DIN ISO 13485: This is how quality management for medical devices works
Last updated: 28 January 2026
Manufacturers in the pharmaceutical and medical technology industries are subject to the highest requirements for quality and safety. With DIN ISO 13485 or EN ISO 13485, there is a unified standard that defines the requirements for quality management systems (QMS) for manufacturers of medical devices. This standard serves two key purposes: first, it ensures that products meet legal requirements; second, it provides the central foundation for manufacturers to demonstrate that their QMS supports and facilitates compliance with the MDR (Medical Device Regulation).
The internationally recognized ISO 13485 was developed by the ISO/TC 210 Technical Committee (ISO stands for International Organization for Standardization) and harmonized by the European Committee for Standardization (CEN, Comité Européen de Normalisation). This explains the prefix EN in EN ISO 13485. The European orientation has largely replaced the prefix DIN (Deutsches Institut für Normung e. V.), which is why the international designation (EN) ISO 13485 is more common. In Germany, it is listed as DIN EN ISO 13485.
Definition of DIN ISO 13485
ISO 13485 is defined as the foundation for the safe development, production, and supply of all types of medical devices. It incorporates the requirements of ISO 9001 (international standard for QMS) but is more specific to medical devices and has a strong regulatory focus. It is relevant for manufacturers, distributors, suppliers, and service providers in the healthcare sector.
At Rommelag, ISO 13485 forms the quality framework for the development, validation, and production of Blow-Fill-Seal (BFS) systems in the medical technology sector.
Scope of EN ISO 13485
As an international standard for quality management of medical devices, ISO 13485 covers a wide range of applications. In principle, it applies to all steps involved in manufacturing medical products, as well as to all organizations that manufacture, supply, or provide related services. Specifically, it applies during development and production, but may also be relevant for installation and maintenance depending on the context.
For example, the scope of EN ISO 13485 already begins with suppliers of raw materials or packaging materials, including manufacturers of primary packaging such as BFS containers, which are part of the validated product system. It ensures consistent quality and complete traceability of raw materials and packaging. For manufacturers, regulatory requirements are particularly strict — ISO 13485 defines specific requirements for process control, validation, risk management, documentation, and traceability. Packaging and distribution follow, where the standard focuses on QMS for critical processes such as product protection, filling, and compliant supply chains.
Advantages of EN ISO 13485
In summary, DIN ISO 13485 offers numerous advantages for medical device manufacturers, authorities, research institutions, and ultimately for consumers.
Because the standard is internationally recognized, manufacturers benefit from uniform, accepted rules for quality management. This provides regulatory security and enables them to offer products worldwide. Proper ISO 13485 documentation also makes it easier for authorities to regulate the market, which increases both customer trust and overall product safety — essential in the field of medical devices.
Furthermore, the ongoing development of EN ISO 13485 is closely linked to process reliability optimization, resulting in overall safer and more stable processes.
Steps to Certification under EN ISO 13485
Certification according to ISO 13485 is a multi-step process. The following overview shows the general sequence; specific details may vary depending on the industry and product.
Step 1: Analysis & Assessment
The process begins with a gap analysis and assessment of the system, which is documented.
Step 2: Implementation of the QMS
Next, the quality management system is established or — as in most companies — expanded. The standard introduces requirements regarding design control, traceability, and sterility.
Step 3: Training of Employees
This step is crucial. ISO requires qualified personnel, and compliant implementation heavily depends on trained employees. Training is often conducted by third-party providers and covers topics such as standard requirements and documentation obligations.
Step 4: Two-Stage Certification Audit
Finally, a two-stage audit is conducted to issue the certification. Only accredited bodies can grant certification under ISO 13485.
Internal and Surveillance Audits
ISO 13485 certification is a dynamic process. After certification, regular inspections are required. Companies often perform internal audits to self-check, and the certification body also conducts annual surveillance audits.
Which Certification Bodies Exist?
In Germany, several organizations are authorized to issue certifications under EN ISO 13485, provided they are accredited by DAkkS (Deutsche Akkreditierungsstelle).
Examples of accredited certification bodies include:
- TÜV SÜD
- TÜV Rheinland
- TÜV Nord
- SGS
- DEKRA