| Both sides previous revisionPrevious revisionNext revision | Previous revisionNext revisionBoth sides next revision |
| articles:iso17025-2017_oe_requirements-1 [2019/08/31 15:22] – rrandall | articles:iso17025-2017_oe_requirements-1 [2019/09/01 09:31] – rrandall |
|---|
| |
| ^ # ^ Documents & Procedures ^ Sec. ^ | ^ # ^ Documents & Procedures ^ Sec. ^ |
| | 1 | The laboratory shall define and //**document**// the __range of laboratory activities__ for which it conforms with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis. | 5.3 | | | 1 | The laboratory shall define and //**document**// the __range of laboratory activities__ for which it conforms with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis. \\ <wrap hi>**[The __range of laboratory activities__ is typically referred to as the "scope".]**</wrap> | 5.3 | |
| | 2 | The laboratory shall: \\ c) //**document**// its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results. \\ <wrap em>**[SUBJECTIVE REQUIREMENT - while "//the extent necessary//" is completely subjective, this requirement can only be verified through confirming "__consistent application__" of the laboratories "activities and the validity of the results."]**</wrap> | 5.5c | | | 2 | The laboratory shall: \\ c) //**document**// its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results. \\ <wrap em>**[SUBJECTIVE REQUIREMENT - while "//the extent necessary//" is completely subjective, this requirement can only be verified through confirming "__consistent application__" of the laboratories "activities and the validity of the results."]**</wrap> | 5.5c | |
| | 3 | The laboratory shall //**document**// the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience. \\ <wrap hi>**[This documentation //may// exist in "Job Descriptions", Competency Matrices, etc.]**</wrap> | 6.2.2 | | | 3 | The laboratory shall //**document**// the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience. \\ <wrap hi>**[This documentation //may// exist in "Job Descriptions", Competency Matrices, etc.]**</wrap> | 6.2.2 | |
| |
| |
| <note tip>**# 2 ** \\ For guidance on documenting "a general description of relevant interested parties", read: [[articles:context_of_the_organization|Context of the Organization... and "Interested Parties"]]</note> | <note tip>**# 1 ** \\ For information on how to create/craft the language of the "__range of laboratory activities__" reference: \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9162|ANAB ADMINISTRATIVE PROCESS RULE: PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 CALIBRATION LABORATORIES]] \\ • [[https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=9161|ANAB ADMINISTRATIVE PROCESS RULE: PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 TESTING LABORATORIES]]</note> |
| | |
| <note tip>**# 3** \\ Guidance from ISO on crafting an acceptable QMS "scope" can be found online in the: [[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/General/APG-Scope2015.pdf|ISO 9001 Auditing Practices Group Guidance on: "Scope of ISO 9001, Scope of Quality Management System (QMS) and Scope of Certification"]]</note> | |
| | |
| <note important>**# 3** \\ When asked "//Is it allowable for an organization to claim non-applicability with any sub-clause or sub-paragraph of 9100-series?//", the response contained in the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] stated: \\ //"Yes. Organizations can claim non- applicability even down to a shall statement or portions of a shall statement."// \\ \\ Also, when asked "//Is it required that any non-applicability with a requirement be documented in the scope section of the __Quality Manual__?//", the response contained in the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] stated: \\ //"No. It is required that any non-applicability with a clause or “shall” statement be documented information but does not have to be documented in the scope section of a __Quality Manual__."//</note> | |
