Remote Assessments for Laboratories

What Is a Remote Assessment?

ISO/IEC 17011:2017 defines remote assessment as an assessment of the physical location or virtual site of a conformity assessment body (CAB) using electronic means. Remote assessments may be used as part of an assessment activity if allowed by the accreditation program.

Before the remote assessment process is used, it is mutually agreed upon by the customer and ANAB in accordance with information security and data protection measures, as well as any applicable regulatory requirements. Schemes, regulatory requirements, normative documents, and conformity assessment standards may impose limitations on the use of information and communication technology (ICT) for remote audits and/or assessments and take precedence over this document.

Information technology supports conformity assessment and is leveraged for remote assessments. Videoconferencing, file sharing, document scanning, and other ICT tools are used during remote assessments to accomplish the objectives of the assessment.

Remote assessments provide the opportunity for increased safety, better timing, inclusion of conformity assessment body (CAB) personnel that may not be easily accessible, and avoidance of travel delays and restrictions. Remote assessments provide more flexibility with scheduling with the ability to conduct assessments from anywhere.

CAB Eligibility

Many factors are considered when determining if a CAB is eligible and willing to participate in a remote assessment. Some of these factors include the availability of information and communication technology, previous assessment results, the scope of accreditation, and other factors related to the accreditation and assessment process. The determination may be made in conjunction with the assessment team assigned to the CAB, as well.

ANAB staff evaluate risks and opportunities that may impact the effectiveness of using information and communication technology to complete the assessment. The CAB must be able to provide all documents and records related to the assessment electronically, including the capability of scanning paper records into electronic form. Based on the risk evaluation, ANAB staff may determine that all, part or none of the assessment will be handled remotely.

Time Allocation and Preparation

Remote assessments often take additional time to complete than onsite assessments. Troubleshooting connectivity issues, communication, document viewing, and method witnessing create additional challenges that require more time to complete the assessment. Communication and pre-planning can be used to determine the appropriate amount of time needed which will be reflected in the additional billable time on the cost estimation worksheet provided to the CAB.

Preparing for a remote assessment also takes additional time and consideration. Technical interviews are completed remotely which requires access to audio and video where CAB activities are performed. Additionally, the assessment team may require specific documents and records supporting CAB activities in addition to documents normally required for an on-site assessment. The assessment team also relies on CAB personnel to relay key information, such as lot numbers, equipment identification, etc., which is normally visually observed by the assessor when on-site.

Remote Assessment Planning

The lead assessor is responsible for working with the CAB to determine and define how the assessment will be performed and the technology needed. Considerations include, but are not limited to:

Computer requirements
Remote access to documents
Remote access to people
Time zones
Online and offline time
Day length

CL 2915, Conformity Assessment Body Remote Assessment Process Checklist and CL 2916, Assessor Remote Assessment Process Checklist provide additional information and guidance.

Conducting a Remote Assessment

Similar to on-site assessments, the lead assessor is responsible for coordinating assessment activities to ensure the assessment is conducted according to the activity plan. The assessment team prepares reports and checklists, report on the assessment process, complete the opening and closing meetings and prepare and present any opportunities for improvement and/or nonconformities identified during the assessment.

Remote assessment repots and related records provide evidence of the effectiveness of the CAB in achieving assessment objectives and the extent to which the accreditation standard has been implemented by the CAB. Assessment follow-up includes review of responses to nonconformities and technical review of assessment documentation. The accreditation decision is based on the assessment documentation and technical review.

Additional Resources

For additional information on activities related to remote assessments, refer to PR 2316, Administrative Process Rule: Remote Assessment Activities.

Remote assessments were relied on heavily during the travel restrictions of the Covid pandemic for many different accreditation programs at ANAB, including laboratory accreditation and management systems accreditation.

ANAB provided an analysis on remote assessments in the product accreditation program and the effects of remote assessments on ISO/IEC 17020 accreditation.

ANAB also hosted three webinars on remote assessments: