ISO 13485 - Standard for QMS from medical device manufacturers

ISO 9001 already defines the basic requirements for quality management systems. However, ISO 13485 extends further requirements such as:

Involvement of the management
Traceability of the products
Validation of software for production, maintenance and monitoring
Clinical validation
Measures for sterility and cleaning

Although a QMS is mandatory according to MDR 2017/745, certification for class I medical devices (e.g. examination gloves) is not mandatory. However, certification is an objective quality feature and sometimes helps when choosing a manufacturer.

4 basic process areas

ISO 13485 defines four large process areas, each of which must include one or more processes. This can be done, for example, in the form of procedural instructions.

The basic process areas are:

Responsibility of the management
Management of resources
Product realization and service provision
Measurement, analysis and improvement

Certification process

Certification according to ISO 13485 is a complex project and includes several important sub-steps and the involvement of certifiers.

1. Select certifier (notified body)

In order to obtain certification, it is necessary to select a notified body that is approved for certification according to ISO 13485.

For example, the German DaKKs publishes the certifiers approved in Germany, whereby a distinction is also made here between the certification of medical devices and in-vitro diagnostics

2. Establish quality management

In order to establish quality management, the creation of a QM manual is a prerequisite.

Here it is advisable to develop a really lean system that should keep ongoing compliance and maintenance simple.

In principle, the QM manual is a documentation of all processes and activities.

Various providers offer corresponding modular systems that significantly minimize the effort involved in creating them.

If a QMS according to ISO 9001 has already been established, a QMS according to ISO 13485 can sometimes be based on it.

3. Live QMS

This requirement, which sounds natural, is sometimes difficult to live with in reality and only works if all departments and employees are appropriately involved.

In order to check the guarantee of this, audits are carried out to check the actual practice and to be able to improve it if necessary.

When applying for an audit, the manufacturer must work according to the established rules.

4. Invite the notified body to the audit