Understanding ISO/IEC 17025:2005 http://www.a2la.org/faq/faqfinder170252005.cfm A2LA Criteria Council Approved Applications to the Standard Thu, 11 Mar 2010 21:00:00 GMT 4.11.2 What is meant by a “root cause” investigation and how do I go about this? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=115 Fri, 06 Nov 2009 05:00:00 GMT A2LAORG115Nov62009 4.6.3 What specific items does A2LA look for in my purchasing documents in order to meet the requirements in Section 4.6.3? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=113 Thu, 10 Sep 2009 04:00:00 GMT A2LAORG113Sep102009 4.13.2.3 What is considered an “equivalent measure” for avoiding loss or change of original data that is stored electronically? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=114 Thu, 10 Sep 2009 04:00:00 GMT A2LAORG114Sep102009 4.3.2.1 Is the master list my lab created to meet Section 4.3.2.1 of the Standard considered a record or is it considered a document that would be subject to document control requirements? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=109 Thu, 06 Aug 2009 04:00:00 GMT A2LAORG109Aug62009 5.9.1 What sort of quality control practices can my laboratory implement for destructive and/or pass/fail types of tests in which no equipment is used? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=110 Thu, 06 Aug 2009 04:00:00 GMT A2LAORG110Aug62009 4.5 My laboratory is part of a multi-laboratory organization. All laboratories within my organization are A2LA accredited and fall under the classification of a “branch system” as defined by A2LA. If my laboratory receives work from a client but sends the work to another of our accredited branch laboratories (with the final report being issued by my laboratory), is this considered sub-contracting? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=111 Thu, 06 Aug 2009 04:00:00 GMT A2LAORG111Aug62009 4.1.5b Do the clauses 4.1.5 (b) and (d) require our laboratory to have a Code of Ethics in place? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=112 Thu, 06 Aug 2009 04:00:00 GMT A2LAORG112Aug62009 5.5.9 Does the requirement in Section 5.5.9 apply to equipment that has been sent out for calibration? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=108 Thu, 04 Sep 2008 04:00:00 GMT A2LAORG108Sep42008 4.7.2 In what ways may a laboratory seek feedback, and how must this feedback be analyzed? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=65 Thu, 10 Jul 2008 04:00:00 GMT A2LAORG65Jul102008 4.15.1 Who is considered to be a laboratory’s “top management”? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=52 Thu, 05 Jun 2008 04:00:00 GMT A2LAORG52Jun52008 5.5.1 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? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=92 Thu, 05 Jun 2008 04:00:00 GMT A2LAORG92Jun52008 4.2.2 Does section 4.2.2 require that all of the quality policy statement elements (4.2.2 a - e) be contained in one contiguous statement? Or can the elements be addressed in different areas of the quality manual? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=99 Thu, 05 Jun 2008 04:00:00 GMT A2LAORG99Jun52008 4.14.1 I am a new laboratory getting ready to apply for accreditation. Do I have to perform a complete internal audit of my management system and testing activities before I can become accredited? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=105 Thu, 05 Jun 2008 04:00:00 GMT A2LAORG105Jun52008 4.15 I am a new laboratory getting ready to apply for accreditation. Do I have to perform my management review before I can become accredited? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=106 Thu, 05 Jun 2008 04:00:00 GMT A2LAORG106Jun52008 4.3.1 What is expected by way of document control for software as required in Section 4.3.1? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=107 Thu, 05 Jun 2008 04:00:00 GMT A2LAORG107Jun52008 5.2.1 For one particular test/measurement on our laboratory’s Scope of Accreditation, we only have one person in our laboratory that is competent to perform the test. During the assessment, must that person be available for demonstration for each test/measurement on our Scope that only they are capable of performing? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=93 Tue, 06 May 2008 04:00:00 GMT A2LAORG93May62008 5.4.7.2 a) What is required for software validation? If off-the-shelf software is used, must a laboratory also verify that software? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=28 Sun, 13 Apr 2008 04:00:00 GMT A2LAORG28Apr132008 5.10 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? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=97 Thu, 06 Dec 2007 05:00:00 GMT A2LAORG97Dec62007 5.10.2 j 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? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=103 Thu, 06 Dec 2007 05:00:00 GMT A2LAORG103Dec62007 5.10.4.4 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? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=104 Thu, 06 Dec 2007 05:00:00 GMT A2LAORG104Dec62007 4.14.1 My laboratory performs an internal audit annually per our predetermined schedule and procedure. Since we have over 100 test methods on our Scope of Accreditation, we do not address all elements of our management system and its compliance to ISO 17025 during each audit, nor do we address every test method defined on our Scope of Accreditation. Instead, we audit a sampling of the management system and methods at each interval. Are we required to perform an audit on all elements of our management system and its compliance to ISO 17025 and an audit of all testing methods defined on our Scope of Accreditation at each audit interval? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=102 Thu, 04 Oct 2007 04:00:00 GMT A2LAORG102Oct42007 4.2.6 My laboratory’s quality manual contains clear statements of the roles and responsibilities for our quality manager and technical management. However, none of these explicitly state that they are responsible for the laboratory’s compliance with ISO/IEC 17025. Does this warrant a deficiency? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=100 Thu, 06 Sep 2007 04:00:00 GMT A2LAORG100Sep62007 4.13.2.1 (Note 1) How does Note 1 from Section 4.13.2.1 apply to my laboratory? My lab runs a significant number of the same tests each day. It seems impractical for me to record and retain so much original data when my customers do not wish to receive this additional information with their final test reports. http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=101 Thu, 06 Sep 2007 04:00:00 GMT A2LAORG101Sep62007 4.3.1 What does A2LA consider to be “normative documents” that my laboratory must control under our document control system? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=98 Thu, 12 Jul 2007 04:00:00 GMT A2LAORG98Jul122007 4.6.2 Must the records of actions taken to check compliance of received supplies, services and/or consumable materials be tied to the specific shipment/box/lot of material received? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=85 Thu, 14 Jun 2007 04:00:00 GMT A2LAORG85Jun142007 5.5.1 During the assessment, does my laboratory have to have at least one piece of MT&E 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… http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=91 Thu, 14 Jun 2007 04:00:00 GMT A2LAORG91Jun142007 4.1.4, 4.1.5 What is meant by “key personnel”? Is this different from A2LA’s term “essential personnel”? Who should I consider “key” vs. “essential”? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=94 Thu, 14 Jun 2007 04:00:00 GMT A2LAORG94Jun142007 Advertising Policy, Section 11 Since my clients do not need or require my A2LA accreditation, I do not issue endorsed test/calibration reports and my contract review records clearly indicate that I am not required to conduct tests/calibrations under accredited conditions for these customers. As such, I feel I am not obligated to meet all of the accreditation requirements, particularly those related to the Traceability Policy, and so none of my equipment is calibrated by an appropriately accredited calibration laboratory. Is this appropriate? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=95 Thu, 14 Jun 2007 04:00:00 GMT A2LAORG95Jun142007 5.2.1, 5.2.5 Must my laboratory maintain records of actual competency data for all technical personnel? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=96 Thu, 14 Jun 2007 04:00:00 GMT A2LAORG96Jun142007 4.11.4 Does my laboratory have to maintain records to show that we have monitored the results of corrective actions taken? http://www.a2la.org/faq/faqfinder170252005.cfm?faqpk=81 Thu, 03 May 2007 04:00:00 GMT A2LAORG81May32007