introduce. (What the standard requires is that the effectiveness of preventive actions are required to be reviewed after implementation)

Clause 4.14.1 - General

As well as stating thatyou must have procedures for both corrective and preventive actions, this Clause states that the actions must be "to a degree appropriate to the magnitude of the problems and commensurate with the risks..". (In other words, don't go overboard!)

Clause 4.14.2 - Corrective Actions

This clause requires a number of key actions, which must be described in the procedures, and must be recorded when they occur :

• Customer Complaints must be processed (recorded, actions taken, effectiveness of actions reviewed)
• Nonconformities of goods or services ("product"), processes and the quality system must be processed.
• determination of actions to eliminate the cause of the nonconformance (this is generally considered to be in the wrong position, as it really refers to preventive actions, and is in any case duplicated in 4.14.3)
• systems to ensure the action has actually been taken, and that it was effective.

Clause 4.14.3 - Preventive Actions

This clause requires a number of key actions, which must be described in the procedures, and must be recorded when they occur :

• The use of appropriate sources of information (e.g. audit results, concession notes, inspection results, etc) in order to detect and prevent potential problems.
• the determination of the steps required in order to put the preventive action in place.
• systems to ensure the action was effective.
• a method of ensuring that information on preventive actions is submitted for Management Review. (See Clause 4.1)