ISO 9001 / 9002 INTERNATIONAL STANDARD

Clause 4.10 - INSPECTION

General Comments

Very simply, the standard required that you inspect :

• items and services that you receive
• the items or services that you provide

It also requires that you keep records of such inspections, and that you identify who is responsible for conducting the inspection and releasing the goods or services for use.

Clause 4.10.1 - General

This clause requires that you have documented procedures for inspection activities.

Clause 4.10.2 - Receiving Inspection

This clause requires that you inspect incoming goods and services at an appropriate level. The level can depend upon a number of factors :

• the risk of mistakes and of their consequences
• the likelihood of receiving defecting goods or services

If you can demonstrate that your suppliers never let you down, you can perform very low levels of inspection. In some cases, it may be possible to permit suppliers to deliver directly to your production area without any receiving inpsection being performed. You would need to have some mechanism to detect if any problems were present, which would then be found later on (during the in-process or final inspection stages) and you might have to argue strongly with the certifying registrar, although this practice is common in Europe and with Japanese manufacturers.

This clause states that if you permit un-inspected goods to be used, you must have a means of identifying where they were used and for recalling them if you later find that the goods were defective.

Clause 4.10.3 - In-process Inspection

This clause requires that all in-process inspection is adequately controlled. (you should note that not all processes require or are suitable for such inspection) Examples of such inspections would include :

• the testing of an engine prior to installation in a vehicle
• the testing of a Printed Circuit Board before installation into a television, etc
• the verification of a procedure before integration into a quality manual

Clause 4.10.4 - Final Inspection

Final inspection is normally considered to be the tests that are performed when all manufacturing, configuration, etc has been completed. (usually just before packaging) This clause requires that the "release authority" is defined. This means that your procedures must detail exactly who is permitted to allow the goods to be released to customer.

Also, this clause requires that the final inspection should ensure that all previous inspections (such as the in-process checks given as examples above) have been satisfactorily conducted and recorded.

Clause 4.10.5 - Records

The general requirement for inspection records is that :

• all inspections are recorded
• the results of the inspection are recorded, including :
  • any measurements made are recorded
  • the results show whether the items passed or failed
  • the name of the inspector is recorded (usually a dated signature)