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.
- Medical devices - Quality management systems according to DIN EN ISO 13485:
- non-active Medical Devices (General non-active, non-implantable medical devices)
- non-active orthopedic and rehabilitation devices
- Parts and services
- Medical product sales
- Transport of medical products
- Customized products according to Medical Devices Act
in the field
- Orthopedic and orthopedic shoe technology
- Reha technology
- 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 technology - Security techniques - Information security management systems - Requirements according to DIN EN ISO/IEC 27001/27006
- Conformity to type based on quality assurance of the production process according to Regulation (EU) 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 are 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 on an operational basis, whereby proven structures need not be touched as a rule, but they must be clearly documented. On a national and international level, it is becoming more and more common to demand proof of a certified management system from suppliers in business relationships.Proof is provided by certification from a certification body accredited for this purpose.
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 a certification body 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 according to PPE Regulation (EU) 2016/425 Annex VIII represents an approved monitoring of PPE of category III. This can be carried out independently or in addition to an existing quality management system according to DIN EN ISO 9001.
Social Standards (ETI): The Ethical Trading Initiative focuses on companies that manufacture, supply or sell goods for consumer goods markets. The ETI Code is based on the principles of the International Labour Organisation (ILO), is widely recognised as a model code for working conditions and aims to improve the living conditions of people affected by poverty worldwide. The aim of the ETI audits is to ensure the application of the basic social standards and to monitor compliance with them. The audit evaluates the company's environmental protection, occupational health, and safety.