ISO Laboratory Accreditation Audit Checklist

Diagnostic labs & pathology

4.1 Impartiality
Has laboratory management demonstrated a strong commitment to impartiality in all activities?
Are all laboratory operations structured and managed to safeguard impartiality?
Is the laboratory free from commercial, financial, or external pressures that could compromise impartiality?
Does the laboratory continuously identify and assess risks that may threaten impartiality?
When risks to impartiality are identified, does the laboratory have a process to eliminate or minimize them?
4.2 Confidentiality
Does the laboratory ensure confidentiality of all customer information and test results?
Are personnel obligated to protect confidential information even after employment ends?
Are documented procedures available to manage confidential information securely?
Is customer consent obtained before disclosing confidential information to third parties?
Are IT systems and physical records safeguarded against unauthorized access?
Is confidentiality reviewed during internal audits and management reviews?
Do external service providers sign confidentiality agreements before accessing lab data?
Are breaches of confidentiality recorded and investigated?
Are personnel trained periodically on confidentiality requirements?
Does the laboratory ensure that test subjects’ personal identity is not revealed without justification?

Edit & customize templates as per your needs in simple steps

Pulse allows you to edit the checklists from the library to suit your specific needs. With our smart checklist builder and editor, you can infuse logic in your questions for more clarity and better visibility.

SIGN UP TO EDIT TEMPLATES

Digitize your existing templates in simple steps

Pulse helps you convert your existing inspection templates into digital ones. Simply upload them in PDF, Excel and Word format and leave the rest for our support team. We will get back to you with digital forms.

Company

Features

Industries

Legal

© 2022. Pulse Business Solutions Inc. All Rights Reserved.