Quality management system certification according to EN ISO 13485
Certification of a quality management system in accordance with ISO 13485 is a key element for medical device manufacturers. This standard ensures that the quality management system meets the requirements specific to medical devices, resulting in safe and effective products.
ISO 13485 is an international standard that specifies requirements for quality management systems in the context of medical devices. It focuses on aspects related to the design, manufacture, installation and servicing of medical devices. The aim of the standard is to ensure that products are safe and effective throughout their life cycle.
ISO 13485 requirements
The requirements of ISO 13485 are for the manufacturer to implement and maintain an effective quality management system (QMS) that covers all stages of a medical device’s life, from design to servicing. Risk management is another important requirement, which involves performing a risk analysis at each stage of the product life cycle and identifying potential hazards and implementing countermeasures. The manufacturer must also maintain complete technical documentation, including product specifications, manufacturing processes and quality records, which must be regularly updated and available to notified bodies. Manufacturing processes must be controlled and in accordance with the requirements of the standard and the manufacturer must maintain quality and production safety records.
Medical devices must undergo a conformity assessment process, which may include internal and external audits, and notified bodies may be involved in the conformity assessment of high-risk devices.
ISO 13485 quality management system certification process
The certification process for a quality management system to ISO 13485 is a multi-stage process that requires collaboration with a certification body. The process starts with the preparation of documentation, where the manufacturer prepares technical documentation and a description of the quality management system in accordance with the requirements of the standard. The certification body then verifies the documentation to confirm its compliance with the requirements of the standard. The next stage is a pre-audit, during which the certification body conducts an audit at the production site, assessing the implementation of the quality management system and its effectiveness. Following a successful pre-audit, a certification audit is carried out, where the auditors assess the compliance of the production and quality management processes with ISO 13485. Upon successful completion of the certification audit, the certification body issues a certificate of conformity, which confirms that the quality management system meets the requirements of the standard and that the medical device is safe and effective.
ISO 13485 certification
Certification according to ISO 13485 enables products to be legally marketed, ensures compliance with international standards and builds customer confidence. Certification also helps to identify and manage risks, resulting in safe and effective medical devices. Our certification body offers support at every stage of the certification process to ensure that the manufacturer has an effective quality management system in accordance with ISO 13485.
