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.
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 for efficiency improvement, restructuring, process improvement, process outsourcing, and cost reduction in production, quality, and logistics
- Interim management, especially in SMEs
- Lean management
- Bridging vacancies
- 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
Dieudonné M.
Last position:
External Auditor at SGS Switzerland
- QMS setup according to international standards
- ISO 9001 and ISO 13485 certification audits
- Environmental management audits according to ISO 14001 (training and application)
- Conducting audits in the DACH region (remote and on-site)
- Remote and on-site audit experience (EU, DACH, APAC)
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 19 Sep 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Switzerland are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge 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 19 Sep 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
What ISO 9001 covers
ISO 9001 is the international standard for quality management systems, commonly called a QMS. It helps an organization control how work is planned, delivered, checked and improved. The standard focuses on consistent processes, customer requirements, documented evidence, risk-based thinking and continual improvement rather than on a specific product or industry.
Where it is used
ISO 9001 supports quality assurance in manufacturing, medical technology, construction, logistics, software, professional services and public-sector supply chains. Companies use it to make responsibilities clear, reduce process variation and show customers that their operating model is controlled.
- Establish a quality policy and measurable objectives
- Map operational processes and their interactions
- Control documents, records, suppliers and nonconformities
- Prepare evidence for internal and external audits
QMS ecosystem
A strong QMS connects process maps, procedures, work instructions, risk registers, training records, corrective actions and management reviews. Specialists may work with document-control tools, enterprise resource planning systems, ticketing platforms, audit software and reporting workflows. ISO 9001 can also align with ISO 14001, ISO 45001 or sector-specific requirements.
When companies need support
Companies often bring in freelance expertise before certification, during a major audit, after recurring nonconformities or when a QMS must scale across sites. Switzerland-based organizations may need professionals who can collaborate on site with operational teams while coordinating remote workshops and documentation reviews across locations. Language expectations should be agreed early, especially where procedures and audit evidence use German, French, Italian or English.
- Diagnose gaps against ISO 9001 requirements
- Design or simplify a practical QMS
- Train process owners and audit participants
- Manage corrective and preventive action workflows
What strong professionals deliver
Effective professionals translate clauses into usable daily practices. They can interview teams, identify process risks, define clear evidence, write concise procedures and build ownership beyond the quality function. They also understand that certification is not the finish line: the system must support reliable operations and produce useful management information.
How to assess expertise
Review examples of QMS implementation, internal audit leadership, certification preparation and corrective-action work. Ask how the professional would handle weak process ownership, incomplete records or a supplier issue, and listen for a practical answer tied to evidence. The best fit combines ISO 9001 knowledge with change management, facilitation, data analysis and clear communication.
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 controls processes, responsibilities, records and improvement activities. Companies use it to increase consistency, meet customer or tender requirements and prepare for certification audits.
ISO 9001 provides a recognized framework for a quality management system, while approaches such as Lean, Six Sigma or Total Quality Management provide methods and principles for improving performance. They can complement each other, but ISO 9001 places particular emphasis on documented processes, risk-based thinking, customer focus and audit evidence.
A strong ISO 9001 specialist often brings internal auditing, process mapping, corrective-action management and supplier-quality experience. Skills in change management, training, document control, data analysis and standards such as ISO 14001 or ISO 45001 can also be valuable.
The right level of ISO 9001 experience depends on the assignment. A gap assessment may need focused audit and process knowledge, while building a QMS across several functions requires broader implementation, facilitation and stakeholder-management experience.
ISO 9001 work can often be done remotely when interviews, document reviews, training and action tracking are well organized. On-site time remains useful for observing processes, speaking with operational teams and checking whether documented practices match actual work, particularly across Swiss production or service locations.
An ISO 9001 gap assessment should compare current practices and evidence with the applicable requirements. The deliverable should identify risks, missing controls, unclear ownership and prioritized actions rather than simply repeat the wording of the standard.
Look for a ISO 9001 professional who asks about the business, customers, processes and existing evidence before proposing documents. Quality is shown through practical recommendations, clear audit trails, usable procedures and improvements that process owners can maintain.
ISO 9001 applies to organizations of many types, including software, logistics, healthcare suppliers, construction and professional services. Its requirements are adaptable because the QMS is designed around the organization’s own context, risks, processes and customer commitments.
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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