Differences

This shows you the differences between two versions of the page.

Link to this comparison view

Both sides previous revisionPrevious revision
Next revision
Previous revision
articles:iso17025-2017_oe_requirements-1 [2019/10/24 14:45] rrandallarticles:iso17025-2017_oe_requirements-1 [2023/02/01 18:38] (current) rrandall
Line 36: Line 36:
 |  **15**  | The laboratory shall have a //**procedure**// that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The //**procedure**// shall ensure that: \\ a) the responsibilities and authorities for the management of nonconforming work are defined; \\ b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; \\ c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; \\ d) a decision is taken on the acceptability of the nonconforming work; \\ e) where necessary, the customer is notified and work is recalled; \\ f) the responsibility for authorizing the resumption of work is defined.|  7.10.1  | |  **15**  | The laboratory shall have a //**procedure**// that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The //**procedure**// shall ensure that: \\ a) the responsibilities and authorities for the management of nonconforming work are defined; \\ b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; \\ c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; \\ d) a decision is taken on the acceptability of the nonconforming work; \\ e) where necessary, the customer is notified and work is recalled; \\ f) the responsibility for authorizing the resumption of work is defined.|  7.10.1  |
 |  16  | Laboratory management shall establish, //**document**//, and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization. \\ <wrap hi>**[While not specifically required, this is typically accomplished through a Quality Manual.]**</wrap> |  8.2.1  | |  16  | Laboratory management shall establish, //**document**//, and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization. \\ <wrap hi>**[While not specifically required, this is typically accomplished through a Quality Manual.]**</wrap> |  8.2.1  |
 +|  17  | The policies and objectives shall address the competence, impartiality and consistent operation of the laboratory. \\ <wrap hi>**[Often overlooked are the requirements that must be included in the above documented "__policies and objectives__". Particularly "competence" & "impartiality".]**</wrap> |  8.2.2  |
  
- +<WRAP center round tip 80%> 
-<note tip>**# 1 ** \\ For information on how to create/craft the language of the "__range of laboratory activities__" reference ANAB Administrative Process Rule: \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9162|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 CALIBRATION LABORATORIES]] \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=12602|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 DIMENSIONAL MEASUREMENT LABORATORIES]] \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9161|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 TESTING LABORATORIES]]</note>+**# 1 ** \\ For information on how to create/craft the language of the "__range of laboratory activities__" reference the applicable ANAB Administrative Process Rule: \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9162|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 CALIBRATION LABORATORIES]] \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=12602|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 DIMENSIONAL MEASUREMENT LABORATORIES]] \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9161|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 TESTING LABORATORIES]]</WRAP>