EN ISO 13485:2016 – Certification of the quality management systems of medical device manufacturers, their suppliers and other players in the medical device Environment
An efficient and standard-compliant quality management system is of crucial importance in the medical technology sector. Certification according to EN ISO 13485:2016 confirms compliance with the highest standards and significantly contributes to strengthening the trust of your stakeholders.
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Medical devices- quality management system according to EN ISO 13485
The aim is to produce safe and high-quality medical devices. Medical device manufacturers and their suppliers must set up and maintain a quality assurance system and, if necessary, have it certified by an independent body.
Target groups of EN ISO 13485
Industrial and service companies in the medical device sector.
Validity period of the certificate
3 years - in the sense of continuous further development, a surveillance audit takes place annually and a recertification audit after 3 years.
Recognition of the SQS certificate
The SQS certificate ISO 13485 is internationally valid and recognised worldwide through IQNET membership.
Responsible for the product and there for you
Lucas Pfeifer
Do you have any questions about the standard or our service? Would you like to know more about the certification process and the costs? Or may we provide you with a concrete offer for the certification?
We are happy to help you. Our account management team and I, as the product manager, will be happy to forward your questions to our experienced auditors. We want to make it as easy as possible for you to access certified management systems.
Please let us know how we can support you. We look forward to hearing from you!
Kind regards
Lucas Pfeifer
Contribution to patient safety
A certified QM system according to EN ISO 13485 ensures that processes for the manufacture, monitoring and traceability of medical devices and their components are effectively planned, implemented and evaluated. This supports the long-term fulfilment of safety, performance and conformity requirements and makes an important contribution to patient safety.
Reliable framework for cooperation
ISO 13485 creates the basis for stable processes and seamless traceability from development to delivery. Risks are methodically recorded and controlled, technical evidence is documented and traceable at all times.
Clear and optimised processes
The standard requires risk-based, systematic processes, documentation and control mechanisms. Thus, optimisation opportunities can be identified and implemented at an early stage. This promotes continuous improvement and strengthens quality awareness throughout the company.
If you feel fit for the standard, you are welcome to use the form above to register for certification. Otherwise, your path to ISO 13485 certification could look like this:
#1 – Building up the system
Implement your management system in accordance with the requirements of the standard so that you are ready for your first external certification audit by SQS.
#2 – Registration for the certification
After registering for certification, you can benefit from a preliminary talk or pre-audit. The pre-audit identifies system-relevant gaps and enables efficient certification.
#3 – Auditing
We first review your system documentation, assess your readiness for certification and draw up a detailed audit plan together with you. Our auditors then visit your company to assess the relevant test objects and the maturity degree of the management system and compile a report.
#4 – Certificate with a three-year validity
If the report is positive, you receive the certificate in digital and printed form. You can communicate it internally and externally for three years. Annual audits ensure compliance with the standard and enable continuous improvements. A comprehensive recertification takes place after three years.
How long does it take to obtain an EN ISO 13485 certificate?
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The duration depends on factors such as the size of the company, the complexity of the products and the degree of preparation. Well-structured documentation, defined processes and clear responsibilities can speed up the certification process considerably.
How often does an EN ISO 13485 certificate need to be renewed?
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The certificate is valid for three years. A surveillance audit is carried out every year during this period. At the end of the three years period, a recertification audit is carried out to maintain the status.
What are the costs associated with an EN ISO 13485 certification?
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The costs vary depending on the size of the company, product portfolio, product risk class and location. We would be happy to prepare a customised offer tailored to your requirements.
Does SQS also offer consultancy services?
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No, our core competence is certification. You will find our current training offerings on the website.
How can a company verify the validity of an EN ISO 13485 certificate?
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Each certificate is given a unique registration number. Interested third parties can check the validity at a certification body such as SQS, at IQNET or in corresponding databases. To the query.
Can a company have several certifications at the same time?
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What happens if a company does not fulfil the requirements of EN ISO 13485?
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If non-conformities are identified during the audit, the company is given a deadline to initiate corrective actions. Without successful implementation, the certificate cannot be issued or extended or must be suspended.
How do EN ISO 13485 and other management systems interact?
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EN ISO 13485 is partly based on ISO 9001, but has additional requirements regarding medical device safety, risk management, validation, traceability, and documentation. Integrated management systems combine different standards, reducing organisational effort.
What is the difference between EN ISO 13485 and the EU directives (e.g. MDR 2017/745)?
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While EN ISO 13485 is a standard for quality management systems, the EU regulation (e.g., MDR 2017/745) defines the essential safety and performance requirements for medical devices. Successful certification according to EN ISO 13485 can facilitate conformity assessment, but does not replace all regulatory requirements.
How does an EN ISO 13485 certified management system contribute to the company image?
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A certification signals to customers, business partners and authorities that a company consistently meets the safety and quality requirements for medical devices. This strengthens trust in the brand and can make a decisive contribution to success in national and international markets.