How Tiki Safety used Bizzmine quality management software to manage document control, CAPA and calibration while achieving ISO certification faster.
Tiki Safety develops respiratory protective equipment used in healthcare and construction. As the company prepared for ISO certification, managing documentation and quality processes required a structured digital system. Tiki Safety implemented Bizzmine quality management software to centralise document control, CAPA management and calibration processes. The platform enabled the organisation to manage compliance requirements efficiently and support certification across multiple ISO standards.
This case study explains how Tiki Safety uses Bizzmine quality management software to:
centralise ISO document control and version management
manage CAPA and complaint workflows
structure calibration and maintenance processes
support compliance with ISO 9001, ISO 13485 and ISO 14001
accelerate certification and audit preparation
Tiki Safety is a Swedish manufacturer of respiratory protective masks used as personal protective equipment in healthcare and construction environments. The company develops high technology respiratory solutions that purify air through battery powered filtration systems. Tiki Safety products are designed to provide advanced protection while remaining easy to use for professionals working in demanding environments.
Operating in the medical device industry requires strict compliance with international standards and a structured quality management system.
To manufacture and supply medical devices, Tiki Safety needed to obtain ISO certifications including ISO 13485, ISO 9001 and ISO 14001.
During the preparation process the organisation realised that managing document approvals and quality documentation through manual processes would not provide sufficient control or traceability.
The organisation therefore required a digital system that could manage document control and support structured workflows for quality processes such as CAPA and complaint management.
Tiki Safety implemented Bizzmine as its digital quality management system to support document control and quality workflows.
The organisation configured processes for document management, CAPA management, complaint handling and calibration management within the platform.
Templates provided within the software allowed the organisation to start using the system quickly. The calibration module also enabled the company to manage maintenance schedules for machines and measuring equipment that require regular validation.
The digital quality management platform enabled Tiki Safety to structure its documentation and quality workflows within one central system.
Document updates and approvals are now managed through version controlled workflows, ensuring that employees always work with the latest procedures.
Calibration activities for machines and measuring devices are also managed through the system, supporting compliance with maintenance requirements.
Key results after implementing Bizzmine
ISO certification completed in approximately 7 months
Document control centralised within one system
Calibration processes managed through structured workflows
CAPA and complaint management digitised
Templates enabling rapid system adoption
“With Bizzmine, we feel that we have a secure and homogeneous environment to maintain, order, and standardise our ISO documents.”
Tiki Safety began by implementing document control to manage quality documentation and version approvals.
Once document management was established, the organisation introduced additional workflows for CAPA management, complaint management and calibration processes.
Templates provided by the platform allowed the company to start using the system quickly while adapting workflows to match operational needs.
Medical device manufacturers must manage documentation, quality processes and regulatory requirements in a structured environment. Manual document management can make certification and compliance processes difficult to control.
Digital quality management software allows organisations to centralise documentation, automate workflows and maintain the traceability required for regulatory compliance and certification.
Quality management software is a digital platform used to manage processes such as document control, CAPA management, audits and compliance workflows.
Document control ensures that procedures and records are version controlled, traceable and accessible during certification audits.
CAPA management software records corrective and preventive actions, assigns responsibilities and tracks resolution of quality issues.
Calibration management software tracks maintenance schedules for equipment and ensures that machines and measuring devices are validated according to required intervals.
Quality management software is widely used in medical devices, pharmaceuticals, manufacturing and other regulated industries where compliance and traceability are essential.
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