Then, your organization's operations and records are evaluated against your QM to verify that you are doing what you say you are doing. In the second phase, anything in your QM is fair game for the auditor to look at. One advantage of electronic documents is that links to other documents, of any type, can be embedded in the document. In the example QM, links are represented by blue underlined text, but they are simulated.
In your real document, each link would actually point to a real document on your file server. This ability makes control of documents easier. Therefore, whenever someone clicks on the link, they will always — and only — see the current version of the referenced document.
The older version can be saved under a different name; the easiest way to do that is to simply add the revision date, in ISO format 2 , to the file name. For example, assume that procedure QP with the revision date of November 10, is being replaced with a new version revised today. No links have to be changed, and the date added to the old version file name uniquely identifies it. Sharp readers will also note that a version of ISO date format appears in a number of places in the example QM.
The date is always written with the biggest time unit year on the left and the smallest time unit day of month for dates on the right. One advantage is that the format is unambiguous and culture-independent. Another is that a date in this format as part of the file name is always sorted in correct order by a computer. The most common permissible exclusion is clause 7.
However, it is generally not a good idea to simply omit the excluded parts from the QM. It is much better to include reference to them, specifically state that they are excluded and why, and what the plans are if the current situation ever changes.
Section 7. In some cases, such as the case of the example QM, the scope of the QMS is so tightly defined that functions normally part of the QMS are actually performed by organizational departments that are outside the defined QMS. In the case of Mythical True Value Metrology, purchasing is an example of that. The metrology organization only has limited authority for small purchases; all others must go through the corporate purchasing department, which is not part of the QMS.
In cases like this, the organization should do two things. Previously, ISO was applied by various industries, especially manufacturing.
The manufacturing industry applies the ISO quality management system to assure customers that the products they produce are of guaranteed quality from the beginning to the end of the process within the organization. This manufacturing industry also ensures that all processes are carried out according to international quality management standards.
So that the resulting product can meet the needs of demand on an international scale. Even today there are several non-profit organizations implementing the ISO quality management system, including: Health Office, Social Service and other government institutions.
This organization considers the implementation of ISO can improve the performance of the organization's services to customers in this case is the general public, so it is hoped that public satisfaction with the services provided will increase. The ISO requirements have been issued since and organizations that are still implementing the old ISO standard are given the opportunity no later than 3 years after This year September is the deadline for changes to the ISO standard.
This shows that organizations must be ready to face the latest challenges in implementing this new version of the quality management system. The implementation of the use of ISO has been tried in various fields in various studies, but research that summarizes the impact of the implementation of ISO on the quality management system in various sectors has not been carried out so that this research is important to do in order to summarize the extent of the impact of ISO implementation on various sectors.
There are several general characteristics of a quality management system: a. Quality management systems cover a wide range of activities in modern organizations. Quality or quality can be defined through five main approaches: 1 Transcendent Quality is an ideal condition for excellence, 2. Product Basic Quality is a product attribute that meets quality, 3.
Manufacturing Based quality is conformity to standard requirements, and 5. Value Based Quality is the degree of excellence at a competitive price level. The quality management system focuses on the consistency of the work process. This often includes some level of documentation against work standards. The quality management system is based on error prevention so that it is proactive, not reactive error detection. The ISO based Quality Management System was created to regulate management within an organization to be more planned and systematic in order to effectively fulfill what customers expect by making continuous improvements conditional improvement.
The ISO Quality Management System has 7 principles that must be applied, namely customer focus, leadership, people involvement, process approach, improvement, evidence-based decision making, and relationship management.
Therefore, every organization or institution must understand the needs and desires of customers, both current and future needs and wants. In addition, the leader of the organization or institution must create and maintain an internal environment so that people can become fully involved in achieving the goals of the organization or institution. By involving all people, the benefits received by the organization or institution will be greater. Organisasi harus menyimpan informasi The organization shall retain documented terdokumentasi dari masukan desain dan information on design and development pengembangan.
Kegiatan They can be conducted separately or in any tersebut dapat dilakukan secara terpisah atau combination, as is suitable for the products and dikombinasikan, sebagaimana diperlukan untuk services of the organization. Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi pengukuran, jika sesuai, dan kriteria and acceptance criteria; keberterimaan; d menentukan karakteristik produk dan jasa d specify the characteristics of the products yang penting untuk tujuan yang dimaksud and services that are essential for their dan penyediaan yang aman dan tepat.
Organisasi harus menyimpan informasi The organization shall retain the documented Penanggung jawab Penggunaan: Kepala Bidang Pendidikan dan Pelatihan Standardisasi terdokumentasi dari keluaran desain dan information on design and development pengembangan.
Organisasi harus menyimpan informasi The organization shall retain documented terdokumentasi: information on: a perubahan desain dan pengembangan; a design and development changes; b hasil tinjauan; b the results of reviews; c otorisasi perubahan; c the authorization of the changes; d tindakan yang diambil untuk mencegah d the actions taken to prevent adverse dampak negatif.
Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi langsung pada pelanggan oleh penyedia directly to the customer s by external eksternal atas nama organisasi; providers on behalf of the organization; c proses atau bagian proses yang c a process, or part of a process, is disediakan oleh penyedia eksternal provided by an external provider as a sebagai hasil keputusan organisasi. Organisasi harus menetapkan dan The organization shall determine and apply menerapkan kriteria untuk mengevaluasi, criteria for the evaluation, selection, Penanggung jawab Penggunaan: Kepala Bidang Pendidikan dan Pelatihan Standardisasi memilih, memantau kinerja dan monitoring of performance, and re-evaluation mengevaluasi ulang penyedia eksternal of external providers, based on their ability to berdasarkan kemampuannya menyediakan provide processes or products and services proses atau produk dan jasa sesuai dengan in accordance with requirements.
The persyaratan yang ditentukan. Organisasi organization shall retain documented harus menyimpan informasi terdokumentasi information of these activities and any kegiatan ini dan tindakan apapun yang necessary actions arising from the diperlukan yang timbul dari evaluasi.
Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi produk dan jasa yang disediakan oleh externally provided processes, products penyedia eksternal memenuhi and services meet requirements.
Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi Organisasi harus menggunakan cara yang The organization shall use suitable means to sesuai untuk mengidentifikasi keluaran identify outputs when it is necessary to proses, bila diperlukan untuk memastikan ensure the conformity of products and kesesuaian produk dan jasa, services.
Organisasi harus mengidentifikasi status The organization shall identify the status of keluaran proses sehubungan dengan outputs with respect to monitoring and persyaratan pemantauan dan pengukuran measurement requirements throughout sepanjang penyediaan produksi dan jasa.
Penanggung jawab Penggunaan: Kepala Bidang Pendidikan dan Pelatihan Standardisasi Organisasi harus mengendalikan identifikasi The organization shall control the unique unik dari keluaran proses ketika mampu identification of the outputs when traceability telusur dipersyaratkan dan menyimpan is a requirement, and shall retain the informasi terdokumentasi yang diperlukan documented information necessary to enable untuk memelihara ketertelusuran.
Bila properti milik pelanggan atau penyedia When the property of the customer or eksternal hilang, rusak atau ditemukan tidak external provider is lost, damaged or sesuai untuk digunakan, organisasi harus otherwise found to be unsuitable for use, the melaporkannya pada pelanggan atau organization shall report this to the customer penyedia eksternal dan menyimpan or external provider and retain documented informasi terdokumentasi saat terjadi.
CATATAN Preservasi dapat termasuk NOTE Preservation can include identification, identifikasi, penanganan, pengendalian handling, contamination control, packaging, kontaminasi, pengemasan, penyimpanan, storage, transmission or transportation, and transmisi atau transportasi dan proteksi.
Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi Organisasi harus memenuhi persyaratan The organization shall meet requirements for kegiatan pasca penyerahan yang terkait post-delivery activities associated with the dengan produk dan jasa.
Dalam menentukan jangkauan dari kegiatan In determining the extent of post-delivery pasca penyerahan yang diperlukan, activities that are required, the organization organisasi harus mempertimbangkan: shall consider: Penanggung jawab Penggunaan: Kepala Bidang Pendidikan dan Pelatihan Standardisasi a persyaratan peraturan perundang- a statutory and regulatory requirements; undangan; b konsekuensi potensial yang tidak b the potential undesired consequences diinginkan terkait dengan produk dan jasa; associated with its products and services; c sifat, penggunaan dan masa pakai yang c the nature, use and intended lifetime of its dimaksudkan dari produk dan jasa; products and services; d persyaratan pelanggan; d customer requirements; e umpan balik pelanggan.
CATATAN Kegiatan pasca penyerahan dapat NOTE Post-delivery activities can include termasuk tindakan dari ketentuan garansi, actions under warranty provisions, contractual kewajiban kontrak seperti jasa pemeliharaan, jasa obligations such as maintenance services, and tambahan seperti daur ulang atau pembuangan supplementary services such as recycling or final akhir.
Organisasi harus menyimpan informasi The organization shall retain documented terdokumentasi yang menjelaskan hasil information describing the results of the tinjauan perubahan, otoritas orang yang review of changes, the person s authorizing mengubah dan tindakan lain yang the change, and any necessary actions diperlukan, yang timbul dari tinjauan. Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi yang relevan dan, jika berlaku, oleh relevant authority and, as applicable, by the pelanggan.
Organisasi harus menyimpan informasi The organization shall retain documented terdokumentasi atas pelepasan produk dan information on the release of products and jasa. Informasi terdokumentasi harus services. The documented information shall mencakup: include: a bukti kesesuaian dengan kriteria a evidence of conformity with the Penanggung jawab Penggunaan: Kepala Bidang Pendidikan dan Pelatihan Standardisasi keberterimaan; acceptance criteria; b ketertelusuran pada otoritas orang yang b traceability to the person s authorizing melepas.
Organisasi harus mengambil tindakan yang The organization shall take appropriate sesuai berdasarkan sifat ketidaksesuaian action based on the nature of the dan pengaruh terhadap kesesuaian produk nonconformity and its effect on the dan jasa. Harus berlaku juga untuk conformity of products and services.
This ketidaksesuaian produk dan jasa yang shall also apply to nonconforming products terdeteksi setelah penyerahan produk, and services detected after delivery of selama atau sesudah penyediaan jasa. Organisasi harus sepakat terhadap The organization shall deal with ketidaksesuaian keluaran dengan satu atau nonconforming outputs in one or more of the lebih cara berikut: following ways: a koreksi; a correction; b pemisahan, penahanan, pengembalian b segregation, containment, return or atau penangguhan penyediaan produk suspension of provision of products and dan jasa; services; c memberi tahu pelanggan; c informing the customer; d memperoleh otorisasi untuk diterima d obtaining authorization for acceptance karena konsesi.
Kesesuaian terhadap persyaratan harus Conformity to the requirements shall be diverifikasi ketika ketidaksesuaian keluaran verified when nonconforming outputs are dikoreksi. Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi a menjelaskan ketidaksesuaian; a describes the nonconformity; b menjelaskan tindakan yang diambil; b describes the actions taken; c menjelaskan konsesi yang didapat; c describes any concessions obtained; d mengidentifikasi otoritas yang d identifies the authority deciding the action memutuskan tindakan terhadap in respect of the nonconformity.
Organisasi harus mengevaluasi kinerja dan The organization shall evaluate the keefektifan sistem manajemen mutu. Organisasi harus menyimpan informasi The organization shall retain appropriate terdokumentasi yang sesuai sebagai bukti documented information as evidence of the hasil tersebut. Organisasi needs and expectations have been fulfilled. Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi persepsi pelanggan dapat meliputi survei perceptions can include customer surveys, pelanggan, umpan balik pelanggan pada customer feedback on delivered products and penyerahan produk dan jasa, bertemu dengan services, meetings with customers, market-share pelanggan, analisis pangsa pasar, pujian, klaim analysis, compliments, warranty claims and garansi dan laporan agen.
Hasil analisis harus digunakan untuk The results of analysis shall be used to evaluasi: evaluate: a kesesuaian terhadap persyaratan; a conformity of products and services; b tingkat kepuasan pelanggan; b the degree of customer satisfaction; c kinerja dan keefektifan sistem manajemen c the performance and effectiveness of the mutu; quality management system; d jika perencanaan telah diterapkan dengan d if planning has been implemented efektif; effectively; e keefektifan tindakan yang diambil e the effectiveness of actions taken to ditujukan pada risiko dan peluang; address risks and opportunities; f kinerja penyedia eksternal; f the performance of external providers; g keperluan untuk peningkatan pada sistem g the need for improvements to the quality manajemen mutu.
Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi Keluaran tinjauan manajemen harus meliputi The outputs of the management review shall keputusan dan tindakan terkait dengan: include decisions and actions related to: a peluang peningkatan; a opportunities for improvement; b keperluan perubahan apapun terhadap b any need for changes to the quality sistem manajemen mutu; management system; c kebutuhan sumber daya.
Penanggung jawab Penggunaan: Kepala Bidang Pendidikan dan Pelatihan Standardisasi Organisasi harus menyimpan informasi The organization shall retain documented terdokumentasi sebagai bukti hasil tinjauan information as evidence of the results of manajemen. Hal ini harus mencakup: This shall include: a meningkatkan produk dan jasa untuk a improving products and services to meet memenuhi persyaratan seperti juga untuk requirements as well as to address future kebutuhan dan harapan masa depan; needs and expectations; b memperbaiki, mencegah atau mengurangi b correcting, preventing or reducing pengaruh yang tidak diinginkan; undesired effects; c meningkatkan kinerja dan keefektifan c improving the performance and sistem manajemen mutu.
CATATAN Contoh peningkatan dapat NOTE Examples of improvement can include mencakup koreksi, tindakan korektif, peningkatan correction, corrective action, continual berkelanjutan, perubahan terobosan, inovasi dan improvement, breakthrough change, innovation re-organisasi. Tindakan korektif harus sesuai dengan Corrective actions shall be appropriate to the pengaruh dari ketidaksesuaian yang ditemui. Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi Organisasi harus meningkatkan kesesuaian, The organization shall continually improve kecukupan dan keefektifan sistem the suitability, adequacy, and effectiveness manajemen mutu secara berkelanjutan.
Organisasi harus mempertimbangkan hasil The organization shall consider the results of dari analisis dan evaluasi, serta keluaran analysis and evaluation, and the outputs tinjauan manajamen, untuk menentukan jika from management review, to determine if ada keperluan atau peluang yang harus there are needs or opportunities that shall be ditangani sebagai bagian dari peningkatan addressed as part of continual improvement.
Copy Standar ini dibuat oleh BSN untuk Penyusunan materi pendidikan dan pelatihan Standardisasi informatif informative Klarifikasi struktur, terminologi dan Clarification of new structure, konsep baru terminology and concepts A. Tidak ada persyaratan dari Standar ini There is no requirement in this Standard for terhadap struktur dan terminologi untuk its structure and terminology to be applied to diterapkan pada informasi terdokumentasi the documented information of an sistem manajemen mutu organisasi.
Struktur dan isi dari objectives and processes. The structure and informasi terdokumentasi yang terkait content of documented information related to dengan sistem manajemen mutu seringkali a quality management system can often be lebih relevan pada penggunanya jika more relevant to its users if it relates to both keduanya berhubungan dengan the processes operated by the organization pengoperasian proses oleh organisasi dan and information maintained for other informasi dipelihara untuk tujuan lain.
Tidak ada persyaratan untuk istilah yang There is no requirement for the terms used digunakan oleh organisasi untuk digantikan by an organization to be replaced by the oleh istilah yang digunakan dalam Standar terms used in this Standard to specify quality ini pada persyaratan sistem manajemen management system requirements. Organisasi dapat Organizations can choose to use terms memilih untuk menggunakan istilah yang which suit their operations e.
Table A. Implementing a project like ISO is easier with the support of management. Use our project proposal template to help achieve the approval and commitment necessary from top management to progress.
Template MS Word. Implementing a project like ISO will be much easier with the support of management. Use our presentation template to help you gain the approval and commitment you need from top management. Checklists 8 Checklist MS Word. This checklist is intended for internal auditors in manufacturing companies that need to perform an ISO internal audit. It outlines the specific questions to be asked for the manufacturing process in order to check if the process is compliant with the requirements of the ISO standard.
Checklist PDF. This diagram presents the four basic steps in the ISO risk management process, starting with defining how to assess the risks, and ending with creating the controls to decrease the risk. Checklist MS Word. This checklist will enable you to easily keep track of all the steps of your ISO implementation project.
There are 12 major steps and 44 tasks, starting with obtaining management support all the way through to your certification audit. Completing your ISO transition project before the deadline, with as little stress as possible, can be daunting. This checklist aims to simplify the procedure, by identifying all the required steps to follow.
It also provides guidance on how to implement the changes in a straightforward manner, aimed at easing the workload for all those involved in Quality Management Systems. This easy-to-follow diagram offers step-by-step guidance for your ISO implementation, with particular focus on the changes required by the revision. View the whole project at a glance, from the start right through to the certification process. ISO specifies requirements for a quality management system when an organization: a needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b aims to enhance customer satisfaction through.
ISO 4. Clause 4. ISO has left that open for organizations to decide based on the context of the organization. This gives more flexibility to the organization to decide.
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