Quality Systems
OZQA provides consulting support for the establishment, maintenance, and improvement of Quality Management Systems (QMS) for pharmaceutical, biotech, and medical device companies.
We support organisations operating under GxP requirements as well as ISO 9001 and ISO 13485, with a focus on clear documentation, defined responsibilities, and inspection-ready processes.
Areas of Support
Pharmaceutical Quality Systems (GxP)
We support pharmaceutical and biotech companies operating under GxP requirements, including:
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GMP and GDP compliance
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Quality Management Systems (QMS)
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SOP development, review, and implementation
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Deviation, CAPA, Change Control, and OOS processes
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Audit and inspection preparation
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Oversight of CMOs, CROs, laboratories, and distributors
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Batch release–related processes and documentation
Support is documentation-focused and aligned with EMA, FDA, and EU GMP expectations, with attention to real inspection scenarios.
Medical Device Quality Systems (ISO 13485)
We support medical device companies with quality system activities in accordance with ISO standards, including:
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ISO 9001 and ISO 13485 compliance
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Quality Management Systems (QMS)
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SOP and procedure development
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Document control and training systems
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Internal audits and audit preparation
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Support during notified body audits
The focus is on clear, usable, and proportionate QMS structures that support both regulatory compliance and daily operations.
How We Work
Our consulting approach is:
Practical and inspection-focused
Based on clear, structured documentation
Proportionate to company size, complexity, and regulatory setup
Focused on usability as well as compliance
Delivered without long-term commitments
We support specific quality tasks or broader QMS activities, depending on your needs.
Typical Use Cases
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Establishing or restructuring a QMS
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Preparing for authority, partner, or notified body audits
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Strengthening deviation, CAPA, or change control processes
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Supporting oversight of outsourced activities
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Addressing audit findings and corrective actions
Our approach is pragmatic and proportionate, designed to meet regulatory and certification expectations without over-engineering quality systems.
