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In the forensic industry, if a new standard could reduce doubt in the courtroom and enhance scientific analysis, every director would want to implement it into their laboratory. ISO 17025 accreditation does just that. Gaining ISO 17025 accreditation is an internationally recognized achievement that enhances the reputation of the laboratory and testifies to the value of continuously reaching excellence. But, as all laboratory directors know, receiving accreditation is not a single milestone, but an ongoing process.

If you are planning a new facility or renovation, this process starts as early as the design phase and continues as far as impacting the daily activities of the director, quality manager, and every staff member.

The new standard for laboratory accreditation is ISO 17025. It provides a framework for the specific needs of organizations that want to control their laboratory processes. The requirements of ISO 17025 encompass all aspects of laboratory management, including calibration procedures, analytical testing proficiency, report generation and record keeping, and to ensure calibrations are performed by properly trained personnel using controlled test methods and procedures. The bottom line is that to be ISO accredited, the laboratory must not only be consistent in their procedures, but have a properly designed facility.

This article focuses on Good Laboratory Practice (GLP) that when implemented, will assist in the process of gaining accreditation. GLP is the opportunity to incorporate design specifications required for ISO before even applying for accreditation.

Having the right laboratory environment for every staff member is a vital part of ISO 17025 requirements and clearly represents GLP. The following spaces may or may not exist in your current or proposed facility but the Quality Manager (QM) and his/her staff will benefit greatly if the following spaces are implemented. It is my opinion that as the forensic industry evolves and more state-of-the-art facilities are designed, these spaces will become industry standard for all laboratories seeking ISO 17025 accreditation.

The general requirements of ISO 17025 states in section 4.1.5i that, “The laboratory shall appoint a member of the staff as Quality Manager.” The QM’s office should be a private location with at least 121 net square feet (NSF). For the purpose of this article, 121 NSF will be used as the typical building block module. This office should be designed with four walls and a lay-in ceiling. Standard office furniture must be provided, including a locking door and two guest chairs. The door can be solid or have a vision panel of safety glass. When implementing a locking mechanism for the office, I recommended using the staff member’s ID badge that activates a proximity card reader. Adding a smart board to the office will assist in group discussions and offer the option of scanning data into electronic media. It is also crucial thatthe office have direct access into a workroom.

The workroom needs to be at least 121 NSF with four walls and a hard, dry walled ceiling for extra security. Other features that are needed include a 3’X4’ table, 2 chairs, a temporary file cabinet, and a locking door. The purpose of this space is to provide the QM with a room that can be secured for days if necessary and provide enough space to bring files in while working on a large project. Both the QM’s office and workroom are intended to be located near the laboratories described below.

Having a Health and Emergency Lab Panel (HELP) Station in every laboratory is an asset when seeking ISO accreditation. A fire extinguisher, fire system annunciator, fire blanket, spill kit, first aid kit, and emergency phone are all items found in a HELP station. This is also a suitable place for documents including, but not limited to, the MSDS Sheets and the Emergency Operations Manual. Section 4.3.2.2 of ISO 17025 requires that, “Appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are preformed.” If an emergency shower and eyewash equipment are required for your specific lab, it can also be located near or in the HELP station.

I recommend having two laboratories dedicated for the QM and staff to use at anytime. This space is required for verifying the quality of reagents and consumable supplies, setting up double blind tests, and validating new science methodologies and new instrumentations. Both labs should be located near the central receiving and storage space so that materials can be easily accessible for testing.

The layout of these two labs should be similar. The preparation space in the front section needs to be 121 NSF with a fixed perimeter bench, sink, and a chemical fume hood. The next 121 NSF section is for workstations. It consists of a mix of fixed and movable casework to mimic the workstations in the forensic lab. The last 121 NSF space is designed for instrumentation with movable instrument carts. A 121 NSF Exam/ALS Room should be accessible from both laboratories and have a small amount of fixed bench and a forensic exam table in the center of the room. The main difference between these two labs is that one is intended for chemistry activities and the other for biological activities.

Three states have already mandated ISO 17025 accreditation when testifying in court. It is only a matter of time before a national standard is implemented. If you are still in the design phase of your future facility or even looking to renovate your current space, I strongly suggest incorporating an office for the QM, workroom, HELP stations, and two laboratories for chemistry and biological activities.

Ken Mohr is a Principal and Sr. Forensic Laboratory Planner with HERA, Inc., laboratory consulting partner firm in Crime Lab Design. His 17 years of experience with advanced laboratories includes nearly 3 million square feet of forensicfacilities. Ken can be reached at kmohr@herainc.com

 

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