ISO 9001 / 9002 INTERNATIONAL STANDARD

Clause 4.6 - PURCHASING

Clause 4.6.1 - General

Note : The term "Subcontractor" when used by ISO9001 and ISO9002, refers to suppliers of goods and services to your organisation. (the terms "Subcontractor" & "vendor" may be considered to be identical within this section of ISO 9001/2.

This Clause of the standard covers the purchase of "product", which includes goods and services. You should note that it also covers the use of subcontracted labour, where relevant. The essence of the requirements is that you must ensure that purchase orders contain sufficient details to adequately describe the required item and that the order is reviewed before it is placed. You must also ensure that your suppliers are suitable for the purpose.

Clause 4.6.2 - Evaluation of Subcontractors

This Clause requires that you conduct assessment of your subcontractors (i.e vendors or suppliers), which ensures that they have the capability of supplying materials or services of the required standard. Some type of formal assessment of capability is needed, possibly through one or more of :

• a formal audit of the subcontractor's quality
• "trial-run" methods
• by way of other evidence.

Documented evidence of the assessments is required, and your procedures should describe who is responsible for the approval of subcontractors. The procedure only needs to be as comprehensive as required for the type of item concerned.

You will probably end up with a list of suppliers that you have approved, which should be subject to document control (See also Clause 4.5) in the same way as any other document.

Clause 4.6.3 - Purchasing Data

You must ensure that your Purchase Orders contain sufficient, unambiguous information which adequately specifies your requirements to the subcontractor. This may include :

• reference to a quotation or specification document (in which case it should also refer to the relevant issue level or date of the document concerned)
• a catalogue number
• a description of the item

This is one of the very few places that the standard describes a specific action : You must ensure that all orders placed are reviewed for adequacy of the data contained in it. However, the standard does not state who should conduct the review (ie it does not state that it must be a different person to the person raising the order). It is acceptable for the person raising the order to review it, although you may wish to specify the use of a checklist in this case. The review should include a check that the order has been placed with a supplier that you have previously assessed and approved (see above). Above all, the reviewer must be competent to determine if the order is adequate. (e.g. a highly technical item should be reviewed by a technically-competent person)