ISO 13485 or ISO 15378: two standards for two families of products
Two quality standards keep coming up in healthcare specifications, and they are often confused. One covers medical devices, the other the packaging that touches a medicine. Asking for the wrong one means asking a supplier the wrong question.
By Tecmom editorial team · 2 min read
ISO 13485, the standard for medical devices
ISO 13485, in its 2016 version, sets the requirements of a quality management system "for regulatory purposes" for medical devices: syringes, dressings, instruments, equipment. It is aimed at organisations that design, manufacture, store or service these devices, and at their suppliers.
Compared with ISO 9001, it puts more weight on regulatory requirements, risk management and process validation. In Europe, Regulation (EU) 2017/745 requires medical device manufacturers to run a quality management system, and ISO 13485 is the reference standard for demonstrating it.
ISO 15378, the standard for medicine packaging
ISO 15378 (2017 version) covers a different object: the primary packaging materials of medicines, those that touch the product, such as a bottle, a cap or a pill container. It takes ISO 9001 and adds good manufacturing practice (GMP): control of the production environment, batch traceability, change management, prevention of mix-ups.
The medicine remains subject to its own law, that of marketing authorisation. The primary packaging is described there, and its manufacturer must be able to document it. See what the standard requires.
Two different logics
The difference lies in the product's status. A medical device carries its own conformity: its manufacturer answers for it before the authority. A medicine bottle has no status of its own: it becomes part of the medicine's dossier, and the laboratory answers for it.
Some items sit on the boundary, such as a dropper or a dosing cup. Their status depends on how they are placed on the market, with the medicine or separately, and the product's dossier settles it.
What a buyer should ask for
For the primary packaging of a medicine, the certification to expect is ISO 15378. For a medical device sold under its own name, it is ISO 13485. The two certifications are not interchangeable: each checks a system designed for one type of product.
Tecmom is certified to ISO 9001 and ISO 15378; see our quality approach. A supplier audit remains the way to check what a certificate does not say; see the supplier audit.
A standard answers a precise question. Before asking for a certificate, you need to know which product you are buying.
Glossary
- Medical device
- A health product whose main action is not pharmacological: syringe, dressing, instrument.
- ISO 13485
- The quality management system standard for medical devices.
- ISO 15378
- The standard that applies ISO 9001 and GMP to the primary packaging of medicines.
- GMP
- Good manufacturing practice, the rules that ensure consistent quality.