The purpose of this view is to provide access to the quality manual in advance of an on-site assessment and to save time for the your laboratory and assessors. Not all assessors will use R18LabQMS the same way, but hopefully we can clarify a few questions that seemed to come up.
The assessor will first go to the application log-in page and create an account by clicking “AMRL Auditor Sign Up.” Once an account for the assessor is created they can log in and request to view a specific laboratory’s QMS. Once the request has been made an email will be sent to the primary lab manager (PLM) with the request, the request will be visible on the dashboard and the “Manage Lab” tab. The primary lab manager can then either grant access or deny access. Once access has been granted the PLM can disable access anytime.
The assessor will be able to access your entire QMS from the assessor’s account prior to and during the on-site inspection. Access includes the quality manual, internal audit report and the 5-year procedure history. However, in the case that an assessor requires clarification or more information from your QMS through your account it is recommended that a user with PLM or Lab Manager access to the application be the account the assessor views, as these users have full access to the application. There are different roles assigned to lab personnel that have limited access to information within the QM, i.e. Lab Technician.
When an on-site assessment has been completed the assessor may inform the laboratory of non-conformities found. All non-conformities must be responded to by logging into your account at AMRL.net. From this point going forward AMRL requires that any documentation responding to non-conformities must be uploaded with a PDF or Word document. You may save a given section or page within the QM, as a PDF, and then upload as a file for AMRL. You cannot direct a quality analyst to your R18LabQMS account to resolve non-conformities.
The R18LabQMS team is providing training to AMRL assessors to become familiar with the application, to prepare them for on-site inspections with R18LabQMS users.
Contact your assessor and inform them they can access your QMS using R18LabQMS at least 30 days prior to an assessment.
If your laboratory has had a recent on-site assessment we welcome all comments and questions as this will help us build a better product. All questions can be directed to R18LabQMS.com by clicking the Contact Us tab.
– Gary Irvine