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.

Today, environmental protection has a high priority in our society and is therefore also playing an increasingly important role for small and medium-sized companies. In addition to factors such as reliability, price and quality, more and more attention is being paid to companies' environmental performance when dealing with them. Companies that face up to this responsibility have a clear advantage both nationally and internationally.

The world's most important standard, ISO 14001, defines the requirements for environmental management that companies and other organisations should fulfil.

ISO 14001 ENVIRONMENTAL CONSULTING - PERSONALLY COMPETENT

• Environmental policy - We work out common goals and ideas with you
• Modular service packages, implementation and execution
• Education and training documents
• Personal, holistic support up to certification
• Integration of energy and environmental management to apply for funds under the Peak Efficiency Scheme Ordinance (SpaEfV)

ISO 14001 - YOUR BENEFITS

• Your commitment to environmental standards and environmental interests is clearly evident
• You prove that you comply with the applicable regulations and standards
• With DIN ISO 14001 certification you demonstrate innovation and progress
• You more easily win new customers
• You show that your company has diverse environmental risks under control
• Evidence within the scope of the procedure according to the EMAS regulation according to § 4 Paragraph 6 also in conjunction with § 5 Paragraph 5 SpaEfV

OUR PRAGMATIC APPROACH:

The focus is always on your company and its goals. Environmental management is not a predefined or even fixed system or a complex software solution. With ISO 14001 certification, you focus on a continuous improvement process of your company's environmental performance. This includes:

• An improvement in the environmental performance of your products and services
• A more economical use of energy and raw materials and the associated cost reduction
• A reduction in environmental risks
• Greater trust in your company from the public, authorities and banks

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

Understand risks - protect assets

The IT infrastructure of companies is exposed to many risks and attacks. However, companies are not powerless against this. We help you set up an information security management system (ISMS) in accordance with ISO/IEC 27001 and thus strengthen your IT security.

The internationally recognised security standard ISO/IEC 27001 provides a security framework that includes procedures and guidelines and options for monitoring whether these are actually being adhered to. Important here: It is not the standard, but the company itself that determines exactly how internal processes should run. Because every company works differently.

The standard only provides framework conditions and ensures that all relevant aspects are taken into account. The goal is transparent and robustly functioning processes that lead to consistently good information security. The processes in your company become better and more efficient.

Regardless of whether you simply want to protect your company assets or whether you are expected to map certain security precautions as a supplier to a KRITIS company: We help you to systematically reduce the risk of attack and failure and to increase operational data protection. If desired, we can also provide external data protection officers.

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.

The General Data Protection Regulation (GDPR) makes companies responsible and requires the development of new strategies for dealing with the challenges of data protection. Data protection incidents are a risk factor that can be countered through appropriate risk management.

As a combination of legal and operational requirements under a systematic, management-oriented approach, a data protection management system (DSMS) is recommended - also integrated into existing management systems (for example ISO 9001, 13485, 14001, etc.).

Three steps to a DSMS:

• Situation analysis: Analysis of the current status (inventory) of data protection structures and processes
• Target planning: The DSM is planned taking into account legal, procedural, organisational and technical aspects (IT protection goals according to the GDPR). Implementation of processes such as audits, data protection impact assessment (Art. 35 GDPR), information obligations towards the data subject, examination of order processing, etc.
• Implementation and documentation: In cooperation with your employees, the DSMS is implemented and comprehensibly documented and certified by a certification company upon request.

If required, we also provide an external data protection officer.

• Quality management, environmental management and data protection represent an important economic factor. For this reason, management consulting in these areas is funded by the Federal Office of Economics and Export Control, for example, with up to € 1,500 (existing companies) and up to € 2,000 (young companies).
  
  Qsano is a accredited consulting company with the BAFA-ID: 193682

Pharmaceutical quality management systems cover all aspects of a product’s life cycle, from development to patient use. Quality assurance measures, known as “good practice”, are in place for every step along the way. These include good manufacturing practice (GMP) guidelines and guidelines for the distribution of medicinal products (good distribution practice, GDP).

We support pharmaceutical companies and their QPs in efficiently integrating these standards into their own quality management systems, complying with GxP guidelines and proving compliance to regulatory agencies during inspection. Our consultants develop QM manuals and standard operating procedures (SOPs) so that standardised processes reflect the individual workflows of the company. With expertise and efficiency.

Customised, GMP-compliant quality management

We ensure that pharmaceutical companies get a quality management system that fits their needs.