Opportunity to optimise business processes

The introduction of such a system takes place in several steps and its duration depends on the initiative of the person in charge and the size of the company.

In the following steps, we provide practical, qualified and cost-optimised advice and support for your company on the way to certification according to DIN ISO 9001 or 13485:

• Comprehensive ACTUAL STATE analysis to determine the conditions in the company
• Development of a process landscape and its representation in process maps and work instructions
• Training or instruction of employees in the use of the new management system
• Performance of internal audits
• Support up to the certification audit by an accredited company

You will receive all the documents, forms, records and checklists you need to meet the standard requirements. We do not change the set-up your company to comply with the QM system, but adapt the QM system to your needs.

If you are already successfully certified according to an ISO standard, we will be happy to support you in updating your system according to new and additional requirements or in transferring your systems to a multi-standard management system:

• Target - actual comparison in the form of a delta audit
• Adaptation of your documentation

The degree of change required depends on the effectiveness of your current management system, your process orientation and organisational structure.

An external quality or environmental manager strengthens your own resources. Sub-processes such as internal audits can be outsourced to relieve the quality or environmental manager.

If internal resources are lacking, for example due to fluctuation or commitment in projects, temporary support "onsite" - i.e. within the company - is also possible.

Advantages of external support:

• No tying up of company resources
• Independent view of the processes from the outside
• New input and solution approaches through years of experience in different industries
• Higher acceptance of an external quality management representative or environmental management officer among employees
• Preparation of all information for the management assessment and fulfilment of all standard requirements

Quality Management - Technical Documentation - Regulatory Affairs - Data Protection in the Medical Environment

We implement documentation and management systems at medical device manufacturers, distributors and suppliers. For this purpose, we coordinate the project up to certification and support our customers in the creation and structuring of product files and the international approval of medical devices.

Our constantly updated knowledge of new and established regulatory requirements and employees from the medical (product) sector serves as the basis for our and therefore your success. We integrate regulatory requirements, especially those from the new EU MDR 2017/745 for safe medical devices, into your QM system. To this end, we offer individualised services such as gap analyses, workshops and training.

• Quality management, environmental management, energy management and data protection represent an important economic factor. For this reason, the Federal Office of Economics and Export Control (BAFA) provides funding of up to € 1,750 for management consulting in these areas. Within the funding guidelines from 01.01.2023 - 31.12.2026, each eligible company can receive funding for 5 consultations, max. 2 per year.
  
  QSANO is an approved consultancy firm under BAFA ID: 193682.

• As an authorized partner of the KEFF+ and BERE programs, QSANO provides tailored solutions in the areas of energy efficiency, resource efficiency, and climate neutrality. We support you in integrating sustainable and environmentally friendly practices into your company. Maximum subsidy per consultation: €5,500.