【正文】 origin are identified and their distribution controlled? f) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? () ? Document approval authority. ? Document approval records. ? Availability of documents in various locations. ? Knowledge of documents location. ? Document accessibility. ? Storage and disposal of obsolete documents. ? Process for notification/distribution of documents from internal and external origins. ? Review and approval of revised documents. Engineering specifications Does the anization have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes (including the updating of appropriate documents) based on customer required schedule? () ? Process for notification/distribution of customer engineering standards changes. ? Process for implementation of customer initiated changes. ? Document changes triggered by engineering changes. Does the anization maintain a record of the date on which each change is implemented in production? () ? Records of engineering changes implemented. Control of records 企業(yè) ()大量管理資料下載 8 Has the anization established and maintained records to provide evidence of conformity to requirements and of the effective operation of the quality management system? () ? Quality management system records. ? Records maintenance system, including disposal of records.. Are records legible, readily identifiable and retrievable? () ? Quality management system records legibility. ? Identification of quality management system records. ? Environment and storage conditions must be patible with the file storage medium (ex: hard copy, floppy disk, etc.) Has the anization established a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records ? () ? Quality manual according to TS 16949. ? Defined record retention time pared to customer/regulatory requirements ? Record disposal after retention period expires ? Including identification of obsolescence documents. ? Identification of invalid/obsolete documents. Does the anization treats quality records as a special type of document and control them according to the requirements given in questions and ? () ? Evidence of quality records being maintained and controlled per quality manual. 5 Management responsibility Management mitment Does top management have evidence of providing mitment to the development and implementation of its quality management system? () ? Documented policy statement with clearly defined and measurable quality objectives approved by CEO 企業(yè) ()大量管理資料下載 9 Does the anization’s top management have evidence of providing mitment to continually improving its quality management system effectiveness by a) municating to the anization the importance of meeting customer as well as statutory and regulatory requirements? b) establishing the quality policy? c) ensuring that quality objectives are established? d) conducting management reviews? e) ensuring the availability of resources? () ? Customer defined objectives (Customer specifications) and pany goals stated in the business plan and their alignment with the quality policy statement. ? Quality manual according to TS 16949. ? Management reviews meeting minutes。 attendance and adequate frequency. ? Action plans and followup. Process Efficiency Does anization’s top management monitor the product realization processes and the support processes to assure their effectiveness and efficiency? () ? Review of product realization and support processes by top management. ? Indicators and records. ? Reporting process. Customer Focus Does top management ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction? () ? Description of an objective process ? Methodology used for surveys ? Original Customer data and scope such as customer satisfaction feedback (surveys, scorecards, awards, etc) Quality policy 企業(yè) ()大量管理資料下載 10 Does top management ensure that the quality policy: a) is appropriate to the purpose of the anization? b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system? c) provides a framework for establishing and reviewing quality objectives? d) is municated and understood within the anization? e) is reviewed for continuing suitability? () ? Documented policy statement with clearly defined and measurable quality objectives approved by CEO ? Records of improvement. ? Quality objectives included/linked to the business plan. ? Scope of the Quality objectives. ? Direct interviews with randomly selected people of the anization. ? Evidence of periodic review of the quality policy. ? Review of all the elements of the quality system to insure its continuing suitability and effectiveness. Quality objectives Does the anization’s top management ensure that quality objectives, including those needed to meet requirements for product (see section of the ISO/TS 16949:20xx(E) technical specification) are established at relevant functions and levels within the anization? () ? Are the anization’s quality objectives measurable and consistent with the quality policy? () ? Quality cost indicators and quality indices ? Quality objectives included/linked to the business plan. Did top management define a