Dear International Accreditation New Zealand,

According to ISO 15189, each organisation which is accredited for medical laboratory and radiology services must maintain a Quality Management System (4.2) and requires a quality manual which specifies the list of Controlled Documents.

Request 1: I respectfully request the list of Controlled Documents each medical laboratory must maintain in order to be compliant with IANZ accreditation.

Request 2: I respectfully request the list of Controlled Documents each radiology services provider must maintain in order to be compliant with IANZ accreditation.

I recognize that not every laboratory or radiology department will have exactly the same set of policies or documents, depending on the services they provide; however, I would expect there to be a list of essential documents (policies, protocols or best practice documents) every accredited body must maintain in order to be compliant with the accreditation standards. I would expect, at a minimum, policies, protocols or best practice documents on Quality, Records Maintenance and Archiving, Safety, Health Information Privacy (per the Privacy Act), Collection and Handling of Laboratory Samples, Requests by Third Party Providers, Written Reports, Requests for Second Opinions, Communication and Interactions with Patients and Health Professionals, Professional Ethics, Electronic Communication and Data Safety, etc.

I look forward to receiving the information.

Kindest regards,

Amy S Van Wey Lovatt