【正文】 dditional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Quality Management System ? Retain responsibility for all outsourced processes [] ? Review customer engineering specifications changes within 2 weeks [] ? Control records of regulatory and customer requirements [] 3/15/2023 24 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Product Realisation ? Include customer requirements and reference to in the planning of product realisation [(.1)] ? Define and approve acceptance criteria with the customer [] ? Ensure confidentiality of customer contracted products and product information during design development and production. [] ? Have change control process that。 ? evaluation of the statistical data received from the supplier ? receiving inspection ? 2nd or 3rd part audits with records of acceptable delivered performance ? part evaluation by a designated laboratory [] 3/15/2023 35 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Product Realisation (cont’d) ? Maintain calibration records including ? Equipment identification ? The standard against which the equipment is calibrated ? Revisions following changes to equipment ? Assessments of the impact of outofspecification equipment ? Notifications to customer of any product that may have been affected by outofspecification measuring equiment ? A positive statement of the acceptance of the calibration for the intended purpose [] 3/15/2023 40 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Measurement, Analysis and Improvement (cont’d) ? Define a programme for continual improvement [] ? Focus manufacturing improvement on reducing variation [] ? Define a process for problem solving [] ? Use error proofing methods in the corrective action process [] ? Apply corrective action to other similar processes and products [] ? Minimise the time for corrective action [] 3/15/2023 46 Pro Enviro Ltd Wayside House Wilson39。 ? location is measured by the mean [ X ] ? spread is measured by the range [R] or standard deviation [sd] ? SPC can be applied to see if variation is unacceptable 3/15/2023 51 Pro Enviro Ltd Wayside House Wilson39。 ? reduction of variation, and, ? prevention of defects / waste. ? Applied to all processes whose output measures offer ? Variable data . part dimensions ? Attribute data – conforming。 ? stability of the process ? capability of the inspection and test process ? capability of the reaction plans to contain the effect of any nonconformity [] 3/15/2023 43 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Product Realisation (cont’d) ? Validate all processes for product and service provision to demonstrate the ability of these processes to achieve planned results – where applicable through。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 ? Product Realisation (cont’d) ? Document and include the following in ?product design output’ in ways that demonstrate that all design inputs have been met ? design FMEAs including diagnostic guidelines to predict failure modes ? reliability results ? special characteristics ? an analysis of error proofing ? product drawings, specifications and calculations ? product design reviews [] 3/15/2023 32 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Resource Management ? Personnel with product design responsibility shall be petent to achieve design requirements and skilled in applicable tools and techniques. [] ? Document procedures for identifying training needs and achieving petence of personnel [] ? Provide onthejob training, including the consequences to the customer of nonconformities [] ? Have a process to motivate employees to。n ISO/TS 16949:2023 Contact customer Renault ISO/TS 16949:2023 Contact customer Rover Contact customer [ RG2023 Supplier Management System ] Saab Contact customer Contact customer Subaru Contact customer [ Subaru Supplier Manual ] Toyota Contact customer [ Supplier Quality Assurance Manual ] 3/15/2023 20 Pro Enviro Ltd Wayside House Wilson39。 Honda UK。s Lane Coventry CV6 6NY Key Aspects – Customer focus ? Customer specific requirements are included in an audit for ISO/TS 16949 ? “Customer specific quality management system requirements supplemental to ISO/TS 16949 shall be included in the audit in order to obtain customer recognition of such certification” ? What is your process for identifying and using customer specific quality management system requirements? 3/15/2023 16 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Key Aspects – Overview ? Focus on Human Resource management including ? processes for defining petence requirements, ? providing training (including on the job training for employed, temporary and agency personnel), ? verifying effectiveness of actions taken ? A process to motivate employees to ? achieve quality objectives, ? make continual improvement, and ? create an environment to promote innovation. ? A process to measure the extent to which personnel are aware of the relevance importance