What ISO 13485 means when you buy a treatment table

When two tables look alike in photos, the difference often lies in how they were made and how the maker handles problems. ISO 13485 is the most useful single signal of that, as long as you know what it does and does not say.

What the standard covers

ISO 13485:2016 sets requirements for a quality management system in organisations that design, produce, install or service medical devices. In practice an auditor looks at how the company:

• Designs products: requirements, drawings, prototypes, testing and approval before release.

• Controls purchasing: how steel, foam, motors and electronics are chosen and checked.

• Manufactures: work instructions, in-process inspection and final testing.

• Traces units: which parts and batches went into which product.

• Handles problems: complaints, defects, corrective action and, where needed, recalls.

• Services products: installation, repairs and spare parts.

It builds on the general quality standard ISO 9001 but adds requirements specific to medical devices, especially around documentation, risk management and traceability.

What a certificate does not tell you

• A certificate covers the quality system of the certified company and site, within its stated scope. It is not a test report on one table.

• It is separate from product regulation. Depending on your country, a device may also need registration or a conformity mark from the local regulator. Ask the maker what applies where you are.

• It is only current between its issue and expiry dates, and depends on surveillance audits in between.

How to check a certificate

1. Holder and address. The company name and site on the certificate should match the company you are buying from and the place the product is made.

2. Standard. It should say ISO 13485:2016, the current edition.

3. Scope. The scope describes what is certified. It should mention the kind of product you are buying, for example treatment, drop or decompression tables.

4. Dates. Check the issue date and the expiry date, and ask when the last surveillance audit took place.

5. Certification body. Note who issued the certificate and which accreditation body stands behind it, then confirm the certificate number with the issuing body.

Smart Medicure's certificate number is UQ-30465. You can read the details and check it with the registrar from our quality page.

Questions to ask any maker

• Can you send the certificate, and does its scope cover this product?

• Where is the product made, and is that site covered?

• How do you test each unit before dispatch?

• What happens if a part fails: who diagnoses it, how fast are spares sent, and are they in stock?

• How long is the warranty, what does it cover, and what support is there after it ends?

For reference, our tables are built and tested in our Surat factory, carry a one-year warranty on manufacturing defects, and come with lifetime telephone support. Spare parts are stocked in Surat.

Why it matters to a clinic

A table is used many times a day for years. The quality system is what makes the tenth unit match the first, keeps drawings and parts consistent so a spare fits, and makes sure someone investigates when a customer reports a fault. That is worth more over the life of a table than any single feature on a brochure.