Quality & Compliance
Quality management.
A strategic foundation—not just overhead. We implement, optimize, and audit quality management systems (QMS) for the medtech, pharmaceutical, and biotech industries in accordance with ISO 13485, GMP, and the MDR.
How do medtech and pharmaceutical companies establish an effective quality management system?
An effective QMS is the foundation for any regulatory approval. However, regulated industries face typical growth challenges:
- The QMS formally complies with the standards, but does not function as a strategic management tool in day-to-day operations.
- The effort required for documentation outweighs the benefits—the company lacks a genuine culture of compliance.
- Rapid business growth and M&A activity are disrupting quality control systems that have evolved over time.
- QMS certifications are expiring, and upcoming recertifications are turning into a crisis.
Is your QMS actively implemented and used throughout the company—or is it merely maintained with great effort just for the audit?
Our QMS services.
We build QMS systems that work in everyday practice: fully compliant with regulations and easy to manage in practice.
QMS Design & Implementation
Establishment of a comprehensive QMS in accordance with ISO 13485, GMP guidelines, or ISO 9001. Definition of core processes, document structure, responsibilities, and key performance indicators. Integration into existing organizational structures.
QMS Optimization & Gap Analysis
Review of existing QMS systems against current standards. Identification of weaknesses, process gaps, and documentation deficiencies. Prioritized improvement plan with quick wins and sustainable measures.
QMS Audits & Certification Preparation
Preparation for external certification audits through internal preliminary reviews and mock audits. Coordination of the certification process with accredited certification bodies.
eQMS Implementation & System Migration
Selection and implementation of electronic QMS systems (eQMS). Data migration, validation, and training during system transitions to prevent gaps in documentation.
Frequently Asked Questions About Quality Management.
What is the difference between ISO 9001 and ISO 13485?
ISO 9001 is the general quality standard for all industries. ISO 13485 is specific to medical device manufacturers, focuses on product safety and risk management, and is directly aligned with MDR/IVDR requirements.
What are the minimum requirements for a QMS under ISO 13485?
Quality policy and objectives, management review, risk-based approach, CAPA system, complaint management, internal audits, supplier evaluation, documented processes, and record control.
How long does it take to implement a QMS in accordance with ISO 13485?
For companies without a prior system: 6 to 18 months until certification readiness. For existing ISO 9001 systems: 4 to 9 months for the transition. The key factors are complexity and resources.
Can the QMS be certified to multiple standards?
Yes. Integrated management systems (IMS) combine multiple standards—such as ISO 13485, ISO 9001, and ISO 14001. Synergies are leveraged, and separate certification audits can often be combined.
Additional expertise in the area of Quality & Compliance.
Expertise
ISO 13485 certification
From strategic gap analysis to a successful certification audit.
ExpertiseCAPA Management
Turning deviations into opportunities: Managing corrective and preventive actions.
ExpertiseLean Six Sigma
Systematically optimize processes, minimize waste, and increase efficiency.
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