AIHA LAP Remote Assessment FAQ
What is a remote assessment?
A remote assessment is a method of evaluating a laboratory to a specific Standard (e.g. ISO/IEC 17025:2017) or set of requirements without a Site Assessor physically on-site. Remote assessments can utilize one or more web-based technologies including, but not limited to, video conferencing to conduct meetings and interviews as well as screen sharing of documents.
Why is AIHA LAP moving toward remote assessments?
Due to the COVID-19 pandemic, most AIHA LAP on-site assessments have been postponed because of imposed travel restrictions, and in some cases, the location of the laboratories would put the assessors at risk (some laboratories are located in regions designated as “hot spots”). Until further notice, AIHA LAP is conducting remote assessments to achieve its goal of accrediting all labs to ISO/IEC 17025:2017 and to allow laboratories that are in good standing to maintain their accreditation status. More importantly, remote assessments allow us to assess labs without incurring the risks that may be presented with on-site assessments.
If my laboratory is not accredited to the new standard by year end, what will be the impact?
AIHA LAP will not recognize laboratories that have not been assessed and accredited to ISO/IEC 17025:2017 by the end of the year and any laboratory not accredited to the new standard by then will be suspended.
How will I know if my laboratory is a candidate for a remote assessment?
An AIHA LAP Accreditation Specialist will contact you to discuss your situation and will ask that your laboratory staff complete a survey to determine your readiness for a remote assessment. Based on your responses, the Accreditation Specialist will let you know if your laboratory is a candidate for a remote assessment.
What if my laboratory is not a candidate for remote assessment?
If your laboratory is unable to undergo a remote assessment or is considered to not be a candidate for a remote assessment, you may be granted an extension to your laboratory’s accreditation cycle up to 3 months to allow the laboratory to acquire the technology and take other steps to prepare for a remote assessment. The decision to grant an extension will not be automatic, but rather, will be made on a case-by-case basis (to labs in good standing) with the understanding that a remote assessment must be arranged and conducted before September 2020.
If my laboratory is deemed to be a candidate for a remote assessment, what should I expect next?
Your assigned AIHA LAP Site Assessor will contact you to discuss the agenda and to ensure all key personnel know when to be available as well as what documents or procedures to have ready to be reviewed. You will also be able to work with the Site Assessor to discuss the video conferencing options to which you both have access and familiarity (such as Skype, FaceTime, Zoom, GoToMeeting) as well as systems or platforms you plan to use to share documents or information.
How do I prepare for a remote assessment?
You should prepare for a remote assessment like you would an on-site assessment conducted by AIHA LAP. Like an on-site assessment, the Site Assessor will work closely with your laboratory to develop an agenda and identify key personnel that will be available for interview along with documents or procedures needing to be reviewed. For more details of documents and records that will be reviewed as part of the assessment, refer to The Onsite Documents and Records Review List at: https://www.aihaaccreditedlabs.org/policies
How will my lab be assessed during a remote assessment?
As a remote assessment is designed to be conducted with the same technical rigor as an on-site assessment, you can expect the Site Assessor to evaluate your laboratory’s quality management system and technical requirements. You can expect the opening and closing meetings to be conducted via video conferencing, and you will be able to share certain documents via a webcam or other technology that you have agreed to use. You may be asked to gather documents and be prepared to share them with the Site Assessor during another web-based meeting or on another platform. While no two remote assessments will be alike, generally they will take place in shorter segments over one or more days.
What happens once my remote assessment has been conducted?
Like an on-site assessment, the Site Assessor will submit their findings at the conclusion of a remote assessment, and the laboratory will have up to three rounds of responses to resolve them. From there, the assessment materials will be reviewed by our Technical Advisory Panel (TAP) and voted on for accreditation by the Analytical Accreditation Board (AAB).
Once accredited to ISO/IEC 17025:2017, will my laboratory receive an AIHA LAP certificate and an accreditation symbol?
Yes. All AIHA LAP laboratories successfully assessed remotely will receive a two-year AIHA LAP accreditation certificate and be allowed to use the 2017 version of the AIHA LAP accreditation symbol (designed for each program) after signing a Licensing Agreement. These symbols, which are used in conjunction with lab identification numbers, have been updated to include ISO/IEC 17025:2017 in the rim of the symbol.
Does AIHA LAP follow up the remote assessment with an on-site visit?
Yes. A Post Remote Assessment Surveillance visit will need to take place on-site at your laboratory once our assessors are able to travel. This will ensure all deficiencies have been adequately addressed and all areas of ISO/IEC 17025:2017 have been sufficiently covered. This will be a condensed site visit to review those topics and elements that are best observed on-site. The scope of this Surveillance Assessment will vary and will depend on how much was covered during the remote assessment, but the number of the days the Site Assessor is on-site will be reduced.
What will the Site Assessor expect to see regarding risk-based thinking during a remote assessment?
Risk-based thinking is big part of ISO/IEC 17025:2017 and the Site Assessor will expect to see records on risk identification and mitigation or elimination to risks to impartiality on an ongoing basis (per Sections 4.1.4, 4.1.5). Records of risk identification and any actions taken to address risk will also be required (Section 8.5) and your laboratory’s management reviews require records of inputs related to the results of risk identification (Section 8.9.2.m).
What are the fees for remote assessments?
As it does for on-site assessments, AIHA LAP will invoice your laboratory for the document review conducted by the Site Assessor and for his/her time either by the day or hourly. Please contact Anthony Hodge at firstname.lastname@example.org to request the 2020 AIHA LAP Fee Schedule if you are not certain of our rates.
Who do I contact for more information?
Please contact AIHA LAP at: https://www.aihaaccreditedlabs...