Audits & Inspections
Make audits a strategic tool for quality, efficiency, and patient safety
Audits are more than just a monitoring activity—they are a tool for developing operations, strengthening quality management systems, and ensuring compliance. We support organizations throughout the entire audit process, from preparation to follow-up and improvement.
Challenges
Common challenges
Being Prepared—Despite Limited Resources and Complex Requirements
Working in auditing involves ensuring compliance with multiple regulatory frameworks while ensuring that the organization is prepared, efficient, and ready for an audit.
Lack of resources and expertise
Complexity in the Supply Chain and Supplier Management
CAPA and Root Cause Analysis
Challenges Related to the Conduct of the Audit
Challenges Related to Monitoring and Action
Challenges Related to Documentation and Traceability
Challenges Related to Coordination and Accountability
We Offer
Operations-Oriented Audits and Inspection Support
A Structured Three-Step Audit Process
Audits are more than just a monitoring activity—they are a tool for developing operations, strengthening quality management systems, and ensuring compliance. PREPARATION for audits through structure, planning, and clearly defined requirements. CONDUCTING audits with a focus on quality, efficiency, and clear methodology. FOLLOW-UP and improvement to strengthen quality, compliance, and long-term development.Internal Audits
Conducting internal audits in accordance with applicable regulations and standards.
Supplier Audits
Auditing and monitoring suppliers to ensure quality and compliance.
Simulated Audits (Mock Audits)
Conducting simulated audits to identify areas for improvement in preparation for external audits.
GAP analysis
Identification of non-compliance with regulations, standards, and guidelines.
Reporting
Preparation of audit reports with clear insights and recommendations.
Root Cause Analysis
Analysis of deviations to identify root causes and improvement measures.
CAPA (Corrective and Preventive Actions)
Support in establishing and following up on corrective and preventive actions.
Auditing Education
Training for auditors and support for the organization in its auditing work.
Value We Create
Audits that Drive Strategic Improvements and Long-Term Development
Greater assurance throughout the entire audit process
Insights that translate into concrete improvements in quality, efficiency, and patient safety
Customer cases
Here's How We Overcame Past Challenges
Reliable audits with the right expertise
Problem: Recurring audits in the medtech industry place high demands on both preparation and execution. Many organizations lack the resources or collective expertise to manage the entire audit process effectively and securely.
Solution: By combining internal audits with expert support during external audits, the entire process—from planning to implementation—was ensured. The approach focused on structure, regulatory compliance, and using audits as a driver for continuous improvement.
Results: Successful audits and certifications obtained—including ISO 13485, MDSAP, and ISO 17025—strengthened both regulatory compliance and market position. At the same time, the client achieved a more self-improving organization with improved quality and long-term efficiency.
Internal Audits
Conducting internal audits in accordance with applicable regulations and standards.
Supplier Audits
Auditing and monitoring suppliers to ensure quality and compliance.
Simulated Audits (Mock Audits)
Conducting simulated audits to identify areas for improvement in preparation for external audits.
GAP analysis
Identification of non-compliance with regulations, standards, and guidelines.
Reporting
Preparation of audit reports with clear insights and recommendations.
Root Cause Analysis
Analysis of deviations to identify root causes and improvement measures.
CAPA (Corrective and Preventive Actions)
Support in establishing and following up on corrective and preventive actions.
Auditing Education
Training for auditors and support for the organization in its auditing work.
Common challenges
-> Lack of resources and expertise
-> Complexity in the Supply Chain and Supplier Management
-> CAPA and Root Cause Analysis
-> Challenges Related to the Conduct of the Audit
-> Challenges related to follow-up and corrective actions
-> Challenges related to documentation and traceability
-> Challenges related to coordination and accountability
Features and benefits
-> Audits that drive strategic improvements and long-term development
-> Greater assurance throughout the entire audit process
-> Insights that translate into concrete improvements in quality, efficiency, and patient safety
CONTACT
Talk to someone who knows your area
Karin Tördahl
Head of Unit Quality & Validation
Karin Tördahl
Head of Unit Quality & Validation