| Requirement |
Source |
Application, Guidance or Interpretation |
Date Posted |
| 4.1.2 |
ISO/IEC 17025:2005 |
If a Level 1 Corrective Action Request is issued during an assessment, this requirement will be marked "NO" and it will remain "NO" until corrective action is completed and accepted for all Level 1 Corrective Action Requests. |
11/7/2007 |
| 4.1.3 |
ISO/IEC 17025:2005 |
Accreditation in the Crime Scene discipline remains optional in the ASCLD/LAB-International program. However, opting not to seek accreditation in the Crime Scene discipline does not exempt a laboratory from meeting this requirement. |
11/7/2007 |
| 4.1.5 b |
ISO/IEC 17025:2005 |
"Arrangements" can be any combination of policies, procedures, practices, etc. (this meaning applies throughout the requirements). |
11/7/2007 |
| 4.1.5 h |
ISO/IEC 17025:2005 |
The requirement for "technical management" is applicable to all disciplines. |
11/7/2007 |
| 4.1.5 i |
ISO/IEC 17025:2005 |
"Member of staff" means a position under the control of the laboratory director or laboratory system director. The laboratory director may also serve as the quality manager. |
11/7/2007 |
| 4.2.1 |
ISO/IEC 17025:2005 |
A common nonconformance in first-time applicant laboratories is not implementing one or more documented policies or procedures. |
11/7/2007 |
| 4.3.1 |
ISO/IEC 17025:2005 |
"Management system" documents means any administrative, quality or technical document related to the testing activities of the laboratory. |
11/7/2007 |
| 4.3.2.1 |
ISO/IEC 17025:2005 |
"Authorized personnel" may be defined by the laboratory as more than the laboratory director. |
11/7/2007 |
| 4.4.1 |
ISO/IEC 17025:2005 |
There are a number of requirements in ISO/IEC 17025:2005 (related to test methods) that call for (or at least discuss in a note) advising the customer of the test method, seeking customer agreement of the test method, etc. See 4.4.1, 4.4.4, 4.5.2, 4.7.1 [note 2], 5.4.1, 5.4.2 [twice], and 5.4.4 (not to mention the language in the 5.10 reporting area).
For all of the clauses above, the current ASCLD/LAB-International application is that the forensic laboratory may either handle these communications and notifications on a case-by-case basis (exactly as indicated in the requirement), or the laboratory may communicate with their customers in a general way (for example, by placing general information about test methods on a web site). A forensic laboratory may inform customers in a general communication that the most appropriate test method will be selected by the laboratory.
If the laboratory chooses the general communication approach, they may construct and provide a general communication to customers that touches on all of the topics covered in the areas cited above.
Generally, this application does not apply to private testing laboratories where testing is carried out in accordance with a formal contract and an agreed upon test method(s). |
11/7/2007 |
| 4.5 |
ISO/IEC 17025:2005 |
ASCLD/LAB Board of Directors Interpretation
Transferring a test item(s) to another ASCLD/LAB accredited laboratory in a laboratory system is not considered subcontracting as long as both the sending and receiving laboratory work under the same documented management system. |
11/7/2007 |
| 4.5 continued |
ISO/IEC 17025:2005 |
A subcontractor need not be ISO/IEC 17025:2005 accredited, but the laboratory using the subcontractor must maintain objective evidence of how the subcontractor was determined to be competent to perform the testing in question. |
11/7/2007 |
| 4.6.2 |
ISO/IEC 17025:2005 |
"Standard specifications or requirements" for supplies, reagents and consumable materials may be "defined" in a variety of ways (for example, in the purchasing documents; in the test method; etc.) |
11/7/2007 |
| 4.6.4 |
ISO/IEC 17025:2005 |
Note that 4.6.4 and the requirement to evaluate suppliers only applies to "critical" consumables, supplies and services which affect the quality of testing. This is different than 4.6.2 which applies to any purchased supplies, reagents and consumable materials that affect the quality of tests. |
11/7/2007 |
| 4.13.2.1 |
ISO/IEC 17025:2005 |
An "audit trail" is defined as sufficient records to track a particular case through the laboratory's management system. |
11/7/2007 |
| 4.13.2.1 continued |
ISO/IEC 17025:2005 |
ASCLD/LAB Board of Directors Interpretation
Audio recordings made at crime scenes, as part of the documentation of observations, must be treated as field notes and be maintained (in addition to transcription) as examination documentation. |
11/7/2007 |
| 4.13.2.3 |
ISO/IEC 17025:2005 |
ASCLD/LAB Board of Directors Interpretation
Laboratories using electronically-recorded examination documentation (technical records) will have a policy declaring when such examination documentation (technical record) is completed. This completion date must be prior to case review. At the time the laboratory considers the examination documentation (technical record) completed, it will be considered as “stored,” and any changes made after that time must be tracked, either electronically or on a hard copy of the examination documentation (technical record). |
2/21/2008 |
4.13.2.5.1
4.13.2.6 |
2011 Supplemental Testing Requirement |
If electronically recorded examination documentation is printed, the unique identifier for that case must be on each page of the printed documentation; but if the documentation is maintained in electronic form only, the unique identifier must appear visibly on the screen related to the document. |
11/7/2007 |
4.13.2.5.1 continued
4.13.2.6 continued |
2011 Supplemental Testing Requirement |
When a CD is used to store examination documentation, the removable media, or its proximal container, which is used to store examination documentation must be marked with a unique identifier. The initials of the preparer(s) of the examination documentation must be recorded on the media or proximal container unless the electronic equivalent is recorded on the media. |
11/7/2007 |
| 4.13.2.6 continued |
2011 Supplemental Testing Requirement |
When an analyst's initials have been recorded in a photograph, the analyst is not required to re-initial the photograph that already shows the analyst's initials. |
11/7/2007 |
| 4.14.1 |
ISO/IEC 17025:2005 |
"Trained and qualified personnel" in this instance means trained and qualified to conduct audits. Objective evidence of audit training and qualification must be maintained by the laboratory. |
11/7/2007 |
| 4.14.1.2 |
2011 Supplemental Testing Requirement |
First-time applicants are not required to have five years of audit records. While first-time applicants need to start maintaining these records, this requirement will be marked "N/A" for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked "Yes" if the laboratory has appropriate records for each year of accreditation. |
11/7/2007 |
| 4.14.5 |
2011 Supplemental Testing Requirement |
Not applicable to first time applicant laboratories in the ASCLD/LAB-International program. |
11/7/2007 |
| 4.15.1.2 |
2011 Supplemental Testing Requirement |
First-time applicants are not required to have five years of management review records. While first-time applicants need to start maintaining these records, this requirement will be marked "N/A" for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked "Yes" if the laboratory has appropriate records for each year of accreditation. |
11/7/2007 |
| 5.1.3.1 |
2011 Supplemental Testing Requirement |
Testing the reliability of a prepared reagent may occur at any time prior to use - not necessarily at the time the reagent is prepared. |
11/7/2007 |
| 5.2.3 |
ISO/IEC 17025:2005 |
A "contract" employee must meet all requirements of regular employees (training, education, qualifications, competency and proficiency testing, and adherence to the laboratory's management system requirements). |
11/7/2007 |
| 5.2.6.1.5 |
2011 Supplemental Testing Requirement |
ASCLD/LAB Board of Directors Interpretation
Crime Scene personnel who have been trained and competency tested to perform presumptive screening tests at crime scenes may conduct the same tests in the laboratory as an extension of their crime scene responsibilities without having to meet the educational requirements for the discipline(s) represented by the screening tests which they perform. These individuals may issue reports which are appropriately qualified based upon the limitations of the screening test performed.
As an example, if appropriately trained and competency tested crime scene personnel bring crime scene evidence back to the laboratory and processes the evidence for latent prints due to poor lighting at a crime scene (or for other reasons), the processing of latent prints within the laboratory facility is considered a continuation of crime scene duties. The evidence brought back to the laboratory for processing must be the evidence collected at the crime scene, and it must be processed by the crime scene personnel who collected the item(s) at the scene. The time period between collection at the scene and processing in the laboratory cannot be open-ended.
Crime Scene evidence processed in the laboratory that is not a continuation of the crime scene is considered technical support of the discipline represented. As an example, if crime scene personnel retrieve items of evidence from the property room to process for latent prints in the laboratory, the processing of latent prints is not a continuation of the crime scene and such work is performed as technical support to the latent print discipline. Laboratory personnel functioning as technical support in the laboratory, in any discipline, must meet all applicable accreditation requirements for technical support personnel.
|
3/17/2009
|
| 5.3.6 |
2011 Supplemental Testing Requirement |
Any part of the laboratory's documented health and safety program may be selected by the assessment team for review. |
11/7/2007 |
| 5.4.1 |
ISO/IEC 17025:2005 |
When thin-layer chromatography is used exclusively as a screening test, blanks are not required. However, if the thin-layer testing is used as a part of the confirmation testing, a negative control is necessary. |
11/7/2007 |
| 5.4.6 |
ISO/IEC 17025:2005 |
The ASCLD/LAB policy for estimated uncertainty of measurement will remain active until or unless a revised version is released in the future. However, customers should note that the December 31, 2008 date for showing full conformance, as stated in the policy, has been rescinded. To understand the updated approach for showing conformance with estimated uncertainty of measurement requirements, please read the "updated approach" document posted on 10/10/2008 BEFORE reading the policy.
ASCLD/LAB-International Updated Approach to Estimation of Uncertainty of Measurement ← READ THIS FIRST
ASCLD/LAB-International Estimation of Uncertainty of Measurement Policy
New Note: One sentence in the current ASCLD/LAB-International Estimation of Uncertainty of Measurement Policy is being misinterpreted by some individuals. The sentence is: "At this time, the ASCLD/LAB requirement for estimating uncertainty of measurement applies only to a numerical value in quantitative analysis which appears in a test report." The phrase "numerical value in quantitative analysis" is misleading some, and should be read as "quantitative measurements." |
3/17/2009
|
| 5.5.2 |
ISO/IEC 17025:2005 |
When using an AFIS terminal or other instruments and equipment at a location external to the accredited laboratory, the user must ensure and document that the terminal and or equipment is in proper working order prior to use. |
11/7/2007 |
| 5.6.2.1.1 |
ISO/IEC 17025:2005 |
ASCLD/LAB Program Clarification Endorsed by the Board
External Calibration of Measuring Instruments - Testing Laboratories |
7/17/2009 |
| 5.6.3.1 |
ISO/IEC 17025:2005 |
"Reference standard" generally means reference standards of units of measurement. |
11/7/2007 |
| 5.7 |
ISO/IEC 17025:2005 |
"Sampling" requirements are not applicable to the forensic science practice of "sample selection."
Policy on Sampling, Sampling Plans and Sample Selection in the Drug Chemistry Discipline
Guidance Document on Sampling, Sampling Plans and Sample Selection
|
Revised Policy Posted 10/12/2011(See note at the top of the page)
Effective March 1, 2012 |
| 5.8.1 |
ISO/IEC 17025:2005 |
If the laboratory intends to use test-fired ammunition as evidence for future comparisons, the laboratory must treat the test-fires as evidence from the beginning. Test-fired ammunition, which is treated as reference material by the laboratory, cannot routinely be re-designated as evidence at a future time. |
11/7/2007 |
| 5.8.1 continued |
ISO/IEC 17025:2005 |
There are times and situations in which ESDA lifts are made from evidence which cannot be preserved for reproduction because of the nature of the evidence or because of additional testing of the evidence. Under such circumstances, positive ESDA lifts must be treated as evidence. Laboratories, which use ESDA methodology, must define in their procedure when ESDA lifts must be treated as evidence. |
11/7/2007 |
| 5.8.4.3 |
2011 Supplemental Testing Requirement |
ASCLD/LAB Board of Directors Interpretation
When multiple items or sub-items of evidence are contained within a properly sealed and properly marked container, it is not always required that each item or sub-item be marked with a unique identifier. As an example: if a properly marked and sealed container contains multiple similar packets of white powder and the analyst conducts an analysis on the contents of a portion of the packets, each packet which had its content analyzed must be marked with a unique identifier. As long as the analyst properly documents the existence of the remaining packets and the outer container is properly resealed, it is not required that the unexamined packets be marked with a unique identifier. |
11/7/2007 |
| 5.8.4.6.1 |
2011 Supplemental Testing Requirement |
A laboratory handling individual characteristic database samples for another laboratory (such as a private DNA laboratory processing subcontracted samples) will be assessed against 5.8.4.6.1 through 5.8.4.6.4. |
11/7/2007 |
| 5.9 |
ISO/IEC 17025:2005 |
A laboratory is not required to practice all of the quality control procedures specified in "a" through "e" |
11/7/2007 |
| 5.9.3.3 |
2011 Supplemental Testing Requirement |
ASCLD/LAB Board of Directors Interpretation
A proficiency test may test a specific job related skill or skills, but does not have to test all aspects of an employee's job function. Laboratories should consider varying the design of proficiency tests so that over time an employee is tested on all aspects of the assigned job functions. |
11/7/2007 |
| 5.9.3.3.1 |
2011 Supplemental Testing Requirement |
ASCLD/LAB Board of Directors Interpretation
Where does DNA analysis begin
For the purposes of determining who must participate in DNA proficiency tests, the ASCLD/LAB Board has determined that DNA analysis begins with the extraction of DNA from cellular material. |
3/17/2009
|
| 5.9.3.6 |
2011 Supplemental Testing Requirement |
First-time applicants are not required to have five years of proficiency test records. While first-time applicants need to start maintaining these records, this requirement will be marked "N/A" for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked "yes" if the laboratory has appropriate records for each year of accreditation. |
11/7/2007 |
| 5.9.4.3 |
2011 Supplemental Testing Requirement |
ASCLD/LAB Board of Directors Interpretation
Generally, a single technical reviewer will be assigned for each test report; however, ASCLD/LAB recognizes and accepts that more than one technical reviewer may be required under certain circumstances (e.g. batch processing of casework; certain DNA applications where multiple laboratory personnel work on the same case; etc.). As long as no individual technically reviews his/her work, the use of more than one technical reviewer is allowed for a test report. |
Posted on June 29, 2011
Effective immediately
|
| 5.9.7 |
2011 Supplemental Testing Requirement |
First-time applicants are not required to have five years of testimony monitoring records. While first-time applicants need to start maintaining these records, this requirement will be marked "N/A" for the first assessment. For each year of the first cycle of accreditation, this requirement will be marked "yes" if the laboratory has appropriate records for each year of accreditation. |
11/7/2007 |
| 5.10.1 |
ISO/IEC 17025:2005 |
As stated in the requirement, a documented test report must be prepared for all testing completed in the laboratory, and the laboratory is not exempt from this requirement even when the customer requests that no documented report be provided. As well, this documented report must be available in the laboratory's case record. |
11/7/2007 |
| 5.10.1 continued |
ISO/IEC 17025:2005 |
Results obtained from non-specific tests must not be reported as unqualified confirmative results. |
11/7/2007 |
| 5.10.1 continued |
ISO/IEC 17025:2005 |
ASCLD/LAB Board of Directors Interpretation
Reporting negative database searches
If a sample (e.g. latent print, test fire or DNA profile) is searched as a one-time event, then a report must be generated clearly stating the results of the search. A "one-time" event means that the sample will not be retained in the database and automatically searched against the database on some routine basis.
If a sample is entered into a database(s) and is repeatedly searched with negative results, a report is not required for each search. However, the first time the sample is entered into the database a report (which may be in the form of a simplified notification) must be generated which clearly informs the customer that the sample was entered into the database. Anytime a positive association is made a report or follow-up report must be generated. |
3/17/2009
|
| 5.10.5 |
ISO/IEC 17025:2005 |
ASCLD/LAB Board of Directors Interpretation:
ASCLD/LAB Discussion, Interpretation and Application of Opinions and interpretations - Ver 1.1
Updated version posted on March 17, 2009
The intent of the updated version is to clarify that the Board, by striking one example, has made an allowance that laboratory management may use their own judgment as to whether certain test results in controlled substances and toxicology constitute a conclusion, opinion or interpretation. |
3/17/2009
|
