Important Terminology

ANAB is a name you will have to know when working for a New York State Crime Laboratory because of the accreditation requirement. This requirement is mandated by The Commission of Forensic Science which is part of the New York Division of Criminal Justice Services (NYDCJS). ANAB stands for The ANSI National Accreditation Board, and its goal is to accredit laboratories that follow the accreditation standards that the board sets.

The ANAB standards are based on the ISO/IEC 17025: International General Requirements for the Competence of Testing and Calibration Laboratories. The calibration portion of this document is not relevant for Forensic Laboratories, therefore it will be ignored for the rest of the article. ANAB takes the ISO standards and adds the AR3125 document, which is a supplement that adds more specific requirements for forensic service providers. Below we will dissect the ISO requirements, which are separated into different numbered sections. These sections are usually mimicked by the Quality Assurance’s (QA) Standard Operating Procedure (SOP) to ensure that the laboratory follows all the standards. The ISO document is generally vague when it comes to requirements, it’s up to the laboratory to get more specific in their QA SOP, and then ensure that all the requirements are followed at all times.

The sections that start the document are more introduction based than the actual standards that a laboratory should follow. Section 1 is the “Scope,” which explains the purpose of the document. Section 2 is “Normative References” and Section 3 is “Term and Definitions.” These sections are self-explanatory and they do not go into any specific requirements. 

Section 4 is the first section that creates requirements for the laboratory and it is appropriately titled, “General Requirements.” This section mainly focuses on impartiality and confidentiality. The next section, Section 5: “Structural Requirements,” discusses the management and personnel responsibilities, along with the activities and their requirements. Sections 4 and 5 are small when compared to the next two sections, which are the sections that make up the majority of a Laboratory’s QA manual.

Section 6, “Resource Requirements” is one of the biggest sections and is one that the QA section will focus most of their manual on. The sub-sections of Section 6 are split up as follows: General (6.1), Personnel (6.2), Facilities and Environment Conditions (6.3), Equipment (6.4), Metrology Traceability (6.5), and Externally Provided Products and Services (6.6). Below I will explain some of the sub-section for better clarity. I will skip 6.1 because it does not contain anything of value for a general examination of the document.

(6.2): This section goes over the education, qualifications, training, and experience of the personnel. The agency needs to have the requirements for these categories and the records to support them. The personnel should also have competency in their laboratory activities.  

(6.3): Requirement to list and record all the environmental factors that can affect the validity of the results.

(6.4): To keep a record of the equipment that is used in testing and to ensure the equipment conforms to specified requirements: measurement accuracy and measurement uncertainty. There must also be recorded calibration and checks on the instruments.

(6.5): There has to be documentation for metrological traceability. These measurements must be traceable to SI units.

(6.6): Records of what will approve a product and what will make it conform.

Next is Section 7 which is the review of requests, tenders, and contracts. This section is split up into 11 sub-sections. This section will affect more of the report writing and the way analyst must conduct their examinations. The sub-sections cover the following:

(7.1): Procedure for the review of requests, tenders, and contracts

(7.2): Selection, verification, and validation of methods that must be appropriate and correct. There must be a manual for the methods, standards if applicable, and a verification process.

(7.3): This section goes into depth about sampling. There must be a plan and must address any factors.

(7.4): This section goes into the handling of test or calibration items. Also requires a procedure for storage, transportation, receipt, etc. of these items.

(7.5): The testing records must be complete so they can be replicated. The original observations, data, and calculations at the time they were made must be recorded.

(7.6): Evaluation on Measurement Uncertainty. There will be another article posted on measurement uncertainty and its importance at a later date.

(7.7): Requiring the monitoring of results so that trends can be detectable. This can be done through functional checks, retesting of retained items, replicate testing, etc.

(7.8): This section dives deeply into the reporting of results. The results must be accurate clear and unambiguous, and objective. The section also provides guidance on what the report should include: title, the method used, data, etc. On top of report writing the section addresses calibration certificates and what they should include. To keep this section brief I would like to conclude that most of the guidance in the final product is found in this sub-section. This sub-section is very important to the QA section and other sections in the laboratory when crafting their own SOPs.

(7.9): This sub-section goes through the complaint process when a customer files a complaint.

(7.10): Anything dealing with non-conformance work is found in this sub-section

(7.11): Lastly this sub-section finishes off with control of data and information management.

The last section of this document is the management system requirements, which is section 8. They split this section into an “A” option and a “B” option. The “A” option is usually taken by crime laboratories and the “B” option is taken by laboratories that use the ISO 9001. The “A” option goes over control of documentation of the laboratory, corrective actions, internal audits, identifying areas of improvement, and policies and objectives for the fulfillment of this document.

This article is just to teach you the basic idea and summary of the ISO/IEC 17025:2017 document. Overall, the document is just general requirements that any laboratory can take and mold into its own SOPs. The ANAB Accreditation Requirements (AR 3125) has all the same sections as the ISO 17025 document, but the information is geared more towards forensic laboratories. Although the AR3125 document is still pretty general in nature, it does have more forensic-specific requirements. Once these documents are incorporated into the QA manual and the other section’s SOP is when they become more specific to the specific laboratory they are incorporated into. At this point, the laboratory is responsible for following its own manuals in addition to the ISO and AR documents when an assessment is performed on the laboratory.

This information can be used by the scientist who is preparing to help their lab with accreditation. They can use also use this article as a quick reference or to better understand what the ISO standards are. This information can also prove to be very useful for the student who is looking for a job or internship. This knowledge is sought after when hiring because this is huge for the laboratory, but is usually eclipsed by casework.