ISO 9001 Experts in Switzerland
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Meet FRATCH Experts in Switzerland, who have recently used ISO 9001
Tomas H.
Last position:
Senior Advisor at Private Equity company (Business Integration)
Engaged to build governance, risk and process-improvement capabilities from scratch across approximately 30 fast-growing, decentralised lines of business in Germany, driving quality and productivity gains across business and functional teams.
- Applied Six Sigma root-cause analysis methodology (5-Why, Fishbone/Ishikawa) to lead investigations and process-improvement initiatives across the organisation’s finance, risk, IT and procurement functions, driving corrective actions and process redesign through to verified, sustained closure.
- Delivered structured training programmes to approximately 1,200 employees, for Compliance topics, incl. Six Sigma analysis and process-improvement methodology, building a continuous-improvement mindset and self-assessment capability across business and functional leaders.
- Analysed and optimized finance, risk and procurement processes across approximately 30 decentralised lines of business, developing and implementing continuous-improvement strategies and collaborating with cross-functional stakeholders (Finance, Controlling, IT, Procurement) to achieve measurable quality and productivity gains.
Dieudonné M.
Last position:
External Auditor at SGS Switzerland
- QMS development according to international standards
- ISO 9001 & ISO 13485 certification audits
- Environmental management audits according to ISO 14001 (training & application)
- Conducting audits in the DACH region (remote & on-site)
- Remote & on-site audit experience (EU, DACH, APAC)
Gregory R.
Last position:
Site Director and Turnaround (interim) at Dalli – De Klok BV
- Site leadership – 230 employees; €150M
- Turnaround and transformation of the site
- Introduction of Lean principles based on IWS (P&G)
- Increase of OEE by 20%
- Stabilization of delivery performance and elimination of out-of-stock situations, working closely with customers
- Close collaboration with the group to ensure the site was used to its full capacity
Matthias L.
Last position:
Consultant, Technical Project Manager at POCTIM Leicht
- Consulting, leading, and contributing to projects focused on increasing efficiency, restructuring, process improvement, process outsourcing, and cost reduction in production, quality, and logistics
- Interim management, especially for SMEs
- Lean management
- Filling vacant positions on an interim basis
- Management and process consulting as a Lean Trainer
- Technical Project Manager (IPMA Level D)
Károly A.
Last position:
NIS2 & Risk Strategy Consultant at RRC power solutions GmbH
- Developed a compliant information security management system (ISMS)
- Advanced a modern risk management framework based on NIST for NIS2 compliance
Rainer T.
Last position:
Managing Director at Tolksdorf.digital GmbH
- Independent consulting for digital transformation, quick checks and business case development
- Delivered systems and digital engineering, Industrie 4.0, workflow & AI agents
- Implemented digital sales and service solutions, KMU open source introduction, data migration, hosting and maintenance of customer IT systems
- Applied methods: Lean Innovation, ISO 9001:2015, Scrum; managed teams of 2–80 people and project volumes up to 22 Mi0 USD
Oliver W.
Last position:
Specialist Planner / Cleanroom Planning Lead at Major Aircraft Manufacturer
- Start-up and commissioning of the cleanroom
- Certification of the cleanroom
Jürgen A.
Last position:
Requirements Engineer / System Engineer at CCC Systems Engineering Suisse GmbH
- Supported design, setup, maintenance and enhancement of IBM Rational DOORS (9.6 and DNG) and IBM Rational Publishing Engine
- Conceived IT solutions and implemented them, including acceptance tests, considering customer-specific requirements
- Ensured functionality of tools and systems in scope
- Identified needs and advised departments and projects, designed single solutions when necessary
- Monitored and maintained central requirements engineering systems (servers, software, subcomponents)
- Advised on tool selection, features and application use cases for engineering applications
- Handled support requests from employees, customers and development teams autonomously
- Created system documentation and user guides
- Participated in cross-departmental IT projects and led subprojects
Jürgen S.
Last position:
Manager Manufacturing Operations USP at Thermo Fisher Scientific
- Liquida, aseptic/sterile, fill & finish, solida in production & packaging
- CAPEX/Greenfield, 5kL SUT Owner, CVQ, runs/SCM/SCORE, SFM, KPI, CAD, CQV, MSAT, trainings, audits, EHS
- Organization, construction, sterile production, operations, packaging, PPQ, Op-readiness, RM, audits, documentation authoring
Stefan L.
Last position:
Senior Manager, Project Manager, Auditor and Consultant at Laager Consulting GmbH
Many years of experience in application development, ICT infrastructures, systems management, hardware and software, telecommunications, ICT strategies, business models, database management, data center consolidations, support and call center setup
Since 1999 independent consultant and project manager: ICT strategies and governance, processes, audits, security, infrastructure (including cloud, DevOps and tools), data and output management, organizational restructurings, business project management and consulting in various industries
Generalist with analytical skills, strong communicator at all hierarchy levels, deployable as manager, coach, project manager or consultant
Hans S.
Last position:
Interim Manager, Consultant, Facilitator at Business Excellence Services GmbH
Interim manager, consultant, facilitator
Project management with focus on trouble shooting & customer care and/or product development/reengineering; regulatory management
Supply chain; risk and quality management; people management
Experienced within medical device; aerospace; packaging; small- & large equipment; optical- & electrical-systems; metal & plastics; free auditor
Since 2016, working for various accredited organizations as a freelance auditor regarding systems according to ISO 13485 and ISO 9001
2023-2024: Medical device product development, supply-chain and regulatory set-up with regard to a medical device re-engineering/launch and manufacturing
2023-2024: Project trouble shooter & customer care in the European aerospace industry within precision optics systems manufacturing; project risk and validation management including software validation
2022: Validation (FMEA, IQ OQ, PQ) management assigned with design and process risk assessment of complex electrical (IEC60601-1) mechatronics robots for MDR approval following ISO 14971
2022: Interim head of QM in aluminum-foil deep drawing process improvement; people and international Nespresso supplier quality management
2021-2022: Cytiva Cell Therapy greenfield project; assigned with design and implementation support of a certification, validation, GMP commissioning strategy for the technical infrastructure, e.g., clean rooms
2020-2021: Interim QA-Leader in Denmark assigned with the software release, manufacturing and distribution of Class IIb laser equipment for Candela, including international notified body and manufacturing transfer project
2020: Quality support and interim quality management for a manufacturer in the IVD test equipment supply chain and dialysis supplies in Bavaria
2018-2020: Expert/SME in Q-Management/Q-Engineering for orthopedic and arthroplasty device and tool production: turning, milling, cleaning, surface treatment and sterile packaging
2017: Re-engineering of the Medela product development process regarding cGMP 21CFR820.30/ISO 13485:2016 and MDR design control requirements for soft and hardware design regarding Class IIb pumps
2017: MDSAP preparation support and mock-audit coaching
2016: Interim senior QE-Expert for Maquet extracorporeal circulation devices manufacturing as ISO 14971 risk and change management expert in a Roche CAPA remediation and compliance project of IVD blood analyzers/gas sensor production
2016-2017: Orthopedic and arthroplasty implants design history file (DHF) review regarding compliance to 21 CFR 820.30 design control requirements
2015: Assigned by Novartis with design control for a new parenteral drug delivery system; manufacturability assessments during design evaluation; assessing potential plastic injection molding and/or high-volume assembly contractors in Europe and the US
2014: Assessing/auditing metallurgy process validation (IQ/OQ/PQ) of Zimmer contract manufacturers around Europe for FDA audit readiness; Depuy-Synthes subject matter expert (SME)
2013-2014: CAPA-8D process reengineering and setting in place/training new EtQ software tools; coaching of project and product managers in working through individual CAPAs; remediation of global legacy CAPAs; supporting complaint and field action (FSCA) management
2012-2013: QA/RA Manager at Sias AG for in vitro diagnostics (IVD) liquid handling robots manufacturing; led small team for electrical safety CE/CB scheme product approvals; QMS, change and CAPA management
2011-2012: Site Quality Manager at Medtronic for drug eluting balloon and Nitinol stent-catheter manufacturing; quality operations including Q-engineering and control; led 15 direct and indirect reports
2009-2010: Supported quality initiatives in medical device industry; assessments and audits for manufacturers and suppliers as a consultant of Business Excellence Services
Andrew L.
Last position:
Service Manager - Testing at Takeda Pharmaceutical International AG
- Managing the Testing services for the Global IT Testing Centre of Excellence (TCoE) team, which is responsible for managing and supporting the Product & Project Testing Workstreams on various Regional Projects, especially in Pharmacovigilance, Digital Supply Chain, Clinical Practice and R&D, etc.
- Managing Client relationships, escalations and continuing to grow the project services globally, while also driving the testing efforts on Takeda’s AI, DevOps, Agile, and Digital projects.
- Led the implementation of a Quality Management System (QMS), ensuring compliance with GCP, GMP, and Swiss and EU regulations, resulting in a huge improvement in audit readiness.
- Overseeing projects for systems including ERP, EDGE, SAP ECC, SAP Transportation Management, S/4 HANA migration etc.
- Led an AI/ML PoC for AI implementation.
- Led a cross-functional team to ensure compliance with MDR, FDA regulatory guidelines and achieved successful project deliveries.
- Led and managed change management and communication for TCoE, keeping the Takeda organisation informed of change communication and practices, including presentations to various stakeholders.
- Ensuring TCoE outsource vendor resources adhere to regulatory, compliance and quality system standards and practices for GxP & non-GxP System Development Life Cycle (SDLC) including aSDLC and TCoE Global Standards.
- Translated the product vision, strategy and requirements into backlog items, which were prioritised based on potential business impact and customer value.
Peter Z.
Last position:
Interim Procurement Manager DACH at Zug-Einkaufsoptimierung
- Corporate management
- Interim management and consulting in strategic and operational procurement in the medical technology, mechanical engineering, automotive, and vehicle manufacturing sectors
- Leadership
- Procurement management
- Personnel and technical leadership of procurement teams of up to 15 members; onboarding new purchasing managers
- Negotiation
- Market economy
- Developing and implementing purchasing and sourcing strategies
- Analyzing procurement markets and selecting suitable suppliers
- Restructuring
- Conducting contract negotiations and annual discussions with A and B suppliers; contract management
- Developing and implementing logistics concepts
- Introducing and improving key figure and evaluation systems to increase procurement efficiency
- Revising supplier evaluations
- Supporting reorganization and restructuring of procurement departments
- Supporting optimization of procurement processes
- Participating in the digitalization of business processes
- Project support for product launches and investment negotiations
- Supporting product launches
- Assisting in production relocations
Martin A.
Last position:
Martin Aicher
Main areas of activity ⋅ Martin Aicher
Areas of expertise
Medical technology
Sensor technology
Technical optics
Mechatronics
Microsystems technology
Biocompatible materials
Implants and endoprosthetics
Project management
Quality management IPMA
Regulatory affairs
Education
Dr.-Ing. Medical Technology
M.Sc. Medical Technology
Dipl. Ing. (FH) Medical Technology
Surgical mechanic, precision mechanic
Methodical product development
26 years of research, development, verification and agile product development
5 years of hands-on manufacturing of micromechanical instruments and implants
Projects
Development and verification of technical optics
Microscopy
Endoscopy
Immersion optical systems
Optical sensors
Light guides
Device development — medical electronics, active medical devices
Electromagnetic therapy devices for microcirculation of blood vessels
Electric drives, precision mechanics motors
Embedded devices, Medicine 4.0 / Industry 4.0
Feasibility studies, prototype design, electromechanical, chemical and hydrodynamic characterization up to series maturity
Structural integration of motors for pump systems
Integration of motors for catheter drives
Implantable drive systems with motors
Bone saws with Maxon motors
Osteosynthesis implant (bone implant) with linear drive
Electromagnetic therapy devices for microcirculation of blood vessels
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Characterization and development of battery cells and Li-ion batteries
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Vacuum device with pumps for wound healing
Braided tubes (reinforced hoses)
Shaft instruments and trocars
Surgical instruments, minimally invasive instruments (MIC)
Analytical instruments, sensors and fluid preparation
Monitoring systems
In vivo diagnostics (IVD)
Inline measurement systems for monitoring and analytical devices
Feasibility studies, prototype design, electrochemical and hydrodynamic characterization up to series maturity
Electrochemical deionization (EDI) as a monitor
Membrane technology
Measurement method and control of carbide saturation in cooling water
pH sensor
Optical sensors with laser diodes and LEDs
Dissolved O2 sensor
CO2 sensors
Ion-selective sensor (ISE)
Conductivity sensors
Turbidity sensor according to ISO 7027
Biosensors
Flow and pressure sensors
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Design of plastic injection-molded components and housings
Calculation and design of fluid channels
Design of metal die-cast components
Design of sheet metal parts
Implants and prostheses
Endoprosthetics: knee and hip endoprostheses
Bypass implants
Nitinol stents
Bone plates
Dental implants
Precision meshes
Instruments for medical technology
Angioplasty: PTCA percutaneous transluminal coronary angioplasty with balloon catheter
Catheter system as minimally invasive heart pump
EN ISO 10555-4: intravascular catheters
Braided tubes (reinforced hoses through precision meshes)
Thrombectomy with rotablation catheter
Trocars
Surgical instruments, minimally invasive instruments (MIC)
Endoscopes ISO 8600-1, EN 60601-2-18, EN 62471
Regulatory affairs for medical devices
CE for Europe (Class II and III), EU Medical Device Regulation 2017/745 (MDR)
EU Regulation 2017/746 for in vitro diagnostics (IVDR)
Ensuring complete documentation according to current regulatory requirements
FDA registration and approval 510(k), PMN, PMA, Class II, III
Design History Files (DHF), Device Master Record (DMR), Device History Record (DHR)
Internal and external audits
FDA and CE audits
Mock audits
Requirement engineering, user requirement specifications, functional requirement specifications
Quality management and relevant standards for medical technology
EN ISO 9001:2015
EN ISO 13485:2021
USA FDA 21 CFR 820 Quality Management System
FDA 21 CFR §§ 803, 806, 807, 830
In vitro diagnostics (IVD, IVDR) FDA 21 CFR §§ 600, 610, 660
USA FDA risk management for medical devices DIN EN ISO 14971:2019
P-FMEA for production
Usability of medical devices EN 62366-1:2021
CAPA (Corrective and preventive action) and GMP
Medical electrical equipment EN 60601-1:2013
EMC for medical devices DIN EN 60601-1-2:2022
Medical device software EN 62304:2018
Cell culture in cleanroom with different cell lines for biocompatibility testing of polymers and alloys
Biological evaluation of medical devices EN ISO 10993
Clinical investigation of medical devices ISO 14155
Manufacturing technology and processes
Process qualification and validation
Injection molding technology
CNC micromechanical manufacturing
Microsystems technology, printed circuit boards (PCB)
Joining technologies: laser welding of titanium, stainless steel, plastics as well as gluing and ultrasonic welding
Evaluation, setup and qualification of equipment
Thin film and surface technology
Coating of implants and tribological surfaces with chemical vapor deposition (CVD) and physical vapor deposition (PVD), sputtering of precious metals, stainless steels, nitinol, titanium alloys, polymers and ceramics
Plasma technology for functional coatings: hydrophilic and hydrophobic surfaces
Nanotechnology: surface functionalization: self-assembled monolayers (SAM)
Product Life Cycle Management
Finite element method
ANSYS FEM
Structural mechanics, statics
Fluid mechanics, flow simulations
Electrical engineering, electromagnetic fields
Characterization and testing of microelectronics
PCB (printed circuit board)
Sensor technology
Microcontrollers
CAN bus: ISO 11898, SAE
Control and data management with LabVIEW and Matlab
Programming language
Python 3.14
CAD
Autodesk Inventor
Pro/ENGINEER, PTC Creo Parametric
SolidWorks
Siemens NX
Solid Edge
Standards-compliant technical drawings
Endurance tests, mechanical, fluid mechanical, electrical and chemical characterization
Verification, V-Model, End of Line (EOL) testing
Writing work instructions for production, English regulatory documents and scientific articles
Support of clinical studies
Data processing, digital data management and statistics
Professional handling of Microsoft Office applications: PowerPoint, Word and macro programming for Excel
© 2026 M. Aicher
Thomas H.
Last position:
Sales Partner at SourceWeb Group
- Consulting and sales in cyber security
Discover over 15,000 top freelancers
Statistics of experts using ISO 9001
Aggregated from the professional profiles of matched freelancers.
Experience
29 years
Position duration
4.8 years
Positions per freelancer
11
Top business areas
Project Management, Quality Assurance, Operations
Top industries
Healthcare, Manufacturing, Professional Services
Certification focus areas
Quality Assurance, Information Technology, Project Management
Bachelor's degree or higher
87%
Master's degree or higher
67%
Doctorate
13%
Certifications per freelancer
5
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 29 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Switzerland are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows the share of experts charging within that range.
Average rates of experts in Switzerland using ISO 9001
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 29 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
ISO 9001 experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (65%)
- Manufacturing (65%)
- Professional Services (47%)
- Banking and Finance (35%)
- Automotive (29%)
- Energy (29%)
- Insurance (29%)
- Information Technology (29%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
ISO 9001 explained
ISO 9001 is the internationally recognized standard for quality management systems. It gives organizations a structured way to control processes, meet customer requirements, manage risks, and improve performance. The standard applies across industries, from manufacturing and life sciences to professional services and technology.
What companies build
An ISO 9001 system turns quality expectations into documented, repeatable practices. It can support supplier control, customer feedback, corrective action, internal audits, change management, and evidence-based decisions. In Switzerland, companies often connect the standard with multilingual teams, regulated supply chains, and customer requirements from international markets.
- Quality policies and measurable objectives
- Process maps, procedures, and controlled records
- Risk-based planning and corrective actions
- Internal audit and management review routines
Methods and tooling
Professionals work with the ISO 9001 standard alongside quality management system, or QMS, methods. Their tools may include document-control software, audit trackers, enterprise resource planning systems, customer relationship management data, and workflow platforms. The right setup keeps evidence accessible without creating unnecessary paperwork.
When specialists help
Companies bring in freelance ISO 9001 experts when certification is approaching, an audit has exposed weaknesses, or a growing operation needs consistent processes. They may also need independent support after a merger, new supplier strategy, product change, or shift from informal controls to a documented QMS.
- Prepare for certification or surveillance audits
- Identify gaps and prioritize corrective actions
- Train teams on process ownership and evidence
- Integrate quality controls into existing operations
What strong experts deliver
Strong professionals translate standard language into practical work instructions. They understand process interaction, risk-based thinking, nonconformity handling, root-cause analysis, audit evidence, and management review. They also know when a lean process is better than adding another form, and can communicate clearly across technical, operational, and leadership teams.
Choosing the right fit
Look for evidence of completed ISO 9001 implementations, effective audit preparation, and measurable process improvement rather than documentation alone. Ask how the specialist would understand your scope, sites, suppliers, and existing systems before proposing changes. For Swiss projects, clarify language needs, site access, and how remote workshops will work with local teams.
Frequently asked questions
Need clarity? These are the questions we hear most often about ISO 9001.
ISO 9001 is used to establish and maintain a quality management system that consistently meets customer and legal requirements. It helps organizations control processes, manage risks, learn from problems, and demonstrate that quality is managed systematically.
ISO 9001 is a broad, sector-neutral quality management standard. Unlike sector-specific frameworks such as IATF 16949 or ISO 13485, it does not prescribe every technical control for one industry, so companies often use it as a foundation alongside specialized requirements.
A strong ISO 9001 specialist usually brings process mapping, internal auditing, root-cause analysis, risk management, document control, and change management skills. Familiarity with ERP, QMS, or workflow tools can make implementation easier to sustain.
The right level of experience depends on the scope, operational complexity, and starting point of the quality management system. A focused gap assessment may need a different specialist profile from a multi-site implementation, audit recovery, or full certification preparation.
ISO 9001 work often combines remote document reviews, interviews, and workshops with on-site process observation. Swiss companies should agree on site visits, secure access to records, and the working languages required for employees, suppliers, and auditors.
ISO 9001 certification does not guarantee that every product or service is defect-free. It confirms that an organization operates a quality management system designed to control relevant processes, meet requirements, and improve when issues occur.
Ask a ISO 9001 specialist to explain how they have turned requirements into usable processes and objective evidence. Strong answers cover scope, risks, process ownership, audit findings, corrective action, and how teams will maintain the system after the engagement.
Before starting an ISO 9001 engagement, clarify the certification scope, applicable customer requirements, current documentation, audit history, decision owners, and access to operational teams. Success depends on practical adoption, not simply producing a complete set of documents.
The average hourly rate of freelancers in Switzerland who have used ISO 9001 in their recent projects is 128 €, which corresponds to a daily rate of about 1,021 € based on an 8-hour working day.
Of the freelancers in Switzerland who have used ISO 9001 in their recent projects, 87% hold at least a Bachelor's degree, 67% hold at least a Master's degree, and 13% hold a doctorate.
On average, freelancers in Switzerland who have used ISO 9001 in their recent projects have 29 years of professional experience, with a single engagement typically lasting around 4.8 years.
The most common languages among freelancers in Switzerland who have used ISO 9001 in their recent projects are German (100%), English (100%), and French (47%).
The most common industries among freelancers in Switzerland who have used ISO 9001 in their recent projects are Healthcare (65%), Manufacturing (65%), and Professional Services (47%).
The most common business areas among freelancers in Switzerland who have used ISO 9001 in their recent projects are Project Management (82%), Quality Assurance (71%), and Operations (59%).
Main locations of FRATCH Experts, who have recently used ISO 9001
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
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