![]() The organization shall retain documented information as evidence of the results. Monitoring, measurement, analysis and evaluation The organization shall retain documented information that describes the nonconformity, actions taken, any concessions obtained and identifies the authority deciding the action in respect of the nonconformity. The documentation shall include evidence of conformity with the acceptance criteria and traceability to the person(s) authorizing the release. The organization shall retain documented information on the release of products and services. The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review. When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred. Property belonging to customers or external providers The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain documented information necessary to enable traceability. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations. The organization shall retain documented information on design and development changes and the results of reviews.Ĭontrol of externally provided process, products and services The organization shall retain documented information on the design and development outputs. The organization shall apply controls to the design and development process to ensure that documented information of these activities is retained. ![]() The organization shall retain documented information on design and development inputs. The organization shall consider the documented information needed to demonstrate that design and development requirements have been met. The organization shall retain documented information, as applicable, on the results of review and on any new requirements for products and services. Review of the requirements for products and services The organization’s QMS shall include documented information determined by the organization as being necessary for the effectiveness of the QMS. The organization shall retain appropriate documented information as evidence of competence. #Contoh dokumen iso 14001 verificationMeasuring equipment shall be 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 standard exists, the basis for calibration or verification shall be retained as documented information. The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. ![]() The organization shall maintained documented information on the quality objectives. Quality objectives and planning to achieve them The quality policy shall be available and maintained as documented information. To the extent necessary, the organization shall retain documented information to have confidence that the processes are being carried out as planned. To the extent necessary, the organization shall maintain documented information to support the operation of its processes. The scope of the organization’s QMS shall be available and be maintained as documented information. Baik dokumen dan rekaman harus dikendalikan mengikuti persyaratan standar ISO 9001: 2015 pada klausul 7.5.īerikut ini adalah daftar “informasi terdokumentasi” yang di wajibkan untuk dikendalikan dalam standard ISO 9001:2015: Clause Formulir adalah dokumen, ketika formulir diisi itu menjadi rekaman. Pemahaman dasar dari perbedaan “rekaman” dan “dokumen” adalah bahwa rekaman adalah informasi yang didokumentasikan yang “disimpan”, sedangkan dokumen adalah informasi yang didokumentasikan yang “dipertahankan”. ![]() ![]() Oleh karena itu, diharapkan perusahaan yang menerapkan manajemen sistem wajib menjaga dan mengontrol media serta informasi yang dimilikinya. Sesuai definisi ISO 9000: 2015, istilah informasi yang didokumentasikan mengacu pada informasi yang harus dikontrol dan dipelihara. Keduanya sekarang disebut “informasi yang didokumentasikan” (documented information). Standar ISO 9001: 2015 tidak lagi menggunakan istilah “dokumen” dan “rekaman”. Permasalahan klasik yang seringkali dihadapi perusahaan pada tahap awal penerapan Management System adalah kendala dalam pengelolaan dokumen dan data atau rekaman (records), yang merupakan bagian dari mengubah mindset dan habit personil untuk membiasakan diri bekerja dengan pola dokumentasi yang konsisten. ![]()
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