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Paragraph 7.4.1 – Purchasing process
ISO 9001
| ISO 13485
| The organization shall define the requirements for the purchasing processes.
| The organization shall maintain a documented procedure describing the purchase processes in order to ensure that purchase processes are performed according to defined requirements.
| For every type of supplier and purchased product the organization shall determine the appropriate requirements and control. The requirements and control would be suitable according to the effect the purchased product has on the realized sub products or the final product.
| For every type of supplier and purchased product the organization shall determine the appropriate requirements and control. The requirements and control would be suitable according to the effect the purchased product has on the realized sub products or the final product.
| The organization shall determine the criteria for supplier's evaluation to supply the products.
| The organization shall determine the criteria for supplier's evaluation to supply the products
| The organization shall evaluate and select the suppliers according to their ability to supply appropriate product to the determined requirements.
| The organization shall evaluate and select the suppliers according to their ability to supply appropriate product to the determined requirements. | A re-evaluation shall be performed according to determined criteria.
| A re-evaluation shall be performed according to determined criteria.
| The responsibility for conducting the suppliers' evaluation shall be defined
| The responsibility for conducting the suppliers' evaluation shall be defined
| Records of the suppliers' evaluation would be maintained and kept. The evaluation process would be introduced to the records control process according to paragraph 4.2.4 – control of records.
| Records of the suppliers' evaluation would be maintained and kept. The evaluation process would be introduced to the records control process according to paragraph 4.2.4 – control of records.
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The main different requirement for the purchasing process is that the ISO 13485 Standard requires maintaining a documented procedure describing the purchase process within the organization. The difference between the ISO 13485 Standard and the ISO 9001 Standard is that the 9001 requires to define a process but not to document it in a procedure. The process would be proven through the records. When the organization purchases finished medical devices from its suppliers, it is required to describe in a procedure how the organization ensures that the medical devices are effective and more importantly, safe. What is required to ensure? That would be discussed during chapter 7.4.3 – verification of purchased products. The control over the purchase ensures the organization that suppliers supply according to prior requirements. You would like your medical device to be a quality device; therefore you implement a quality management system. But the quality management system is implemented in your organization and not within the supplier's organization. The purchasing control puts the supplier's goods under your quality management system. The same extent of control applies to services as well. When your purchase a service that has an effect on medical device – it means that this service is a part of your medical device. Therefore it should be under control as well as other processes participating within the product's realization processes.
The extent of the control over your suppliers shall apply on materials or services that are related to your product. When the organization purchases parts components, or services that has affect on the medical device (and its effectiveness) the procedure should define how the organization ensure their safety and effectiveness. If your organization purchases coffee every month, unless it is a coffee related organization, and uses the coffee to realize their product, the coffee must not be included under the purchasing control. Only what the organization purchases and uses after that to realize the product, should be included under the purchase control. |
