During the assessment, does my laboratory have to have at least one piece of M&TE available for demonstration for each test/measurement on our Scope of Accreditation? What if my laboratory uses rental equipment to perform tests/measurements on our Scope…Would we be required to have at least one piece of this rental equipment available for demonstration for each test/measurement that the rental equipment is used for? 06/05/2008
5.5.1
Section 5.5.1 of ISO/IEC 17025 requires that the laboratory be furnished with all items of measurement and test equipment required for the correct performance of the tests and/or calibrations on its Scope. In order to confirm that this is indeed the case, the assessor must be able to verify demonstration by the lab on at least one piece of measurement and test equipment (even if some of this equipment is rented) for each test/measurement on the lab’s Scope.
Some flexibility may be allowed on a case-by-case basis, however, for laboratories undergoing a renewal assessment for that particular test or calibration, as it is understood that there may be instances where a piece of equipment owned or rented by the lab is unavailable because it is, for example, out for its regularly scheduled preventive maintenance or calibration. As long as this can be verified through review of records and calibration/maintenance schedules (even if these must be supplied by the rental agency) and as long as the test/calibration in question was thoroughly examined by the previous assessor (including the necessary equipment), then a deficiency may not be cited.
For new assessments and for assessments of newly added tests/calibrations, this flexibility cannot be allowed as it would prevent the assessor from making a critical, initial determination of whether or not the laboratory is indeed furnished with the appropriate equipment (even if this is rented equipment).
Is software considered equipment? 04/30/2005
5.5.5
Sections 5.5.2 through 5.5.7 all state that software is considered part of a laboratory’s equipment. As such, the same requirements apply (e.g., unique identification, maintenance of records and checks before use).
What should be included in maintenance procedures? 04/30/2005
5.5.6
Maintenance procedures should state in detail:
how historical maintenance information is kept;
how an instrument that has been subjected to any influences that might cause doubt as to its integrity is handled;
how out-of-service-equipment is identified and/or isolated to prevent its use;
how effects of previous calibrations or tests are determined;
how operational status is identified; and
where equipment is held while out of service.
Is this section on “Sampling” applicable to my laboratory? 04/30/2005
5.7
If the laboratory is not involved in the collection of samples, but rather merely tests the items as they arrive, this section on Sampling is not generally applicable.
However, if the laboratory uses the results of their testing to make a statement about a population, then Sampling does apply. It is important to note that the population may exist external to the laboratory (e.g., a lot/batch of production items or an entire freshwater lake) or the population may be a large sample submitted by the client from which the lab must sub-sample.
Does this section apply to my laboratory if we are simply testing a sample taken from a larger, client-supplied sample? 02/08/2006
5.7
Yes. When a laboratory performs sub-sampling from a larger, client-supplied test item, Section 5.7 applies and the laboratory must have documented procedures for sub-sampling and/or homogenization to ensure that a representative test portion is used for analysis.
If my laboratory meets the “A2LA General Requirements for Proficiency Testing for Accredited Testing and Calibration Laboratories” have we met the requirements of Section 5.9 of the standard?
(section 5.9.1 of ISO 17025:2005) 04/30/2005
5.9
Section 5.9 requires quality control procedures for monitoring the validity of tests and calibrations undertaken by an accredited laboratory. This includes all tests and calibrations listed on the Scope of Accreditation. The “A2LA General Requirements for Proficiency Testing for Accredited Testing and Calibration Laboratories” outlines an acceptable sampling of methods (per sub-discipline) contained on the Scope over a four-year period. However, per the Proficiency Testing Requirements, not all methods within each sub-discipline need to be covered by proficiency testing (which is only one of the monitoring activities suggested by Section 5.9). For those methods on the Scope not covered by proficiency testing in order to meet the A2LA General Requirements for Proficiency Testing, the laboratory must engage in other quality control activities (as also discussed in Section 5.9) so that some form of monitoring is done for every test and/or calibration on their Scope of Accreditation.
Does the planned monitoring mentioned in the clause require documentation?
(section 5.9.1 of ISO 17025:2005) 04/30/2005
5.9
Yes. The laboratory’s plan for monitoring the validity of tests and/or calibrations must be documented.
Are all of the items under Section 5.9 required? 04/30/2005
5.9
As the note following the section states, the selected methods for quality control should be appropriate for the type and volume of work undertaken. The laboratory should have a systematic quality control program for checking or monitoring the reliability or accuracy of its results for all methods and measurement processes.
The particular quality control schemes and statistical techniques vary greatly with the nature and volume of calibration or testing done. Statistical quality control charts or equivalent tabulations for monitoring accuracy and precision performance should be maintained for quality control test items (such as reference test materials/standards and replicate tests from the same material source) as is practicable. However, depending on the data, trends may be detectable by a review of data alone or through some type of regression analysis.
The use of reference materials/standards provides for the monitoring of accuracy performance. Replicate testing of duplicate test items and repeated measurements provides for the monitoring of precision performance. The retention and re-rest of test items may be specified in response to questionable results or complaints. Evaluation of interrelated characteristics of individual test items can aid in detecting errors.
More detailed quality control requirements may be specified in program requirements document (e.g., for the Environmental Lead program). For additional requirements relating to proficiency testing, refer to the “A2LA General Requirements for Proficiency Testing for Accredited Testing and Calibration Laboratories”.
Must the "pre-defined criteria" be documented, and what type of "planned actions" are required for out-of-tolerance data? 07/19/2005
5.9.2
Two separate pieces of objective evidence are required to demonstrate full compliance with this clause: (1) A document outlining the “pre-defined criteria” for the laboratory’s quality control data, and (2) A record of the “planned action” that is required for out-of-control data. Analysis of the data itself may be accomplished by a variety of means (most frequently through the use of control charts, pareto analyses, scatter diagrams, histograms, cause and effect diagrams, etc.), but visual analyses or special instructions particular to the application may be used in some cases. When considering out-of control data and the “planned action” to be taken, the laboratory is required to initiate any correction that is required by their procedure for Section 4.9 of the standard related to Non-Conforming Work. The laboratory is also required to initiate their Corrective Action procedure required by Section 4.11.1, since out-of-control data is not in compliance with a pre-defined parameter specified and documented within their management system.
My laboratory is internal to a larger, manufacturing organization. Test results are communicated from the laboratory via an intranet to another department of the organization which prepares and issues the final test reports, but they may or may not contain all of the elements of Section 5.10.2 through 5.10.4. Can a deficiency be cited against our laboratory for non-compliance with these clauses of ISO/IEC 17025? 12/06/2007
5.10
In the case of captive or internal laboratories, the “customer” is most often considered to be another department within the larger, overall organization. As long as there is a documented understanding from that other department within the organization as to the format that the final report issued by the captive laboratory will take, then the laboratory is free to issue a simplified report under the provisions of Section 5.10.1. According to these provisions, the laboratory may issue a report to their “customer” within the organization such that not all elements of 5.10.2 through 5.10.4 need be included, as long as the results are reported accurately, clearly, unambiguously and objectively. However, the lab itself must maintain records to satisfy the elements of 5.10.2 through 5.10.4 in the event that information is ever needed.
Now, if the other department within the organization wishes to distribute the captive laboratory’s results to someone outside the organization, they may do so. The results are only considered “accredited”, however, if the laboratory’s actual report is given to this outside party. In other words, the other department within the organization may not repackage, manipulate or re-present the laboratory’s data in another form before it is distributed to this external party and still have it considered “accredited” or have it display the “A2LA Accredited” symbol (or reference to A2LA accreditation). If the other department re-packages, manipulates or re-presents the data and still makes reference to A2LA accreditation in its issued report, we would consider this department of the organization (not the laboratory itself) to be issuing a fraudulent report, and would take necessary action.
Internal calibration laboratories are particularly cautioned when they issue a calibration certificate to an internal “customer” within their organization, as only certificates bearing the “A2LA Accredited” symbol may be used to demonstrate traceability by any ultimate, outside end user in accordance with the A2LA Policy on Measurement Traceability, Section T2.
Are accredited laboratories required to put the “A2LA Accredited” logo on test reports and/or calibration certificates? 04/30/2005
5.10.1
While A2LA accreditation entitles an accredited laboratory to place the “A2LA Accredited” symbol on reports/certificates, laboratories are generally not required to do so. A2LA accredited calibration laboratories are required to include the symbol or reference to their accredited status on accredited calibration reports or certificates if those reports/certificates are intended to be used to demonstrate compliance with the A2LA Traceability Policy.
A2LA strongly encourages the use of the symbol by a laboratory when its accredited status contributed to its obtaining the contract for the work. The calibrations or tests reported in this manner must be performed under the terms of their accreditation and must be included on the laboratory’s Scope of Accreditation.
In order to demonstrate the international acceptance of A2LA accreditation, accredited laboratories are also encouraged to use the combined “ILAC MRA – A2LA Accredited” symbol in place of the “A2LA Accredited” symbol alone. Prior agreement must be obtained from A2LA on the proposed form and use of this combined symbol but it adds an important dimension to a laboratory’s claim of accreditation.
For more information on use of the “A2LA Accredited” symbol and the combined “ILAC MRA – A2LA Accredited” symbol, refer to the document “Laboratory Reference to A2LA Accredited Status – A2LA Advertising Policy”.
Does this requirement apply for subcontracted results? 04/30/2005
5.10.2 b)
This does not apply to subcontracted results, which are addressed in Section 5.10.6.
Does this require identification of the revision date of the method? 04/30/2005
5.10.2 e)
The issue date or other identification of version of the test method should be included in the report, particularly where that information is critical to the interpretation of the reported results. For example, if a laboratory is using an older, superseded version of a test method (for whatever valid reason) this should be indicated on the report, as it will otherwise be generally assumed that the laboratory used the version of the method in effect on the date the report was issued.
Does this require more information be reported than Section 5.8.3 requires to be recorded? 04/30/2005
5.10.2 f)
Section 5.8.3 only requires that abnormalities or departures from normal or specified conditions be recorded. A similar practice is acceptable in reporting results – i.e., a general statement regarding the acceptable condition of the item should suffice, with more detail given when abnormalities or departures from the norm are encountered.
Is a written signature required? 04/30/2005
5.10.2 j)
The use of photographic, electronic and mechanical means of reproduction of signatures or names of signers may be acceptable, as long as:
the user can identify the person taking responsibility for the report, and
automated signatures are safeguarded.
What is considered to be an “equivalent identification of the person(s) authorizing a test report or calibration certificate”? Is only an electronic signature or mark considered acceptable and equivalent? 12/06/2007
5.10.2 j
ISO/IEC 17025 does not define what it considers to be an “equivalent identification” of the individual assuming responsibility for an issued report. As such, any form of identification is acceptable, as long as it can be unequivocally traced by the laboratory to the exact individual who has taken responsibility for that report. For example, a report may include this individual’s electronic signature or mark, their social security number, their driver’s license number, a company-assigned employee number, etc. in place of the name/function/signature. Or the report may include any combination of these things, as long as the identification included can be traced to the specific individual who has assumed responsibility for the report.
Our calibration laboratory is “captive” and part of a larger original equipment manufacturer (OEM). The items manufactured by our company are accompanied by a calibration certificate generated from our laboratory, however the recipient of this equipment is not known at the time of calibration. Our company would like for us to include a recalibration interval on the calibration certificates, but since the ultimate recipient of the equipment is not known, we cannot obtain their prior approval to include this interval. Is it still alright for us to include it on the calibration certificate? 12/06/2007
5.10.4.4
In the case of captive or internal laboratories, the “customer” is most often considered to be another department within the larger, overall organization. As long as there is a documented understanding and approval from that other department within the organization, then the laboratory may include a recalibration interval on the calibration certificates that they issue to that department. If the cal certs are ultimately intended to meet the A2LA Policy on Measurement Traceability (P102), then they must be appropriately endorsed and must meet all ISO/IEC 17025 requirements. If the OEM intends for their equipment to meet P102 when it is ultimately sold to their customers, then they must include the original, unaltered and endorsed calibration certificates with the equipment.
Can opinions and interpretations be included in a report endorsed with the A2LA logo? 04/30/2005
5.10.5
In order for opinions to be included in a test report or calibration certificate endorsed with the “A2LA Accredited” symbol, the basis for arriving at the opinion must be part of a method or procedure included in the laboratory’s Scope of Accreditation. If the opinions are not based on a process described in an accredited method or procedure, any expression of opinion or statement in amplification of the results may be provided in a separate, unendorsed document.
It is important to note that statements of compliance with a specification are not considered opinions when the compliance decision is based upon objective data.
For further guidance on Opinions and Interpretations, refer to the document UKAS LAB 13, which can be found on the A2LA website using the Document Finder and selecting the Guidance category.
Does electronic transmission of results require any additional security measures? 04/30/2005
5.10.7
Laboratories are increasingly producing electronic test reports in CD and/or transmitting electronic test reports via email attachments. There are two issues that laboratories should consider: One is that the client could have the ability to modify an electronic report. The other is that the Internet is open to the public and client confidentiality cannot be assured. To satisfy both concerns, test reports should be converted to a non-editable format that can also be encrypted. An example would be to use Adobe PDF format and then a lab password to prevent changing or editing the document. An additional customer password would then be used to open the document (which is emailed separately).
Microsoft Word security does not contain sufficient encryption or protection from editing and is generally not considered to be an acceptable method of security.
Must all of the information listed in Sections 5.10.1 – 5.10.3 be included in my reports? 04/30/2005
5.10.1 - 5.10.3
Section 5.10 allows for a considerable amount of flexibility in the reporting of results, as long as all client requirements are met and as long as the results are reported in a clear, unambiguous and readily interpretable manner. Any data from 5.10.1 – 5.10.3 that is not included on a laboratory report (when a laboratory has valid reasons for not including it) must be present and retained within the lab’s record system in the event that it is needed in the future.
It is important to note that specific program requirements may contain additional instructions for reporting that override the reporting requirements of ISO/IEC 17025 Section 5.10.
