We provide
- Consulting on QM Systems and Regulations
- Flexible support for establishing, maintaining and auditing Quality Managing Systems
- Executing company internal QMS Audits
- Assisting in QMS certification audits
Which benefits do you have by commissioning an external quality expert?
- Expertise and experience: External experts often have specialist knowledge and extensive experience in their field, which can lead to a higher quality of work.
- Objectivity: An external consultant can provide an unbiased perspective on problems or challenges that may not be recognised internally.
- Conserving resources: By outsourcing certain tasks to experts, internal resources can be conserved so that the team can concentrate on core competences.
- Up-to-date knowledge: Experts are often aware of the latest trends, technologies and regulations, which is beneficial for implementing best practices and innovations.
- Flexibility: Hiring an external expert enables companies to quickly access additional capacity or specific expertise as required without making long-term commitments.
- Cost efficiency: In many cases, hiring an external expert can be more cost-effective than hiring a full-time employee, especially for time-limited projects.
- Faster results: External experts can often deliver results faster because they can focus on their specific tasks and are not distracted by other internal commitments.
- Overall, co-operation with external experts can help to increase the efficiency and effectiveness of a company and at the same time improve the quality of the results.
A Quality Management Systems (QMS) has several central objectives, which aim to ensure the quality of services and to improve it continously. Some of the most important tasks of a QMS are listed following:
Quality planning
Definition of quality objectives and standards, which shall be achieved. This also includes planning of processes and resources in order to achieve the goals.
Documentation
Creation and maintenance of documents as quality regulations, procedure instructions and work instructions in order to ensure, that all employees have the necessary information
Process monitoring
Monitoring and measurement of processes in order to ensure, that they comply with the defined standards. This can happen by audits, inspections and performance indicators.
Training and further education
Assurance, that all employees have the necessary knowledge and skills in order zu perform their tasks in accordance with the quality requirements.
Risk management
Identification of potential risks for quality and development of strategies for minimising these risks.
Customer feedback
Collection and analysis of customer feedback for improvement.
Certification of QM Systems, which have been established in companies, are required in some sectors. These are granted by means of performed audits, which get repeated in regular temporal intervals.
There are numerous Quality Management Systems (QMS), which are applied in various sectors and organisations. See an overview of the most well-known and common systems following:
ISO 9001
- Description: ISO 9001 is the standard, which is most common for Quality Management Systems
- Characteristics:
- Focus on customer satisfaction.
- Process-oriented approach.
- Continous improvement.
- Risk-based thinking.
- Application: universally usable in all sectors and organisations.
ISO 13485
- Description: Quality Management System specifically for medical technology.
- Characteristics:
- Requirements concerning safety and effectiveness of medical products.
- Integration of legal and regulatory requirements.
- Application: Medical technology and healthcare.
GMP (Good Manufacturing Practice)
- Description: Regulations for production and quality assurance, particularly in the pharmaceutical and food industries.
- Characteristics:
- Strict controls of production processes.
- Documentation and traceability.
- Application: Pharmaceutica industry, cosmetic, food.
DIN EN 15224
- Description: QMS specifically for healthcare based on ISO 9001.
- Characteristics:
- Considers pacient-related risks.
- Focus on quality of treatment and safety.
- Application: Hospitals, care facilities, medical-care centers.
These systems provide different aproaches and focal points so that companies and organisations can select the appropriate Quality Management System depending on sector, objective and regulatory requirements.
EN 
DE