Internal QA Master Control Compilance Checklist

Diagnostic labs & pathology

Organisation & Management
Does the laboratory comply with ISO 15189 requirements while performing its activities?
Are staff members trained and informed about the code of ethical conduct?
Is the laboratory’s quality policy clearly displayed and visible to employees and visitors?
Has a laboratory director been officially appointed?
Is the current Job Description (JD) of the Laboratory Director updated with all roles and responsibilities defined?
Has a Quality Manager been formally designated for the laboratory?
Is the Quality Management System (QMS) fully implemented in day-to-day operations?
Is the JD of the Quality Manager documented with detailed responsibilities?
Are leadership roles (LD/QM) reviewed periodically to ensure accountability?
QMS
Has the laboratory established, documented, and applied a QMS according to ISO guidelines?
Is the valid Shop & Establishment Certificate displayed prominently?
Are all QMS-related documents kept up to date and accessible to staff?
Is the Quality Manual available and in current version?
Are other relevant regulations and standards (e.g., BMW policy, ISO requirements) available in the laboratory?
Is there evidence of internal audits and management reviews conducted as per QMS requirements?

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