Our accredited and EU-approved certification body is a competent and reliable partner in all matters relating to quality and environmental management. Certification by PFI sends a clear quality signal to your customers. Furthermore, a strategically focused management system will provide a sound basis for rapid reaction to changing market situations or new legislation.
- Quality Management Systems for medical devices according to DIN EN ISO 13485:
- non-active Medical Devices (general non-active, non-implantable medical devices)
- non-active orthopaedic and rehabilitation devices
- non-active ophthalmologic devices
- Customized products according to Medical Devices Act (non-sterile) in the field:
- Ophthalmic optics
- Orthopaedic and orthopaedic shoe technology
- Reha technology
- Including medical supply stores
- Medical product sales
- Transport of medical products
- Quality Management Systems according to DIN EN ISO 9001
- Environmental Management Systems according to DIN EN ISO 14001
- Energy Management Systems according to DIN EN ISO 50001/50003
- Information Security Management Systems according to DIN ISO 27001/27006
- Quality Assurance Systems according to PPE Regulation 2016/425 Annex VIII (Model D)
- Social standards
Quality Management Systems according to DIN EN ISO 9001, DIN EN ISO 13485, Environmental Management Systems according to DIN EN ISO 14001, and Energy Management Systems according to DIN EN ISO 50001 describe forms of organisation which conform to internationally accepted rules. They aim to achieve flexibility and effectiveness. Quality assurance represents just one aspect. Energy management systems have the goal of improving the energy-related performance of companies, including energy efficiency, energy use, and energy consumption. This is of advantage not only for the companies but also for society and the environment, thanks to the reduction of greenhouse gas emissions and other environmental impacts. The management systems should be designed with the company in mind. As a rule there will be no need to change proven structures; however, they should be unequivocally documented. It is increasingly becoming nationally and internationally accepted practice to demand proof of a certified management system from suppliers when establishing a business relationship. Certification by an accredited organisation will provide such proof.
An Information Security Management System (ISMS) defines rules, procedures, and measures, which represent and ensure information security. It is the task of an ISMS to ensure the confidentiality, integrity, and availability of information at all times. Certification by an organisation accredited for ISO/IEC 27001 provides proof of information security in a company.
Quality Assurance Systems: Monitoring of conformity to type based on quality assurance of the production process as set out in PPE Regulation 2016/425 Annex VIII constitutes a permissible monitoring of PPE of Category III of the PPE Regulation. This can be carried out entirely independently or in conjunction with an existing DIN EN ISO 9001 quality management system.
Social Standards (ETI): Die Ethical Trading Initiative focusses on companies which manufacture, supply, or sell articles for consumer goods markets. The ETI Base Code is founded on the conventions of the International Labour Organisation (ILO) and is an internationally recognised code of labour practice. The goal of an audit is to guarantee basic social standards and to monitor compliance therewith. In the audit, the in-company environment and occupational health and safety are examined. The living conditions of poverty-stricken people in the whole world should be improved.