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Quality Management
Quality Management is much more than just quality assurance.
Quality Management is the process of managing an organization’s overall quality performance to meet customer requirements, applicable regulations, and company goals. Quality Management has four main components: Planning, Assurance, Control and Improvement.
All four components together support an organization’s customer requirements as well as external regulations and internal goals while striving to maximize customer satisfaction.
We work with you across all components from system creation to day-day management.
Support
We work with you across all components from system creation to day-day administration.
Management Reviews
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Cost of Quality
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Training Management
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Non-conformity / CAPA Management
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Vigilance
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Statistical Analysis
From process control to measurement system analysis and product performance.
Complaints Management
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Continuous improvement
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Quality system Design
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Supplier Management
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Process Quality
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Risk Management
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Product Realisation
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
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