ISO 13485 is a harmonized standard that specifies requirements for quality management (QM) or the QM systems of medical device manufacturers.
Medical device manufacturers can be identified v.a. therefore certified according to ISO 13485, because they can thus explain the conformity of your products according to Annex II of the medical product directive MDD. For medical devices that contain software or are stand-alone software, the IEC 62304 also requires a QM system and recommends one according to ISO 13485.
Is an ISO 13485 certified QM system required?
When you place medical devices on the market, you usually need an ISO 13485 certified quality management system. However, the following exceptions:
Your medical device falls into class I according to MDD. They are a pure sales partner (and no PLM selling OEM products). The scope of your QM system depends on the type and class of your product, for example whether the development is to be included.
Can ISO 9001 certification replace ISO 13485 certification?
No. However, you did most of the work with an ISO 9001 compliant QM system. Here you will find information on the differences between the two standards.
How long does it take for a quality management system to be built and certified?
We typically provide companies with an ISO 13485 certificate in typically six to nine months. Currently, the overloading of the notified bodies may delay this period. Decisive is, v.a. the will of the organization.
How much effort is required to build a QM system?
The effort is strongly dependent on the size of the organization and the areas to be certified. Small and medium-sized companies spend between 15 and 50 days building their QM system Maintaining the QM system on a permanent basis also means expenses, which should be overcompensated by lower error sequence costs (call-backs, rework, unnecessary iterations during development).
What external costs are incurred?
Small and medium-sized companies have to expect one or two auditors with an expenditure of 1-4 days (visit, preparation). If you are supported by us, we need between six and 15 days depending on the size and support of the companies.
How can a certification project expire?
We have described on this page how the route from your initial contact to the ISO 13485 certified system can go.