ISO 13485 certification:
Getting through the audit without any nasty surprises
When it comes to medical devices, every detail counts. Mistakes are not only costly but can even cost lives in the worst-case scenario. This is precisely why especially strict rules apply in medical technology. ISO 13485 is the internationally recognized standard for quality management systems that ensure compliance with these high requirements.
Do you want to be certified according to ISO 13485? Then read on. On this page you will find out:
- Which specific requirements you need to fulfill for ISO 13485 certification - and how to implement them efficiently and in compliance with standards
- How to perfectly prepare your company for the audit
- How to avoid pitfalls and set up a robust, audit-capable quality management system from the outset
What is the ISO 13485 standard
and why is it so important for medical device manufacturers?
ISO 13485 is the central quality standard for the development, production, installation and maintenance of medical devices. It was developed specifically for medical technology companies and therefore differs significantly from the more general quality management standard ISO 9001 in many respects.
While the ISO 9001 is aimed at general quality principles, the ISO 13485 standard focuses on product safety, traceability, risk minimization and regulatory compliance. It is considered a global reference and is the de facto requirement for the approval of medical devices in many markets.
In many cases, a certified QMS (quality management system) in accordance with ISO 13485 is mandatory for permission to place medical products on the market at all. A self-assessment or internal certificate of conformity is not sufficient in the medical sector.
In concrete terms, this means No market access without certification. If you want to gain a foothold in the development of medical devices, you will not be able to avoid ISO 13485 certification in the long term.
DIN ISO 13485 Summary:
Content, significance and requirements at a glance
ISO 13485 is also fundamentally based on the high-level structure model of the ISO world, but deviates from it in key points: It is more formal, more documentation-heavy and more regulatory than other standards.
The key requirements at a glance:
- Risk management along the entire product life cycle, based on ISO 14971
- Validation of processes - for example for sterilization, software or measuring systems
- Documentation requirements that also ensure traceability and product responsibility
- Complaint, recall and CAPA processes that must be fully documented and verified
- Design and development processes, including verification and validation
- Training and competence certificates for all quality-relevant activities
- Technical documentation that complies with regulatory requirements (in particular MDR / IVDR)
- Management responsibility, with a clear commitment to the QMS
- Regular internal audits, management reviews and corrective measures
What we would like to emphasize at this juncture: ISO 13485 is not a "slimmed-down" offshoot of ISO 9001. Quite the opposite. It requires an even higher degree of discipline, verification and risk awareness. Many companies underestimate this and later find themselves on the spot needing to explain during the audit.
5 advantages of a
ISO-13485 certification
Absolute legal certainty in interesting markets
In countries such as Canada, Australia, Japan and Brazil, ISO-13485 is the basic requirement for the approval of medical devices. Market entry without certification is prohibited and can result in hefty fines, prison sentences and other sanctions.
Competitive advantages
In the EU, the USA and many other countries, ISO 13485 certification is not a legal requirement, but it is a de facto prerequisite for participating in major tenders.
Minimized security risks
ISO 13485-compliant risk management protects against recalls, liability cases and reputational damage - and strengthens the trust of stakeholders and customers.
Risk Minimization & Compliance
A clearly structured ISO 13485-compliant QMS reduces waste, improves communication and strengthens process stability.
Better quality
Ultimately, ISO 13485 certification sustainably improves the quality of your products - which both increases your business success and protects the people who depend on your medical devices.
ISO 13485 certification:
The process in 5 steps
Step 1
Status check & GAP analysis
Analysis of existing processes and identification of all gaps with respect to the standard.
Step 2
System design & QMS architecture
Development of a tailor-made system - with clear roles, processes and documentation.
Step 3
Implementation & Training
Implementation and training of all quality-relevant team members.
Step 4
Internal Audit & Review
Simulation of the external audit, final adjustments and preparation.
Step 5
Certification & Guidance
Get your ISO 13485 certificate and show the world that your medical quality is set in stone.
Common pitfalls on the way to ISO 13485 certification ‒
and how you can do it better:
Many companies believe that it is primarily about documenting processes and working through checklists. However, this leads to systems that work on paper but offer no added value day to day.
We have been supporting our customers with quality management certifications for over 20 years and have observed the same stumbling blocks time and time again:
QMS systems are too technocratic
Many companies get bogged down in unnecessary formalities and complicate simple processes. Instead of creating real benefits, the result is a bureaucratic monster - which meets with resistance internally in 95% of cases.
Management is not consistently involved
Without genuine leadership, every QMS is just a compulsory exercise for the QM department. The result: Lack of responsibility, slow progress and poor data quality.
Processes are created "for the auditor" from scratch
If processes are not described and anchored in a realistic manner, a dangerous gap between target and reality arises. This takes its toll in the day-to-day running of the company when a yawning gap appears between aspiration and reality, or possibly sooner than that.
Context analysis is underestimated
If you only take a superficial look at external influences, stakeholders and risks, you are building your QMS on an incomplete foundation - and missing out on important strategic opportunities.
Do not see ISO 9001 as a control system, but as a management tool
If you manage to understand your QMS as a real tool for improving your organization, its full potential will be unlocked.
Start with the core processes
Do not try to record all processes at once. Firstly, prioritize the processes that are most relevant to quality and customer value and build your system from there.
Use existing tools
Many companies already have software solutions (e.g. for project management, complaints, document control) that can be quickly and easily integrated into the QMS. This reduces effort and increases internal acceptance.
Rely on a strong management assessment
Most companies see it as a chore, but it is the central management tool for keeping their QMS on track. Use the management review actively and consciously to optimize measures, responsibilities and targets.
How to get the most out of it
Your ISO 13485 certification:
A major advantage of ISO 13485: It can be dovetailed perfectly with other management systems, provided you know how to set the parameters. If you make targeted use of synergies, you not only reduce the documentation effort, but also create a lean, robust overall system that is convincing in regulatory and operational terms.
Combinations with the following frameworks are particularly useful:
ISO 9001
The basis of many quality management systems. Those who already work in compliance with ISO 9001 can adopt core structures such as process documentation, audit planning or management evaluation and expand them in a targeted manner.
ISO 27001
Indispensable when software, hardware components or digital medical products play a role. Particularly important for sensitive patient data, cloud-based services and networked devices.
ISO 27701
For companies that have to provide evidence of a certified data protection management system - e.g. in the context of clinical studies or in patient communication.
MDR / IVDR
The logical addition to ISO 13485. The two systems are directly interlinked, especially when it comes to technical documentation, risk management and conformity assessment.
Practical tip:
Many companies try to operate their systems side by side - and end up drowning in audit chaos. However, the key to success lies in integrated management processes with coordinated review cycles. For example, those who set up their management assessment, audit planning and action tracking across systems save up to 40% of time and minimize the risk of contradictory evidence - a real game changer in practice.
FAQs –
other important questions about the
ISO 13485 framework
The ISO 9001 is a general quality standard for all industries. ISO 13485 is specifically tailored to medical technology and places significantly more emphasis on regulatory requirements, risk management and product conformity.
ISO 13485 focuses on effective quality management for medical devices - with clear specifications for risk management, traceability, technical documentation and regulatory safety. Regular ISO 13485 training courses are required to meet the requirements over the long term, ideally in German and practically tailored to your own area of responsibility.
In many markets, a certified QMS in accordance with ISO 13485 is a de facto requirement, and in some countries even a legal requirement. Without certification, you will probably be denied market access in many countries.
Depending on the initial situation, resources and project structure, the introduction and certification process takes between 3 and 9 months.
The currently valid version is ISO 13485:2016. It is the international reference for quality management in medical technology.
Upon successful implementation you will receive an official certificate from an accredited certification body - your proof of a robust quality management system in the healthcare sector.
Without detours to
ISO 13485 certificate
Do you want to implement ISO 13485 in a clean, efficient and legally compliant manner - but don't have a clear overview between MDR specifications, test requirements and constantly new documentation requirements?
We provide you with clarity and help you get started. In a free quick check, we take a look at your initial situation together and give you practical recommendations for a successful ISO 13485 certification - without sales pressure, but with maximum clarity.
