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:
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:
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.
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 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.
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.
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.).
If required, we also provide an external data protection officer.
We check the requirements for various funding programmes, support you in applying for your funding and thus save you time and money.
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.
We ensure that pharmaceutical companies get a quality management system that fits their needs.
We support companies by planning, documenting and preparing audits and inspections. We help them to adapt to changing conditions and much more. Our services include: