Service
Legal Security as a Service
Through the national and increasingly European legislation, it is becoming more and more complicated for many companies to guarantee sufficient legal security. The organisational structure required for this must facilitate proof of “proper company management” (Legal Compliance).
The foundations of a solid chain of evidence is formed by the documentation of a systematically developed organisation from our following building blocks:
REACh, threat analyses (CSA), safety data sheets (GHS / REACh), chemical management, management systems, audits and inspections, ESAD II, system of authorised representatives and GMP.
Organigramm für den Bereich Service
Legal Compliance
Through the national and increasingly European legislation, it is becoming more and more complicated for many companies to guarantee sufficient legal security. The organisational structure required for this must facilitate proof of “proper company management” (Legal Compliance). The foundations of a solid chain of evidence is formed by the documentation of a systematically developed organisation from our following building blocks: REACh, threat analyses (CSA), safety data sheets (GHS / REACh), chemical management, management systems, audits and inspections, ESAD II, system of authorised representatives and GMP.
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REACh
Manufacturers and importers are solely responsible for the safe handling of their substances. Only substances, for which companies have a minimum data record, which must be registered within certain time periods as part of the registration to the European Chemicals Agency (ECHA), can be marketed in the EU. About 30,000 substances throughout the EU, which are manufactured or imported in quantities of at least 1 tonne per year and company, are affected.
Threat Analyses
Threat analyses are required by various fields of law:
The Ordinance on Hazardous Substances, REACh, labour protection laws, the Ordinance on Industrial Safety and Health and also by ADR 1.10/SÜG (Security Clearance Check Act). Even HACCP can be included here. We will advise and support you in carrying out the analyses in accordance with your focal points.
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Safety Data Sheets
For almost 20 years now, we have been compiling safety data sheets, even for customers outside of the Biesterfeld Group. Over the years, a considerable basis of material has been developed, which will considerably reduce the time needed, for example, for planning the required raw materials for preparations and which exploits other synergies.
Chemical Management
We will advise and support you in developing a chemical management system which clearly increases the legal security of your organisation.
Management Systems
We will advise and support you in developing or restructuring your quality management systems. Starting with the determination of standard principles through to the description of processes in the form of instructions and handbooks and the training of your employees, we will develop your system for you step-by-step.
Audits and Inspections
Be it process audits, product audits, system audits or documentation audits, we will carry out your internal audits for you.
We audit your departments in accordance with guidelines such as:
ISO 9001:2008
ISO 14001
OHSAS 18001
ESAD II
GMP
Legal Compliance
HACCP
EASD II
At first glance, the list of questions for the European Single Assessment Documents seems to be inexhaustible. But, upon closer inspection, it proves itself to be a very useful tool. We will offer you support through to the actual assessment by an authorised assessor.
System of Authorised Representatives
A number of legal standards demand “representatives” to be named for certain duties. We will support you in analysing which representatives are legally required and which could also be a wise choice and what else you must take into account when delegating duties.
GMP
Production and trade in the medical and pharmaceutical sector demand strict compliance with the standards and the documented instructions (SOP). We will accompany you and assist you in creating documentation through to subsequent approval by the authorities.
