ISO/IE C 17025 – the internationalstandard on laboratories（一） [复制链接]

 The flagship laboratory quality standardin the world is ISO/IEC 17025–General Requirements for the Competence ofTesting and Calibration Laboratories. Basedon years of experience using the standard,the author is recommending that the standardbe divided into two standards—one for kk#%x#L[  
testing laboratories and one for calibrationlaboratories. This recommendation is based on the confusion that arises in Clauses 4 and 5 of the standard’s treatment of the essential missions of testing labs and calibration labs. Another factor is the unique, vital procedures carried out by all calibration labs. In contrast, testing labs deal with a wide range of disciplines; any given test lab might not offer the capabilities of other facilities operating as test labs. A look at the Table of Contents of the present standard is instructive. {~q"Y]?  
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THE PERTINEN T CLA USES =`Ii?xo  
Clauses 1– 3 Xb#!1hA  
The first three clauses of the standard are Scope, Normative References, and Terms and Definitions. Clearly, the Scope would have to be changed since it attempts to address both testing and calibration laboratories. A modified Clause 1.1 might read as follows for testing labs: This International Standard specifies the general requirements for the competence to carry out tests including sampling. It covers testing performed using standard methods, non-standard methods,and laboratory-developed methods. $O nh2 ^  
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And for calibration labs, Clause 1.1 would read: This International Standard specifies the general requirements for the competence to carry out calibrations including sampling. It covers calibration performed using standard methods, non-standard methods, and laboratory-developed methods. aF8'^xF  
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The Normative References in Clause 2 would change only slightly for either the testing or the calibration laboratory standard. Similarly the Terms and Definitions in Clause 3 would also remain much the same for both testing and calibration labs since this clause simply cross-references ISO/IEC 17000 (Conformity Assessment – Vocabulary and General Principles) and VIM (International Vocabulary of Basic and General Terms in Metrology). i,
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Clause 4 sHqa(ynK  
Management Requirements is the subject of the fourth clause of ISO/IEC 17025. This part of the standard, of course, is closely aligned with ISO 9001. In fact, Annex A of ISO/IEC 17025 is an informative annex that consists primarily of nominal cross-references between ISO 9001:2000 and ISO/IEC 17025. Throughout Clause 4, the term “testing and calibration” would have to replaced with “testing” or “calibration.” One important clause that would be clarified by splitting the standard into two standards is Clause 4.5 (Subcontracting of Tests and Calibrations). The 2000 version of ISO 9001 changed the definition of “subcontracting” and that has led to much confusion in the laboratory arena. (Clause 3 of ISO 9001:2000 states that the relationship designated by supplier-organization-customer has re-placed the older trilogy of subcontractor-supplier-customerfrom ISO 9001:1994). This confusion is more prevalent in laboratories in non-English-speaking countries. Thus, for testing laboratories, Clause 4.5.4 would read “The 6?(yMSKa  
laboratory shall maintain a register of all subcontractors that it uses for tests and a record of the evidence of the compliance of those subcontractors with this International Standard for FUVp}>#U  
the work in question.” For testing laboratories, this would eliminate the confusion between “subcontracting testing” and “subcontracting calibration.” In other words, testing labs 6Ki!j<  
could subcontract testing to other qualified testing laboratories, but to comply with best practices, they would have to purchase “calibration services” from external vendors. \Up~"q>Kb  
(This requirement is covered under Clause 4.6—Purchasing Services and Supplies). It is hoped that, in the future, we continue to see a continued alignment of the management requirements in ISO 9001 and Clause 4 of ISO/IEC 17025. jp;]dyU  
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ISO/IEC 17025 – Table of Contents %:s+5*SKe  
The main clauses in the present ISO/IEC 17025 are: DRpFEWsm  
? Scope :>iN#)S  
? Normative References !Rc %  
? Terms and Definitions c4u/tt.)  
? Management Requirements +;\w'dBi,  
?? Organization " >G*hS  
?? Management System n 7i5A:  
?? Document Control "
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?? Review of Requests, Tenders, and Contracts M 9-Q  
?? Subcontracting of Tests and Calibrations $cIaLq  
?? Purchasing Services and Supplies :>.{w$Ln%  
?? Service to the Customer b6 %m*~  
?? Complaints eJTU'aX*   
?? Control of Nonconforming Testing and/or x)*Lu">  
Calibration Work j{OA%G(I  
?? Improvement `=H*4I-"  
?? Corrective Action WVRIq'  
?? Preventive Action Z?{\34lPj  
?? Control of Records Zu,:}+niU  
?? Internal Audits gS~H1Ro  
?? Management Reviews @e)}#kN.  
? Technical Requirements %XGm\p  
?? General 0SL{J*S4[#  
?? Personnel /A7( `l;6  
?? Accommodation and Environmental Conditions ]W5*R07
 
?? Test and Calibration Methods and Method X+;[Gc}(W  
Validation [KK |_  
?? Equipment jaoZ}}V_$  
?? Measurement Traceability b&rBWp0#  
?? Sampling 4zMvHe  
?? Handling of Test and Calibration Items o+1(N#?m9  
?? Assuring the Quality of Test and Calibration J8:s=#5  
Results eft=k}  
?? Reporting the Result >+%#m'Y&&  
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