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ISO 9001 Consulting
Consulting for quality management systems
ISO 9001 CONSULTING & SERVICES FOR THE IMPLEMENTATION OF THE QM SYSTEM
Our QM team offers ISO 9001 consulting and support for small and medium-sized enterprises (SMEs). Our services provide a pragmatic approach to developing a certifiable quality management (QM) system, particularly for software companies, which is one of our specialties.
If you are a software company considering introducing an ISO 9001 quality management system or aiming to further developing your existing system, our team will support you on site or in online video conferences.
With ISO 9001 consulting and customised services for the implementation of the QM system, our team supports SMEs in its introduction or further development in line with ISO 9001. We are also at your side when preparing for certification for ISO 9001, so that you can approach your ISO 9001 audit with confidence.
Experience in QM, ISO Certification, and Market Placement
Our QM team has many years of QM experience in ISO certifications according to ISO 9001 and ISO 13485 as well as placing medical software on the market. This experience can greatly benefit you!
The diversity of our expertise is best illustrated by our customer projects and our own projects for ISO certification in accordance with ISO 9001 and ISO 13485 and by our experience with placing medical software on the market.
Whether you're working on complex therapy solutions, health apps, medical software, or custom software for various service and product sectors, we provide comprehensive advice and support.
We cover topics such as:
- Product authorisation: CE marking, market placement and technical documentation
- QM consulting and support in line with ISO 9001 and ISO 13485: certification, internal audits, external QMB and QM manual creation
Look for yourself and let our QM team advise you.
What is ISO 9001?
ISO 9001 is a standard that specifies requirements for quality management systems for companies. The QM system forms the foundation for a company's entire management framework, enabling structured management, planning, and implementation of all business processes.
Let us now take a closer look at what the benefits of ISO 9001 consulting are for quality management systems.
The following services for a QM system according to ISO 9001 are available to you:
- Analysis of existing processes and comparison with the requirements of the standard to determine the need for action
- Guidance on addressing identified issues, including:
- Establishment of a practical quality policy
- Review and, if necessary, revision of the organizational structure including its roles/functions/powers
- Identification of the company processes and strengthening of the process concept
- Advice and support in quality management documentation, adapted to the company's specific company processes
- Measures controlling: Comparison of process results with process goals
Folgende Services für ein QM-System nach ISO 9001 stehen Ihnen zur Verfügung:
- Project planning: procedure, responsibilities and deadlines
- Support in the creation of a QM manual
- Conducting the internal audit and management review
- Implementation of training courses for employees
- Support in the implementation of the annual management review
- Support in the implementation of the external certification audit
- Support in the selection of suitable notified bodies for certification (e.g. TÜV)
- Support in the implementation of improvement measures and continuous development
ISO 9001 certification project process
The project process of ISO 9001 certification is outlined in 7 steps.
- Projektvorbereitung durch das Projektmanagement-Team des Kunden
- Terminplanung und Projektkoordination
- Auswahl und Angebotseinholung passender Zertifizierungsstellen wie z. B. TÜV
- Project start on site at the company with our QM consultants, who specialize in ISO 9001 consulting for quality management systems for software companies
- Inventory of existing QM documentation, such as organizational charts, process landscape, process descriptions, work or procedure instructions
- Analysis of existing processes, such as involvement of suppliers, consideration of the legal situation and dealing with opportunities, risks and errors
- Gap analysis (gap identification) to the ISO 9001 standard
- Estimation of the effort involved in setting up the quality management system: The more gaps are found in relation to the requirements of ISO 9001, the higher the effort required to set up the quality management system
- Presentation of the action plan and discussion of the timeline of the project
- Joint development of the missing topics, such as the formulation of a quality policy, process landscape, risk assessment or the creation of QM documentation
- Provision of templates and checklists
- Preparation for the standard requirements of ISO 9001
- Determination and presentation of all relevant processes
- Preparation of documented information
- Definition of quality objectives and establishment of risk management
- Final check of compliance with all ISO 9001 requirements
- Review relevant requirements from interested parties, such as customers or suppliers
- Conducting the internal audit and management review
- Effectiveness test of the implemented measures and final corrections, in case of possible deviations
- Basic training on ISO 9001
- Introduction to the documentation of the QM system
- Explaining the importance of the continuous improvement process
- Advice on how to behave correctly during the certification audit
Why do companies get ISO 9001 certified?
The answer to why companies are certified according to ISO 9001 can be answered as follows.
Companies that comply with the requirements prove that they provide products and/or services that meet customer requirements and legal or regulatory requirements. The main goals are to improve the quality of products and services and to increase customer satisfaction.
ISO 9001 focuses on four key areas:
- Management responsibility
- Resource management
- Product/service realization
- Performance assessment, analysis, and improvement
By adhering to the DIN EN ISO 9001 standard, companies can demonstrably improve processes, making them more efficient. As a result, businesses with certified quality management systems are often more successful.
DO YOU NEED SUPPORT WITH YOUR ISO 9001 QUALITY MANAGEMENT SYSTEM?
