I am an assessor of EMC Labs for Accreditation to ISO/IEC 17025 for various EMC related fields/industries (commercial, military, automotive, etc. tests)
The John Shinn post is accurate. However, the autoritative answer must be found in the words of the requirements document which is provided herein. Because this post is long I have provided section numbers to help in readibility. 1- Acceptability of Approach Must Be In the Requirements Document Proper assessment techniques would lead us to determine acceptability or not of other than lab staff using lab equipment based on the words of the standard or a test methods. If a deficiency can not be described or referenced to the words of the ISO/IEC 17025 standard, the methods documents used for accreditation (e.g. ANSI C63.4, EN55022, MIL-Std 461E, CISPR25, etc.), or the laws of physics it does not exist. 2- Issue Raised - Can test equipment for tests outside the Scope of Accreditation be operated by staff not authorized to do accredited tests? The issue stated was as follows: "Now, they won't let us do that with reference to their accreditation status. The test lab personnel have to operate the test equipment. Does it make sense, is there any restriction in the accreditation ?" The question implies that test equipment for tests outside the Scope of Accreditation may be operated by staff not authorized to do accredited tests. This is generally correct, but still needs further review as described herein. 3- Accreditation Focus or Area of Coverage The Accreditation Body focuses on the Scope of Accreditation and does not extend it's evaluation to other test methods or other activities as long as (1) the quality and competence of the accredited test methods are not negatively impacted and (2) an incorrect or misleading claim to accreditation is not made. A lab may be accredited only for certain EMC tests (e.g. those supporting Declaration of Conformity requirements under government regulations) and not for many other EMC or mechanical or other tests actually performed at the lab. In addition, the same tests that the lab is accredited for may be performed as research and development tests or as pre-compliance or equivalent tests without being in violation of the scope of accreditation using simplified means provided no indication or implication that these tests are under the scope of accreditation is made. Government regulations or the standards themselves should be referred to for tests or rigor of tests used before one should claim compliance without even considering accreditation. 4- Guidelines for Acceptable Reference to Accreditation The Accreditation Bodies worldwide typically encourage use of the Accreditation Body logo or other means of indication when the test, calibrations or inspections come under the accredited scope. Only reports bearing the logo or equivalent can benefit from the recognition that mutual recognition agreements/arrangements amongst accreditation bodies bring. Accreditation indication by logos or the equivalent provides formal recognition that a testing or calibration laboratory or an inspection body is capable of meeting certain standards. These are standards of quality, performance, technical expertise and competence. The international guideline that provides more information is ILAC-G14:2000, "Guidelines for the Use of Accreditation Body Logos and for Claims of Accreditation Status". The individual Accreditation Bodies meet ISO/IEC Guide 58:1993 clauses 4.2.2 and 4.5(f) that require accreditation bodies to have arrangements for controlling the manner in which an accredited laboratory (or inspection body) may refer to its accredited status and to have requirements, restrictions or limitations on the use of the accrediting body?s logo and on the ways of referring to the accreditation granted. Consequently, the individual Accreditation Body should be contacted for their specific rules. 5- Specific Requirements of ISO/IEC 17025 Relating to the Issue of Discussion The above indicated the basis to indicate or reference accreditation. Included was quality, performance, technical expertise and competence. Another organization or staff that is not enveloped under the lab scope of accredition is not normally included under the assessment practices of the Accreditation Body and therefore the quality, performance, technical expertise and competence of the tests can not be endorsed by reference to accreditation. The following are excerpts of some of the actual clauses used in accreditation that relate to the issue raised: ISO/IEC 17025 clause 5.2.1 includes (among other things) the following: "laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates." ISO/IEC 17025 clause 5.2.3 includes (among other things) the following: "laboratory shall use personnel who are employed by, or under contract to, the laboratory. Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's quality system." ISO/IEC 17025 clause 5.3.4 includes the following: "Access to and use of areas affecting the quality of the tests and/or calibrations shall be controlled. The laboratory shall determine the extent of control based on its particular circumstances." ISO/IEC 17025 clause 5.5.9 includes the following: "When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory shall ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service." On the basis of the actual requirements the accredited lab must do much work to allow someone other than their own staff authorized to do tests under their scope of accreditation or allow others to use the test equipment that was assessed by the Accreditation Body for use in accredited tests. They must: "ensure the competence of all who operate specific equipment" "ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's quality system" "ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service" The above desribed the foundation to assess if someone outside the test personnel can operate the accredited test lab's equipment. Other provisions of ISO/IEC 17025 may be pertinent when details of the actual relationship and circumstances of the situation are assessed. 6- Bottom Line Answer - Can Tests by Non-Accredited Lab Staff Be Done Without Violating Accredited Status a) In general, the controls and precautions to protect the integrity of the equpment and the scope of accredition is not in place such that Tests by Non-Accredited Lab Staff using the equpment supporting the scope of accreditation would lead to a deficiency by the Accreditation Body Assessors (as well as lab internal quality audts). b) With proper control, consistent with ISO/IEC 17025, Tests by Non-Accredited Lab Staff can be done if the lab has objective evidence that the individual is competent to "operate operate specific equipment" and "that they work in accordance with the laboratory's quality system". This approach is found in several in-house accredited laboratories I have assessed that allows EMC development engineers to run tests -- but these are performed as research and development tests or as pre-compliance or equivalent tests without being in violation of the scope of accreditation as no indication or implication that these tests are under the scope of accreditation is made. c) Equipment not used to support accreditation is used by outsiders in a manner sufficiently contolled or monitored to prevent jeopardizing the status of accreditation. Areas for client use or troubleshooting are often designated as such. d) Accredited lab staff from one accredited lab may actually use the other accredited lab's facility which is generally based on an agreement being in place that defines that all staff operating the equipment are competent to operate specific equipment and the provisions of ISO/IEC 17025 are met by the user's of the facility and that the user's are from an Accredited lab. Note, some regulatory authorities may not accept this as they want the accredited lab to own the test facility and equpment being used. An Assessor would write deficiencies against item 6(a) above. Item 6 (b), (c) with adequate objective evidence would be generally accepted. Item 6 (d) would be accepted; however, accreditation to a national standard from the nation that required the accredited lab to own the test facility and equpment being used would not generally be granted. I hope this input has been helpful and may establish some guidelines to determine acceptability of various approaches. Larry Gradin *************************************************************** * Larry Gradin, PE, QMS-LA * Email: [email protected] & [email protected] * Integrity Solutions Group, Inc. * 6419 Bridgewood Terrace * Boca Raton, FL 33433 USA * Phone 561-289-9137 * Efax: 978-285-6589 * Email to Mobile Phone: [email protected] * Web Page http://www.Integrity-Solutions.org _______________________________________________________ Remember - Quality depends on Integrity, Attention To Detail, Cost-Effective Action, and Commitment -- not buzzwords. ***************************************************************** ----- Original Message ----- From: "John Shinn" <[email protected]> To: <[email protected]>; "'"EMC-PSTC (E-mail)" <'" <[email protected]> Sent: Thursday, May 23, 2002 12:06 PM Subject: RE: Accreditation - testing ourselves > > Yes, it does make sense. I am speaking from the position of an Accredited > Laboratory. > When a lab is accredited, it will receive a certificate of accreditation > which states that > it is accredited to ISO 17025 (and the accrediting body) and a "Scope of > Accreditation". > The Scope of Accreditation will list those acitivites (or standards) that > the lab is may > perform under the accreditation. > > During the accreditation process, the lab personnel are evaluated in their > knowledge > and ability to perform those tests. The Accredited lab is responsible for > ascertaining > that the test were performed correctly and according to the documented > procedure. > Thus, in order to assure that the test was performed correctly, the lab will > require that > the lab personnel perform the test. > > However, the lab may perform other tests outside of their scope. In doing > so, they are > not allowed to use the logo of the accrediting body, or indicate that the > test report is > generated by an accredcited laboratory. > > If you want to do an Engineering Evaluation and want data only, then it > would probably > be ok if you ran the test, but that would depend upon the policy of the Lab. > There is > no requirement that they have to allow you to use their equipment for > performing the > test. > > If you want a Final Test Report with all of the applicable accreditations, > then you would > want the lab's personnel to perform the test. The result would be a test > report that > would be recognized by many regulatory agencies, depending upon the lab's > accreditation > and MRA status. > > John Shinn, P.E. > Manager, Lab Operations > Sanmina-SCI Homologation Services > > > > -----Original Message----- > From: [email protected] > [mailto:[email protected]]On Behalf Of > [email protected] > Sent: Thursday, May 23, 2002 5:25 AM > To: "EMC-PSTC (E-mail)" < > Subject: Accreditation - testing ourselves > > > > Hi all, > > An EMC test lab is accredited according to ISO/IEC 17025. They are also > accredited for many tests as the IEC61000-4-series, EN55022 and many other. > We have previously done some EMC pre-testing in this lab and we have > operated the test equipment ourselves. Now, they won't let us do that with > reference to their accreditation status. The test lab personnel have to > operate the test equipment. Does it make sense, is there any restriction in > the accreditation ? > > We have always made a clear cut between pre-testing and accredited testing. > > Best regards > Amund Westin > > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Ron Pickard: [email protected] > Dave Heald: [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > http://ieeepstc.mindcruiser.com/ > Click on "browse" and then "emc-pstc mailing list" > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Ron Pickard: [email protected] > Dave Heald: [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > http://ieeepstc.mindcruiser.com/ > Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
