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| articles:as9100d_oe_requirements-2 [2020/10/19 18:35] – rrandall | articles:as9100d_oe_requirements-2 [2020/10/19 18:45] – 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>**[While this requirement is SUBJECTIVE, the Accreditation Body auditors have interpreted this to mean that EVERYWHERE the standard uses the word "PLAN", there must be an associated record. This significantly expands the number of records required to include: \\ | | **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, the ACCREDITATION BODY AUDITORS have interpreted this to mean that EVERYWHERE the standard uses the word "PLAN", there must be an associated record. This significantly expands the number of records required to include: \\ |
| 5.3e (ensuring that the integrity of the quality management system is maintained when changes to the quality management system are implemented) \\ | 5.3e (ensuring that the integrity of the quality management system is maintained when changes to the quality management system are implemented) \\ |
| 6.1.2a - actions to address risks and opportunities \\ | 6.1.2a - actions to address risks and opportunities \\ |
| d. the requirements of the test plan and the test procedures are observed; \\ | d. the requirements of the test plan and the test procedures are observed; \\ |
| e. the acceptance criteria are met." \\ | e. the acceptance criteria are met." \\ |
| 8.5.1 - "when sampling is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability)." \\ | 8.5.1f - "the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;" \\ |
| | 8.5.1n - "the availability of evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized;" \\ |
| ]**</wrap> | 4.4.2b | | 8.6 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met." \\ |
| | 8.6 - "The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer." \\ |
| | 9.1.2 - "The organization shall develop and implement __plans__ for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results." (this is typically "recorded in management reviews) \\ |
| | 9.2.1 - "The organization shall conduct internal audits at __planned__ intervals to provide information on whether the quality management system;" \\ |
| | 9.2.2a - "__plan__, establish, implement, and maintain an audit program(s) including the frequency, methods, responsibilities, planning requirements, and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;" \\ |
| | 9.3.2 - "The management review shall be __planned__ and carried out taking into consideration:" \\ |
| | \\ |
| | While many of these "planning-related" records are required elsewhere, this interpretation does add a few more records to the list.]**</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 address this topic]**</wrap> | 7.1.5.1 | | | **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 | |
| | **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 | |
