Quality

Quality Management System

At Nordic BioAnalysis, our Quality Management System (QMS) ensures that all testing activities meet the highest standards for accuracy, consistency, and regulatory compliance. As a specialized analytical lab supporting both pharmaceuticals and medical devices, we operate under a quality framework designed for inspection readiness, quality assurance and client trust.

Our QMS is built on internationally recognized standards including Good Manufacturing Practice (GMP) and ISO/IEC 17025:2017, ensuring that every procedure, method, and result can stand up to the strictest scrutiny.

Our QMS is built to ensure:

Full compliance with cGMP for medicinal products
Accreditation to ISO/IEC 17025
Alignment with current international pharmacopoeia specifications, such as Eur. Ph., USP, and JP
Implementation of ICH Q9/Q10 Quality Risk Management/Pharmaceutical Quality System
Validated methods and calibrated equipment with periodic performance reviews
Regular audits by customers, notified bodies and regulatory authorities

Our QMS supports every stage of analysis, from method development and validation to reporting, ensuring consistent, traceable and inspection-ready results.

Key certifications

GMP certificate from Medical product agency (MPA) – Läkemedelsverket
ISO/IEC 17025:2017 accreditations from SWEDAC
Pharmacopeial alignment: EudraLex Volume 4, ICH guidelines

All analytical methods and instruments are validated according to approved Standard Operating Procedures (SOPs), with regular performance reviews to ensure ongoing compliance.

How our QMS supports your projects

Our quality system is a foundation for reliable partnerships and successful project outcomes. As a certified GMP laboratory and accredited ISO 17025 lab, we help clients:

Maintain quality assurance across all analytical results
Submit regulatory filings with confidence, backed by validated methods
Minimize risk through proactive quality oversight and deviation control
Ensure reproducibility and data integrity for long-term studies and audits
Collaborate efficiently with clear documentation and SOPs

Whether you’re developing a sterile drug product or validating a raw material, our QMS ensures you receive compliant, audit-ready results.

Trusted partner in Quality-critical testing

With a certified QMS, validated methods, and proven regulatory compliance, Nordic BioAnalysis is a trusted partner for pharmaceutical and medical device companies seeking precision, traceability, and audit-ready results.