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ISO 9001:2015
Company: Client-no.: Order-no.:
Requirements ensure that docu. info. is amended, and persons are aware of the changed req., when the req. are changed. (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) 8.3 8.3.1 8.3.2 Design and development of products and services *Min. of 1 ex. per cycle: establish, implement and maintain a des & dev process to ensure provision of prods and servs. consider: a) nature, duration and complexity of des & dev activities b) required process stages, incl. des & dev reviews c) required des & dev verification and validation activities d) responsibilities involved in the des & dev process e) internal and external resource needs f) need to control interfaces between persons involved g) need for involvement of customer and users h) req. for subsequent provision of prods & servs i) level of control expected by customers and other interested parties j) docu. info. needed to demonstrate that des & dev req. have been met 8.3.3 Design and development inputs determine the req. essential for the prods and servs to be designed and developed. consider: a) functional and performance req. b) info. derived from previous similar des & dev activities c) statutory and regulatory req. d) standards or codes of practice that the org. has committed to implement e) potential consequences of failure of the prods & servs retain docu. info. 8.3.4 Design and development controls apply controls to ensure that: a) results are defined b) reviews are conducted c) verification activities to ensure that outputs meet the input req. d) validation activities to ensure that the resulting prods & servs meet the req. for the specified application e) actions are taken on problems determined during the reviews, Evidence showing the inputs for the design and development process: Evidence showing the actions taken on problems determined during review, verification of validation activities: crt_f_07.96e Revision 1
Valid from 01/01/2016
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ISO 9001:2015
Company: Client-no.: Order-no.:
Requirements f) docu. info. of these activities is retained 8.3.5 (Audit notes identified with “*” are to be reported in the Audit Report) Audit notes E (Implementation / Documented Information / reviewed evidence ...) Design and development outputs ensure that outputs: a) meet the input req. b) are adequate for the subsequent processes for the provision of prods & servs c) include or reference monitoring and measuring req., d) specify the characteristics of the prods and servs retain docu. info. des & dev outputs. 8.3.6 Evidence describing the outputs from the design and development process: Design and development changes Evidence on design and development changes: identify, review and control changes made , that there is no adverse impact on conformity to req. retain Docu. info. on: a) des & dev changes b) results of reviews c) authorization of the changes d) actions taken to prevent adverse impacts Control of externally provided *Min. of 1 ex.: 8.4.1 processes, products and services ensure that externally provided processes, products, and services conform to req. 8.4 determine the controls to be applied to when: a) prods & servs from external providers are intended b) prods & servs are provided directly to the customer(s) c) a process, or part of a process, is provided by an external provider . determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers retain docu. info. of these activities and actions arising from the evaluations. 8.4.2 Type and extent of control ensure that externally provided processes, prods & servs do not adversely affect the org.’s prods & servs . The org. shall: a) externally provided processes remain within control b) define the controls to apply to an external provider and those to apply to the resulting output crt_f_07.96e Revision 1
Valid from 01/01/2016
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