Your fast-track to ISO 13485 certification

Your quick path to QM manual and ISO 13485 certification

Our auditors and QM experts help you to 

  • create your QM handbook, i.e.
  • formulate your quality policy and your quality objectives ,
  • identify your processes and document them in procedure instructions (e.g. development, production, supplier control, CAPA, market surveillance, document control, internal audit, management review etc.)
  • describe the interaction of processes
  • review and improve your QM handbook 
  • add missing content in order to achieve conformity with standards
  • remove regulations and specifications that hinder you and thus streamline your QM manual
  • redesign processes together with you so that you achieve the goal of quality management: greater market success through the high quality of your products and services.
  • finally audit your QM system in a trial audit , identify any remaining non-conformities and correct them.

This will give you everything you need to 

  • pass your ISO 13485 Audit with 100% certainty (to date, all(!) of our clients have passed their ISO 13485 without any issues.)
  • get your products onto the market quickly,
  • speed up and improve development and production

Get in touch with us so we can design your lean QM system!

Your ISO 13485-certified QM system in seven steps

We often manage to create a tailor-made QM manual in just a few days. The reason we can do this so quickly is because, as auditors and software experts, we have already done this hundreds of times and can rely on templates. 

  1. Getting in touch

    • You get in touch with us (e.g. via our contact form or by phone) and tell us what you need. In a very short time, you will have a crystal-clear idea of whether and how we can help you.
  2. Quotation

    • We will provide an overview of the costs for the entire project in an initial quote. This allows you to estimate costs right away, regardless of who you are working with.
  3. Project launch

    • You make your decision and give the go-ahead.
  4. Kick-off: Initial workshop

    • We spend one to two days with you, get to know you, your company and products, browse all previous documents, discuss your processes, identify the tasks and create the project plan together with you.
  5. Initial manual draft

    • We create an initial draft of your QM manual, tailored to your specific situation.
  6. Optimization and implementation

    • We present the system, train you in how to use it (this is very quick) and show you the items that you still have to incorporate and implement in order to pass the next audit.
  7. Audit, certification

    • If you wish, we can conduct a trial audit so that you are well-prepared for the most common audit questions. You can then be certified by the notified body.

Get in touch with us to talk about creating a QM system!

Workload and costs

What workload and costs depend on

It goes without saying that the workload and costs of setting up an ISO 13485-compliant quality management system depend on many factors such as:

  • the size of the organization to be certified
  • the scope of the QM system (e.g. development, production, sales, support etc.)
  • whether you have a QM system already in place e.g. ISO 9001-compliant
  • the determination of management to introduce a QM system

Typical workload

Admittedly, we don't always achieve this timeframe, but most of the time we get everything done with 10 to 20 days of work. And in 100% of cases, the ISO 13485 audits are passed first time.

Since we have now successfully guided over a hundred companies through ISO 13485 certification and because we specialize in SMEs, we are just the people to accurately estimate the workload and costs for an ISO 13485 certification.

 

Nothing unnecessary

We create a lean QM manual.

This not only means less work for us, but also for you both to understand and develop the system and to introduce the QM system

Partnership approach

We involve you in its creation.

We do not pursue the goal of working with every single medical device manufacturer and focusing purely on profit. On the contrary: we empower you and your business and minimize your workload and costs.

Experience

We are professionals and we have experience.

Our team consists exclusively of auditors, experienced natural scientists, computer scientists, engineers and medical technicians. We are certified as "Certified Professionals for Medical Software". We have set up several hundred QM systems quickly and safely guided them through certification.

Background knowledge

We are auditors and know exactly what matters.

Our team trains notified bodies and thus their auditors. We even write audit guidelines for them in some cases, and we are represented in standards committees. This means we know exactly what matters in audits. So we can concentrate on the essentials.

Construction kit

We make use of proven documents.

Some parts of an ISO 13485-compliant quality management manual must be formulated very specifically for a company in order to make its central value creation processes more effective and efficient. For example, to develop medical devices more quickly and in higher quality. Other parts such as requirements for purchasing or "human resources" are often identical. As a result, we sometimes work with templates that have proven themselves in many audits. This reduces workload and costs.

quality management manual documents what you would like to do. We help you to formulate your own specifications in compliance with the ISO EN DIN 13485 standard in such a way that your company will be happy to follow them because they will help you manufacture your medical devices more quickly and more effectively. Sounds almost too good to be true, doesn’t it? Maybe, but that's what we do.

 

Get in touch with us to talk about creating a QM system!