ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.4.1 Purchasing Process  

ISO 9001 Training - Key Explanation Points and Tips:

Clause 7.4 covers the following purchasing activities:

Requirements to control purchased product (clauses 7.4.1 and 7.4.3)

Requirements to control suppliers you buy from (7.4.1)

Requirements to control your buying process (7.4.2)

Purchased product includes raw materials, components, subassemblies, supplies, tooling, machinery and equipment, sequencing, sorting, rework, testing, calibration, maintenance, etc.

Note that clause 7.4 requirements apply to items that - go into the product, manufacture the product, check the product or deliver the product; whether paid for or customer provided.

These may include materials, production equipment; tooling; measuring and test equipment; facilities; transport vehicles; returnable packaging; intellectual property (drawings, specifications or proprietary information); product returned for servicing under warranty, product sent for outsourced work; etc.

You must have specifications/criteria for purchased product. These specifications may come from your organization, customer, regulatory bodies, supplier or industry. As documents, these specifications must be controlled as per clause 4.2.3

Many times the customer may require the use of pre-approved purchased products and suppliers. The onus is still on you to ensure that purchased product from customer-designated sources meets all requirements.

You must control both, the product you buy, as well as the supplier or subcontractor you buy from. Your controls must primarily be based on prevention of nonconformities in both product and supplier/subcontractor performance.

Determine how important the purchased product is to design, manufacture, assemble and maintain your end product. If you recall from product design input (clause 7.3.2) we considered factors such as - targets for product quality, life, reliability, durability, maintainability, and cost. You must apply similar criteria to purchased product as well as outsourced processes for work going into your end product. Your objective must be to proactive and downstream specified controls to ensure product quality. You are paying for quality product. You want to minimize or eliminate rework, incoming inspection or material or product returns.

Your purchasing process should include all the controls for outsourced work. Refer to clause 4.1 for how outsourced needs to be identified and controlled.