Consultancy with in-depth technical expertise

Consultancy with in-depth technical expertise

Zwei Kolleginnen und Kollegen im Gespräch am Konferenztisch, moderne Büroatmosphäre bei KooSys

Standards, certifications and process requirements can be overwhelming. We bring clarity, structure and a practical implementation strategy tailored exactly to your situation.

The Problem

Your product is technically strong, but the audit becomes tight. You know you need processes, but you do not know where to start. Or you have processes that do not fit your daily work and only exist on paper in the handbook.

Our experience shows that most companies only come to us once the pressure is already there, whether it is an upcoming audit, a project at risk of failing, or a level of complexity that has grown beyond control. The earlier we get involved, the more we can achieve, but even a late start can still make a real difference.

Our areas of expertise

Standards & Regulatory Consulting

From Automotive SPICE® through ISO 26262 and IEC 61508 to IEC 62443, we know the relevant standards and translate them into feasible measures, regardless of industry and tailored to your specific situation.

Process Development & Optimization

We build development processes with you that fit your team size and your goals, with assessment and optimization according to ISO 9001, CMMI, and SPICE (ISO/IEC 15504 / 330xx).

Audit Preparation & Certification

We prepare you for assessments, not with paper tiger processes, but with structures you will still want to use after the audit. TISAX, ISO 21434 and industry specific extensions.

We help you build quality and management systems that do not just pass audits, but noticeably improve your day to day work. From the gap analysis to continuous support, we stand by your side.

Sound familiar?

You know you need a quality management system, but where do you start? The standard is extensive, the requirements are unclear and there is no time in day to day business to work through it thoroughly. Or you already have processes, but they are not really lived because they exist in the handbook instead of being applied in everyday work.

Maybe an audit is coming up and you are not sure where you currently stand. Maybe a customer is requiring a certification you do not yet have. Or you simply notice that your processes work, but they are not documented, not traceable and not scalable.

We know these situations from numerous projects and this is exactly where we come in. The earlier we get involved, the more we can achieve, but even a late start can still set a lot in motion.

From the initial assessment to a fully operational system.

Gap Analysis

Where do you stand today and where do you need to get to? We analyze your processes, documentation and structures against the relevant standards and deliver a clear picture of your strengths, gaps and priorities.

 

🎯 Your Result: A prioritized action plan so you can deploy your resources in a targeted way.

Consulting & Implementation

Together with you, we build processes, structures and documentation that fit your team size, your industry and your daily work, pragmatic and without oversized frameworks.

 

🎯 Your Result: A management system that fits you and is truly lived in practice.

Internal Audits

We support internal audits as an objective assessment and identify potential for improvement, so you are always prepared when the external audit arrives.

 

🎯 Your Result: Confidence that your system delivers on what it promises, along with a clear plan for the next steps.

Ongoing Support

We stay by your side for regular reviews, adjustments to new requirements and as a sparring partner when questions come up. A management system needs care and ongoing development.

 

🎯 Your Result: A partner who keeps thinking ahead even after certification and keeps your system alive.

Training

We train your employees in a practical, hands on way tailored to your day to day work, from awareness workshops to specialized training for internal auditors. Processes only work if the people behind them understand and support them.

The Standards We Cover

Organizational Level

ISO 14001

Environmental Management

Development and integration into an existing QMS

ISO 27001 / TISAX

Information Security

ISMS development, gap analysis, certification preparation

ISO 9001 / IATF 16949

Quality Management

Implementation, improvement, audit preparation, internal audits

Project Level

SPICE / A-SPICE

Software Process Assessment (Automotive)

Assessment preparation, process development, coaching

CMMI

Capability Maturity Model

Maturity level analysis, process optimization, appraisal preparation

Our offering is aimed at SMEs in the DACH region and beyond, regardless of industry. Whether you are a manufacturing company, a software house or a service provider: if you want to build, improve or have your processes certified, you are in the right place with us.

Typical Starting Situations: You do not yet have a formal management system and do not know where to start. Or you have one, but it is not really lived in practice. Or a customer or a market requires a specific certification and you need support on the way there.

Your point of contact within your company: The collaboration works best when there is a person or a small team on your side that coordinates the topic. We work closely together with you, not around you.

There are many consultants out there. This is what makes us different.

We come from practice, not from theory

We have built management systems ourselves, passed audits and know what actually works in day to day practice and what only looks good on paper.

As an engineering company, we understand not just the processes, but also the technology behind them. This makes our consulting more concrete and more relevant to your daily work.

We build systems that fit your team size and your resources, not corporate scale solutions for SMEs.

We stay involved, from the gap analysis through implementation to ongoing support. We do not leave you alone with just a PDF.

We ask the questions others skip, because a management system only works if it is built on genuine understanding, not on ticked off checklists.

Functional safety according to IEC 61508, ISO 26262 and industry specific standards, from the safety analysis through to the finished safety case.

When functional safety becomes relevant.

Your product contains safety relevant functions, but you are not sure what requirements arise from this and how to implement them systematically. Maybe a customer requires a safety case or proof of compliance with ISO 26262, and you do not know where to start.

Or you are already developing according to safety standards, but the processes are not consistent, the analyses are not complete and the documentation is not audit proof. Product liability is becoming more complex, authorities like the KBA are tightening requirements, and your customers expect verifiable safety.

Functional safety has long since stopped being relevant only to the automotive industry. Whether industrial automation, defence or even aerospace: wherever systems perform safety relevant functions, comparable requirements apply. We help you find the right framework and implement it according to your needs.

The Basis We Work On

IEC 61508

General, industry independent

Basic standard for functional safety, applicable across all industries as the reference standard and starting point for industry specific derivatives.

ISO 26262

Automotive

Industry specific derivative of IEC 61508 for road vehicles. Defines ASIL levels A to D, system requirements and the entire safety lifecycle.

ISO 26262 builds on the general IEC 61508, makes it more specific for automotive development and defines the entire product development process (PEP) from a safety perspective. The VDA regulates the specific application of the standard within the German automotive industry, while the KBA (Federal Motor Transport Authority) is responsible as the approval authority for compliance with the requirements.

ASIL Levels: The Language of Functional Safety

The Automotive Safety Integrity Level (ASIL) classifies the risk of a safety relevant malfunction into four levels, from A (low risk) to D (highest risk). The higher the ASIL level, the stricter the requirements for development, verification and evidence. We help you determine the correct ASIL level and apply the resulting requirements according to your needs.

Our Service Portfolio in the Area of Functional Safety

Gap Analysis & Maturity Assessment

Where do you stand in terms of functional safety, and what do you still need to do? We analyze your existing development processes, documentation and evidence against the relevant standards and determine your current safety maturity level. The result is a clear assessment with prioritized recommendations for action.

 

🎯 Your Result : A clear maturity level report showing where you stand and which measures have priority.

Safety Analyses & Verification Methods

Functional safety requires systematic analysis methods to identify, assess and verifiably address risks. We are proficient in the established methods and apply them to your systems according to your needs:

FTA (Fault Tree Analysis)

DFA (Dependent Failure Analysis)

FMEDA (Failure Modes, Effects and Diagnostic Analysis)

D-FMEA (Design Failure Mode and Effects Analysis)

Decomposition

 

🎯 Your Result : Complete and traceable safety analyses that hold up to scrutiny from your customers as well as testing bodies and authorities.

Safety Case Development

The safety case is the central piece of evidence that your product ensures functional safety. It brings together all safety requirements, analyses, test results and evidence into one coherent overall argument. We support you in building and creating this evidence, from structuring through to final documentation.

 

🎯 Your Result : An audit proof safety case that meets the requirements of your customers, the KBA or other approval authorities.

Process Development & Development Phases

Functional safety needs to run through the entire product development process, not be added on at the end. We integrate safety into every development phase: from concept through requirements derivation and implementation to release, and support you in building a genuine safety culture within your team.

 

🎯 Your Result : Consistent safety processes embedded in your day to day development work.

Training & Safety Awareness

We train your teams in functional safety, from the fundamentals of IEC 61508 and ISO 26262 through ASIL determination and analysis methods to practical application in day to day project work, hands on and understandable, not an academic lecture.

 

🎯 Your Result : Teams that understand functional safety and can apply it independently in their day to day work.

We are convinced: functional safety needs to fit your product and your organization, not the other way around.

Hands on Instead of Just Paper

We work directly on your systems and products, not just on documents. Our consulting is concrete and based on your actual development situation.

Tool Independent

We work with the tools you already have. Whether Doors, Polarion or a simple spreadsheet: what matters is the content and the methodology, not a specific tool landscape. It also works without any specialized tool at all, if your situation requires it.

State of the Art, Not Blind

The standards require the "state of the art". This does not mean you have to apply every method at maximum depth. It means knowing what the state of the art is and consciously and traceably deciding what is relevant for your product. We help you make and document these decisions properly.

Stakeholder Management

Functional safety concerns not only development, but also customers, suppliers, authorities like the KBA, testing bodies and internal management. We help you with reporting, escalation and coordination with all relevant stakeholders.

What Makes Us Stand Out in This Area

Automotive Depth as a Foundation

We have implemented ISO 26262 and the highest ASIL requirements in practice, from ASIL determination through FTA and FMEDA to the finished safety case. We bring this knowledge into every industry.

We work directly on your systems and products, not just on process documents. Safety is created in practice, not in an ivory tower.

Not every product requires ASIL D level effort. We help you define the right scope and deploy resources where they are actually needed.

We know what matters to auditors and authorities. Our analyses and safety cases are audit proof, traceable and to the point.

Whether Doors, Polarion or Excel: we work with your existing tool landscape and do not force new infrastructure on you.

Product Liability & Duty to Provide Evidence

 

Functional safety is not just a technical requirement, it is also a key part of product liability. In the event of damage, you must be able to prove that your product was developed according to the state of the art and meets all relevant safety requirements. Without thorough documentation and traceable evidence, this becomes very difficult in a real case.

We help you integrate this duty to provide evidence into your development process from the very beginning, so that you have solid documentation ready if it is ever needed.

Regulatory requirements such as the Cyber Resilience Act, ISO 21434 or IEC 62443 affect companies worldwide today. We help you implement these requirements systematically, whether you manufacture in Europe, export there or need to secure international supply chains.

Why Cyber Security Needs to Be on Your Agenda Now

The regulatory landscape in the field of cyber security is changing fundamentally. Under the Cyber Resilience Act (CRA), from 2027 all products with digital elements sold in the EU must meet verifiable cyber security requirements. This affects not only European manufacturers, but also any international company that wants to enter the European market or supply components into European supply chains.

In the automotive industry, cyber security has already been in practical use for some time: ISO 21434 and UNECE R155 have long been mandatory for anyone integrating electronics into vehicles. Suppliers worldwide, including those from India, China and Southeast Asia, must meet these standards if they want to succeed in the European or North American market.

At the same time, NIS 2, the EU Machinery Regulation (EU) 2023/1230 and IEC 62443 are tightening the requirements for industrial systems and critical infrastructure. And in North America, separate regulations are emerging that increasingly exclude Chinese software from the market.

The question is no longer whether, but when you need to address cyber security systematically. And the earlier you start, the less it will cost and the better positioned you will be.

Two Markets, One Approach

Automotive

For everyone integrating electronics into vehicles, the rule today is: no cyber security, no type approval, and no type approval, no market access. This is especially relevant for international suppliers, for example from India or China, who want to supply components and systems for the European or North American market. We support companies in understanding, implementing and proving compliance with the required standards.

Industry

The Cyber Resilience Act (CRA) applies to all manufacturers placing products with digital elements on the EU market. Electromechanical systems from international manufacturers wanting to export to or import from Europe are equally affected.

Relevant Standards

ISO 21434 (Automotive Cybersecurity Engineering), UNECE R155 (UN regulation for cyber security management systems, applicable worldwide).

Relevant Standards

CRA (Cyber Resilience Act, EU, from 2027), NIS 2 (Network and Information Security Directive), EU Machinery Regulation (EU) 2023/1230, IEC 62443 (Industrial Automation and Control Systems Security), ISO 27001 / TISAX (Information Security).

The Regulatory Requirements We Cover

Automotive

ISO 21434

Automotive Cybersecurity Engineering

Gap analysis, process development, threat analysis (TARA), support through to compliance

UNECE R155

Cyber Security Management System 

CSMS development, audit preparation, evidence provision for type approval

TISAX

Information Security in the Automotive Industry

Assessment preparation, ISMS development according to VDA ISA and support through to ENX approval

Industry

CRA

Cyber Resilience Act (EU, from 2027)

Product classification, gap analysis, recommendations for action,
Compliance Support

NIS-2

Network and Information Security (EU)

Requirements analysis, implementation support, often in partnership

IEC 62443

Industrial Cyber Security 

Protection needs analysis, secure development processes, security requirements at component level

ISO 27001

Information Security

ISMS development, certification preparation (see also QMS area)
Gap Analysis & Recommendations for Action

Where do you currently stand in terms of cyber security, and what do you need to do? We analyze your current situation against the relevant standards and deliver a clear assessment with prioritized recommendations for action, whether for a single product or your entire company.

 

🎯 Your Result : An action plan showing what you specifically need to do to meet the regulatory requirements, with clear prioritization and realistic timeframes.

Product Classification & Scoping

The CRA distinguishes between different product categories with different levels of requirements. We correctly classify your products (hardware and software) and define the scope of your cyber security measures, so you know exactly what applies to you.

 

🎯 Your Result : Clarity on which of your products fall under which requirements and what level of effort is realistically involved.

Process Development & Implementation

Whether it is a Cyber Security Management System (CSMS) according to R155, Threat Analysis and Risk Assessment (TARA) according to ISO 21434, or Security Level determination according to IEC 62443: we build the processes, structures and documentation you need together with you. Practical, matched to your company size and not oversized.

 

🎯 Your Result : A cyber security management system and technical processes that do not just pass the audit, but actually make your products more secure.

CVE Management & Vulnerability Handling

Common Vulnerabilities and Exposures (CVE) are a key part of every cyber security strategy. We support you in building a systematic vulnerability management process, from detection through assessment to remediation and documentation.

 

🎯 Your Result : A structured process to identify, assess and traceably address vulnerabilities in your products and systems.

Training & Awareness

Cyber security is not purely a technical topic, it concerns the entire organization. We train your teams in a practical, hands on way on the relevant standards, threat scenarios and organizational requirements, from management to the development department.

 

🎯 Your Result : Employees who understand cyber security and apply it in their day to day work, not just experts in a specialized department.

Localization & On the Ground Contact

For international companies, especially from India and China, that want to enter the European market, we offer a special service: we act as your local point of contact in Europe. We take care of regulatory compliance, act as a local interface to authorities and certification bodies, and support you throughout the entire process of gaining access to the EU market.

 

🎯 Your Result : A European presence for your cyber security compliance, without you needing to build up your own local structures right away.

What Makes Us Stand Out in This Area

Automotive DNA Meets Industrial Breadth

We know ISO 21434 and R155 from our own project experience and bring this knowledge into the CRA and IEC 62443 context as well. The CRA is a mix of both worlds, and that is exactly our profile.

We understand the challenges faced by international companies looking to enter the European market. As a local point of contact in Europe, we act as the bridge between your products and the requirements here.

As an engineering company, we understand not just regulations, but also the technology behind them. Our consulting is concrete and relates to your actual products and systems.

Our cyber security consulting is provided personally by experienced experts who know your industry and your challenges and are directly available.

Where does your system really stand?

Whether you are right at the beginning, in the middle of implementation or need to prepare for an audit: we look at your situation together. In a 30 minute initial conversation, without any sales pressure and with real added value, we find out how we can best support you.

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