ISO 9001:2008 specifies three aspects to purchasing:
To be effective, the purchasing process should define the activities required to ensure a purchased product conforms to specified quality requirements.
- Implement a combination of supplier controls
- Define product requirements
- Perform product inspections, taking into account the potential consequences of a non-conforming product
7.4.1 Supplier evaluation
Establish and maintain control of the purchasing process:
- Determine the extent of control to be applied to suppliers
- Develop criteria for the selection of suppliers
- Evaluate suppliers to ensure they are able to meet requirements
Potential and existing suppliers might be evaluated by:
- Evidence of an effective continuous improvement process
- Looking at their process control data
- Analyzing of supplier corrective action process when responding to non-conformities
- Determining effectiveness of corrective action responses
- Performing an audit at the supplier's premises
- Evidence of an effective ‘zero defect’ program in the process flow of the supplier
- Evidence of product quality objective attainment based upon agreed KPI; e.g. on-time delivery, cost, quality
7.4.2 Purchase orders
Describe the product to be purchased:
- Define the product approval requirements, e.g. certificates of conformity
- Define the intended verification arrangements, e.g. prototyping, witness testing or test evidence
- Define personnel qualifications, e.g. evidence of competence
- Define QMS requirements
7.4.3 Goods receipt checks
Establish and implement a process for inspection to ensure purchased products conform to the:
- Purchase order
- Product specification
- National or international standards
Should I document our purchasing process?
It is not a mandatory requirement to document your purchasing process. However, you should always look to adequately define and control any operational processes that directly impacts product quality. Therefore, the implementation of a purchasing procedure will be appropriate to most businesses where such activities are undertaken.
How's best to document my purchasing process?
Develop and implement a procedure for 7.4 that defines:
- How the organization ensures purchased products conform to specified requirements
- How the organization evaluates potential suppliers
- What information is required for product approval
- Any QMS requirements
- Any design and development interfaces
- How the purchased product is verified
Looking for help documenting 7.4?
We provide a template for the operational procedure '7.4 Purchasing' to help you document this process in many of our ISO Templates.
Measuring purchasing process effectiveness
The effectiveness of the purchasing process and supply chain might be evaluated by reviewing how critical suppliers are assessed, or determining the frequency of product rejection and the volume of concessions that have been raised for previously rejected products.