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Certificates: Certificate "Quality Control Officer - Medical Devices Industry"
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Additional Certificates: Certificate "Quality manager with TÜV Rheinland certified qualification"
Certificate "Quality auditor with TÜV Rheinland certified qualification"
Certificate "Process optimization with Lean, Kaizen and CIP"
Certificate "Quality management in the medical device industry" -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
Qualitätsmanager:in mit TÜV Rheinland geprüfter Qualifikation
Qualitätsauditor:in mit TÜV Rheinland geprüfter Qualifikation -
Teaching Times: Full-timeMonday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
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Language of Instruction: German
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Duration: 16 Weeks
Quality manager with TÜV Rheinland certified qualification
Basics of process management (approx. 2 days)
Recognize and systematize processes
Visualize and analyze processes
Mastering processes - control variables, key figures
Improving and reorganizing processes
Process management in planning, logistics and service - Production and service
Tools for process management (approx. 3 days)
Application of standard tools, including process flow diagram, cause-effect diagram, histogram, scatter diagram, Pareto diagram
7 management tools and their function - affinity diagram, relation diagram, tree diagram, matrix diagram, portfolio diagram, problem-decision plan, network diagram
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Planning with FMEA and QFD and Design Thinking (approx. 2 days)
The Failure Mode and Effects Analysis: Quality Function Deployment (QFD)
Design Thinking
Statistical methods and evaluation procedures (approx. 2 days)
Types of statistics
Descriptive statistics - Visualization
Inductive statistics - Static
The world of Six Sigma (approx. 1 day)
Meeting customer expectations with Six Sigma
Six Sigma and the spread in the process
The Six Sigma method in practice
It doesn't work without employee participation
The DMAIC cycle: Five steps to success
The history of quality awards (approx. 0.5 days)
The quality prizes at a glance
Japan: The Deming Prize
USA: The Malcolm Baldrige National Quality Award (MBNQA)
The EFQM Levels of Excellence program
The EFQM Model for Excellence (approx. 0.5 days)
Orientation in the EFQM model
Realization in the EFQM model
Results in the EFQM model
EFQM diagnostic tool: RADAR
EFQM Recognition: Ludwig Erhard Prize Basic concepts of excellence
The Balanced Scorecard (BSC) (approx. 1 day)
Perspectives of the BSC
Alignment of the organization with the strategy
BSC pyramid, BSC process
Benefits of the BSC
Learning from the best - Benchmarking (approx. 0.5 days)
Origins of benchmarking
Benchmarking methods
Procedure of a benchmarking process
The continuous improvement process (approx. 1 day)
Kaizen and the continuous improvement process
Dealing with non-conformities (errors, prevention, correction)
Classification of errors
Further building blocks of the CIP
Employee orientation (approx. 0.5 days)
Necessity of employee orientation and qualification
Employee orientation and the EFQM model
Employee orientation as a management task
Employee appraisal
Employee survey
Knowledge management
Legal basics (approx. 0.5 days)
The areas of law
National law, European law
Relationship between EU law and national law
LkSG - Supply Chain Due Diligence Act
Product and manufacturer liability (approx. 1 day)
Product liability from contract - material defects,
Warranty claims, positive breach of contract, burden of proof and statute of limitations, delimitation of warranty, commercial obligation to give notice of defects
Statutory product liability claims
Strict liability under the German Product Liability Act (ProdHaftG)
Product liability under administrative law
Criminal product liability
Damage avoidance strategies (approx. 1.5 days)
Drafting contracts (contract management, general terms and conditions, limitations of liability)
Quality assurance agreements
quality management
organization
documentation
Project work, certification preparation and certification examination "Quality Manager with TÜV Rheinland certified qualification" (approx. 3 days)
Quality auditor with TÜV Rheinland certified qualification
Fundamentals of auditing, audit types (approx. 2 days)
Audits as a management tool
Audit classification according to participants
Audit classification according to the subject of the audit
Standards as a basis for auditing and certification (approx. 0.5 days)
Industry-independent certification standards
Industry-specific certification standards
Management of an audit program (approx. 1.5 days)
Defining the audit program objectives
Audit program risks and opportunities
Defining, implementing and monitoring the audit program
Reviewing and improving the audit program
Carrying out an audit (approx. 3 days)
Initiating the audit
Preparing the audit activities
Carrying out audit activities
Creating and distributing the audit report
Concluding the audit
Carrying out audit follow-up measures
Competence and assessment of auditors (approx. 1 day)
Determining the competence of auditors
Determining the assessment criteria for auditors
Selecting the appropriate assessment method
Carrying out the auditor assessment
Maintaining and improving auditor competence
Audit communication (approx. 2 days)
Basics of communication
Audit opening
During the audit
After the audit
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Certification (approx. 1 day)
ISO 9001: A model for success
Certification - Why?
Selection of the certification company
Certification process
Process requirements for certification (approx. 4 days)
Activities prior to certification
Planning audits
Initial certification
Certification decision
Maintenance of certification
Appeals, complaints
Customer records
Document review
Project work, certification preparation and certification examination "Quality auditor with TÜV Rheinland certified qualification" (approx. 5 days)
Process optimization with Lean, Kaizen and CIP
What is CIP/Kaizen/Lean? (approx. 0.5 days)
Definition, goals, benefits (CIP vs. Kaizen vs. Lean)
Principle of small steps
Historical development of the CIP (approx. 1 day)
Supply/demand orientation
Japanese corporate culture
Toyota Production System
Development of modern quality and management systems (e.g. TQM)
Overview of maturity level and assessment models (EFQM)
Framework conditions for successful CIP (approx. 0.5 days)
Role of management
Communication and transparency
Employee participation
Corporate culture and motivation
Interface and team management
Quality management principles (e.g. ISO 9001)
Philosophy of CIP/Kaizen (approx. 1 day)
The five central principles
Internal customer/supplier principle
Interaction of innovation, standard and kaizen
Tasks of management and employees
Customer requirements and satisfaction (approx. 1.5 days)
Market and stakeholder analysis
Kano model
Requirements and wishes
CTQ methods (Translation Matrix, CTQ Tree)
Vuca and agility
Integrated management systems
Process optimization: Efficiency for the benefit of customers - Lean management: Value and waste (approx. 1 day)
Philosophy: Focus on customer requirements
Productivity - Quality - Availability - Flexibility
Value creation and non-value creation
The 7 types of waste (TIMWOOD)
3 MU: Muda, Mura, Muri
Implementation of Kaizen and CIP (approx. 1 day)
Prerequisites for Kaizen in the company
Development of a continuous improvement culture
5S method/5A campaign
Kaizen as a management system
Kaizen roadmap
Synchronize processes (approx. 0.5 days)
Production in the customer cycle
Cycle time, cycle time, throughput time
Cell logic
One-piece flow
Pull principle (supermarket) and push principle
Just-in-time logistics [JIT]
Value stream analysis (approx. 0.5 days)
Value stream mapping (actual and target value stream)
Value added quotient [WQ]
Visualization: benefits, symbols, data box
Level production/Heijunka (approx. 0.5 days)
Heijunka vs. series
Heijunka box
Batch size 1
Application example
Increasing the number of cycles
Kanban flow system (material and information flow)
Improve production facilities (approx. 0.5 days)
Total Productive Maintenance (TPM) incl. autonomous maintenance
Key process indicators (KPIs, OEE)
Minimization of set-up times (SMED)
Standardize processes (approx. 1 day)
Quality policy standardization
Advantages of standards
Standards in the company
Questions about the standard
Defining processes, from the process landscape to the process description
Visualization
3 process states
Worker self-check
Controlling processes (approx. 2.5 days)
ISO 9001 requirements (4.4, 8.1, 8.5.1): Customer key figures (Cpk/Sigma level)
Process management
Process analysis
Standard tools: Q7 and M7
Process efficiency analysis
AI-supported data analysis, statistical process control [SPC]
SPC in series production: interpreting quality control charts [QRK], automation (Jidoka)
Evaluation models (approx. 1 day)
PDCA: Improvement of improvement
Self-assessment maturity level ISO 9004 and EFQM
Management assessment according to ISO 9001
6-W questioning technique
4-M/7-M checklists
Benchmarking and best practice
Balanced Scorecard (BSC)
Hoshin Kanri, X-Matrix
AI-supported evaluation of trends, key figures and assessments
Measurement of customer and employee satisfaction
Error prevention and systematic problem solving (approx. 2 days)
Development according to customer requirements
Risk management: risk landscape, matrix [FMEA]
Poka Yoke, error classification, error culture/Hansei
Internal audits
Customer communication: complaint management, 8D report
10 steps to problem solving with tools (Q7, M7)
Root cause analysis: 5 Why, 6 W (Root Causes)
A3 problem solution sheet
AI-based pattern recognition for error and quality data
Empowering employees (approx. 1 day)
Ownership and entrepreneurship
Roles of managers and employees
Change management
Promoting employees (TWI)
Employee satisfaction
Competence and awareness, knowledge management (ISO 9001)
Idea management (BVW)
Teamwork in a lean context
Quality Circle [QC]
Agile methods
Community of Practice (CoP)
Coaching Kata and Improvement Kata
Visual Management and Shopfloor (approx. 0.5 days)
Principles of visual control
Visual process control, Andon (traffic light)
Store floor management
Digital dashboards and AI-supported process visualization
Quality controlling - finances (approx. 0.5 days)
Quality cost model, conformity/defect costs, rule of 10 (as a mental model)
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
QM in the medical device industry
Introduction to general quality management (approx. 1 day)
Basics of QM
Q-methods and Q-tools
QM - Medical devices ISO 13485 (approx. 1.5 days)
Structure, scope, area of application of ISO 13485
Relationship between MDR/IVDR and ISO 13485
ISO 13485 in the context of the requirements of 21 CFR Part 820
Artificial intelligence (AI) in the work process (approx. 0.5 days)
Document review with AI support
Regulatory requirements (AI Act)
Requirements for management systems (approx. 3 days)
Management standard ISO 9001:2015
Provision and management of resources
Basics in the area of measurements and tests
Requirements for measuring equipment management for medical devices and diagnostics
Process-oriented QM (approx. 2 days)
Importance of processes, process orientation, process description and process validation
Corrective and Preventive Actions (CAPA process)
Continuous improvement process (CIP)
Monitoring products on the market (approx. 2 days)
Error and complaint management
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
European database EUDAMED
Reporting procedures and complaint handling
Communication with authorities and notified bodies: Feedback and reporting
Documentation systems (approx. 3 days)
Basics of general QM documentation, document control and archiving
Validation parameters (IQ, OQ, PQ)
Summary Technical Documentation: STED
Risk management (approx. 2 days)
Importance of the risk management standard ISO 14971
Product and process risks
Risk areas and typical product risks
Audits and inspections (approx. 2 days)
Application of EN ISO 13485
Certifiers and the responsible authorities
EN ISO 13485 vs. MDR (Medical Device Regulation)
ISO 13485 as the basis for the global MDSAP (Medical Device Single Audit Program)
Auditor duties, audit planning and implementation
Audits taking into account the implementation of legal and technical requirements
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Changes are possible, the course content is updated regularly.
Once you have completed the course, you will be able to plan and implement quality management systems and have competent knowledge of strategic management methods. You will also have the know-how to carry out qualified audits in the company. You can identify potential for improvement and carry out step-by-step optimization in an efficient and targeted manner. You are also familiar with the regulations, standards and certifications for medical devices and can contribute to the implementation of EN ISO 13485:2021 and ISO 14971:2021.
The course is aimed at science students, engineering graduates, production managers, quality assurance officers and all employees working in the areas of development, production, quality control and quality assurance in medical device companies.
In order for a medical device to be sold on the German and European market, medical device regulations must be complied with during production. Specialists who are familiar with the production process and the applicable quality standards are in high demand in the medical device industry. In addition, such knowledge also helps the pharmaceutical industry to better understand the regulatory requirements at the interface between the pharmaceutical and medical technology industries.
Didactic concept
Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).
You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.
Virtual classroom alfaview®
Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.
The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).