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articles:as9100d_oe_requirements-2 [2020/01/22 20:21] rrandallarticles:as9100d_oe_requirements-2 [2021/04/18 09:27] rrandall
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 ^  #  ^  “Retained” as Documented Information (Records)  ^  Sec.  ^ ^  #  ^  “Retained” as Documented Information (Records)  ^  Sec.  ^
-|  **1**  | //To the extent necessary//, the organization shall:  \\ b. //**retain documented information**// to have confidence that the processes are being carried out as planned. \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> |  4.4.2b +|  **1**  | //To the extent necessary//, the organization shall:  \\ b. //**retain documented information**// to have confidence that the processes are being carried out as __planned__. \\ <wrap em>**[While this requirement is SUBJECTIVE, it is clarified in: \\ 
-|  **2**  | The organization shall //**retain __appropriate__ documented information**// as evidence of fitness for purpose of the monitoring and measurement resources. \\ <wrap em>**[SUBJECTIVE requirement - because AS 9100D fails to adequately address this topic]**</wrap> |  7.1.5.1  |+7.5.1 General \\ 
 +The organization’s quality management system shall include: \\ 
 + • documented information required by this International Standard; \\ 
 + • documented information DETERMINED BY THE ORGANIZATION as being necessary for the effectiveness of the quality management system\\ 
 + \\ 
 +AND Annex A.6 \\ 
 +“THE ORGANIZATION is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained, and the media to be used for its retention." \\ 
 + \\ 
 +NOTE: //Some// ACCREDITATION BODY AUDITORS from ANAB have incorrectly interpreted 4.4.2b to mean that EVERYWHERE the standard uses the word "PLAN", there must be an associated record. This would significantly expand the number of records required. However, the AS9100 IDR has stated that this interpretation was incorrect.] \\ 
 +**</wrap> |  4.4.2b 
 +|  **2**  | The organization shall //**retain __appropriate__ documented information**// as evidence of fitness for purpose of the monitoring and measurement resources. \\ <wrap em>**[SUBJECTIVE requirement - because AS 9100D fails to adequately define what is considered to be __appropriate__ .]**</wrap> |  7.1.5.1  |
 |  **3**  | When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: \\ a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be //**retained as documented information**//; |  7.1.5.2a  | |  **3**  | When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: \\ a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be //**retained as documented information**//; |  7.1.5.2a  |
 |  **4**  | The organization shall: \\ // d. **retain __appropriate__ documented information**// as evidence of competence.  |  7.2d | |  **4**  | The organization shall: \\ // d. **retain __appropriate__ documented information**// as evidence of competence.  |  7.2d |