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.
Standar ISO 9001: 2015 tidak lagi menggunakan istilah “dokumen” dan “rekaman”. Keduanya sekarang disebut “informasi yang didokumentasikan” (documented information). Sesuai definisi ISO 9000: 2015, istilah informasi yang didokumentasikan mengacu pada informasi yang harus dikontrol dan dipelihara. Oleh karena itu, diharapkan perusahaan yang menerapkan manajemen sistem wajib menjaga dan mengontrol media serta informasi yang dimilikinya.
Pemahaman dasar dari perbedaan “rekaman” dan “dokumen” adalah bahwa rekaman adalah informasi yang didokumentasikan yang “disimpan”, sedangkan dokumen adalah informasi yang didokumentasikan yang “dipertahankan”. Formulir adalah dokumen, ketika formulir diisi itu menjadi rekaman. Baik dokumen dan rekaman harus dikendalikan mengikuti persyaratan standar ISO 9001: 2015 pada klausul 7.5.
Berikut ini adalah daftar “informasi terdokumentasi” yang di wajibkan untuk dikendalikan dalam standard ISO 9001:2015:
| Clause | Topic | Type of documented information | Requirement |
| 4.3 | Determining the scope of the QMS | Document | The scope of the organization’s QMS shall be available and be maintained as documented information. |
| 4.4.2 a | QMS and its processes | Document | To the extent necessary, the organization shall maintain documented information to support the operation of its processes. |
| 4.4.2 b | QMS and its processes | Record | To the extent necessary, the organization shall retain documented information to have confidence that the processes are being carried out as planned. |
| 5.2.2 a | Communicating the quality policy | Document | The quality policy shall be available and maintained as documented information. |
| 6.2.1 | Quality objectives and planning to achieve them | Document | The organization shall maintained documented information on the quality objectives. |
| 7.1.5.1 | Monitoring and measuring resources | Record | The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. |
| 7.1.5.2 a | Measurement traceability | Record | Measuring 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. |
| 7.2 d | Competence | Record | The organization shall retain appropriate documented information as evidence of competence. |
| 7.5.1 b | Documented information | Document | The organization’s QMS shall include documented information determined by the organization as being necessary for the effectiveness of the QMS. |
| 8.2.3.2 | Review of the requirements for products and services | Record | The organization shall retain documented information, as applicable, on the results of review and on any new requirements for products and services. |
| 8.3.2 j | Design and development planning | Record | The organization shall consider the documented information needed to demonstrate that design and development requirements have been met. |
| 8.3.3 | Design and development inputs | Record | The organization shall retain documented information on design and development inputs. |
| 8.3.4 f | Design and development controls | Record | The organization shall apply controls to the design and development process to ensure that documented information of these activities is retained. |
| 8.3.5 | Design and development outputs | Record | The organization shall retain documented information on the design and development outputs. |
| 8.3.6 | Design and development changes | Record | The organization shall retain documented information on design and development changes and the results of reviews. |
| 8.4.1 | Control of externally provided process, products and services | Record | The organization shall retain documented information of these activities and any necessary actions arising from the evaluations. |
| 8.5.2 | Identification and traceability | Record | The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain documented information necessary to enable traceability. |
| 8.5.3 | Property belonging to customers or external providers | Record | 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. |
| 8.5.6 | Control of changes | Record | 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. |
| 8.6 | Release of products and services | Record | The organization shall retain documented information on the release of products and services. The documentation shall include evidence of conformity with the acceptance criteria and traceability to the person(s) authorizing the release. |
| 8.7.2 | Control of nonconforming outputs | Record | 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. |
| 9.1.1 | Monitoring, measurement, analysis and evaluation | Record | The organization shall retain documented information as evidence of the results [of QMS performance evaluation]. |
| 9.2.2 f | Internal audit | Record | The organization shall retain documented information as evidence of the implementation of the audit program and the audit results. |
| 9.3.3 | Management review outputs | Record | The organization shall retain documented information as evidence of the results of management reviews. |
| 10.2.2 | Nonconformity and corrective action | Record | The organization shall retain documented information as evidence of the nature of the nonconformities and any subsequent actions taken and the results of any corrective action. |
IntiMutu Consulting saat ini memiliki layanan aplikasi EDMS (Electronic Data Management System) yang memberikan kemudahan bagi perusahaan-perusahaan yang telah menerapkan Management System seperti ISO 9001; ISO 27001; ISO 14001; ISO 45001; ISO 20000-1 dan standar ISO lainnya yang menuntut pengelolaan Dokumen dan data secara terintegrasi, tertelusur dan terukur serta mudah di akses dimanapun dan kapan pun saat dibutuhkan. Berikut ini adalah fitur EDMS yang kami tawarkan:
Selain itu, kami IntiMutu Consulting juga memberikan layanan aplikasi “Customize” secara tailor made sesuai dengan kebutuhan perusahaan untuk mendukung continual improvement meliputi HR Management System, Warehouse Management System, Manufacturing Management System, Project Management & ERP.