Ensure audit readiness with our checklist
Meeting the requirements of ISO 15189 can be daunting. To help you, we have put together a checklist to track you lab's readiness for achieving this standard.
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Learn what is required for ISO 15189 accreditation
Compliance with ISO 15189 includes many rigorous demands. The best way to unlock and simplify compliance is to use powerful, tried-and-tested quality management software. Ideagen Quality Management offers a trusted solution for managing ISO 15189 compliance worldwide, helping the achieve accreditation with ease.
This checklist covers every aspect of the ISO 15189 standard and the actions required from you to attain this.
What is covered in the checklist?
Our ISO 15189 checklist covers all the criteria of ISO 15189 and their clauses. It's designed to provide you with the required key checks and a documented log of evidence, ensuring compliance in every area of the standard.
Access the checklist to ensure your quality management process is robust.
Download nowGeneral requirements
Clauses included: confidentiality, impartiality, management of information and more.
Resource requirements
Clauses included: authorization, facility controls, equipment requirements and more.
Process requirements
Clauses included: patient consent, internal quality control, nonconforming work and more.
Structural and governance management
Clauses included: legal entity, delegation of duties, risk management and more.
Management system requirements
Clauses included: amendments of records, quality indictors, review output and more.
Solution snapshot
See how Ideagen solutions can help you meet each part of ISO 15189.
Access the checklist to ensure your quality management process is robust.
Download nowSpire Healthcare
As a long-term Ideagen customer, Spire Healthcare utilized our quality management solution to attain ISO 15189 accreditation. Spire upgraded their outdated, paper-based platform to our innovative digital solution, which enabled seamless document and audit storage to be distributed across all 22 laboratories. This enabled them to achieve consistent operating quality standards across all sites.
[Ideagen Quality Management] has definitely improved my job satisfaction because it allows me to work within a system that’s made for quality. Quality has gone from being one person’s responsibly to every staff member taking ownership.
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See how your organization can achieve and maintain ISO 15189 accreditation.
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"Excellent quality management tool"