ISO 9001:2008

ISO 9001:2008 GENERAL REQUIREMENTS

klik di sini untuk kejelasan sumber : http://yayasanislamicvillage.wordpress.com/http://yayasanislamicvillage.wordpress.com/

Blogged by Ismail Mohammad Latiff 12 March 2009 on his blog, original article as linked below.
http://iso9001documents.blogspot.com/search/label/ISO%209001:2008%20General%20Requirements


The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standards. The organization

• shall determine the processes needed for the quality management system and their application throughout the organizations,
• determine the sequence and interaction of these processes,
• determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
• ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
• monitor, measure (where applicable) and analyze these processes, and
• implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
NOTE 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.
NOTE 2: An outsourced process is identified as one being needed for the organization’s quality management system, but chosen to be performed by a party external to the organization.
NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
b) the degree to which the control for the process is shared;
c) the capability of achieving the necessary control through the application of clause 7.4.
Clause 4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
documented statements of a quality policy and quality objectives,

• a quality manual,
• documented procedures and records required by this International Standard,
• documents including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes

NOTE 1: Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel.
NOTE 3: The documentation can be in any form or type of medium.
4.2.2 Quality Manual
The organization shall establish and maintain a quality manual that includes the scope of the quality management system, including details of and justification for any exclusions (see 1.2), the documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management.
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed

• to approve documents for adequacy prior to issue,
• to review and update as necessary and re-approve documents,
• to ensure that the changes and the current revision status of documents are identified,
• to ensure that relevant versions of applicable documents are available at points of use,
• to ensure that documents of external origin are identified and their distribution controlled, and
• to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. Records shall remain legible, readily identifiable, and retrievable.

Tinggalkan sebuah Komentar

Ditulis dalam English Articles, Info, ISO 9000, ISO 9001, ISO 9001:2008, Uncategorized | Tag:Artikel, English, ISO 9000, ISO 9001:2008

Oleh: Ibnu Haris | Juli 9, 2009

IMPLEMENT ISO 9001 IN 6 STEPS

Blogged by Ismail Mohammad Latiff 16 March 2009 on his blog, original article as linked below.
http://iso9001documents.blogspot.com/search/label/ISO%209001:2008%20Implementation
If your organization is planning to implement the ISO 9001 QMS model, then you could consider this plan. Execute this plan well and you will be ready for your ISO 9001 QMS certification audit. The road map to your ISO 9001 QMS planning and implementation consists of these six steps:

1. Understand
2. Plan
3. Document
4. Implement
5. Audit
6. Review

• Understand
  First and foremost, you need to understand what ISO 9001 expects of your quality management system. You are going to need these documents (you can buy them online at hxxp://www.iso.org):
  ISO 9001:2008 Quality management system – Requirements
  ISO 9000:2005 Quality management systems – Fundamentals and vocabulary
  ISO 19011:2002 Guidelines for auditing quality/environmental management systems
  ISO 9004:2000 ISO 9004:2000, Quality management systems – Guidelines for Performance Improvement
• Plan
  Once you know what ISO 9001 expects out of your quality management system, you can start planning. You may also want to conduct a Gap Analysis of your current system. The information that you gather form this analysis will benefit your planning process tremendously in terms of providing essential inputs. It also gives you a basis for improvement purposes.
• Document
  Once you have planned out your quality management system, you can start the documentation process.
• Implement
  When all your plans have been documented, you can start implementing the quality management system. But before that you may want to launch and promote the QMS amongst the members of your organization. Implement the QMS for at least 3 to 6 months to generate sufficient records for performance measurement, analysis and improvement purposes. You will need to implement every clause within your Quality Manual. Pay close attention to the training needs of your staff and get them trained.
  The key to success is good communication and the key to good communication depends on your QMS organization structure and its communication points.
• Audit
  After you have generated sufficient quality records and after you feel comfortable enough with the operations of the QMS, you need to conduct your first internal audit.
  The Internal Auditors need to be competent. This is important because a quality audit will bring great benefits to your organization.
• Review
  When the Final Audit Report is ready, you can start planning to conduct your first Management Review of the whole QMS. This is a top-level review to assess the performance and needs of the QMS.

Tinggalkan sebuah Komentar

Ditulis dalam English Articles, Info, ISO 9000, ISO 9001, ISO 9001:2008, Realitas | Tag:Artikel, English, ISO 9000, ISO 9001:2008

Oleh: Ibnu Haris | Juli 9, 2009

STILL WONDERING WHAT ISO 9001 CAN DO FOR YOUR ORGANIZATION?

Blogged by Ismail Mohammad Latiff 30 April 2009 on his blog, original article as linked below.
http://iso9001documents.blogspot.com/2009/04/still-wondering-what-iso-9001-can-do.html
The ISO 9001 serves two fundamental purposes:

• It demonstrates your organization’s ability to meet all customer and legal requirements related to your products, which includes all goods and services; and
• It aims to enhance your customers’ satisfaction towards your product, where this is achieved by determining and meeting all customer and legal requirements related to the products.

Most countries have used these inherent characteristics of the ISO 9001 standard to regulate their respective economies to their benefits. By requiring a certification to the ISO 9001 standard, regulators from the governments are able to optimize their markets by ensuring that

• only quality products are allowed to enter their local economies so that there will be less consumer-related issues, and
• all local statutory and regulatory requirements related to the products are complied with.

Not only international economies are benefiting from the ISO 9001 standard, local organizations are also able to control the quality of all products that enter into their organizations through the purchasing process where suppliers of goods and services can also be made to comply with related legal requirements.
All of this control reduces the cost of managing and doing business, and therefore increasing the bottomline. ISO 9001 may be used to optimize your operations if understood and used correctly.

Tinggalkan sebuah Komentar

Ditulis dalam English Articles, Info, ISO 9000, ISO 9001, ISO 9001:2008, Realitas | Tag:Artikel, English, ISO 9000, ISO 9001:2008

Oleh: Ibnu Haris | Juli 9, 2009

WHAT IS ISO 9001?

Blogged by Ismail Mohammad Latiff 27 December 2008 on his blog, original article as linked below.
http://iso9001documents.blogspot.com/2008/12/what-is-iso-9001.html
ISO 9001 is a management system model designed by the International Organization for Standardization (ISO – a Greek word which means “equal”) to facilitate an international standard for the management of product quality. Within the ISO 9001 context, a product can be physical and/or intangible, such as services. It is not a product standard. It is a management system model applicable to any kind of organization whether public, private, NGO, etc. It is now being implemented in 175 different countries from around the world. All major economies use this standard as a prerequisite for doing international and national businesses. ISO 9001:2008 is the current version now, superceding the ISO 9001:2000 version. The revisions made were minimal, leaving the structure of the model intact. If you are planning to certify your quality management system to the ISO 9001:2008 standard, here is what you need to do:

• Understand the requirements
• Plan your quality management system
• Document your quality management system
• Implement your quality management system
• Audit your quality management system
• Review your quality management system

When you have done all that, appoint a Certification Body or Registrar to get your QMS certified. The benefits of having an ISO 9001-certified QMS can be seen within your organization and externally. Internally, your processes become aligned to one sole objective: Meeting customer requirements with the intention of enhancing their satisfaction. Externally, it gives your organization credibility and it opens up opportunities.

1 Komentar

Ditulis dalam English Articles, Info, ISO 9000, ISO 9001, ISO 9001:2008 | Tag:Artikel, English, ISO 9000, ISO 9001:2008

Oleh: Ibnu Haris | Juli 9, 2009

ISO 9001 ( SISTEM MANAJEMEN MUTU)

Cuplikan daripada
http://tentangiso.wordpress.com/2009/03/30/iso-9001-sistem-manajemen-mutu/
ISO 9001:2008 adalah suatu standar internasional untuk sistem manajemen  Mutu / kualitas.  ISO 9001:2008 menetapkan persyaratan – persyaratan dan  rekomendasi untuk desain dan penilaian dari suatu sistem manajemen mutu. ISO 9001:2008 bukan merupakan standar produk, karena tidak  menyatakan persyaratan – persyaratan yang harus dipenuhi oleh sebuah  produk (barang atau jasa).  ISO 9001:2008 hanya merupakan standar sistem  manajemen kualitas. Namun, bagaimanapun juga diharapkan bahwa produk  yang dihasilkan dari suatu sistem manajemen kualitas internasional,  akan berkualitas baik (standar).
Sehingga dapat disimpulkan bahwa Quality Management Systems (ISO 9001:2008) adalah  Merupakan  prosedur terdokumentasi dan praktek - praktek standar untuk  manajemen sistem, yang bertujuan menjamin kesesuaian dari suatu proses  dan produk (barang atau jasa) terhadap kebutuhan atau persyaratan  tertentu, dimana kebutuhan atau persyaratan tertentu tersebut  ditentukan atau dispesifikasikan oleh pelanggan dan organisasi.
Manfaat Penerapan ISO 9001:2008 adalah :

• Meningkatkan Kepercayaan Pelanggan
• Jaminan Kualitas Produk dan Proses
• Meningkatkan Produktivitas perusahaan & “market gain”
• Meningkatkan motivasi, moral & kinerja karyawan
• Sebagai alat analisa kompetitor perusahaan
• Meningkatkan hubungan saling menguntungkan dengan pemasok
• Meningkatkan cost efficiency & keamanan produk
• Meningkatkan komunikasi internal
• Meningkatkan image positif perusahaan
• Sistem terdokumentasi
• Media untuk Pelatihan dan Pendidikan

ISO 9001 : 2008 berisi standard / elemen yang memungkinkan organisasi / industry dalam melakukan perbaikan yang berkesinambungan ( Continual Improvement ) pada :
1.        Proses yang terkait dengan pelangan
2.        Sistem Kepemimpinan / Leadership
3.        Manajemen sumber daya
4.        Perbaikan dan peningkatan proses
5.        Sistem manajemen
6.        Sistem perbaikan yang berkesinambungan
7.        Pengambilan keputusan yang Factual
8.        Hubungan saling menguntungkan dengan pemasok