Norma en revision

1. © ISO/IEC 2016
General requirements for the competence of testing and
calibration laboratories
Exigences générales concernant la compétence des laboratoires d’étalonnages et d’essais
ICS: 03.120.20
Reference number
ISO/IEC DIS 17025:2016(E)
DRAFT INTERNATIONAL STANDARD
ISO/IEC DIS 17025
ISO/CASCO Secretariat: ISO
Voting begins on: Voting terminates on:
2016-12-29 2017-03-22
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
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STANDARD UNTIL PUBLISHED AS SUCH.
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
This document is circulated as received from the committee secretariat.
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2. ii © ISO/IEC 2016 – All rights reserved
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ISO/IEC DIS 17025:2016(E)

3. ISO/IEC DIS 17025 :2016(E)
3
© ISO/IEC 2016 All rights reserved

Foreword........................................................................................................................................4
Introduction....................................................................................................................................5
1 Scope...................................................................................................................................6
2 Normative references............................................................................................................6
3 Terms and definitions ...........................................................................................................6
4 General requirements ...........................................................................................................7
4.1 Impartiality..........................................................................................................................7
4.2 Confidentiality......................................................................................................................8
5 Structural requirements........................................................................................................8
6 Resource requirements .........................................................................................................9
6.1 General................................................................................................................................9
6.2 Personnel ............................................................................................................................9
6.3 Laboratory facilities and environmental conditions................................................................10
6.4 Equipment .........................................................................................................................11
6.5 Metrological traceability......................................................................................................12
6.6 Externally provided products and services ............................................................................13
7 Process requirements..........................................................................................................14
7.1 Review of requests, tenders and contracts.............................................................................14
7.2 Selection, verification and validation of methods....................................................................15
7.3 Sampling............................................................................................................................17
7.4 Handling of test or calibration items .....................................................................................17
7.5 Technical records ...............................................................................................................18
7.6 Evaluation of measurement uncertainty................................................................................18
7.7 Assuring the quality of results..............................................................................................18
7.8 Reporting of results.............................................................................................................20
7.9 Complaints.........................................................................................................................23
7.10 Management of nonconforming work....................................................................................24
7.11 Control of data Information management............................................................................25
8 Management requirements..................................................................................................26
8.1 Options..............................................................................................................................26
8.2 Management system documentation (Option A) .....................................................................26
8.3 Control of management system documents (Option A) ............................................................27
8.4 Control of records (Option A)...............................................................................................27
8.5 Actions to address risks and opportunities (Option A).............................................................27
8.6 Improvement (Option A)......................................................................................................28
8.7 Corrective action (Option A).................................................................................................28
8.8 Internal audits (Option A)....................................................................................................29
8.9 Management reviews (Option A)...........................................................................................29
Annex A.........................................................................................................................................31
Annex B.........................................................................................................................................33
Bibliography..................................................................................................................................35

4. ISO/IEC DIS 17025 :2016(E)
4
© ISO/IEC 2016 All rights reserved
Foreword
        
          


            





              



               



              


ISO Committee on Conformity Assessment 

            

              
          

             



5. ISO/IEC DIS 17025 :2016(E)
5
© ISO/IEC 2016 All rights reserved
Introduction
           






           







 
 
 



6. ISO/IEC DIS 17025 :2016(E)
6
© ISO/IEC 2016 All rights reserved

General requirements for the competence of testing and
calibration laboratories
1 Scope
1.1 

1.2 

1.3 


2 Normative references
 


 

3 Terms and definitions
 




3.1
impartiality

 

1 


7. ISO/IEC DIS 17025 :2016(E)
7
© ISO/IEC 2016 All rights reserved
 



3.2
complaint


      conformity assessment body or accreditation body replaced by
laboratory and added the term results and removed appeals
3.3
interlaboratory comparison



3.4
intralaboratory comparison


3.5
proficiency testing


 the reference to the Annex and notes deleted.
3.6
laboratory




3.7
decision rule


4 General requirements
4.1 Impartiality
4.1.1         

4.1.2  
4.1.3 


8. ISO/IEC DIS 17025 :2016(E)
8
© ISO/IEC 2016 All rights reserved
4.1.4 
               
             

 


4.1.5                

4.2 Confidentiality
4.2.1            

4.2.2           

 
 
              

 
4.2.3 
           

4.2.4            



4.2.5          


5 Structural requirements
5.1 

 

5.2 
5.3  



5.4 
 

9. ISO/IEC DIS 17025 :2016(E)
9
© ISO/IEC 2016 All rights reserved


5.5 
              
         

 

 

5.6 

 
  

 
 

 
5.7 
 

            

6 Resource requirements
6.1 General


6.2 Personnel
6.2.1 


6.2.2 



10. ISO/IEC DIS 17025 :2016(E)
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© ISO/IEC 2016 All rights reserved
6.2.3 


6.2.4 
6.2.5 
 
 
 
 
 
 
6.2.6 
 
 
 
 
6.3 Laboratory facilities and environmental conditions
6.3.1 

6.3.2 

6.3.3 

6.3.4 

 
 
 
             

6.3.5           
 
  

11. ISO/IEC DIS 17025 :2016(E)
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© ISO/IEC 2016 All rights reserved
6.4 Equipment
6.4.1           
 


6.4.2           

6.4.3             
          

6.4.4 

6.4.5 

6.4.6            

 




6.4.7 
            

6.4.8 
              

6.4.9 

 
 
 
 
 

           


12. ISO/IEC DIS 17025 :2016(E)
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 

 
6.4.10 


 
           

6.4.11         

6.4.12 


6.4.13 

6.4.14 

              
  

         
 
6.5 Metrological traceability
6.5.1           
             

 
 
6.5.2 

 
 
  mises en pratique

6.5.3 

 
 

13. ISO/IEC DIS 17025 :2016(E)
13
© ISO/IEC 2016 All rights reserved
 


 

6.6 Externally provided products and services
6.6.1 

  
 

 
           

           


6.6.2 


 




 
6.6.3 
 
 
 
              


14. ISO/IEC DIS 17025 :2016(E)
14
© ISO/IEC 2016 All rights reserved
7 Process requirements
7.1 Review of requests, tenders and contracts
7.1.1 General
7.1.1.1 

 
            

 

           

7.1.1.2 

7.1.1.3 

 

7.1.1.4            
             


7.1.1.5 

7.1.1.6   

7.1.1.7            

 
             

 

15. ISO/IEC DIS 17025 :2016(E)
15
© ISO/IEC 2016 All rights reserved
7.1.1.8 


7.1.2 Externally provided laboratory activities
7.1.2.1

          

 
         

 
7.1.2.2 
 


7.2 Selection, verification and validation of methods
7.2.1 General
7.2.1.1 
 



7.2.1.2          


7.2.1.3  

 
7.2.1.4 

                  
             

     



