Iso 13485 purchasing controls

Consequently, you should verify the received product against what was agreed with the supplier. Your medical device company will define which product requirements will be controlled, specifications, characteristics, which areas, or issues on the purchased product are to be tested, controlled, evaluated, verified, etc.

The methods for conducting control activities can include testing, reviews, sampling, evaluation of services, etc. It will ensure the purchase order contains all relevant data and it is approved, the purchased product is verified against defined criteria and ready to be released.

We are using cookies in order to offer you the most relevant information. We have published new Cookie Policy which you should read to find out more. Please accept cookies for optimal performance. Purchasing information The ability to transfer clear specifications regarding the product requirements to the supplier is essential. Verification of purchased information Consequently, you should verify the received product against what was agreed with the supplier.

It ensures that only high-quality goods and services are purchased in order to guarantee the manufacturing of high-quality products for own customers. Suppliers which are deemed critical and which underwent initial supplier evaluation are added to the List of Qualified Suppliers. The list is also used to document continuous supplier surveillance and the latest evaluation status of every supplier.

Suppliers are evaluated along these categories by assigning a score value to each category. Score values are as follows:. In order to complete the evaluation, an average score is calculated from all categories. The quality value is weighted double. Employees therefore first check if the supplier is approved in the List of Qualified Suppliers. If it is listed, they can continue with step 2. If the supplier is documented als blocked in the List of Qualified Suppliers, the employee looks for an alternative supplier.

If the supplier is not mentioned in the List of Qualified Suppliers, employees need to request regulatory approval for the purchase from the QMO. The QMO can decide that a supplier is obviously uncritical and that no further supplier evaluation is needed.

If so, the process continues with step 2. If the supplier is not mentioned in the List of Qualified Suppliers and not deemed obviously uncritical, the QMO first conducts an initial supplier evaluation. They can therefore request additional information from the supplier. Only the QMO decides on the approval of a critical supplier. If the supplier is deemed critical and the initial supplier evaluation is completed successfully, the supplier is added to the List of Qualified Suppliers and the process continues with the next step.

If the supplier is deemed critical and the evaluation is unsuccessful meaning, the supplier cannot be qualified for purchasing , the supplier is also added to the List of Qualified Suppliers, but marked as blocked. Alongside suppliers, the regulatory requirements also concern products and services respectively. ISO adds aspects that are specific to medical devices such as:. You can find further requirements on supplier assessment in the ZLG documents, e.

Contrary to ISO , it explicitly mentions a quality assurance agreement:. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. In order to fulfill the above-mentioned requirements, this procedure specification must determine criteria and methods for selecting and evaluating suppliers.

The criteria you can consider when implementing measures for selecting and evaluating your suppliers include:. If the delivered product is or contains software, further criteria are to be taken into account for the supplier evaluation:. If, however, your supplier writes the software for your medical device and is not ISO certified, it is your duty to arrange a supplier audit.

Thus, in the last step you establish which supplier evaluation measures you are to implement and under what criteria. As the rules and regulations can very quickly become confusing, you can group together the measures and stipulate different types of suppliers. As explained above, supplier audits are included in the measures that manufacturers take within the scope of ongoing supplier monitoring and evaluation.

Whether and when supplier audits are to take place depends on the criticality of the products and services delivered, as well as whether the suppliers have their own QM system or not.

In this case, the manufacturers declare their own quality management system and its rules respectively to be binding for their suppliers. Manufacturers must check that suppliers are adhering to these rules by means of supplier audits. These audits should be performed at least once a year. The manufacturer is also audited. According to ISO these audits by notified bodies must also extend to suppliers, meaning that it is possible that the auditor may pay the supplier a visit. As component manufacturers and development service providers do not bring any medical devices into circulation themselves, they do not need to be subjected to any audits by notified bodies.

They normally only allow this to meet the requirements of their customers, the manufacturers. To prevent their own supplier audit from getting out of hand, many manufacturers prefer suppliers who have their own QM system. In this case, audits on the manufacturer carried out by notified bodies are limited to document inspections. In the selection of suppliers, above all companies with ISO certification and not just ISO lend themselves to medical device manufacturers.

However, even with this type of company, an additional supplier audit is also recommended. Such audits must be performed as a part of the contracts between the medical device manufacturer and the supplier.

Conformity assessment procedures refer to the development and production of medical devices. This means that whenever a manufacturer has components developed or produced for their medical devices, these work steps may be subject to a supplier audit. This is different for components that are not specially developed or produced for the medical device such as monitors, mains adapters or off-the-shelf software components.

A supplier audit would not be carried out there or be allowed. Read more on the subject of audits here. Manufacturers must evaluate and select suppliers before commissioning them. This choice must be made based on clear criteria. The manufacturer distributor can only spare themselves this audit if the development partner has their own ISO QM system and presents the corresponding documentation for the product to the manufacturer.

The same applies to audits by the notified body. Manufacturers are increasingly outsourcing tasks like development and production, either wholly or in part. The regulations make it clear that by doing so the tasks may not be withdrawn from a quality management system.

For this reason, the notified bodies are obliged to also inspect the suppliers, if necessary, and in some cases within the scope of unannounced audits. So manufacturers are well advised to select and monitor manufacturers with whom they can guarantee consistent quality management and therefore product conformity and safety. Contact us now. Audit the QM system. Authorized representative. Risk Management ISO Clinical Evaluation. Performance evaluation of IVDs.

FDA relevant documents. Product test Human Factors Research. Safety and EMC test laboratory. Computer System Validation.