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Transisi dan upgrade ke ISO 9001:2008

noreply@blogger.com (Unknown) — Mon, 09 Mar 2009 18:13:00 +0000

Certification of conformity to ISO 9001:2008 will only be issued after the official publication of ISO 9001:2008 and after an audit against ISO 9001:2008.
A document review to ISO 9001:2008 is only required if there have been significant changes to the management system, the client, or the context in which the management system is operating (e.g. changes to legislation). This requirement is the same as for any other surveillance or recertification audit. Since there are no “new” requirements in ISO 9001, nonconformities identified during this audit will follow the usual process and have the standard deadlines. Prior to certification to ISO 9001:2008, all major Nonconformity
Reports must be closed, and all correction and corrective action plans must have been reviewed and accepted for all minor Nonconformity Reports.

Until 12 months after publication of ISO 9001:2008
• All audits may be conducted to either ISO 9001:2000 or ISO 9001:2008.

Beginning 12 months after publication
• All certification and recertification audits must be conducted to ISO 9001:2008.
• Surveillance audits may be conducted to either ISO 9001:2000 or ISO 9001:2008.

Beginning 24 months after publication
All ISO 9001:2000 certificates become invalid and are withdrawn, and clients who do not have an ISO 9001:2008 certificate are no longer certified.

Persyaratan ISO 9001:2008

noreply@blogger.com (Unknown) — Mon, 09 Mar 2009 18:05:00 +0000

ISO 9001:2008 menetapkan persyaratan untuk sistem manajemen mutu di mana organisasi perlu menunjukkan kemampuannya untuk secara konsisten menyediakan produk yang memenuhi persyaratan pelanggan dan persyaratan hukum dan peraturan yang berlaku, dan bertujuan untuk meningkatkan kepuasan pelanggan melalui penerapan sistem yang efektif, termasuk proses untuk perbaikan berkesinambungan dari sistem dan jaminan kesesuaian dengan pelanggan dan persyaratan hukum dan peraturan yang berlaku.

Semua persyaratan ISO 9001:2008 generik dan dimaksudkan agar dapat diterapkan pada semua jenis organisasi, tanpa menghiraukan jenis, ukuran dan produk yang disediakan. Apabila persyaratan mana pun dari ISO 9001:2008 tidak dapat diterapkan karena sifat organisasi dan produknya, maka ini dapat dipertimbangkan untuk dikecualikan. Dimana ada pengecualian, tuntutan kesesuaian ISO 9001:2008 tidak dapat diterima kecuali jika pengecualian tersebut terbatas pada persyaratan dalam pasal 7, dan pengecualian itu tidak mempengaruhi kemampuan organisasi, atau tanggung jawab, untuk menyediakan produk yang memenuhi persyaratan pelanggan dan persyaratan hukum dan peraturan berlaku.

ISO 9001:2008 Vs ISO 9001:2000

noreply@blogger.com (Unknown) — Mon, 09 Mar 2009 17:44:00 +0000

What are the new requirements of the new standard?

Statutory requirements are given scale as any other legal or customer's requirements.
The statutory requirements are including the suppliers as well.
A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality system.
You may include two quality processes in one document and split one process to two documents.
The management representative must be a member of the management.
A requirement to ensure that trainings are suitable for the product in advance and not to check if the training was effective after it was taken.
Information system in now officially considered as a substructure.
Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
Measuring is considered as one of the activities of product realization.
The product must be identifying not only on the shelves but also throughout the realization process.
The management is now responsible for preventive and corrective actions regarding nonconformities that were discovered during audit.
The organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.. (read more..)

Tentang ISO 9001

noreply@blogger.com (Unknown) — Fri, 10 Oct 2008 03:53:00 +0000

Adopsi ISO 9001 merupakan suatu keputusan strategis suatu organisasi. Desain dan implementasi ISO 9001 suatu organisasi dipengaruhi oleh keperluan yang bervariasi, sasaran tertentu, produk yang disediakan, proses yang dipakai dan ukuran serta struktur organisasi.
Kelompok standar ISO 9000 telah dikembangkan untuk membantu organisasi, dari semua jenis dan ukuran, untuk menerapkan dan mengoperasikan sistem manajemen mutu yang efektif.

- ISO 9000 menguraikan dasar-dasar sistem manajemen mutu dan merincikan istilah bagi sistem manajemen mutu.
- ISO 9001 merinci persyaratan dalam sistem manajemen mutu, bila organisasi perlu menunjukkan kemampuannya dalam menyediakan produk yang memenuhi persyaratan pelanggan dan peraturan yang berlaku serta meningkatkan kepuasan pelanggan.
- ISO 9004 menyediakan panduan yang mempertimbangkan balk keefektifan maupun efisiensi sistem manajemen mutu. Sasaran Standar ini adalah perbaikan kinerja organisasi dan kepuasan pelanggan dan pihak berkepentingan Iainnya.
- ISO 19011 memberi panduan tentang pengauditan sistem manajemen mutu dan Iingkungan.

Keempat standar tersebut membentuk satu keterpaduan standar sistem manajemen mutu yang memfasilitasi saling pengertian dalam perdagangan nasional dan internasional.