Why certificates matter when you buy medical equipment
When a hospital, clinic or distributor evaluates a new supplier of beds, stretchers or medical furniture, certificates are usually among the first documents requested. They are not a substitute for looking at the product itself, but they answer an important question early: does this manufacturer work within a recognised, independently audited system, and does the product meet the regulatory requirements of the market where it will be used?
Three terms come up most often: ISO 9001, ISO 13485 and the CE marking. They are related, but they are not the same thing, and each tells the buyer something different.
ISO 9001: a general quality management system
ISO 9001 is the international standard for quality management systems and can be applied by organisations in any sector. A company certified to ISO 9001 has shown an independent certification body that it defines its processes, monitors them, deals with nonconformities, listens to customer feedback and works on continual improvement. The current edition is ISO 9001:2015.
For a buyer, ISO 9001 signals that the supplier is organised and consistent. It does not, on its own, contain requirements specific to medical devices.
ISO 13485: quality management for medical devices
ISO 13485 is the quality management standard written specifically for organisations involved in the design, production and servicing of medical devices. Its current edition is ISO 13485:2016. It builds on the same process logic as ISO 9001 but places much greater weight on safety and regulatory compliance.
What ISO 13485 adds
- Risk management throughout the product's life cycle.
- Documented design and development controls with verification and validation.
- Traceability of materials, components and finished products.
- Controlled production and servicing, including installation and after-sales activities where relevant.
- Handling of complaints and feedback in line with regulatory obligations.
For a medical device buyer, ISO 13485 is therefore the more relevant of the two quality certificates.
CE marking and the declaration of conformity
The CE marking indicates that a product complies with the applicable European Union requirements and may be placed on the EU market. For medical devices, these requirements are set out in the EU Medical Device Regulation (EU) 2017/745. Before affixing the CE marking, the manufacturer must complete the conformity assessment required for the device and draw up a declaration of conformity, a document in which it states, under its own responsibility, that the product meets those requirements.
CE marking is about regulatory conformity, not a grade of quality. That is why buyers often look at it together with product-specific standards. For hospital beds, the key standard is IEC 60601-2-52, which sets out particular requirements for the basic safety and essential performance of medical beds.
Erpomed's certificates
Erpomed's quality management is documented by the following certificates and documents:
- TS EN ISO 9001:2015: quality management system.
- TS EN ISO 13485:2016: quality management system for medical devices.
- Declaration of conformity for its products.
The “TS EN” prefix shows that these are the Turkish adoptions of the European and international standards. Erpomed's quality policy also includes ISO 14001 environmental management, CE and TSE HYB, the service adequacy certificate of the Turkish Standards Institution. In addition, patient beds manufactured by Erpomed are produced in accordance with IEC 60601-2-52.
A practical checklist for buyers
Certificates are most useful when they are read carefully. Before ordering from any medical equipment supplier, it is worth checking a few points:
- Ask for copies of the certificates and check the name and address of the certified company.
- Check the scope: does it cover the design and production of the product types you are buying?
- Check the edition and validity date of each certificate.
- Make sure the declaration of conformity covers the specific product models you are ordering.
- Ask which product standards apply, such as IEC 60601-2-52 for medical beds.
- Find out what technical service, spare parts and user training are available after delivery.
Erpomed's certificates are presented on its corporate page. For copies or product-specific documentation, hospitals, clinics and distributors can contact the team at export@erpomed.com.
