Quality management system (QMS)

QiP GmbH helps its clients to set up, certify and further develop a quality management system in accordance with DIN EN ISO 13485, DIN EN ISO 17025, DIN EN ISO 62304, DIN EN ISO 9001 and others.

The quality management system (QMS) for medical devices is certified according to DIN EN ISO 13485: 2016. The QiP GmbH competence team will be happy to accompany you through this process until you receive your certificate. We are also happy to accompany you in the implementation of the ISO / IEC 27001 standard for IT security.

If you have to implement the laboratory accreditation according to DIN EN ISO 17025 or the requirements of another standard - we will be happy to help you.

Among other things, we also carry out audits.

Certification and further development of a quality management system

Terms in quality management

DIN EN ISO 13485

DIN EN ISO 13485: 2016 is the globally recognized standard for quality management of medical device manufacturers, their suppliers and service providers. This standard is also the basis of many regulatory requirements for certifications such as the EU-MDR, EU-IVDR and MDSAP and a prerequisite for international medical device approvals.


DIN EN ISO 9001 is an HLS standard (High Level Structure), which defines general requirements for a QMS. Individual industries have different, further leading or supplementary standards.


This IT-specific standard was developed to define suitable security mechanisms to protect the elements of the value chain. The IT security management system can be certified according to this standard.

For standards for which corresponding certifications are not possible, companies have the following options to demonstrate their implementation:

  • You yourself declare that your actions comply with the norm
  • The company can ask customers to check and confirm the match.
  • The company hires an external auditor to verify compliance

QiP GmbH - Your Partner


As your commissioned consulting company in this area or as an appointed quality management officer (QMB) / compilance officer, we can take on the following (exemplary recorded) tasks at this point

  • Improvement and standardization of the QM and QS processes
  • Supplier evaluation
  • Determination and evaluation of customer satisfaction
  • Organization of complaint and complaint management
  • Support in carrying out the management assessment
  • Review and adaptation of process descriptions and templates, technical documentation and approval documentation
  • Representation to clients and authorities regarding quality issues and in the context of audits and inspections, etc. a. FDA inspection (according to 21 CFR 820, GMP Quality System Regulation), ANVISA and Belarus inspections etc.
  • Creation, continuation and / or revision of the quality management manual (QM manual, QMH)
  • Help with the implementation of the company's internal quality policy, quality goals and quality guidelines
  • Evaluation and review of the process and interface descriptions
  • Creation and or evaluation of existing standard work instructions (SOPs), work templates (templates), flow charts, checklists and master documents
  • QM specification documents, u. a. for the manufacture of medical devices
  • Graphic representations e.g. Reporting channels, handling and behavior, etc.
  • Key performance indicator system

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