| Requirement |
Source |
Application, Guidance or Interpretation |
Date Posted |
| 1.4 Note 1 |
ISO/IEC 17025:2005 |
The term "management system," used throughout ISO/IEC 17025:2005, is defined as "the quality, administrative and technical systems that govern the operations of a laboratory." ASCLD/LAB customers should apply this definition when reading and interpreting the ISO/IEC 17025:2005 document. |
11/7/2007 |
| 4.1.1 |
ISO/IEC 17025:2005 |
All publicly-funded, government laboratories in the U.S. are recognized by ASCLD/LAB as a legally responsible entity. All private laboratories in the U.S. and all laboratories outside the U.S. must produce objective evidence of legal responsibility. |
11/7/2007 |
| 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 |
| 4.1.4 |
ISO/IEC 17025:2005 |
"Defined" means documented (this meaning applies throughout the requirements). |
11/7/2007 |
| 4.1.5 b |
ISO/IEC 17025:2005 |
"Arrangements" can be any combination of polices, procedures, practices, etc. (this meaning applies throughout the requirements). |
11/7/2007 |
| 4.1.5 c |
ISO/IEC 17025:2005 |
Policies and procedures must be documented (this meaning applies throughout the requirements). |
11/7/2007 |
| 4.1.5 f |
ISO/IEC 17025:2005 |
"Specify" means documented (this meaning applies throughout the requirements). |
11/7/2007 |
| 4.1.5 i |
ISO/IEC 17025:2005 |
"Appoint" means documented (this meaning applies throughout the requirements). |
11/7/2007 |
| 4.1.5 i continued |
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 |
| 4.1.5 j |
ISO/IEC 17025:2005 |
"Key managerial personnel" is determined by the laboratory. |
11/7/2007 |
| 4.1.6 |
ISO/IEC 17025:2005 |
"Top management" is determined by the laboratory (this meaning applies throughout the requirements). |
11/7/2007 |
| 4.1.7 |
2007 Supplemental Calibration Requirement |
"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 Health and Safety Manager. |
11/7/2007 |
| 4.3.1 |
ISO/IEC 17025:2005 |
"Management system" documents means any administrative, quality or technical document related to calibration activities (See 1.4 above). |
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 |
| 4.3.3.2 |
ISO/IEC 17025:2005 |
"Practicable" means if it can be done it shall be done. |
11/7/2007 |
| 4.4 |
ISO/IEC 17025:2005 |
Section 4.4 is applicable to all laboratories. "Tender" means the laboratory's response to a calibration request. "Contract" means the agreement to do the calibration in whatever form that takes (for example a completed submission form accepted by the laboratory). In private laboratories, "contract" generally means a formal contract. |
11/7/2007 |
| 4.4.1 |
ISO/IEC 17025:2005 |
There are a number of requirements in ISO/IEC 17025:2005 (related to test and calibration 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, or the laboratory may communicate with their customers in a general way (for example, by placing general information about test and calibration methods on a web site). A forensic laboratory may inform customers in a general communication that the most appropriate test and calibration method will be selected by the laboratory.
If the laboratory chooses the general 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 calibration laboratories where testing and calibration is carried out in accordance with a formal contract. |
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 or calibration 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 |
| 4.13.2.3 |
ISO/IEC 17025:2005 |
ASCLD/LAB Board of Directors Interpretation
Laboratories using electronically-recorded technical records will have a policy declaring when such records are completed. This completion date must be prior to case review. At the time the laboratory considers the 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 technical record. |
2/21/2008 |
| 4.13.2.4 |
2007 Supplemental Calibration Requirement |
A calibration record is not limited to a single file. A calibration record may be made up of records from various locations in the laboratory. |
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 |
2007 Supplemental Calibration Requirement |
First-time applicant laboratories 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 |
2007 Supplemental Calibration Requirement |
Not applicable to first time applicant laboratories in the ASCLD/LAB-International program. |
11/7/2007 |
| 4.15.1.2 |
2007 Supplemental Calibration Requirement |
First-time applicant laboratories 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 |
2007 Supplemental Calibration Requirement |
Testing the reliability of a prepared reagent may occur at anytime 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, adherence to the laboratory's management system requirements). |
11/7/2007 |
| 5.2.5 |
ISO/IEC 17025:2005 |
"Authorize" means documented (this meaning applies throughout the requirements). |
11/7/2007 |
| 5.2.6.2 |
2007 Supplemental Calibration Requirement |
Competency testing should cover all aspects of an employee's job function. |
11/7/2007 |
| 5.3.6 |
2007 Supplemental Calibration Requirement |
Any part of the laboratory's documented health and safety program may be selected by the assessment team for review. |
11/7/2007 |
| 5.6.3.1 |
ISO/IEC 17025:2005 |
"Reference standard" generally means reference standards of units of measurement. |
11/7/2007 |
| 5.9.3.3 |
2007 Supplemental Calibration Requirement |
"Each employee" means any employee performing a testing or calibration activity which contributes to the quality of the calibration. |
11/7/2007 |
| 5.9.3.3 continued |
2007 Supplemental Calibration 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 |
| 5.9.3.6 |
2007 Supplemental Calibration Requirement |
First-time applicant laboratories 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 |
| 5.10.1 |
ISO/IEC 17025:2005 |
As stated in the requirement, a documented calibration report (certificate, etc.) must be prepared for all calibrations 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 |
