4.6. Purchasing

4.6.1. General

You are required to conduct your purchasing operations in a systematic fashion that ensures you are obtaining the proper materials for the organization's specified requirements.

Compliance with this clause requires that:

• You will develop and demonstrate a working purchasing system with full documentation and records that ensures your purchased materials meet specifications.

4.6.2. Evaluation of subcontractors

Assessment of a supplier must include a formal documented review methodology. The organization must maintain the assessment records of a supplier and a formal documented listing of suppliers who meet this approved process. This approved supplier listing must be available to those using it.

The supplier evaluation process used to determine acceptability is based on the type of product being secured, past experience with the supplier, and its capabilities. In all cases, the assessment must specify the quality of the materials received. You must maintain records of the supplier's evaluation as well as the acceptability of the materials received. A somewhat misunderstood fact is that your suppliers do not have to be certified to ISO 9000. They only have to provide you with good materials that meet your requirements on time.

Evaluation of subcontractors requires that:

• You systematically select a supplier on their ability to meet your quality requirements.
• You include an evaluation of their quality systems.
• You must define how you will ensure that every purchased part and supplier is evaluated.
• You maintain accessible records of your acceptable suppliers (approved vendor list).

4.6.3. Purchasing data

The materials being purchased must be fully described. This includes specific part identification. You will also describe process requirements, inspection instructions, special markings, and any other detailed information relevant to the acceptance of the material.

The purchase document must include notation of compliance to any relevant standard (ISO 9000 may be one of those standards). Prior to the release of the specification requirement to the supplier, an appropriately trained individual must review it to ensure adequacy. This individual can be the originator of the requirement.

To satisfy this clause:

• Your purchasing data must contain a clear description of the product desired.
• The data must incorporate all relevant information regarding composition, form, process requirements, inspection instructions, as well as the quality standard to be applied.
• You must review and approve the purchasing document for all relevant data prior to release.

4.6.4. Verification of purchased product

It is the purchaser's option to perform a source inspection of the product (at your supplier's location) or to perform the inspection on the purchaser's site. In either case, inspection location does not absolve the supplier of the responsibility to inspect and fully comply with its own quality policy, as described to the purchaser. If the purchaser provides for source inspection at the supplier's site, the purchaser does not surrender the right to reject the material at any later time. If you decide to perform a source inspection, it must be noted on your purchase order to the supplier.

Product verification seeks to ensure that:

• When you perform source inspections (inspect at the suppliers location), the arrangement must be specified in the purchasing document.